KU Leuven
Biomedical Sciences Group
Faculty of Medicine
Department of Public Health and Primary Care
Improving Chronic Care
through
Patient Empowerment
CLINICAL AND HEALTH ECONOMIC OUTCOMES
OF NURSE-LED TELECOACHING IN TYPE 2 DIABETES
IRINA ODNOLETKOVA
Promoter:
Co-promoter:
Co-promoter:
Chair:
Secretary:
Jury members:
Prof. dr. Dirk Ramaekers
Prof. dr. Bert Aertgeerts
Prof. dr. Lieven Annemans
Prof. dr. Geert Verbeke
Prof. dr. Steven Simoens
Prof. dr. Jan De Maeseneer
Prof. dr. Pieter Gillard
Prof. dr. Maarten Postma
Prof. dr. Steven Simoens
Dissertation presented in fulfilment of
the requirements for the degree of
Doctor in Biomedical Sciences
May 2016
1
“Nothing in life is to be feared,
it is only to be understood.
Now is the time to understand more,
“The saddest aspect of life right now
so that we may fear less.”
is that science gathers knowledge faster
Marie Curie
than society gathers wisdom.”
Isaac Asimov
2
Table of Contents
Introduction ............................................................................................................................................................4
1.
Diabetes: basic epidemiology and manifestation of “treat-to-target” approach ..........................................4
2.
Therapeutic patient education in type 2 diabetes .........................................................................................7
3.
4.
2.1.
Role of therapeutic patient education in diabetes care .........................................................................7
2.2.
Factors influencing self-care behaviour and contemporary counselling techniques.............................7
2.3.
Emerging standards and organizational aspects of diabetes education ................................................9
2.4.
Patient education as part of chronic care delivery...............................................................................10
Rationale for this thesis ................................................................................................................................12
3.1.
Current organization of diabetes education in Belgium and need for improvement ..........................12
3.2.
Evidence gap .........................................................................................................................................13
3.3.
“The COACH Program” .........................................................................................................................13
Objectives of the Doctoral Thesis .................................................................................................................15
Chapter 1. Cost-effectiveness of therapeutic education to prevent the development and progression of type 2
diabetes. Systematic Review. ...............................................................................................................................16
Chapter 2. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale and design of a
randomized controlled trial. .................................................................................................................................33
Chapter 3. Optimising diabetes control in people with type 2 diabetes through nurse-led telecoaching. ........46
Chapter 4. Delivering diabetes education through nurse-led telecoaching: Cost-effectiveness analysis. ..........61
Chapter 5. Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study
embedded in a randomized clinical trial. .............................................................................................................81
Discussion .............................................................................................................................................................94
List of References ...............................................................................................................................................102
Appendix A. Example of the COACH Program patient progress report. ............................................................108
Appendix B. Search strategies within the Systematic Review............................................................................117
Appendix C. A tool for quality assessment of economic evaluations within the Systematic Review ................122
Summary.............................................................................................................................................................128
Samenvatting ......................................................................................................................................................130
3
Introduction
1. Diabetes: basic epidemiology and manifestation of “treat-to-target” approach
Diabetes mellitus is a group of diverse metabolic disorders characterized by hyperglycemia and
distinctive macro-and microvascular complications (1). About 422 million people worldwide have
diabetes and its prevalence is expected to increase by more than 50% in the coming twenty years (2).
In people with diabetes, the risk of developing cardiovascular diseases (CVD), including coronary artery
disease (CAD), stroke, and peripheral artery disease (PAD), is increased by two to fourfold, making CVD
the main cause of death in diabetes (3-5). Diabetes is also the leading cause of retinopathy with
potential loss of vision, nephropathy leading to renal failure, and peripheral neuropathy with a high
risk of foot ulcers and amputations (1, 5). About 4.9 million deaths per year worldwide are estimated
to be caused by diabetes, and about 50 % deaths regard diabetic patients under 60 years of age (2).
The different types of diabetes include type 1, type 2, gestational diabetes, and other less common
types of diabetes associated with certain specific conditions (6). The majority of people with diabetes
(90-95%) have type 2 diabetes occurring due to a progressive insulin secretory defect combined with
insulin resistance (6).
Persons at high risk of type 2 diabetes usually progress slowly from the onset to the actual diagnosis
during a period of eight to twelve years without experiencing any specific symptoms (7). Genetic
predisposition, age, hypertension and dyslipidemia, and lack of physical activity, are known risk factors
of type 2 diabetes. Overweight and obesity, i.e. body mass index ≥25 kg/m2, in itself may cause insulin
resistance (6, 8). High risk of type 2 diabetes has been referred to as prediabetes, defined as a
condition characterized by glycemia and/or glycated haemoglobin greater than normal (9). Reduction
in hyperglycemia, hypertension and hyperlipidemia in people with prediabetes and type 2 diabetes is
believed to reduce the risk of future micro- and macrovascular complications (9-11).
The measurement of glycated haemoglobin (HbA1c) has revolutionized diabetes management and
enhanced our understanding of effects of glycaemic control on diabetes-related outcomes (12, 13).
The HbA1c test, which measures blood glucose control over the previous three months (linked to the
lifespan of red blood cells), defined an extremely important aspect of diabetes management—tight
control of blood glucose levels (1). A causality between poor glycaemic control and the rate of
occurrence of diabetes-related complications was discovered after the completion of several large
randomized controlled trials. First, the Diabetes Control and Complication Trial (DCCT) published in
1993 showed that tight glycaemic control effectively delays the onset and slows the progression of
diabetic retinopathy, nephropathy, and neuropathy in patients with type 1 diabetes (14).
In 1998, the results of the UK Prospective Diabetes Study (UKPDS) were published, demonstrating an
association between the levels of HbA1c and the development of complications in people with type 2
diabetes. Within the UKPDS, over 5000 patients with newly diagnosed type 2 diabetes were followed
for a median of 11 years. In the intensive treatment group with a mean HbA1c of 7.0%, the risk
4
reduction of progression to retinopathy was 21% and of appearance of microalbuminuria 30%,
compared to controls, where the mean HbA1c was 7.9%. Even though, the post-trial between-group
difference in HbA1c diminished, the long-term reduction in the complication rates implied a
phenomenon referred to as “metabolic memory” (15). A tight glycaemic control did not significantly
reduce individual cardiovascular events. However, tight blood pressure control (mean blood pressure
of 144/82 mmHg in the intervention versus 154/87 mmHg in the control group) resulted in a reduction
of microvascular and macrovascular complications by 37% and 34% respectively (16).
Later, the ADVANCE trial confirmed a significant reduction of microvascular, not macrovascular
complications, through tight glycaemic control in people with type 2 diabetes at a median of 5 years
follow-up (17). Reduced mortality rates through tight blood-pressure control were demonstrated at
more than 5 years additional post-trial follow up (18).
The Veteran Affairs Diabetes Trial (VADT) showed no significant effect on the rates of major
cardiovascular events, death, or microvascular complications with the exception of progression of
albuminuria, in the intensive-therapy group compared to usual care (respective median HbA1c of 6.9%
and 8.4%) after a median follow-up of 5.6 years (19). However, after nearly 10 years of follow-up,
participants of the intensive glucose control group had 8.6 fewer major cardiovascular events per 1000
person-years than those assigned to standard therapy (20).
A higher mortality rate was demonstrated in the ACCORD trial in patients with type 2 diabetes assigned
to intensive glycaemic control with the goal to treat HbA1c to a level below 6%, compared to the group
where more moderate levels of HbA1c (7 to 7.9%) were targeted (21).
The above trials established the evidence that improvement in the control of metabolic abnormalities
decreases the risk of the development of complications and were setting the standards for an
individualized “treat-to-target” approach in diabetes management. Currently, diabetes is recognized
as a chronic illness requiring continuous medical care with multifactorial risk reduction strategies (6).
The glucometer, first built in 1968, brought glucose control from the emergency room and doctors’
offices to the patient’s living room, making the disease more comprehensible and manageable for
diabetic patients (12). Over the years, self-monitoring of blood glucose became an essential part of
diabetes care, while the glucometers steadily improved, becoming smaller in size, requiring less blood
and offering additional options such as memory and computer connectivity (1). Newer techniques of
glucose monitoring such as continuous glucose monitoring, flash glucose monitoring, offer new level
of comfort and quality in diabetes self-care, even making the painful finger lancing for obtaining a
blood drop unnecessary (22).
In absence of means to cure diabetes (23), an adequate diabetes management is crucial to reduce the
risk of diabetes complications and the associated burden. Guidelines for good clinical practice in
diabetes care have been published by national and international associations (6, 24) since about 20
years, and regularly updated according to the emerging clinical evidence.
However, despite improvements in glycaemia, lipids and blood pressure control, still only about 15%
of people with diabetes in Western countries reach the targets recommended by those guidelines for
5
all three risk factors (25). Persistent variation in quality of diabetes care across providers and practice
settings has been observed, indicating a need for further system-level quality improvement in diabetes
care (6).
6
2. Therapeutic patient education in type 2 diabetes
2.1.
Role of therapeutic patient education in diabetes care
It has been estimated that about ninety-five percent of daily care in diabetes is related to patient selfcare (26). Daily management of type 2 diabetes may require from patients to closely monitor
symptoms and respond with appropriate actions, e.g. schedule visits for lab tests and clinician
consultations, adhere to medication regimens, some of which are inconvenient or produce side
effects, make major lifestyle changes. Lifestyle changes may include smoking cessation, reduction of
alcohol consumption, diet modification and exercise increase (27).
Research on the needs and perceptions of people with type 2 diabetes reveals lack of insights in
diabetes self-care and insufficient awareness of diabetes complication risks (28-31). One way to
improve health outcomes for individuals with chronic illness is to provide them with support to
manage their illnesses effectively (27). Though most physicians are highly competent in diagnosis and
treatment, too few seem to educate their patients to manage their condition, due to little time, lack
of awareness of the need to do so, and/ or because the initial training of most medical-care providers
is based principally on diagnosis and selection of a therapeutic regimen (32). A meta-analysis of quality
improvement (QI) strategies in diabetes care found that interventions targeting the system of chronic
disease management along with the patient are likely to be more beneficial than QI strategies
targeting solely health-care professionals (33). However, healthcare systems are not traditionally
designed to provide patients with tailored therapeutic education and self-management support.
Therapeutic patient education (TPE) is defined as helping patients acquire or maintain the
competencies they need to manage as well as possible their lives with a chronic disease (32). TPE is a
patient-centred approach, focussed on patients' needs, resources, values and strategies. It allows
patients to improve their knowledge and skills not only concerning their illness but also their treatment
(34). Its principal purpose is to produce a therapeutic effect additional to that of other interventions,
such as pharmacological therapy (32).
Over the past thirty years, TPE programmes have been introduced for patients suffering from chronic
diseases such as diabetes, cardiovascular diseases, asthma and haemophilia. The contemporary
methods of TPE include educational, psychological, social and biomedical aspects of diseases and their
treatment (32). Unlike traditional patient education programmes, which are aimed at increasing
disease-specific knowledge, self-management programmes are aimed at providing patients with skills
to daily manage their illnesses (35). The pivotal objective of patient self-management support
programmes is to change people’s behaviour (27).
2.2. Factors influencing self-care behaviour and contemporary counselling techniques
Suboptimal health literacy in people with type 2 diabetes is associated with reduced ability to recall
the therapeutic advice and with worse glycaemic control (36, 37). However, health literacy alone is
unlikely to be sufficient to improve diabetes control (38, 39). As the responsibility of the diabetes
7
management rests heavily on the person with diabetes, its success depends on the individuals’ ability
to adequately solve various problems on a day-to-day basis. Individual motivation and empowerment,
health beliefs and self-efficacy have been identified as important elements of successful selfmanagement of diabetes (36).
Motivation is believed to be a major factor in effective self-management (40). The level of motivation
has been found to be associated with health beliefs. Although individuals are aware of the fact that
complications related to diabetes are severe, the degree to which they perceive these risks as a
concern to them personally may differ as some are inclined to believe that their own susceptibility is
not particularly likely (40). Self-efficacy refers to an individual's belief in one's competence in
successfully performing a given task (36, 41). Higher self-efficacy is associated with more prudent selfcare behaviours and better diabetes management (42-47). In addition, co-existing conditions, such as
hypoglycaemia, may affect someone’s abilities to effective diabetes self-management (48). Fear of
hypoglycaemia, a condition where plasma glucose level falls below 70 mg/dl, a common side effect of
insulin and sulphonylurea therapies, may occur because of the unpleasant symptoms, associated
health risks and its socially aversive nature (49). In some individuals, fear of hypoglycaemia may lead
to the tendency to maintain hyperglycaemia, but may be reduced with cognitive behaviour therapy
and blood glucose awareness training (50).
Patient perception on the adequacy of the available social support and provider factors may influence
the degree of self-efficacy. People with type 2 diabetes seem to be frequently misunderstood by their
significant others, which may negatively affect one's diabetes self-management (51-53). They often
perceive their patient–provider relationship as unilateral, i.e. one in which physicians make decisions
and patients are expected to comply (51-53).
Educational research of the last decades endorses motivational interviewing, cognitive behaviour
change strategies, problem solving, self-efficacy enhancement and multidisciplinary communication
(54-56). These allow both the preparation and support of patients during progressive 'step by step'
change (40). Motivational interviewing (MI) was introduced in the nineties and based on the
humanistic school of psychotherapies, founded by American psychologist Carl Rogers (1902 – 1987)
(57), and the “Transtheoretical model of intentional human behaviour change” developed by
DiClemente and Prochaska (58). The negotiation of objectives must allow patients to choose their own
strategies, which normally should cost them the least possible, psychologically, and bring them the
maximum benefit (40). A major principle involved in the motivational interview is reinforcing patients'
personal efficacy and increasing their faith in change (40). Time is believed to be the most limiting
factor in using motivational interviewing in medical settings, where patient encounters typically range
from 10 to 15 minutes (40). Involving paramedical staff in behavioural counselling may offer a solution
of the time constraint issue.
8
2.3.
Emerging standards and organizational aspects of diabetes education
Efforts to establish a national position on diabetes education were undertaken by a few countries.
These include publications of the American Association of Diabetes Educators (AADE) as from 2003
(59-61); “Structured Education for People with Diabetes” issued by Diabetes UK in 2005 (62), and The
Australian national consensus position on outcomes and indicators of diabetes education, released in
2007 (63, 64). These position papers emphasize the need for structured education programs and make
an attempt to specify their principles, goals and measurement dimensions.
The most detailed recommendations for organization of diabetes education delivery can be found in
the American “National standards for diabetes self-management education and support” (61). In these
standards, many practical aspects of diabetes education provision are covered: structure of
organizations providing patient education, the program curriculum reflecting current evidence and
practice guidelines, teaching strategies and learning outcomes, selection, training and certifying of
diabetes educators, continuous quality improvement through data collection, identification of the
target groups and inclusion strategies etc.
Despite the emerging standards and some evidence of positive effects of TPE in diabetes care on
clinical, psycho-social and lifestyle outcomes, questions regarding how to deliver education in clinical
practice remain (61). Diabetes education programs belong to the category of “complex interventions”,
i.e. many elements can vary and potentially influence the outcome, e.g. the program curriculum, the
mode and the frequency of the delivery, the qualifications of the providers etc. (65).
Background of diabetes educators
Historically, nurses and dietitians were the main providers of diabetes education (66, 67). In recent
years, the role of the diabetes educator has expanded to other disciplines, such as pharmacists, in
some countries (68). The role of lay health and community workers and peer counsellors is being
explored (69-70).
Based on a recent report of the European Observatory on Health Systems and Policies, a trend towards
strengthening the role of nurses in chronic care delivery has been observed in most European
countries (71). Certification of diabetes educators has become an accepted credential in the diabetes
community (72). In some countries, such as the Netherlands, diabetes nurses are entitled to prescribe
diabetes medications, following a protocol and/ or after consultation with the general practitioner.
Program curriculum
There is growing consensus that the content of diabetes education needs to be evidence-based and
tailored to match each individual’s needs. The programs may be adapted to the stage of the disease
progression and/ or treatment, such as at diagnosis of type 2 diabetes, at new complicating factors,
and when transitions in care occur (59). An individual baseline assessment has been used to draw an
individualized counselling and follow-up plan (61). Program topics may include diabetes disease
process and treatment options, nutritional management, physical activity, correct use of medications,
monitoring blood glucose and other parameters and interpreting the results for self-management
decision making, preventing, detecting, and treating acute and chronic complications, personal
9
strategies to address psychosocial issues and concerns and achieve sustainable behaviour change (59,
61).
Dosage: frequency and duration
The optimal number and frequency of contacts between educator and patient remains uncertain.
There is some evidence that increasing number of contact hours improves the glycaemic control (73,
74). In socially disadvantaged populations, a high contact intensity showed to be effective: >10 contact
times delivered over a long duration (≥ 6 months), implying a need for additional resources (75).
Delivery modes and potential role of Information and Communication Technologies
Delivered in a group setting or individually, diabetes education has been shown to achieve comparable
effects on glycaemic control (73, 76, 77). The main advantage of individual education may be that it
permits to fully personalize intervention and create a mutual trust and strong interaction between
patient and educator (78). Telephone has been used for patient counselling in type 2 diabetes and
other chronic conditions since the nineties (79). Widely adopted in the U.S., Australia and Canada,
telehealth experiences a slow uptake in Europe (80), even though it appears to yield some beneficial
effect in blood glucose control (81).
2.4.
Patient education as part of chronic care delivery
Next to the particular intervention characteristics, the local healthcare organization may have
influence on the outcomes, such as the clinical- and cost-effectiveness (82). A major barrier to optimal
chronic care is believed to be a delivery system that is poorly coordinated and fragmented, lacks
clinical information capabilities, duplicates or underserves interventions and in general does not fit
the needs of chronic patients (6). The need of a shift of diabetes care from episodic medical checks
toward a chronic care model is recognized. This implies a healthcare team that actively collaborates in
the patient care (78, 83, 84).
The Chronic Care Model (CCM) is believed to be an effective conceptual framework for the
organization of diabetes care (84-86). CCM includes 1) delivery system redesign implying moving from
reactive to proactive care provision, where planned patient visits are coordinated through a teambased approach; 2) self-management support; 3) decision support for care providers (based on
evidence-based guidelines); 4) clinical information systems (using electronic registries providing
patient-specific and population-based analytic information to the care team); 5) community resources
and policies to support healthy lifestyles; 6) quality oriented culture of health systems.
CCM emphasizes communication among the team regarding the patient’s educational goals, plan and
outcomes (61, 87). Shared Electronic Health Record (EHR) has potential to enhance patient centred
communication within the healthcare team (88). The constraints of pre-electronic EHR data systems
limit the clinical scope and sophistication of current diabetes quality measures (89).
Alhough CCM has been one of the most cited theoretical models in healthcare services research, the
implementation of all its elements in national healthcare systems remains challenging (90). Overall,
the knowledge base for guiding adoption and implementation of evidence-based practices is still only
10
modest and has been described as being in an “embryonic” state (91). It has been observed that
introduction of new public health services and organizational changes may face resistance, even if
supported by local authorities (91).
11
3. Rationale for this thesis
3.1.
Current organization of diabetes education in Belgium and need for improvement
In Belgium, reimbursed diabetes education was initially introduced in 1988 in a hospital ambulatory
setting for people with advanced diabetes, i.e. in need of three or more insulin injections per day. It
was extended to primary care in 2009, when “diabetes care trajectories” were launched. Diabetes care
trajectories imply that when insulin therapy needs to be initiated, patients are entitled to a
multidisciplinary care that includes education by a certified diabetes educator and an annual
consultation with an endocrinologist, in addition to the regular GP visits. In primary care, diabetes
education is mostly delivered in individual face-to-face sessions at the patient’s home.
The drawbacks of diabetes education in primary care are: (a) Most of the non-insulin dependent
patients are excluded from the reimbursement; (b) Individual face-to-face education is costly; (c) Lack
of documentation on the conceptual model, content and the specific measurable goals hampers
consistent delivery of high-quality diabetes education and its evaluation. Furthermore, the evaluation
of the care trajectories (CT) four years after their introduction (2013), showed a suboptimal patient
inclusion in diabetes education (92). The reluctance of part of the Belgian GPs in patient referral to a
diabetes educator has been previously reported (93).
The CT evaluation reports that from 300 participants of an on-line survey, 28% said to be informed
about the care trajectory by the GP and 35% and 32% via diabetes educator or endocrinologist
respectively, and that only 57% of the CT participants collected their glucose meter (92). Educators
indicate need for more contact time with the patient, a better compensation and a better referral by
GP as the most essential improvement points. The report advises to allow a combination of practice –
and home based patient education, but does not mention the potential role of ICT. Besides, it
recommends to strengthen multidisciplinary work around the patient, e.g. through introduction of a
shared EHR, simplification of the administrative procedures, documenting processes related to the
different tasks of the healthcare professionals within the multidisciplinary team. The clinical
effectiveness of the care trajectories was not evaluated so far.
In 2014, the Belgian authorities developed an “Integrated vision on chronic care in Belgium”, based on
the recommendations of a specially committed report of the Belgian Health Care Knowledge Centre
(94), a consultation with the stakeholders and upon a recommendation of the Council of the European
Union. The agreed principles for the organization of chronic care in Belgium include: the importance
of patient empowerment; the need to change the acute care model to a proactive, planned model;
the need to increase the flexibility of the healthcare system in order to respond to the individual
patient needs; the need for a shared electronic health record, to facilitate the collaboration and care
coordination within the care team; the importance of equity in access to medical and social care.
The translation of this vision into an actionable plan of reforms yet needs to be realized.
12
3.2.
Evidence gap
The evidence base for the clinical and cost-effectiveness of specific features of diabetes education is
still controversial. Multiple systematic reviews demonstrated high variability of results, both showing
improvement of the risk factors control (73, 76,77), or showing no effect (95, 96). Until now, a positive
effect of certain diabetes education programs on glycaemic control was found only in subgroups with
HbA1c ≥ 8% at baseline, but not in all patients (73). The achieved effect was generally lost within one
to three months after the completion of the program (77). Current health economic evidence on the
topic is too limited to formulate unambiguous recommendations on reimbursement policies. Several
reviews of the cost-effectiveness of patient education in people with type 2 diabetes have been
undertaken, without generating any clear conclusions, mostly due to scarcity of publications or the
limited quality of the studies (95-99).
The clinical- and cost-effectiveness of diabetes education was not previously investigated in Belgium.
Multiple contextual characteristics may affect the outcomes, emphasizing the importance of the local
evidence. Inclusion of all patients and up-scaling of education to other pathologies is a financial and
organizational challenge and urges to introduce alternative to face-to-face counselling, less costly
approaches. Use of ICT applications has potential to improve access to health care and reduce
healthcare costs; however, international findings show conflicting results (100-105). Research of the
effectiveness, efficiency and acceptance of the contemporary self-management support approaches
in the local context should support the policy makers in their further work on the chronic care reform
in Belgium.
3.3.
“The COACH Program”
Within this thesis the therapeutic benefit and the cost-effectiveness of patient education in type 2
diabetes in Belgian primary care was assessed for the first time. For this purpose, we chose a nurseled target driven telecoaching program “The COACH Program”, originally from Australia, and adapted
it to the Flemish context. The choice for the COACH Program (TCP) was supported by several
arguments:
 Tele-education programs may improve access to care, however in Belgium, telecare has not
been previously tested for self-management support of chronically ill people.
 When this thesis commenced, TCP was the only identified telecoaching intervention in chronic
care supported by some evidence. It has been shown to effectively reduce the disease-related
risk factors in patients with established coronary heart disease (CHD) after hospitalisation in
Australia (106).
 Motivational interviewing is applied for patient-coach communication. The underlying “COACH
Model” is a continuous quality improvement cycle, which includes bridging the knowledge gap,
assertiveness training, setting an action plan and (re)assessment (107-108), Figure 1.
13
1
Asking questions for
knowledge, attitude, beliefs
5
2
Explanation
and rationale
Reassessment
4
Goal setting
3
Assertiveness
training
Figure 1. The Coaching Cycle: a 5 stage process.




TCP supports the patients in defining incremental measurable self-care goals. The coach
identifies the “treatment gaps” in the management of each diabetes risk factor, i.e. failure to
achieve the guideline recommended goals, and helps the patient to develop strategies to close
the treatment gap, including lifestyle adjustments and adherence to recommended medication
therapy and/or adjustment of pharmacotherapy.
The program is entirely built upon guidelines, is well-documented and replicable. Nurses are
supported by special patient administration software which helps to structure the coaching
session and to generate a patient progress report with appropriate evidence quotes.
General practitioners (GPs) are engaged through an intake contact initiated by the coach. The
patient progress reports including the agreed action points are shared with patients and their
GPs (Appendix A). The patient is encouraged to take responsibility for the implementation of
the personal action plan.
In the past 15 years, TCP has extended its curriculum to ten different chronic conditions:
Coronary heart disease, Stroke, TIA, Peripheral vascular disease, Heart failure, Type 1 diabetes,
Type 2 diabetes, Pre-diabetes, COPD, and People at high risk of vascular disease.
To summarize, the COACH Program was chosen for the Belgian field trial due to its potential to improve
patient access to therapeutic education, the underlying evidence, the contemporary counselling
method and collaborative nature, its focus on “treat-to target” approach, replicability and upscalability to other pathologies. In the past years TCP has been implemented for support of patients
with different chronic conditions by the health insurers in the Netherlands (Achmea) and the U.K.
(Bupa). Belgium, upon the initiative of the Independent Health Insurance Funds, is the first European
country to test the clinical and cost-effectiveness of the COACH Program in Europe, in type 2 diabetes.
14
4. Objectives of the Doctoral Thesis
1) To update current evidence on the cost-effectiveness of therapeutic education in prediabetes
and type 2 diabetes. (Chapter 1)
2) To analyse the effectiveness of nurse-led target driven telecoaching in improving glycaemic
control and other modifiable risk factors associated with diabetes, compared to usual care, in
Belgium. (Chapter 2 and 3)
3) To analyse the long-term cost-effectiveness of nurse-led telecoaching of people with type 2
diabetes within the Belgian healthcare system. (Chapter 4)
4) To explore the patient and provider acceptance of nurse-led telecoaching in type 2 diabetes in
Belgian primary care. (Chapter 5)
15
Chapter 1. Cost-effectiveness of therapeutic education to prevent the
development and progression of type 2 diabetes. Systematic Review.
Odnoletkova I, Goderis G, Pil L, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. (2014) Cost-Effectiveness of
Therapeutic Education to Prevent the Development and Progression of Type 2 Diabetes: Systematic Review. J
Diabetes Metab 2014; 5:438
16
Abstract
Objective - To update current evidence on the cost-effectiveness (CE) of therapeutic education in
prediabetes and type 2 diabetes.
Research design and methods – A systematic review of economic evaluations of therapeutic
education in prediabetes and type 2 diabetes, based on randomized controlled trials (RCTs) and
published in 2002 - 2014. The quality of the clinical evidence was appraised through the Cochrane
Collaboration’s tool for assessing risk of bias. Economic studies were evaluated through the
Consensus Health Economic Criteria List. The incremental cost-effectiveness ratios (ICERs) of patient
education in prediabetes and type 2 diabetes were compared.
Results – Out of 2031 identified publications, eight studies on prediabetes and nine on type 2
diabetes met the inclusion criteria. The level of the underlying clinical evidence was overall high in
studies on prediabetes and varied in studies on type 2 diabetes. The mean ICER (95% CI) from the
perspective of the healthcare system was €18,000 per QALY (range from dominance to €49,700) in
prediabetes and €29,700 (range from €9,100 to €50,300) per QALY in type 2 diabetes. General flaws
in the economic evaluations were short time horizons, limited uncertainty analysis and a lack of
transparency in the modeling methods.
Conclusions – The number of economic evaluations of patient education in prediabetes and type 2
diabetes has been growing in the past years. Our review compares the health economic evidence on
therapeutic education for both conditions. The findings suggest that offering therapeutic education
already in prediabetes stage may be a better value for money than postponing it till after the
diagnosis. More robust methodologies in health economic evaluations are essential in further
evidence generation.
17
Introduction
Diabetes mellitus is a chronic illness that requires continuing medical care and ongoing patient selfmanagement education (1). About 382 million people worldwide have diabetes and its prevalence is
expected to increase by more than 50% in the coming twenty years (2). The associated healthcare
costs exceeded USD 548 billion in 2013 (2). About 90% of the diabetes population suffers from type 2
diabetes. Persons at high risk of type 2 diabetes usually progress slowly from the onset to the actual
diagnosis during a period of eight to twelve years without experiencing any specific symptoms (3).
High risk of type 2 diabetes has been referred to as prediabetes in people with impaired fasting
glucose (IFG) and/ or impaired glucose tolerance (IGT) (1). Reduction in hyperglycemia,
hypertension, and cardiovascular risk factors in people with prediabetes and type 2 diabetes is
believed to reduce the risk of future micro- and macrovascular complications (4). Early detection of
both conditions and patient support in self-management of their risk factors should be of crucial
importance for the public health care policies.
Therapeutic patient education (also referred to as patient – or self-management education in this
article) is an integral part of treatment and is defined as a collaborative process through which
people with or at risk of type 2 diabetes gain the knowledge and skills needed to modify behavior
and better manage their diabetes risk factors (5) (6). Multiple systematic reviews concluded that
patient education is effective in improving glycemic control in people with type 2 diabetes in the
short term (7) (8) (9).
In individuals with prediabetes, a reduction in the rate of conversion to type 2 diabetes after
intensive lifestyle interventions was demonstrated in several well-conducted randomized controlled
trials, with risk reduction of 51% to 58% compared to controls in the short term and sustained risk
reduction of 34% to 43% over a follow-up period of between 7 and 20 years (10). Reversion to
normal glucose regulation, even if transient, is associated with a significantly reduced risk of future
diabetes (11). In the above-mentioned studies, patient education was the fundamental component
of the lifestyle interventions, with the aim of persuading people about an evidence-based diet and
physical activity management.
Current health economic evidence on the topic is too limited to formulate unambiguous
recommendations on reimbursement policies. Several reviews of the cost-effectiveness (CE) of
patient education in people with type 2 diabetes have been undertaken, without generating any
clear conclusions, mostly due to scarcity of publications or the limited quality of the studies (12) (13)
(14) (15). Most economic evaluations of educational and lifestyle interventions to prevent type 2
diabetes in people with IGT were based on the results of the Diabetes Prevention Program (16).
Application of different modeling techniques produced conflicting results: in general, very costeffective (17) (18) (19), but not cost-effective in the study by Eddy et al. (20).
The objective of this review is to update the knowledge on CE of therapeutic educational programs
for people with prediabetes and type 2 diabetes. This study will be the first to compare the existing
evidence on both conditions.
18
Methods
Data sources and Searches
To identify the relevant studies, we searched the Medical Literature Analysis and Retrieval System
Online (MEDLINE), Excerpta Medica (EMBASE), Cumulative Index to Nursing and Allied Health
Literature (CINAHL), the Cochrane library, the Centre for Reviews and Dissemination database (CRD),
Econlit. The search strategy was based on the combination of the following terms and their
proximate notions: 1) type 2 diabetes or prediabetes; 2) patient education (including telecounseling); and 3) costs or economics or quality adjusted life years or modeling. The search
protocols are included in Appendix B.
Study selection
Criteria for inclusion in the review were a combination of the following study characteristics: 1) the
study population are adults with diagnosed type 2 diabetes or prediabetes; 2) the intervention is any
structural program whose purpose is to improve disease knowledge and self-management skills,
performed by any type of caregiver, with the use of any supporting material or devices; 3) the
comparator is usual care; 4) the economic evaluation is based on a randomized controlled trial (RCT);
5) the health effects are measured as quality-adjusted life years gained (QALYs)1 or life years gained
(LYs); 6) the incremental cost-effectiveness ratio (ICER) is reported unless the intervention is
dominant or dominated2; and 7) the study was published between January 2002 and April 2014.
Exclusion criteria were: 1) partial economic evaluation, i.e. no analysis of the incremental costs of
the intervention in relation to the incremental treatment effects; 2) economic modeling studies
based on systematic reviews or meta-analyses, - due to variability in the organization of behavioral
interventions and their effectiveness; 3) educational intervention did not include a human
interaction, e.g. print – or video material; 4) the study participants represent a particular subgroup
of patients with type 2 diabetes or prediabetes potentially limiting the generalizability of the results;
and 5) published before 2002. Earlier publications were not expected to apply the established
methodologies for cost-effectiveness analysis as demonstrated by the previous systematic reviews
(13) (14) (15).
1
QALYs are a measure of health outcome that integrates quality and quantity of life into a common metric and facilitates
comparison across health conditions and interventions. The quality dimension is expressed by health weights which are
measured on a scale ranging from 0 to 1, where 0 corresponds to death and 1 corresponds to perfect health. These health
weights are obtained through population research based on the economic concept of utilities, i.e. preferences for a health
state.
2
ICER is the commonly accepted measure of the cost-effectiveness in health economics. It is generally calculated by
using the following equation: ICER = ∆Costs/∆QALYs. ∆Costs is the difference between the mean cost in the intervention
group and in the control group. ∆QALY depicts the evolution of the means in QALYs-utilities over time within the
intervention and the control group. An intervention is dominant when it costs less and is at least as effective as the
comparator; and dominated when it costs more and is no more effective than the comparator.
19
The study selection was performed by two reviewers independently (IO and GG) in three rounds:
titles, abstracts, full text. To reduce the risk of omission, the studies were included in the following
selection round if they were selected by at least one of the reviewers. In the last round – full text
inclusion – the study supervisors assisted in reaching a consensus on the final selection of the
studies. The inter-rater agreement was calculated by means of kappa statistics after each selection
round.
Data extraction and Quality of Evidence Assessment
After the final selection of the economic evaluations, the original clinical studies were retrieved. To
assess the quality of the health economic evidence, we first evaluated the internal validity of the
RCTs by using the Cochrane Collaboration’s tool for assessing risk of bias and then applied the
GRADE methodology to rank the level of the clinical evidence. High, moderate, low or very low grade
of evidence was assigned to the studies with downgrading each time when one of the following was
suggested: 1) limitations in design and implementation based on each topic of the risk of bias
analysis; 2) indirectness of evidence; 3) unexplained heterogeneity or inconsistency of results; 4)
imprecision of results; and 5) high probability of publication bias (21). IO and GG performed the
assessment independently.
To critically appraise the quality of the economic evaluations, the Consensus Health Economic
Criteria List (CHEC) (22) was used. We have extended the CHEC with a brief guidance to support each
value judgment based on recently published methodologies (23) (24) (25) and one question,
specifically applicable to the decision-analytic models (Appendix C). The following data were
extracted for each study: the target population, the type of intervention, the comparator and the
effectiveness results observed in the original RCT; the analytic horizon and the study perspective; the
health and economic consequences of the alternative treatments considered and methods to
measure and value costs and health outcomes; the discounting methods; and the performed
uncertainty analysis. For the modeling studies, the models’ structural assumptions and validation
methods were extracted. Each question of CHEC was answered with “yes/rather yes”, “no/rather
no”, or “unclear” and justified. IO and LP assessed the studies independently and agreed on the
assessment results.
Data Synthesis and Analysis
We reported the review results by grouping the economic evaluations per target population, based
on the cost-effectiveness of the education program – from most to least cost-effective. For each
study, the target population, the type of intervention, and the effectiveness results are reported;
and the analytic horizon and the study perspective are specified. If not clearly stated in the study,
the perspective was assumed based on the types of costs included in the analysis and reported as
“assumed”. ICERs were rounded up to hundreds. To make ICERs comparable across the studies we
converted all currencies into Euros by using the average standardized exchange rate of 2012 (26). If
the cost valuation year was not explicitly mentioned, we have assumed it to be the year prior to the
20
study publication. For the purpose of the descriptive statistics, interventions which were found costsaving, were included into the ICER analysis with the ICER value equal to zero. We adopted the
classification of CE applied by Li et al. (17) as established by convention: dominant, or cost-saving; or
- depending on costs per QALY - very cost-effective (0< ICER≤ €20,000); cost-effective (€20,000< ICER
≤ €40,000); marginally cost-effective (€40,000< ICER ≤ €80,000); not cost-effective (> €80,000).
The methodological quality of the studies was summarized by using the Review Manager software.
Results
Design and quality of the included studies
The search yielded 2031 publications. Seventeen studies met the inclusion criteria; eight of them
evaluated CE of lifestyle interventions in prediabetes. The study selection process is depicted in
Figure 1. Eleven studies were based on decision analytic models and considered a long-term time
horizon. All models with the exception of that used by Eddy et al. (20) were Markov state transition
models in which participants move from and to defined health states within discrete time periods.
Most studies on prediabetes included the healthcare system and the societal perspective3. The
societal perspective was not considered in any of the studies on type 2 diabetes.
The level of clinical evidence from the original clinical trials was ranked high in 50% of the RCTs and
was overall higher in studies on prediabetes. One study on prediabetes and three studies on type 2
diabetes were within-trial economic evaluations with a time horizon of no more than 3 years and as
such ignored the long-term consequences of the interventions with regard to health outcomes and
the associated treatment costs. Most modeling studies failed to deliver a transparent presentation of
the model structural assumptions and validation methods. None of the studies was exhaustive in the
performance and presentation of the uncertainty analysis. The accuracy in identification,
measurement and valuation of the costs and outcomes varied. Outcomes of the reporting and
quality assessment of the economic evaluations based on CHEC are summarized in Figure 2. A
detailed report on the methodological flaws of the RCTs and the economic evaluations is available
upon author’s request.
Cost-effectiveness of the studied interventions
The mean ICER (95% CI) from the perspective of the healthcare system was €18,000 per QALY gained
(range from dominant to €49,700) in prediabetes and €29,700 (range from €9,100 to €50,300) in
type 2 diabetes. The boxplots of ICERs are presented in Figure 3. Below, we give a brief description of
each study by reporting results from the original RCT, the type of intervention, the analytic
technique applied and the CE results.
3
Healthcare system perspective includes direct healthcare costs and patient co-payments. Societal perspective includes, in
addition, indirect costs to patients (e.g. diet – and transport costs) and society (e.g. productivity losses resulting from poor
health).
21
Figure 1. Selection of cost-effectiveness studies for systematic review of therapeutic education to
prevent the development and progression of type 2 diabetes
Prediabetes
From eight studies on prediabetes, four were based on the Diabetes Prevention Program (DPP) (16)
and three on 10 years follow-up of DPP. DPP is a well conducted RCT which demonstrated 58%
reduction in incidence of type 2 diabetes in the intensive lifestyle group and 31% in the metformin
group compared to the placebo group at 2.8 years follow-up. The educational intervention was an
intensive lifestyle-modification program with the goals of at least a 7% weight loss and at least 150
minutes of physical activity per week offered in a curriculum of 16 individual lessons during the first
6 months and subsequent individual and group lessons, mostly on a monthly basis.
22
Figure 2. Authors' judgments about compliance with good practices in the included studies, for each
item of the modified CHEC checklist.
Six out of eight studies found intensive lifestyle interventions cost-saving or very cost-effective:
Palmer et al. 2004 (27) used the results of DPP to analyze the CE in five countries - Australia, France,
Germany, Switzerland and the UK, - by applying a simple three-state Markov model with the states
IGT, alive with type 2 diabetes and deceased, over a lifetime horizon. The intervention was found to
be cost-saving in all countries except in the UK, where it was very cost-effective with an ICER of
€6,400 per life-year gained.
Lindgren et al. 2007, Sweden (28) investigated lifelong CE based on the Finnish Diabetes Prevention
Study (29) (30). This RCT of good quality demonstrated a 58% reduction in cumulative incidence of
type 2 diabetes at 6 years compared to controls. The intervention consisted of individual nutritionist
advice on reduction in weight of at least 5%, total fat intake less than 30% and saturated fat intake
less than 10%, fiber intake of 15 g/1000 kcal, and moderate exercise of at least 30 minutes per day.
In addition, supervised individual resistance training to improve the strength of the large muscle
23
groups was offered. In the long-term effect analysis, the transition states of the used model are
limited to IGT, type 2 diabetes, myocardial infarction/ stroke and death. The lifestyle intervention
was found to be cost-saving from the payers and the societal perspective with a maximal cost of
€2,400 per QALY gained.
Figure 3. Boxplots of the incremental cost-effectiveness ratios in Euros (2012) per QALY gained of
patient education in prediabetes and type 2 diabetes from the perspective of the healthcare system.
Eddy et al.
Palmer et al. 2012, Australia (31) projects lifetime clinical and economic outcomes based on the
results from the DPP and a 10 years’ follow-up of DPP, Diabetes Prevention Program Outcomes
Study (DPPOS) (32), from a third-party payer perspective in Australia. The model is similar to that
applied in Palmer et al. (2004) but adds one additional health state, - “normal glucose regulation”
and thus accounts for reversion to normoglycemia. Intensive lifestyle intervention comes out as a
cost-saving intervention, metformin costs AUD 10,100 (€8,100) per QALY.
Herman et al. 2005, U.S. (33) explored the CE of DPP through lifetime modeling. Probabilities of
transition from IGT to diabetes onset, type 2 diabetes, all known diabetes complications and death
were included in the analysis based on an existing model (34), built mainly on data from the United
Kingdom Prospective Diabetes Study (UKPDS). The ICER of the intensive lifestyle intervention was
$1,100 (€ 900) per QALY from the healthcare perspective and $ 8,800 (€ 6,800) per QALY from the
societal perspective.
24
“DPPRG, 10 years’ follow-up”, 2012, U.S. (35) is a within-trial CE analysis of DPPOS (36). At 10 years,
the incidence of diabetes was 34% and 18% lower in the intensive lifestyle and the metformin group
respectively if compared to the placebo group. After DPP, all groups were offered 16 lifestyle
support group sessions during 7 months (DPP-bridge). In the 5.7 subsequent years, all groups could
participate in the Healthy Lifestyle Program (HELP) consisting of four quarterly one-hour group visits.
In addition, the original intensive lifestyle group was offered two group classes aimed at selfmanagement behaviors for weight loss (BOOST). The metformin group continued with metformin.
The attendance rate was 18% for HELP and 17% for BOOST. The ICER was $12,900 (€10,000) per
QALY from the healthcare system perspective and $19,800 (€15,300) from the societal perspective.
Herman et al. 2013, U.S. (36) is based on DPPRG, 10 years’ follow-up and is a post-hoc CE analysis for
the subgroup of “adherent” patients. Adherent lifestyle participants were defined as those without
diabetes who achieved and maintained 5% weight loss at ≥50% of their semi-annual visits; adherent
metformin participants as those without diabetes who took ≥80% of their prescribed metformin;
adherent placebo participants as all those randomized to the placebo group. The incidence of
diabetes among “adherent” patients from the intensive lifestyle group at 10 years was 49.4% lower
than in placebo and 20.8% lower than in metformin group. For the intensive lifestyle intervention,
ICERs were $20,000 (€15,500) and $3,200 (€2,500) per QALY from the healthcare and the societal
perspective respectively. Metformin costs $20,200 (€15,700) per QALY, from the healthcare system
perspective, and is cost-saving from the societal perspective. In this study, the measure of adherence
was the treatment effect in the intensive lifestyle group and the compliance to the intervention
protocol in the metformin group, while in the placebo group all patients were considered adherent.
The inconsistency in the definition of adherence across groups seems a substantial flaw of the study
design and its results should be interpreted with caution.
Marginal cost-effectiveness was found in the within-trial economic evaluation along DPP (37), which
provides an accurate reporting of costs and outcomes within the RCT. However, due to the short
time horizon, it ignores all future consequences of the alternative treatments. The ICER of $51,600
(€40,000) per QALY gained, calculated from the societal perspective, should therefore be interpreted
with caution.
Intensive lifestyle intervention was not cost-effective in the study of Eddy et al. 2005, U.S. (20) which
explored the lifetime CE of DPP by using the Archimedes Diabetes model (38). The model is based on
object-oriented programming and does not involve fixed health transition states. It consists of
hundreds of variables that interact within hundreds of equations. The model was extensively
validated and is described as highly precise. Eddy et al. conclude that delaying the lifestyle
intervention until after a person develops diabetes would be more cost-effective than offering it to
people with IGT. The reported ICERs were $143,000 (€110,900) per QALY from the health plan’s
perspective and $62,600 (€48,500) per QALY from the societal perspective.
25
Type 2 diabetes
In type 2 diabetes, therapeutic education was found cost-saving only in the study of Mason et al.
2005, and only for the subgroup of people with hypertension where the intervention was focused on
blood pressure lowering strategies in the UK (39). It was very cost-effective in the same study for the
subgroup of people with dyslipidemia with an ICER of $8,230 (€6,400) per QALY gained, supposedly
from the health care perspective. The underlying RCT is of a good quality and demonstrates a
significant increase of the percentage of patients at target for the level of total cholesterol (but not
for the level of blood pressure) (40). The specialist nurse-led intervention in this study was aimed at
better control of hypertension and hyperlipidemia in diabetes and included individual target-driven
lifestyle counselling and medication adjustment. The applied model includes the states: type 2
diabetes, myocardial infarction, stroke and death.
Diabetes education was very cost-effective also in two other studies:
Gillett et al. 2010 investigated the lifetime CE of education for ongoing and newly diagnosed
diabetics in the UK and found an ICER of £5,387 (€6,700) per QALY, from the healthcare system
perspective (41). The one-year intervention was a structured 6-hours group education program
focused on lifestyle and goal setting and delivered by professional health educators. There was no
significant between-group difference in effect on HbA1c, but there was a positive significant effect in
odds of non-smoking (42). The study used the Sheffield type 2 diabetes model that includes
progression from diabetes without complications to micro- and macrovascular complications.
Dijkstra et al. 2006, the Netherlands (43) analyzed the life-long CE of a diabetes passport – an
intervention that included education sessions for patients and professionals in hospital setting (44).
Difference in HbA1c change after one year was 0.5% and statistically significant. The NIDDM model
was used for the long-term extrapolation of results. Though the original clinical study reports a 2arm design with a single complex intervention, ICERs of €16,400 per QALY are reported for the
patient-centric and €32,200 per QALY for the provider-centric intervention.
Educational interventions in type 2 diabetes were cost-effective in three studies:
Graves et al. 2009, Australia (45) analyzed the CE of telephone counseling for physical activity and
diet in primary care patients with type 2 diabetes or hypertension (46). The RCT was of a good
quality and demonstrated a significant improvement in intake of fat, vegetables, fruit and fiber
achieved through 18 lifestyle telephone sessions offered by nutritionists. The model applies a 10year time horizon and transition to different behavior states (suboptimal lifestyle – improved diet –
improved exercise – improved diet and exercise) or death, each assigned a particular QALY value.
The model is non-conventional as it uses health behaviors instead of health states. It is not clear how
the evolution of the health status was incorporated into the model, nor how the transition
probabilities and the associated health utility values were estimated beyond the trial. ICERs were
26
AUD78,500 (€63,300) per QALY compared to usual care and AUD29,400 (€23,700) per QALY
compared to “real controls”.
Cleveringa et al. 2010, the Netherlands (47) investigated the life-long CE of the Diabetes Care
Protocol, a complex one-year intervention that included patient education and medication
prescription by nurses upon approval of GPs and with support of a computerized decision support
system (48). This well conducted RCT showed no significant difference in effect on HbA1c but did in
the secondary outcomes – blood pressure and lipid profile. The model is based on Eastman’s Model
of complications of non-insulin dependent diabetes mellitus (NIDDM) (49) adapted to the Dutch
population and simulates progression to cardiovascular diseases (CVD) - angina pectoris and
myocardial infarction, microvascular complications and death. An ICER of €38,200 per QALY from the
health care perspective was reported. Although, the clinical trial did not include the subgroup
analysis for people with and without CVD, the economic evaluation does report the results for these
subgroups: for patients with CVD, the ICER was €14,800, and for patients without CVD €121,300 per
QALY.
The study of Handley et al. 2008, U.S. (50) is a within-trial economic evaluation of a nine-month
education offered to patients with poorly controlled HbA1c. The intervention consisted of an
automated telephone questionnaire and the outbound calls by nurse initiated when the answers are
“out of range” (51). Both the clinical and the economic evaluation contain some essential
methodological flaws. The ICER ranged from $29,402 to $72,407 (€22800 - €56100) per QALY.
A marginal cost-effectiveness of £43,400 (€53,600) per QALY gained was found in the study of Mason
et al. 2006, U.K. (52) which explored the life-long CE of pro-active call center treatment support for
people diagnosed with type 2 diabetes since more than one year in primary care. (53). The original
well-conducted RCT demonstrates a statistically significant reduction of HbA1c after one year by
0.31%, achieved through outbound phone self-management support counselling with tailored
intensity delivered by diabetes nurses. The long-term effects simulated in the model were not
reported. Only a change in HbA1c was considered a risk factor of the disease progression.
Educational support was not cost-effective in the study of Irvine et al. 2011, U.K. (54) which
combines the effectiveness and the health economic analysis in one publication and investigates the
CE of group education for people with IGT and newly diagnosed type 2 diabetes. The study has many
methodological limitations. The reported ICER is £67,174 (€82,900) per QALY. More favorable results
were found for the subgroups of people with IFG and those with a follow-up time longer than 4
months: £20,620 (€25,500) and £17,075 (€21,000) per QALY respectively.
The study of Simon et al. 2008, U.K. (55) is a within-trial economic evaluation. It was based on a 3arm RCT in which usual care was compared to the self-monitoring of blood glucose (SMBG) and to
the SMBG along with coaching for people with non-insulin treated type 2 diabetes (56). The study
reports low adherence rates: only 54 out of 151 people are adherent to the intensive SMBG; only 85
out of 150 – in the normal SMBG. No significant improvement in glycaemic control was found after
27
one year. In both intervention groups, a non-significant loss in QALYs was observed. SMBG was
evidently found to be dominated by usual care.
Discussion
The main finding of our review is that that therapeutic education may be a good value for money in
patients with pre-diabetes and type 2 diabetes. Current evidence suggests that offering education
programs already in prediabetes stage would be a better strategy than postponing them till after the
diagnosis.
Six out of eight studies on prediabetes found patient education cost-saving or very cost-effective.
Other two studies reported less favorable results. One of them considered only a short-term analytic
horizon. The meaningfulness of short-term cost-effectiveness analysis of therapeutic education in
type 2 diabetes is questionable. As confirmed by 10 –years within-trial analysis of DPP, the greatest
costs are observed in the year of the delivery and decreased in the subsequent years, while most of
the benefits occurred after 3 years of follow-up (35).
The other study was a modeling study by Eddy et al. (2005) which concluded that intensive lifestyle
interventions are not cost-effective with an ICER of €110,900 per QALY gained. Five other modeling
studies predicted such interventions to be cost-saving or very cost-effective with a maximum ICER of
€6,400 per QALY gained. The discussion on the predictive accuracy of different models stayed
unresolved in absence of real life data. Only after the recent publication of the 10-years within-trial
CE analysis of DPPOS that calculated an ICER of €10,000 per QALY, it becomes clear that the study by
Eddy et al. produced results least consistent with the real life observations. This may be explained by
adoption of a number of specific structural model assumptions, such as that the intervention would
last for life, or that people with type 2 diabetes who achieve HbA1c below 7%, stay well-controlled
for the rest of their life (38).
In type 2 diabetes, the results were mixed and varied from cost-saving to not cost-effective, or even
dominated. Three out of nine studies were within-trial economic evaluations and thus considered
only a short-term analytic horizon. None of the studies on type 2 diabetes included a long-term
analysis of costs and outcomes based on real life data. The quality of the underlying clinical evidence
was overall stronger in studies on prediabetes. Thus, our review suggests that patient education in
prediabetes stage is more cost-effective and supported by stronger evidence.
The following relativizing thoughts should help to better interpret the results of the review:
The health economic evaluations are generally performed when interventions are clinically effective.
This review should thus not be used to draw conclusions on the clinical effectiveness of therapeutic
education, but on the cost-effectiveness of interventions with a positive health effect, to support the
policy makers and health professionals in their decisions.
Most economic evaluations in prediabetes were based on the results of the Diabetes Prevention
Program. In studies on type 2 diabetes, the quality of the clinical evidence varied. More research on
28
the topic is needed, preferably performed in real-life settings, with special attention to the barriers
and facilitators of successful changes in clinical practice.
In the future, it will be important to identify subgroups where therapeutic education is expected to
be more effective. The extent of beta-cell dysfunction might, for instance, independently affect the
disease progression. The 5.8-year follow-up of DPP showed that participants of the intensive lifestyle
arm, who did not return to normoglycemia at least once during the trial, had a higher risk of
progression to diabetes than the control group (11). A risk reduction of 56% was found in those who
returned to normal glucose regulation irrespective of the previous allocation to the intensive lifestyle
or metformin arm (11).
The overall challenge of reviews in health economics is that inconsistencies in the conduct and
reporting of the cost-effectiveness studies complicate a systematic comparison of the results,
particularly when different time horizons are chosen, different modeling methods applied and the
uncertainty around the structure, its parameters and the methodology is not sufficiently explored.
Commonly accepted methodologies to perform and assess economic evaluations would lead to a
generation of higher quality health economic evidence.
One should be cautious with the generalization of the cost-effectiveness results or their transfer to
other settings. Next to potential differences in clinical effect – e.g. due to divergences in the
organization of usual care, differences in the absolute and relative cost consequences may occur.
The cost-effectiveness classification adopted in our review is conditional and does not necessarily
reflect the national reimbursement policies. It is known that applying an explicit ICER threshold is not
typical for the reimbursement policies in most countries (57). Moreover, in general, costeffectiveness is not the only criterion in the reimbursement decisions. Severity of disease, size of the
target population, budget impact, and availability of the treatment alternatives may play a role next
to legal, ethical and organizational issues.
While keeping in mind these limitations to the synthesis and generalizability of results, our review
suggests that re-consideration of public health priorities in the direction of earlier prevention of
diabetes might be appropriate. This would imply more efficient screening methods for detecting
people with prediabetes. Targeting people at high risk, such as hypertensive and obese patients, is
believed to be cost-effective (58). More insights into the evolution of blood glucose levels are
needed to come up with an optimal re-test frequency.
Conclusion
The number of economic evaluations of patient education in prediabetes and type 2 diabetes has
been growing in the past years. The findings of our review suggest that offering therapeutic
education already in prediabetes stage may be a better value for money than postponing it till after
the diagnosis. More robust methodologies in health economic evaluations are essential in further
evidence generation.
29
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32
Chapter 2. Nurse-led telecoaching of people with type 2 diabetes in primary
care: rationale and design of a randomized controlled trial.
Odnoletkova I, Goderis G, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. Nurse-led telecoaching of people
with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial. BMC
Fam Pract. 2014 Feb 4;15(1):24.
33
Abstract
Background
Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50 %
of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future microand macro-vascular complications. Diabetes self-management education has been shown to
contribute to better disease control. However, it is not known which strategies involving educational
programs are cost-effective. Telehealth applications might support chronic disease management.
Transferability of successful distant patient self-management support programs to the Belgian setting
needs to be confirmed by studies of a high methodological quality. “The COACH Program” was
developed in Australia as target driven educational telephone delivered intervention to support
people with different chronic conditions. It proved to be effective in patients with coronary heart
disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type
2 diabetes needs to be assessed.
Design
Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their
medication consumption data and were recruited by their sickness fund. They were randomized to
receive either usual care plus “The COACH Program” or usual care alone. The study will assess the
difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The
secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood
Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol
and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction
with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses,
to project effects over life-time horizon beyond the trial duration, will be undertaken from the
perspective of the health care system if the intervention is effective.
Discussion
The study will enhance our understanding of the potential of telehealth in diabetes management in
Belgium. Research on the clinical effectiveness and the cost-effectiveness are essential to support
policy makers in future reimbursement and implementation decisions.
Trial registration
Belgian number: B322201213625. ClinicalTrials.gov Identifier: NCT01612520
34
Background
The increasing prevalence of type 2 diabetes poses a challenge to health care systems. Type 2 diabetes
is a complex illness that requires continuing medical care and patient self-management education to
reduce the risk of long-term complications [1]. Despite the efforts of the healthcare community to
improve the quality of diabetes care, about 50 % of the population with type 2 diabetes do not reach
the guideline recommended treatment targets [1,2]. A recent comparative research of quality
improvement strategies in diabetes care found that interventions targeting the system of chronic
disease management along with the patient are likely to be more beneficial than those strategies
targeting solely health-care professionals [3].
Patient education in disease self-management is commonly recognized as an essential part of diabetes
treatment. It has been shown to improve glycaemic control, whereby the intensity of the educational
program is believed to be an important predictor of the outcomes [4-6]. However in Belgium, the
majority of people with type 2 diabetes are not offered coverage of educational programs. Current
evidence of the cost-effectiveness (CE) of diabetes education is limited due to scarcity of publications
in this area and the poor quality of the studies [7-9].
A variety of strategies and techniques can be used to provide adequate education in development of
problem-solving skills in diabetes management. Offered in a group or individually [10,11]; face-to face
or on distance [12-15]; led by people with or without special professional training [16,17]; and
depending on the curriculum, - educational programs may demonstrate different results in terms of
the clinical and cost-effectiveness. The complexity of these interventions make it difficult to detect the
direct effect of specific features of patient education on the outcomes [18,19]. Since a commonly
accepted reporting methodology for interventions in prevention and health promotion within clinical
trials is lacking, patient education programs are frequently poorly described and difficult to reproduce
in other settings.
“The COACH Program” is a well-established target-driven telephone intervention delivered by nurses
or dieticians who undergo special additional training [20]. It showed to effectively reduce the disease
related risk factors in patients with established coronary heart disease after hospitalization [21,22].
After a research phase, The COACH Program became operational in Australia and extended its
curriculum to ten different chronic conditions including type 2 diabetes, in the past 15 years. The
clinical and cost-effectiveness of The COACH Program has not yet been tested in Europe.
The specific aims of the study are: 1) to assess whether The COACH Program can be offered by a
sickness fund and delivered in cooperation with caregivers in Belgium; 2) to investigate whether The
COACH Program helps people with type 2 diabetes to achieve better glycemic control and improved
modifiable diabetes risk factors and self-perceived health compared with usual care alone; 3) to
analyze the cost-effectiveness of The COACH Program from the perspective of the health care system
based on the trial results extrapolated to a life-long horizon.
35
Methods
Study design
The study is a parallel-group RCT, in which patients with type 2 diabetes, affiliated to the Belgian
sickness fund Partena, were selected based on their medication consumption data, recruited by their
sickness fund, and randomized to receive usual care plus The COACH Program or the usual care alone.
The study will assess the difference in outcomes between the two groups. The primary outcome
measure is the level of glycohemoglobin HbA1c at 6 months after randomization. The secondary
outcomes are: total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL),
triglycerides (TG), blood pressure (BP), Body Mass Index (BMI), smoking status; proportion of people
at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetesspecific emotional distress, and satisfaction with diabetes care. The follow-up period is 18 months. All
outcome measurements will be collected 3 times: before randomization, upon the graduation from
the program (6 months after the program start); and at the end of the follow-up period (18 months
after randomization). The allocation ratio is 1:1. Within-trial and modeled cost-utility analyses, - to
project effects over a longer time horizon beyond the trial duration, - will be undertaken from the
perspective of the health care system if the intervention is effective.
Study participants
Study participants are adults between 18 and 75 years old with a diagnosis of type 2 diabetes taking
glycaemia lowering oral and/or injectable medications. Exclusion criteria are people on corticoid
therapy and/or with a debilitating coexisting medical condition such as dialysis, mental illness, cancer;
residents of long term care facilities; pregnant women; and people incapable of telephone
communication in Dutch.
Coaching intervention
The COACH Program consists of 5 monthly telephone sessions of 30 minutes on average delivered by
certified diabetes nurse educators (further referred to as “coach”). Prior to the intervention, they
undergo 5-days training in up-to date clinical guidelines on diabetes self-management and how to give
patients the motivation and the skill to improve their risk factors. Coaches are also trained in the use
of the COACH Program software for patient administration. Coaches use patient’s baseline data
obtained during the first home visit, to assess the individual risk profile and to suggest targets for
diabetes risk factors based on the Flemish and international guidelines for good practice in diabetes
care [1,23-25]. The therapeutic goals are discussed with the GP by phone before the first coaching
session.
Prior to the beginning of the coaching, patients of the intervention group receive a welcome package
with information about the program, a book with advice on nutrition in diabetes and a waist
circumference meter with a BMI calculator. Patients with HbA1c above 6 % (42 mmol/mol) at baseline,
36
who are not in possession of an insurance-covered meter for self-monitoring of blood glucose (SMBG),
receive a SMBG set including lancets and strips.
All risk factors associated with diabetes are addressed by the coaches, - glycaemia, lipids, blood
pressure, kidney, foot and eye checks, nutrition, physical activity, smoking and alcohol consumption.
Patients are instructed on how to perform SMBG and interpret the results. A measurement frequency
of one or two day profiles a week is advised. Depending on the type of the diabetes medication –
causing hypoglycemia or not – a scheme of four or two times a day respectively is recommended.
Considering special skills needed to assist people in smoking cessation, smokers of the intervention
group are motivated to contact the tobaccological service of the Belgian Cancer Federation
“Tabakstop” that offers tailor-made telephone sessions and is free for all patients.
The coach registers and monitors the biomedical risk factors, the lifestyle/behavioral parameters and
the use of the recommended medications. The COACH Program software supports advice on individual
treatment targets and the frequencies for the diabetes risk factors control. The software also helps to
quickly generate a written coaching report with actual advice and comparison of the current status of
the risk factors against the individual treatment targets. These reports are sent to the patients and
copied to their GP’s by e-mail or post. The COACH Program software is built upon several databases,
such as reimbursed medications and standard comments for each diabetes risk factor.
The COACH Program trains patients to ‘drive’ the process of achieving and maintaining the target
levels for their risk factors while working in association with their GP. Coaching is focused on
eliminating the knowledge and treatment gap and motivating the patient to apply the appropriate
lifestyle and medical therapy. Each session is used as the foundation for the next contact. The coaching
model is a continuous five-stage coaching cycle: stage 1 - finding out what the patient knows; stage 2
- telling the patient what he/she should know; stage 3 - assertiveness training; stage 4 - setting an
action plan; stage 5 - reassessment at the next coaching session (monitoring). Patients are invited to
contact their coach between coaching sessions for questions and further information if required.
The control group
The control group receives usual care alone. In Belgium, patients on oral glycaemia lowering
medications are predominantly treated by their GPs. When insulin therapy needs to be initiated
patients become entitled to a “diabetes care trajectory” reimbursed by the national health insurance.
The care trajectory is initiated by the GP and implies coordinated care, including diabetes education
by a certified diabetes educator, and a yearly contact with an endocrinologist, in addition to the regular
GP visits. Patients with advanced diabetes, in need of three or more insulin injections per day, are
normally treated in a hospital setting by an endocrinologist, with support of a multidisciplinary team.
All study participants, including the control group, receive a DVD with educational material on type 2
diabetes, its complications and lifestyle recommendations. The laboratory results of the blood analysis
are mailed to all study participants and their GPs after each assessment.
37
Patient recruitment and randomization
Patients were selected from the administrative database of the sickness fund “Partena” which belongs
to the Group of the Independent Sickness Funds, based on the reimbursement data of glycaemia
lowering medications in the past 12 months. Prior to the start of patient recruitment, their GP’s were
informed about the study by mail. Selected patients were sent a letter of invitation to participate in
the study and invited to express their interest by returning an attached response card. Those
candidates who expressed their interest, or have not reacted to the invitation within two weeks, were
contacted by phone. A home visit for the baseline assessment was scheduled with those patients who
confirmed their participation. The assessment visit was carried out by a nurse not involved in the
intervention delivery.
Randomization was performed every 2 weeks on average. To achieve a comparable HbA1c distribution
within both groups, patients were stratified based on the baseline level of HbA1c: with HbA1c < 7 %
(53 mmol/mol), or with HbA1c ≥ 7 %. Patients from both strata’s were allocated to the intervention or
the control group by a data analyst of the Independent Sickness Funds, further not involved into the
study, by using a random number generator programmed in Excel.
Data collection and analysis
During the assessment visits, the nurses register data. Weight is measured by electronic scale, patients
wearing light indoor clothing, no shoes. Height is measured in the standing position using a portable
anthropometer, feet, knees, buttocks and shoulder blades in contact with the vertical surface, no
shoes. Waist circumference is measured with a measuring tape according to the guidelines of the
Belgian Association for the Study of Obesity [26]. Blood pressure is taken in a sitting position by using
a manual sphygmomanometer. Two measurements are taken, the lower systolic and diastolic
measurements will be used in the analysis. The level of toxic carbon monoxide (CO) is measured in
parts per million (ppm) by a CO meter in addition to self-reporting smoking status.
The patients are asked to fill in the EQ-5D 3-L as a generic health status survey, the questionnaire
Problem Areas in Diabetes (PAID) that measures the level of diabetes-specific emotional distress, and
the Diabetes Treatment Satisfaction Questionnaire (DTSQ). All chosen instruments have a wellestablished cross-cultural validity. In addition, patients in the intervention group are asked to fill in a
specific satisfaction questionnaire about The COACH Program. The blood samples are collected and
delivered to the laboratory “Meidina Medische Analysen” contracted for the period of the trial. For
the biomedical analyses the following methods are used: HbA1c – by ion exchange chromatography;
TC and TG – by enzymatic colorimetric methods; HDL – through neutralization of LDL and VLDL. The
LDL is calculated using the Friedewald equation. Table 1 summarizes the protocol of patient data
collection during the trial.
38
Sample size
Sample size calculation was performed by using the stata software. For the subgroup of people with
HbA1c ≥ 7 %: assuming the difference of 0.4 % between the control and intervention group (7.8 % vs
7.4 %) [4] and the standard deviation of 0.94 % as observed within this subgroup at the baseline data
analysis, we would need 232 people in both arms to achieve a power of 0.90 in this subgroup. 46 % of
the participants represent this group. This means that recruiting 555 people in total would be enough
to power our hypothesis for the subgroup of people with HbA1c ≥ 7 % at baseline if accounting for up
to 10 % drop-out.
For the total study population: based on the assumption that the mean difference in HbA1c between
two groups will be of 0.3 % (7.0 % vs 6.7 %) [2], and standard deviation of 1.05 % - as analyzed at
baseline – to achieve a power of 0.90 with alpha being 0.05, we would require 514 subjects to
complete the study. Allowing for a dropout rate of up to 10 %, the target recruitment number should
be 566 patients totally, or 283 patients in each arm [27].
Monitoring intervention integrity
To keep track on the degree to which The COACH Program is delivered as initially planned and to
monitor the compliance of the patients and their GPs to the advice of the coaches, the following
measures are foreseen: 1) all written coaching reports are reviewed by IO and the head nurse during
the first two months of the intervention and selectively thereafter; 2) several coaching sessions are
audio-recorded; 3) the coaches register patient’s and GP’s compliance to their advice, particularly in
adjusting medication therapy.
Table 1 Patient data collection at three assessment moments during the trial
39
Patient data
Method of collection
Baseline T0 + 6
(T0)
months
Gender
Sickness funds database
x
Age
Sickness funds database
x
Education
self-reporting
x
Occupation
self-reporting
x
Diabetes 2 since
self-reporting
x
Comorbidities:
self-reporting
x
Family history of type 2 diabetes and
cardiovascular disease
self-reporting
x
Blood pressure
home visit test
x
Height
home visit test
x
Weight
home visit test
BMI
T0 + 18
months
x
Cardiovascular: CHD; Heart failure;
Atherosclerosis; past MI; Stroke; TIA
Respiratory: COPD; Asthma
Other: Hypoglycemia; Hypertension;
Dyslipidemia; Kidney disease; Neuropathy;
Depression
x
x
x
x
x
calculated
x
x
x
Waist circumference
home visit test
x
x
x
Prescribed medications
Sickness funds database +
self- reporting
x
x
x
Smoking
self-reporting + CO test
x
x
x
Lifestyle: physical activity; alcohol
consumption; healthy eating
self-reporting
x
x
x
Diabetes risk factor knowledge test
self-reporting
x
x
x
EQ-5D
self-reporting
x
x
x
PAID
self-reporting
x
x
x
DTSQ – status version
self-reporting
x
x
x
HbA1c
pathology lab
x
x
x
Lipid profile: TC; HDL; LDL; TG
pathology lab
x
x
x
Satisfaction about the COACH Program
(intervention group)
self-reporting
Costs
Sickness funds database;
time& material sheets;
contracts
x
x
x
x
Abbreviations: CHD = Coronary Heart disease; MI = Myocardial Infarction; TIA = Transient Ischemic Attack; COPD
= Chronic Obstructive Pulmonary Disease; EQ-5D = EuroQol 5 dimension health status questionnaire; PAID =
Problem Areas in Diabetes Questionnaire; DTSQ = Diabetes Treatment Satisfaction Questionnaire; HbA1c =
glycohemoglobin; TC = total cholesterol; HDL = high-density lipoprotein; LDL = law-density lipoprotein; TG =
triglycerides
40
Cost-utility analysis
Cost-utility analysis will be performed if the clinical study demonstrates a positive difference in clinical
end points between two study groups [28,29]. Within-trial and modeled cost-utility analyses will be
undertaken from the perspective of the health care system, i.e. taking into account direct health care
costs to the system including both the cost for the health insurance as the patient out-of pocket costs
[30].
The incremental cost-effectiveness ratio (ICER) will be calculated by using the following equation: ICER
= ∆Costs/∆QALYs, where ∆Costs is the difference between the mean total cost in the intervention and
the control group and ∆QALY is the area between two curves depicting the evolution of the means in
QALYs-utilities over time in the intervention and the control group.
Modeling will be applied for projecting effects observed within the trial over a life-time horizon. The
assumptions on the progression of type 2 diabetes depending on the known intermediate surrogate
outcomes and the associated health status will be derived from published sources. The model’s
outcomes validity will be tested through critical appraisal by experts. Future costs of type 2 diabetes
without complications, and costs associated with each fatal or non-fatal diabetes-related complication
will be estimated based on the epidemiological data available in Belgium and the database of the
Independent Sickness Funds. Future costs will be discounted at 3 %, future QALYs gained at 1.5 % per
annum [30]. ICERs will be calculated at various time horizons (e.g., 2, 5, 10, 20 years) [30].
Costs of the intervention
The fixed intervention costs consist of the investment into the program development, the
administrative and supporting personnel, the software maintenance, the consultancy services, and
the overhead. Variable costs are those costs which are directly dependent on the number of patients
served by the program and associated with the training of the coaches, the recruitment of patients
into the program, the actual coaching and administration time, once-off per patient fee, and
production and distribution of the program materials for coaches and patients. All costs will be
registered prospectively during the trial based on the individual time and material registration and the
contractual prices. Fixed costs will be allocated to patients through dividing the total fixed costs by the
number of participants in the intervention group.
Within trial costs and health utilities analysis
Information on the utilization of healthcare services will be obtained from the database of the
Independent Sickness Funds. The health care services include primary care visits, visits to emergency
departments, visits to specialists, hospital stays, medications, laboratory tests, imaging techniques,
paramedical care and other therapies. Out-of-pocket costs will be derived from the published
reimbursement regulations. All cost items described above will be specified and expressed in physical,
and in monetary units (Euro’s). As baseline measure of costs in both groups, the costs of health care
consumption in the 12 months period prior to the trial will be taken. Diabetes – and non-diabetes
41
related costs will be distinguished. Costs imposed by the study that are not part of the routine practice,
such as protocol-driven nurse assessment visits and laboratory tests, will not be included into the cost
analysis.
The health utility weights will be derived from the Flemish utility value system based on the EQ-5D
scores obtained during the assessments visits [30]. QALYs associated with the future diabetes
complications will be derived from published sources. QALYs will be calculated assuming linear
interpolation between measurement points and calculating the area under the curve, to give a number
of QALY gained per patient over the trial period [29].
Statistical analysis
The two-tailed unpaired t-test will be used for continuous data and chi-square test for proportions.
Where appropriate, regression analysis will be applied to account for baseline differences between
the two study groups. The results will be expressed as mean (95 % CI) for normal data and median
(range) for skewed data. Sensitivity analysis will examine the effect of loss to follow-up on the
intervention effect. The analysis will be conducted by intention to treat, which means, all patients will
be followed for the full duration of the trial. Exploratory analyses will examine the effect of other
factors, such as socio-demographic variables, on the outcome.
ICERs will be calculated for the mean and for the upper and lower confidence levels of marginal costs
and utilities. One-way sensitivity analysis will be performed to test the relative contribution of
different variables to the uncertainty around ICER and presented by means of a Tornado diagram.
Probabilistic sensitivity analysis (Monte Carlo simulation) will be performed for all model inputs. The
structural uncertainty will be tested through presenting different model scenarios. The results of this
analysis will be presented on the cost-effectiveness plane. Probability of willingness to pay by the
Belgian Health Care system will be forecasted and presented as a cost-effectiveness acceptability
curve [34].
Ethical issues
For the patient detection procedure based on the medication consumption data, an approval has been
obtained from the Belgian Commission for the protection of Privacy. The study protocol has been
approved by the Ethical Committee of the University Hospital of Leuven prior to the beginning of the
recruitment. Written informed consent was obtained from all patients before initiation into the study.
The study is registered at ClinicalTrials.gov, identifier: NCT01612520.
Discussion
Local context can have impact on the acceptability of new forms of care and on their clinical- and costeffectiveness. Telephone coaching has been applied for patient education in USA and Australia since
1990-ties and has a potential to increase access to health care services. However, in systematic reviews
on telehealth in chronic disease management, European studies are poorly represented [13,14,20]. It
42
is therefore important to investigate the transferability of successful telehealth interventions to
European countries through studies of a high methodological quality. To increase the added value of
such research to patients and policy makers, study designs have to consider the clinical effectiveness,
the cost-effectiveness and the implementation potential.
The design of our study has several strengths. 1) The intervention integrity analysis is integrated into
the study protocol. The verification of program integrity should be part of the evaluation of any
behavioural intervention as lowered adherence to the protocol is often associated with poorer
outcome [31]. The integrity assessment also reveals important information about the feasibility of the
intervention in real life settings. 2) The COACH Program is well-established in Australia, which enables
a comparison of the clinical outcomes in relation to the integrity results. 3) Patients were invited into
the study directly, reducing the potential of selection bias. 4) The cost-effectiveness analysis with lifetime horizon will help the policy makers to prepare well informed reimbursement decisions. 5) The
database of the sickness funds is a reliable and comprehensive source of information on health care
consumption.
However, a number of design limitations need to be mentioned. 1) The research setting will to a
certain extent affect the study results. Several elements of the protocol are not part of the usual care,
e.g. home visits for the purpose of the data collection including the additional laboratory analysis. 2)
In the within trial cost-utility analysis, incremental QALYs is one of the primary endpoints of the
economic evaluation but can only be derived from a number of generic health surveys with a limited
capacity in detecting minor differences in health status, at least in the short term. The disease specific
questionnaires have shown to be more sensitive and relevant for use in certain interventions and
patient groups. In the last years, researchers have been developing algorithms to translate the scores
obtained from disease specific health status questionnaires into health utility weights. However the
performance of these algorithms have been criticized [32]. Further research in health-economics
should focus on development of cross-cultural instruments capable of capturing common measures
of well-being with a higher grade of sensitivity to minor condition divergences.
43
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45
Chapter 3. Optimising diabetes control in people with type 2 diabetes
through nurse-led telecoaching.
Odnoletkova I, Goderis G, Nobels F, Fieuws S, Aertgeerts B, Annemans L, Ramaekers D. Optimizing diabetes
control in people with Type 2 diabetes through nurse-led telecoaching. Diabet Med. 2016 Feb 12.
46
Abstract
Aims: to study the effect of a target-driven telecoaching intervention on glycated haemoglobin and
other modifiable risk factors in people with type 2 diabetes.
Methods: Randomised controlled trial in patients on hypoglycaemic agents. Primary outcome:
HbA1c at 6 months in the entire sample and the subgroup with HbA1c≥53 mmol/mol (7%) at
baseline. Secondary outcomes: HbA1c at 18 months; total cholesterol (TC), LDL, HDL, triglycerides,
blood pressure (BP), BMI and proportion of people at guideline recommended targets at 6 and 18
months.
Results: 287 participants were randomised to telecoaching and 287 to usual care. The mean (SD)
baseline HbA1c, mmol/mol [%] was 53 (11) [7.0 (1.0)] overall and 63 (10) [7.9 (0.9)] in the elevated
HbA1c subgroup. At 6 months, the between-group difference in favour of telecoaching was: in
HbA1c (95% CI) -2 (-4; -1) [-0.2 (-0.3;-0.1), P=.003] and -4 (-7; -2) [-0.4 (-0.7; -0.2), P=.001] in the
elevated HbA1c subgroup; in BMI (kg/m2): -0.4 (-0.6;-0.1, P=.003); in TC (mg/dl): -6 (-11; -1, P=.012).
The proportion on target for the composite of HbA1c, LDL and BP increased by 8.9% in the
intervention and decreased by 1.3% in the control group (P=.011). At 18 months, the difference in
HbA1c was: -2 (-3;-0) [-0.2 (-0.3; -0.0), P=.046] and -4 (-7; -1) [-0.4 (-0.7; -0.1), P=.023] in the elevated
HbA1c subgroup.
Conclusion: Nurse-led telecoaching improved the glycaemic control, total cholesterol and body mass
index in people with type 2 diabetes. Twelve months after the intervention completion, there were
sustained improvements in glycaemic control.
Trial registration: http://clinicaltrials.gov/show/NCT01612520
47
Introduction
The prevalence of type 2 diabetes is increasing, posing a challenge to health care systems globally
[1]. Type 2 diabetes is a chronic illness that requires continuous medical care to reduce the risk of
long-term complications by managing blood pressure and lipid profiles, and controlling glycaemia
[2]. However, almost 50% of the type 2 diabetes population do not reach guideline recommended
treatment targets [3, 4]. Research on the needs and perceptions of people with type 2 diabetes
reveals a lack of insight into diabetes self-care and insufficient awareness of diabetes complication
risks [5, 6]. Patient education has been recognised as a cornerstone of diabetes care [2]. It has been
shown to improve diabetes knowledge, glycaemic control, blood pressure and body weight [7-9].
Better patient inclusion in self-management support programmes is an organisational and economic
challenge, underlining the need to investigate schemes that are cost-effective and easy-to-access.
Telephone coaching may improve access to diabetes care. However, the evidence for its
effectiveness is limited and inconclusive, emphasising a need for large well-controlled trials [10]. In
our trial the effectiveness of a replicable Australian programme, “The COACH Program”, was tested
in Belgium. The COACH Program is a risk factor target-driven telephone intervention delivered by
nurses or dieticians who undergo specialised additional training. It has been shown to effectively
reduce the disease-related risk factors in patients with established coronary heart disease after
hospitalisation in Australia [11] and, in the past 15 years, has extended its curriculum to ten different
chronic conditions including type 2 diabetes. However, the local context may affect treatment
outcomes. The effectiveness of The COACH Program has not previously been tested in Europe.
Objective
To investigate the effect of The COACH Program on glycated haemoglobin and other modifiable
diabetes risk factors in people with type 2 diabetes in a primary care setting in Belgium compared to
usual care.
Methods
Study design
The study is a parallel-group randomised controlled trial (RCT), in which people with type 2 diabetes,
affiliated to the Belgian health insurance fund “Partena”, were selected based on their glucoselowering medication consumption, recruited by their health insurance fund, and randomised to
receive usual care plus The COACH Program or usual care only. The study assessed the difference in
outcome between the two groups at the end of the intervention at 6 months and after an additional
follow-up at 18 months. The allocation ratio was 1:1. Details of the trial protocol were published
elsewhere [12]. The CONSORT guidelines for the reporting of RCTs were used [13].
48
Study participants
Study participants were adults between the ages of 18 and 75 with a diagnosis of type 2 diabetes, on
glycose-lowering oral and/or injectable therapy. Exclusion criteria included corticoid therapy and/or a
debilitating coexisting medical condition such as dialysis, mental illness, cancer; residence in long-term
care facilities; pregnancy; insufficient proficiency in Dutch.
Coaching intervention
The COACH Program is designed to empower patients to take responsibility for the achievement of
their risk factor targets. The coach identifies the “treatment gaps” in the management of each
diabetes risk factor, i.e. failure to achieve the guideline recommended goals, and helps the patient to
identify strategies to close the treatment gap, including lifestyle adjustments and adherence to
recommended medication therapy. The underlying “COACH Model” is a continuous quality
improvement cycle, which includes bridging the knowledge gap, assertiveness training, setting an
action plan and (re)assessment (14,15). The program consisted of 5 telephone sessions of 30
minutes on average (range: 10 – 45) delivered at an average interval of 5 weeks (range: 3 – 8) by a
certified diabetes nurse educator (hereafter referred to as “coach”) after a 5-day training course. It
consisted of an update of the best practice guidelines for the management of type 2 diabetes,
motivational interviewing techniques and program software use. All coaches were employed by a
Flemish home care organisation, “Solidariteit voor het Gezin”.
The intervention group received a welcome package containing a nutrition guide, waist circumference
meter, BMI calculator and a set for self-monitoring of blood glucose (SMBG). Participants were
instructed on how to perform SMBG and interpret the results, and were advised on the measurement
frequency. They were encouraged to perform the necessary check-ups and to discuss with their GP
drug treatment intensification when appropriate. The coaches analysed patient risk profiles based on
the baseline assessment data and consulted GPs on the individual therapeutic goals prior to the start
of the program. After each session, a written coaching report was prepared by the coach and sent to
the participant and his/her GP. The reports contained a comparison between the recommended and
the actual outcomes for diabetes risk factors and an agreed action plan to bridge any resulting gap
[12, 14].
The intervention quality control measurements included a review of coaching reports by IO during the
first three months and selectively thereafter, audio-recording of several sessions, and weekly program
monitoring briefings.
The control group
The control group received usual care. In Belgium, patients on oral glycaemia-lowering drugs are
predominantly treated by their GPs. When insulin therapy needs to be initiated, patients are entitled
to a “diabetes care trajectory” that includes diabetes education by a certified diabetes educator and
an annual consultation with an endocrinologist, in addition to the regular GP visits. People with
49
advanced diabetes, in need of three or more insulin injections per day, are normally treated by an
endocrinologist-led hospital-based diabetes team.
All study participants received a DVD with educational material on type 2 diabetes. The laboratory
results of the blood analysis were mailed to all study participants and their GPs.
Outcome measures
The primary outcome was change in HbA1c from baseline to 6 months after randomisation for the
entire cohort and for a subgroup with HbA1c≥53 mmol/mol (7%) at baseline (further “elevated HbA1c
subgroup”). The secondary outcomes were: change in HbA1c from baseline to 18 months; change in
total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides,
blood pressure (BP), body mass index (BMI), smoking status; change in proportion of people on target
for: HbA1c, LDL, systolic and diastolic blood pressure, and for the composite of these four risk factors;
self-perceived health status, diabetes-specific emotional distress, and satisfaction with diabetes care,
at 6 and 18 months’ follow-up [12].
Change in the annual healthcare utilisation compared to the year preceding the date of the
randomisation was explored, in particular the number of visits to the doctor; the guideline
recommended laboratory tests and the use of diabetes-related medications.
Data collection and analysis
The trial data were collected during the home assessment visits by nurses who were blinded to the
allocation of the trial participants. The blood samples were analysed in a single lab. The protocol of
the data collection is described elsewhere [12]. The data entry was performed by the trial assistants
and was subject to quality control by an external expert. Information on the annual healthcare
utilisation was extracted from the health insurance fund database.
Sample size
Assuming a between-group difference in HbA1c of 3 mmol/mol (0.3%) in the entire cohort and 4
mmol/mol (0.4%) in the elevated HbA1c subgroup, 566 subjects in total, or 283 in each arm, needed
to be recruited. The sample size calculation is described elsewhere [12].
Patient recruitment and randomisation
Patients were selected from the administrative database of the health insurance fund based on the
reimbursement data for glucose-lowering agents during the 12 months preceding the selection day.
Selected patients were sent a letter of invitation and asked to return an attached response card. A
nurse home visit for the baseline assessment was scheduled by phone for those who confirmed the
diagnosis of type 2 diabetes.
50
Randomisation by using a random number generator in Excel was performed by a data analyst in the
Independent Health Insurance Fund who was not involved in the study. Participants were stratified
based on the baseline level of HbA1c: with HbA1c < 7 %, or with HbA1c ≥ 7 %, and allocated to the
intervention or the control group. The trial assistant received the allocation sequence and prepared
the mailing with trial information for the participants and their GPs.
Statistical methods
SAS software, version 9.2 of SAS System for Windows was used. The analysis was conducted by
intention to treat. A general linear model for repeated measures with an unstructured covariance
matrix was used to analyse changes in the continuous outcomes over three measurements points. For
outcomes with a skewed distribution of model residuals, a sensitivity analysis was performed after
applying a transformation on the data. Changes in proportions “being on target” from baseline to 6
and 18 months were compared between both groups using a logistic regression model with
generalised estimating equations (GEE). The baseline characteristics and the outcome measures at
baseline were compared between the drop-outs and the patients available for the follow-up using
Mann Whitney U and Fishers’ exact tests.
Results
Patient recruitment and baseline data
Between April 2012 and June 2013, 3115 patients were identified and invited to take part in the
study; of those, 684 patients (22 %) agreed to participate. The main reasons for exclusion were no
interest in the study (27%), sufficient care by own GP (10%), no diagnosis of type 2 diabetes (9%), or
insufficient proficiency in Dutch (4%). 574 were eligible and received the baseline assessment. Their
median age was 64 years, 62% were men, all were on glucose-lowering drug therapy, of whom 14%
on insulin or insulin–analogues. The average time since diagnosis of type 2 diabetes was seven years;
thirty-four percent reported to have at least one comorbidity. The mean (SD) baseline HbA1c was 53
(11) mmol/mol [7.0 (1.0)%] in all participants and 63 (10) mmol/mol [7.9 (0.9)%] in the elevated
HbA1c subgroup, TC: 176 (38) mg/dl, BP: 133 (17)/75 (10) mmHg, BMI: 30 (5) kg/m2. 287
participants were randomized to the intervention and 287 to the control group (Table 1).
Intervention integrity
Of the 287 participants who were assigned to the intervention group, 85% received all five coaching
sessions. Thirty-two patients (11%) discontinued the intervention prematurely after one to three
sessions, mainly due to lack of time or unavailability for the program, health problems or because
their GP was opposed to the intervention, as reported by the patients. 12 patients (4%) withdrew
from the trial after the baseline assessment, without giving a reason.
Outcomes
51
Loss to follow-up at 6 and 18 months was 11% and 16% in the intervention group and 9% and 14% in
the control group respectively, of which one drop-out in the intervention and four in the control
group were caused by death (Figure 1). There was no difference in baseline characteristics between
the patients with complete follow-up and those with at least one missing value.
Primary outcomes
At 6 months, the mean (SD) HbA1c in the intervention group decreased from 53 (12) to 51 (10)
mmol/mol [6.8 (0.9)%] and stayed unchanged in the control group: 53 (12) mmol/mol [7.0 (1.1)%].
The between-group difference in effect on HbA1c (95% CI) was -2 (-4 to -1) mmol/mol [-0.2 (-0.3 to 0.1)%, P=.003], in favour of the intervention. In the elevated HbA1c subgroup, the mean HbA1c fell
from 63 (11) to 57 (10) mmol/mol [7.4 (0.9)%] in the intervention group and did not change in the
control group: 62 (12) [7.8 (1.1)%]. The between-group difference in HbA1c change in the elevated
HbA1c subgroup comprised -4 (-7 to -2) mmol/mol [-0.4 (-0.7 to -0.2)%, P=.001] (Table 2, Figure 2A).
Secondary outcomes
Within-group improvements in LDL, weight, BMI and systolic blood pressure were observed in both
groups at 6 months. The between-group differences in favour of telecoaching were detected in the
changes of TC (mg/dl): -6 (-11 to -1, P=.012) and BMI (kg/m2): -0.4 (-0.6 to -0.1, P=.003), derived
from the corresponding difference in weight change (kg): -1.1 (-1.9 to -0.4, P=.004) (Table 2).
At 6 months, the proportion of patients on target for the composite of the risk factor targets:
HbA1c<53 mmol/mol (7%), LDL<100 mg/dl, systolic blood pressure <140mmHg and diastolic blood
pressure <80 mmHg, increased by 8.9% in the intervention group and decreased by 1.3% in the
control group, resulting in the between-group OR of 2.02 (1.18 to 3.46, P=.011).
At 18 months, the sustained between-group difference in HbA1c change was -2 (-3 to -0) mmol/mol
[-0.2 (-0.3 to -0.0)%, P=.046] in the entire cohort and -4 (-7 to -1) mmol/mol [-0.4 (-0.7 to -0.1)%,
P=.023] in the elevated HbA1c subgroup (Table 2, Figure 2B). No between-group difference in change
of other outcomes was observed at 18 months, with the exception of the self-perceived health
status (expressed in health utilities): -0.04 (-0.076 to -0.004, P=.029)
There were no missing data on healthcare utilisation. Differences in change of healthcare utilisation
in the year after the randomisation date compared to the previous year were observed in the
intervention and control group respectively in the number of annual endocrinologist consultations:
+35.3% versus -10.5% (P=.023), HbA1c tests: +8.6% versus -12.1% (P<.0001), lipid tests: +7.9%
versus -16.2% (P<.0001) and consumption of lipid modifying agents: +14.4% versus +0.5% (P=.042).
52
Table 1 Baseline characteristics of patients in the intervention and usual care groups
Characteristic
Intervention group (n=287)
Control group (n=287)
Sex, No (%)
Male
173 (60)
180 (63)
Female
114 (40)
107 (37)
Age, years
Mean (SD)
63.8 (8.7)
62.4 (8.9)
65.9 (35–75)
46 (16.0)
197 (68.6)
138 (48.1)
63.9 (35–75)
34 (11.8)
209 (72.8)
136 (47.4)
112 (39)
53 (19)
114 (40)
66 (23)
192 (67)
61 (21)
16 (6)
18 (6)
173 (60)
72 (25)
20 (7)
22 (8)
≤ 2 years
46 (16)
41 (14)
≥ 10 years
Median (range)
Treated with insulin or GLP-1 analogues, N (%)
Treated with lipid modifiers, N (%)
Treated with antithrombotics,
Self-reported
Highest level of education, No (%)
Primary
Tertiary
Employment, No (%)
Retired
Employed
Occupationally disabled
Not active in the labour market
Diagnosis of type 2 diabetes since, No (%)
94 (33)
91 (32)
With regular hypoglycaemia
(mild or moderate episodes at least once a month, No (%)
26 (9)
36 (13)
With one or more comorbidities (s), No (%)
Coronary heart disease
Heart Failure
Myocardial infarction
Stroke
Neuropathy
COPD
Asthma
Depression
92 (32)
35 (12)
21 (7)
11 (4)
11 (4)
10 (4)
11 (4)
13 (5)
19 (7)
103 (36)
39 (14)
14 (5)
13 (5)
4 (1)
16 (6)
16 (6)
20 (7)
24 (9)
53
Figure 1. RCT Flowchart
Discussion
This randomised controlled trial in a Belgian primary care setting demonstrated that tailored nurseled risk factor target-driven telecoaching improves glycaemic control, BMI and total cholesterol in
people with type 2 diabetes at 6 months’ follow-up compared to usual care. At baseline, the study
population was already quite well controlled for most diabetes risk factors. Nevertheless, the
telecoaching intervention resulted in a clinically modest HbA1c reduction by 2 mmol/mol (0.2%) in
the total sample and a clinically significant reduction by 4 mmol/mol (0.4%) in the subgroup of
patients with HbA1c≥53 mmol/mol (7%) at baseline. These improvements in glycaemic control were
still observed at 18 months’ follow-up, i.e. 12 months after the completion of the intervention,
sustainably lowering the mean HbA1c in the intervention group to the recommended target below
53 mmol/mol [16, 17]. In addition, clinically modest improvements in total cholesterol and BMI, and
an increase in the proportion of patients who achieved the guideline recommended treatment
targets for diabetes risk factors were observed in the intervention group compared to controls at 6
months’ follow-up.
54
Table 2. Biochemical, clinical and physiological outcomes. Results from the general linear model for repeated
measures.
CI = 95% confidence interval
Outcomes
Primary outcome:
HbA1c, mmol/mol [%]
Intervention group
N
Mean (SD)
Control group
N
Mean (SD)
Intervention vs Control
Between group
difference in effect,
Mean (CI)
Total sample
53 (12)
286
53 (11)
[7.0 (1.1)]
[7.0 (1.0)]
6 months FU
252
51 (10)
260
53 (12)
-2 (-4 to -1)
[6.8 (0.9)]
[7.0 (1.1)]
[-0.2 (-0.3 to -0.1)]
18 months FU
240
52 (11)
246
53 (12)
-2 (-3 to -0)
[6.9 (1.0)]
[7.0 (1.1)]
[-0.2 (-0.3 to -0.0)]
Elevated HbA1c subgroup: HbA1c ≥ 53 mmol/mol (7%) at baseline
Baseline
130
63 (11)
127
62 (9)
[7.9 (1.0)]
[7.8 (0.8)]
6 months FU
115
57 (10)
113
62 (12)
-4 (-7 to -2)
[7.4 (0.9)]
[7.8 (1.1)]
[-0.4 (-0.7 to -0.2)]
18 months FU
108
57 (11)
108
61 (13)
-4 (-7 to -1)
[7.4 (1.0)]
[7.7 (1.2)]
[-0.4 (-0.7 to -0.1)]
Secondary outcomes, total sample:
Total Cholesterol, mg/dl
Baseline
285
173 (37)
285
178 (39)
6 months FU
252
165 (36)
259
176 (39)
-6 (-11 to -1)
18 months FU
241
162 (34)
246
170 (49)
-3 (-9 to 3)
LDL-Cholesterol, mg/dl
Baseline
276
93 (31)
277
97 (32)
6 months FU
247
86 (28)
254
93 (31)
-3 (-7 to 1)
18 months FU
237
83 (29)
239
87 (30)
1 (-4 to 5)
HDL-Cholesterol, mg/dl
Baseline
285
52 (16)
284
51 (14)
6 months FU
250
53 (15)
258
53 (16)
-1 (-2 to 1)
18 months FU
241
52 (15)
246
52 (15)
-1 (-3 to 0)
Triglycerides, mg/dl
Baseline
285
149 (111)
285
160 (152)
6 months FU
252
142 (154)
247
165 (279)
-15 (-37 to 7)
18 months FU
241
141 (100)
246
169 (270)
-15 (-35 to 6)
Systolic BP, mmHg
Baseline
287
133 (18)
284
132 (17)
6 months FU
256
128 (16)
260
130 (16)
-2 (-5 to 1)
18 months FU
241
128 (14)
247
130 (15)
-2 (-5 to 1)
Diastolic BP, mmHg
Baseline
287
75 (10)
284
76 (10)
6 months FU
256
74 (9)
260
75 (9)
0 (-2 to 2)
18 months FU
241
75 (9)
247
76 (9)
0 (-2 to 2)
Body Mass Index, kg/m2
Baseline
285
30.2 (4.9)
283
30.6 (5.2)
6 months FU
256
29.6 (4.9)
259
30.4 (5.1)
-0.4 (-0.6 to -0.1)
18 months FU
238
29.9 (5.0)
246
30.4 (5.1)
-0.1 (-0.4 to 0.2)
Weight, kg
Baseline
285
86.1 (16.9)
283
88.3 (16.6)
6 months FU
256
84.8 (16.4)
259
87.0 (15.9)
-1.1 (-1.9 to -0.4)
18 months FU
238
85.9 (16.6)
246
87.3 (15.4)
-0.2 (-1.2 to 0.8)
Baseline
286
55
P
value
0.867
0.003
0.046
0.421
0.001
0.023
0.113
0.012
0.278
0.087
0.116
0.694
0.530
0.364
0.146
0.472
0.188
0.156
0.750
0.256
0.239
0.298
0.842
0.867
0.255
0.003
0.602
0.140
0.004
0.690
Figure 2. Estimates and 95% confidence intervals of the mean HbA1c at three measurement points from the
general linear model for repeated measures.
Figure 2A. In the entire cohort
Figure 2B. In the elevated HbA1c subgroup.
56
Figure 3. Percentage of patients in target (and 95% confidence intervals) for the composite of HbA1c, LDL and
systolic and diastolic blood pressure at three measurement points. Results are obtained from the logistic
regression model with GEE.
The intervention effect on BMI was comparable with that achieved with The COACH Program in
people with established coronary heart disease [11]. Programs of a higher intensity and with a more
explicit focus on changes in physical activity might be necessary to achieve a greater decrease in the
body mass index [18].
No post-intervention between-group difference in self-perceived health status, diabetes-specific
emotional distress and diabetes treatment satisfaction was shown. One explanation may be a
limited capacity of the generic health survey EQ-5D to detect minor differences in health status in
the short term, and in diabetes treatment satisfaction – already a high level of satisfaction at
baseline. This may also imply that a once- or twice-a-week self-control scheme for the monitoring of
blood glucose recommended by our program to patients not treated with insulin, was not perceived
as a burden, in contrast to more intensive self-monitoring regimens, which resulted in worsening of
self-perceived quality of life and diabetes health distress [19,20]. Adding blood glucose selfmeasurement to a telephone support program has previously shown to significantly improve
glycaemic control when compared to telephone support without self-monitoring [21].
An important confounder of the intervention effect is patient and GP ability to overcome the clinical
inertia and to escalate treatment when appropriate. Analysis of the health insurance data in the year
before and after randomisation demonstrated an increase in endocrinologist consultations, guideline
recommended tests and consumption of lipid modifying agents in the intervention group compared
to controls. Lack of the between-group difference in a change of hypoglycaemic agent consumption
suggests that patient lifestyle adjustment caused the improvement in glycaemic control.
57
The effect on the glycaemic control achieved with telecoaching in the elevated HbA1c subgroup is
comparable to the effect reported by several reviews [7,9]. However, a positive effect on glycaemic
control was previously observed only in subgroups with HbA1c ≥ 8% at baseline, not in all patients
[7]. A loss of the achieved effect within one to three months after the completion of educational
interventions offered in individual and group setting was reported [9].
Until now, most nurse-led telecoaching programs have been unsuccessful in improving glycaemic
control, even though the patients recruited to the scheme had an elevated HbA1c at baseline [22–
25]. However, according to the intervention delivery reporting in two of the trials, the coaching was
not offered to patients as initially planned and/or medication intensification was not sufficiently
addressed [22,23].
A comparison of our telecoaching program with another successful telephone intervention for
diabetes self-management support [26] reveals a number of common features, such as delivery by
trained diabetes educators under the supervision of a senior nurse; tailored session content focused
on patient empowerment; goal setting and negotiation of an action plan that includes appropriate
medical visits, lifestyle adjustments and medication adherence. Educational concepts based on
behavioural change counselling and targeting incremental measurable performance
accomplishments look promising [27].
The main strength of our trial is its internal validity. Patients were invited to take part in the study
directly and all outcome measures were analysed in a single laboratory, independently of the
primary care providers. Acceptance of intervention by the GPs and patients and the quality
monitoring ensured that The COACH Program could be delivered as initially planned to most
participants of the intervention group.
There are possible limitations to the generalisability of the study results. Assuming a reasonable level
of cognitive perception required for a meaningful interaction with the coach, we excluded from the
study people above 75 years of age, those with debilitating co-existing conditions and people with
insufficient proficiency in Dutch. The enrolment rate of 22% may imply positive self-selection and a
need for more insight into the reasons for non-participation. Socially disadvantaged people and those
with limited language skills may present challenges to goal-based care and require more intensive
modes of support (2,28). Research on the acceptance of telecoaching by patients and providers and a
cost-effectiveness analysis will be published elsewhere and will guide the decisions on further
implementation modes.
58
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60
Chapter 4. Delivering diabetes education through nurse-led telecoaching:
Cost-effectiveness analysis.
Odnoletkova I, Ramaekers D., Nobels F., Goderis G, Aertgeerts B, Annemans L. Delivering diabetes education
through nurse-led telecoaching: Cost-effectiveness analysis.
Submitted.
61
Abstract
People with diabetes have a high risk of developing micro- and macrovascular complications
associated with loss in life expectancy and elevated treatment costs. Patient education programs can
improve diabetes control in a short term, but their cost-effectiveness is uncertain. Our study aimed
to analyse the lifelong cost-effectiveness of a nurse-led telecoaching programme compared to usual
care in people with type 2 diabetes from the perspective of the Belgian healthcare system.
The UKPDS Outcomes Model was populated with patient-level data from a 18-months randomized
clinical trial in the Belgian primary care involving 574 participants; trial data were extrapolated to 40
years; Quality Adjusted Life Years (QALYs), treatment costs and Incremental Cost-Effectiveness Ratio
(ICER) were calculated for the entire cohort and the subgroup with poor glycemic control at baseline
(“elevated HbA1c subgroup”), and the associated uncertainty explored.
The cumulative mean QALY (95% CI) gain was 0.21 (0.13; 0.28) overall and 0.56 (0.43; 0.68) in
elevated HbA1c subgroup, the respective incremental costs were €1,147 (188; 2,107) and €2,565
(654; 4,474) and the ICERs €5,569 (€677; €15,679) and €4,615 (1,207; 9,969) per QALY. In the
scenario analysis, repeating the intervention for lifetime had the greatest impact on the costeffectiveness and resulted in the mean ICERs of €13,034 in the entire cohort and €7,858 in the
elevated HbA1c subgroup.
Taking into account reimbursement thresholds applied in West-European countries, nurse-led
telecoaching of people with type 2 diabetes may be considered highly cost-effective within the
Belgian healthcare system.
62
Introduction
About 387 million people worldwide have diabetes and its prevalence is expected to increase by
more than 50% in the coming twenty years (1). People with diabetes have a high risk of developing
cardiovascular disease, kidney failure, neuropathy and retinopathy, that is associated with loss in life
expectancy and health related quality of life and elevated treatment costs (2,3). About 90% of the
diabetes population suffers from type 2 diabetes. Appropriate life style adjustments, medication
adherence and regular risk factor control are recommended to achieve sustainable treatment results
in type 2 diabetes (3,4). Patient education aimed at diabetes self-management optimization has
been shown to improve diabetes knowledge, self-efficacy and risk factor control (5-7).
Empowerment models are believed to improve the outcomes of diabetes education programs (3).
However, the knowledge generated until today does not form a sufficient evidence base for a
general recognition of specific program features as beneficial in terms of their clinical and costeffectiveness (8-10). The economic evaluations of patient education in type 2 diabetes demonstrated
a broad range of results, from cost-saving to not cost-effective at all, while the quality of the studies
as well as the underlying clinical evidence varied (11). Further local context-driven high-quality field
research in this area is needed to support policy makers in their choice of appropriate patient
support strategies within the budgetary constraints.
The clinical and cost-effectiveness of diabetes education was not previously assessed in Belgium.
Reimbursed education by diabetes nurse educators has been offered in Belgian ambulatory care
setting and is mainly focused on training in self-administration of insulin and analogues in people in
need of injectable antidiabetic agents. The majority of non-insulin dependent patients is currently
not offered structured self-management support programs. Telecoaching, i.e. empowerment and
support on distance with use of information and communication technologies, has a potential to
ensure a better patient inclusion in diabetes education, while keeping down the nurse – and patient
transport costs.
In 2012, the Independent Health Insurance Fund of Belgium set up a pragmatic randomized clinical
trial to investigate the effect of nurse-led telecoaching on diabetes risk factor control among its
affiliates with type 2 diabetes. Their claims data were used for the economic evaluation of the
intervention. The COACH Program, originally from Australia, was for the first time tested in Europe
and demonstrated a sustainable improvement in diabetes control (12). The results of the
randomized trial are published elsewhere (13).
63
The objective was to analyse the lifelong cost-effectiveness of “The COACH Program”, a nurse-led
risk factor target driven telephone self-management support program compared to usual care, in
people with type 2 diabetes in Belgium, from the perspective of the healthcare system.
Methods
Study design
A Markov simulation model with a time horizon of 40 years was populated with patient-level data
from a 18-months randomized clinical trial in the Belgian primary care setting involving 574 type 2
diabetes patients (13). Belgian guidelines for health economic evaluations were followed in
methodology and the Consolidated health economic evaluation reporting standards (CHEERS) in
reporting (14, 15).
Intervention
The COACH Program is a risk factor target driven telephone counselling intervention delivered by
diabetes nurse educators, after having followed a one-week training. It consists of five telephone
sessions of 30 minutes on average, spread over 6 months, focused at achieving guidelinerecommended diabetes treatment targets through regular control of diabetes risk factors including
self-monitoring of blood glucose, appropriate lifestyle adjustments and intensification of medication
therapy upon a patient consultation with the patient’s GP (13).
Comparator
The comparator was usual care. In Belgium, people with type 2 diabetes are treated by their GPs.
When insulin therapy needs to be initiated, the care team is extended by a certified diabetes educator
and endocrinologist. Patients with advanced diabetes, in need of three or more insulin injections per
day, are usually treated by an endocrinologist-led hospital-based diabetes team.
Patients
People between the ages of 18 and 75 with diagnosis of type 2 diabetes and on diabetes medication
therapy were invited into the study by their health insurance fund based on the reimbursement data
of glucose-lowering agents in the preceding 12 months. Exclusion criteria comprised patients on
corticoid therapy and/or with a debilitating coexisting medical condition such as dialysis, mental
illness, or cancer (13).
Study horizon
A lifetime prospective modeling was performed with a time horizon of 40 years (16). In addition,
model predictions at time horizons between 1 and 40 years were explored.
Analytic perspective
64
The perspective of the Belgian health care system was applied, i.e. direct health care costs to the
system including both the cost for the health insurance as the patient out-of-pocket costs were
included. Indirect and/ or non-medical costs were not included into the analysis (14).
Outcome Measures
Incremental cost-effectiveness ratio (ICER), Life Expectancy, Quality Adjusted Life Years (QALYs) and
cost of diabetes and its complications. These analysis were performed for the entire cohort as well as
for a subgroup of patients with inadequate glycaemic control at baseline, i.e. glycated heamoglobin
(HbA1c) ≥7%, in line with the clinical trial analysis (13).
Modeling
The UKPDS Outcome Model was applied for projecting effects observed within the clinical trial over a
life-time horizon. It models the occurrence of seven diabetes-related end points: Ischaemic Heart
Disease (IHD), Myocardial infarction (MI), stroke, heart failure, amputation, End-Stage Renal Disease
(ESRD), blindness and death in people with type 2 diabetes to estimate life expectancy, qualityadjusted life expectancy and costs. The model algorithms are based on the observations of the UK
Prospective Diabetes Study (UKPDS) participants who were followed up for between six and twenty
years (16). The model uses an integrated system of parametric equations and predicts the annual
probability of any of the above end points by using risk factors that include age, sex, ethnicity,
duration of diabetes and history of diabetes-related complications, height and weight, smoking
status, total cholesterol, HDL cholesterol, systolic blood pressure and HbA1c (17). The model
structure as well as the algorithms for the sequence of events and the parametric equations used
within the UKPDS Outcome Model are described in detail elsewhere (16). The change in the
modifiable risk factor values (smoking status, total cholesterol, HDL cholesterol, systolic blood
pressure and HbA1c) is modelled based on the observations within the UKPDS study, by predicting
the annual point estimates and the associated 95% confidence intervals. The occurrence of events is
predicted by Monte Carlo methods (17).
The model has undergone internal and external validation (16). Developed using data from patients
with newly-diagnosed type 2 diabetes, it proved to generate results close to those observed in
clinical trials on patients in different stages of type 2 diabetes in a cross-validation exercise (18). The
model is freely available for academic research, as a pre-programmed Excel 2010 file.
Clinical trial
The randomized clinical trial (RCT) underlying this economic evaluation, enrolled 574 Dutch speaking
independently living affiliates of the Flemish Independent Health Insurance Fund “Partena”. 287
patients were assigned to the intervention and 287 to the control group. Their median age was 64
years, 62% were men, all were on glucose-lowering medication therapy whereof 14% on insulin or
analogues. The average duration of type 2 diabetes was 7 years, 34% of patients had at least one
65
comorbidity. The baseline characteristics of the trial participants are described in detail elsewhere
(13).
The primary outcome measure was the mean absolute change in HbA1c at 6 months in the entire
study group and the subgroup with HbA1c≥7% (further “elevated HbA1c subgroup”) at baseline.
Secondary outcomes were: change in HbA1c at 18 months; change in total cholesterol, low-density
lipoprotein, high-density lipoprotein, triglycerides, blood pressure , body mass index, smoking status,
self-perceived health status, at 6 and 18 months follow-up.
At 6 months, the between-group difference in HbA1c change was -0.2 (-0.3 to -0.1, P=.003) overall
and -0.4 (-0.7 to -0.2, P=.001) in the elevated HbA1c subgroup, in favor of the intervention. Other
between-group differences in change were observed at 6 months in BMI (kg/m2): -0.4 (-0.6 to -0.1,
P=.003) and TC (mg/dl): -6 (-11 to -1, P=.012). At 18 months follow-up, i.e. 12 months after the
completion of the intervention, the improvement in HbA1c sustained: -0.2 (-0.3 to -0.0, P=.046) in
the total sample and -0.4 (-0.7 to -0.1, P=.023) in the elevated HbA1c subgroup. No other betweengroup differences were observed at 6 and 18 months follow-up.
Data input
Clinical data
The data collected within the clinical trial were incorporated in the model for each patient of both
trial arms: age, sex, ethnicity, duration of diabetes, history of diabetes-related complications, height
and weight at baseline as well as smoking status, total cholesterol, HDL cholesterol, systolic blood
pressure and HbA1c outcomes at all three measurement points (Table 1A and 1B).
Table 1. Trial participants’ data Incorporated in the UKPDS Model.
A. Baseline characteristics
Characteristic
Intervention group (n=287)
Male, No (%)
Age, years: Median (range)
Control group (n=287)
173 (60)
65.9 (35–75)
180 (63)
63.9 (35–75)
≤ 2 years
46 (16)
41 (14)
≥ 10 years
94 (33)
91 (32)
92 (32)
35 (12)
21 (7)
11 (4)
11 (4)
103 (36)
39 (14)
14 (5)
13 (5)
4 (1)
Diagnosis of type 2 diabetes since, No (%)
With one or more comorbidities (s), No (%)
Ischaemic heart disease
Heart Failure
Myocardial infarction
Stroke
66
B. Risk factor outcomes at three measurement points.
Baseline
Year 1
Risk factor,
Intervention Control
Intervention Control
Mean (SD)
HbA1C (%), all
7.0 (1.1)
7.0 (1.0)
6.8 (0.9)
7.0 (1.1)
HbA1c (%), subgroup 7.9 (1.0)
7.8 (0.8)
7.4 (0.9)
7.8 (1.1)
Weight (kg)
86.1 (16.9)
88.3(16.6)
84.8 (16.4)
87.0(15.9)
BMI (kg/m2)*
30.2 (4.9)
30.6 (5.2)
29.6 (4.9)
30.4 (5.1)
Total Cholesterol
173 (37)
178 (39)
165 (36)
176 (39)
(mg/dl)
HDL-Cholesterol
52 (16)
51 (14)
53 (15)
53 (16)
(mg/dl)
Systolic BP (mmHg)
133 (18)
132 (17)
128 (16)
130 (16)
Non-smokers (%)
85.7%
80.7%
87.8%
81.3%
*Height and weight were required only at baseline and not in the subsequent years.
Year 2
Intervention
Control
6.9 (1.0)
7.4 (1.0)
85.9 (16.6)
29.9 (5.0)
162 (34)
7.0 (1.1)
7.7 (1.2)
87.3 (15.4)
30.4 (5.1)
170 (49)
52 (15)
52 (15)
128 (14)
88.6%
130 (15)
84.0%
Cost data
The mean annual total healthcare cost in diabetes patients without complications at baseline (95%
CI) was €3,921 (3,216; 4,627). It was calculated as mean of the sum of the healthcare system costs
and the legally imposed patient contributions in the subgroup of all trial participants without selfreported comorbidities, in the year prior to the date of the randomization. The claims database of
the sickness funds was used as the data source.
The health care costs associated with each fatal or non-fatal diabetes-related complication in the year
of the event and in the subsequent years were collected from country-specific published sources (1926). All costs were updated to 2013 Euros by using the Belgian health care inflation rates (27) (Table
2).
Health utilities
The initial utility level, derived from self-reporting of the trial participants using the EQ-5D 3-L
questionnaire and calculated as overall sample mean at baseline based on the Flemish utility value
system, was 0.785 (0.765; 0.805) (14,28) and did not deviate from the baseline utility level observed
within UKPDS. Utility decrements for each of the seven diabetes-related complications at time of event
were adopted from the UKPDS Outcome Model and in the subsequent years from other published
research that used the same questionnaire, i.e. EQ-5D 3-L and the UK utility value system (29-33)
(Table 2).
Discounting future costs and outcomes
Future costs were discounted at 3.0 %, future QALYs gained at 1.5 % per annum (14).
67
Table 2. Data input in the UKPDS Outcome Model: Treatment costs of diabetes and complications
and associated health utilities.
Ischemic heart
disease (CHD)
Myocardial
infarction
Heart failure
Stroke
Diabetes related
foot amputation
Diabetes related
blindness
End stage renal
disease
Fatal
(acute)
Non-fatal
(at the time of
event, acute)
Cost in
subsequent
years
€6,044 (20)
Utility
decrement at
diagnosis
(event)
-0.09 (29)
Utility
decrement in
subsequent
years
-0.046 (32)
N.A.
€10,976 (19)
€3,829
(25; 26)
€10,416
(19)
€16,658
(21)
€46,387
(22)
N.A.
€7,989 (19)
€6,044 (20)
-0.055 (29)
-0.032 (32)
€10,416 (19)
€7,431 (21)
-0.108 (29)
-0.05 (32)
€16,658 (21)
€6,030 (20)
-0.164 (29)
-0.061 (32)
€46,387 (22)
€781(22)
-0.280 (29)
-0.13 (33)
€5,382 (23)
5,382 (23)
-0.175 (30)
-0.175 (30)
57,078
(24)
57,078 (24)
57,078 (24)
-0.263 (31)
-0.248 (32)
Incremental costs of the intervention
The incremental cost of the intervention was calculated as sum of three components: 1) incremental
long-term costs forecasted with the UKPDS Outcome Model, 2) incremental costs in the year of the
trial, and 3) costs of the intervention itself.
Within-trial incremental costs
Since the intervention is intended to optimize medical management, it was expected that costs of
care in the intervention arm would increase during the year of the trial compared to the year
preceding the trial. The annual mean baseline healthcare costs, i.e. total healthcare costs in the year
preceding the randomization date, was €5,543 in the intervention and €4,101 in the control group
and in the year of the trial €5,516 and 4,757 respectively. After a regression based adjustment for
the between-group difference at baseline (34), the costs in the year of the trial were €5,181 and
€5,092 respectively, implying an incremental cost caused by the intervention of €90. In the elevated
HbA1c subgroup, the incremental within-trial intervention costs were €244 (Table 3).
Hospitalizations affected 19% and 15% of patients in the intervention and control group at baseline,
accounting for 33% and 23% of total costs, respectively. In the year of the trial, the change in total
annual healthcare costs by -1% in the intervention group and by +16% in the control group was
strongly associated with the change in hospitalization costs (R2=.930, P<.001). As the opposite trend
in the change of hospitalization costs observed in the trial arms could have occurred by chance, an
68
Table 3. Calculation of the total and ambulatory incremental within-trial healthcare costs associated
with the intervention, in the entire cohort and the elevated HbA1c subgroup.
Healthcare costs
Group
Total sample
Elevated HbA1c subgroup
Intervention
Control
Intervention
Control
Total annual healthcare costs, € (95% CI)
Baseline year
Trial year
Trial year, baselineadjusted*
Incremental
intervention costs
5,543 (4,410;6,677)
4,101 (3,375;4,827)
4,587 (3,620; 5,554)
4,051 (3290; 4,811)
5,516 (4,630;6,402)
4,757 (3,892;5,622)
5,525 (4,350; 6,700)
5,008 (3,763; 6,253)
5,181 (4,398;5,964)
5,092 (4,362;5,821)
5,390 (4,347; 6,432)
5,146 (3,940; 6,353)
90 (36; 143)
N.A.
244 (79; 407)
N.A.
Baseline year
Trial year
Trial year, baselineadjusted*
Incremental
intervention costs
3,697 (3,106; 4,288)
3,148 (2,804; 3,492)
3,397 (2,779; 4,015)
3,066 (2,642; 3,490)
4,012 (3,437; 4,587)
3,271 (2,909; 3,633)
3,898 (3,319; 4,478)
4,457 (2,987; 3,927)
3,777 (3,499; 4,054)
3,507 (3,304; 3,711)
3,768 (3,410; 4,125)
3,598 (3,310; 3,867)
270 (395; 343)
N.A.
179 (100; 258)
N.A.
Ambulatory annual healthcare costs, € (95% CI)
*Regression based adjustment for the between-group difference in baseline costs on the observed data, equation:
𝐴𝑑𝑗
𝐻𝐶𝑖2 = 𝐻𝐶𝑖2 − 𝛽(𝐻𝐶𝑖1 − ̅̅̅̅̅
𝐻𝐶1 ), with i=1,2 being the group indicator and 𝛽 obtained from a regression of 𝐻𝐶2 on
𝐻𝐶1 , being the health care cost in the year of the trial and at baseline, respectively) (34)
identical adjustment as described above was performed, however now considering ambulatory costs
only. This resulted in a within-trial ambulatory incremental intervention cost of €270 overall and
€179 in the elevated HbA1c subgroup (Table 3). In the year of the trial, the ambulatory costs
increased by 9% and 4% in the intervention and control group respectively. A change was observed
in the intervention and control group respectively, in the number of endocrinologist consultations:
+35% and -10% (P=.023), HbA1c tests: +9% and -12% (P<.001), lipid tests: +8% and -16% (P<.001) and
consumption of lipid modifying agents (measured in number of daily defined doses): +14% and +1%
(P<.001) (13).
To pursue a conservative methodological approach (14), the highest obtained within-trial
incremental intervention costs were used in the basecase scenario, i.e. €270 for the entire cohort
and €244 for the elevated HbA1C subgroup.
Costs of the intervention
The average operational program cost was €300.3 per patient (Table 4). It consisted of the
recruitment costs, fixed costs (software hosting and maintenance) and variable costs (program
material: nutrition guide, a tape to measure waist circumference and a set for self-monitoring of
blood glucose; patient license fee; actual nurse time spent on coaching and administration;
telephone and mailing costs). All costs were registered prospectively during the trial based on the
individual time and material registration and the contractual prices. The initial investment costs,
such as a 5-day full time nurse training, program translation and technical set-up were not included
in the analysis as, allocated to a limited number of patients, they would skew the per-patient
69
program costs. Instead, the potential variability of the program costs was explored in the sensitivity
analysis. Costs imposed by the study that are not part of routine practice, such as protocol-driven
nurse assessment visits and laboratory tests, were not included into the analysis.
Table 4. Costs of the COACH Program.
Type of costs
Total cost
Recruitment:
Mailing to 3115 patients and their GPs
Fixed costs:
Software hosting, per year
Variable costs:
Welcome package
Software license
Nurse time (5.5 hours)
Communication (telephone and mailing)
Total Program costs
Costs per patient
(N=287)
€3,900.0
€13.6
€3,790.0
€78,494.5
€13.2
€86,184.5
€20.0
€50.0
€192.5
€11.0
€300.3
Incremental effects of the intervention
Difference in Quality Adjusted Life Expectancy between the intervention and control group with
associated 95% confidence intervals was calculated by the UKPDS Outcomes Model and a bootstrap
simulation using 999 probability samples (the maximum number of bootstraps programmed within
the model).
Incremental cost-effectiveness ratio
The ICER was calculated as a ratio between the mean incremental costs and the mean incremental
QALYs of the intervention group versus controls. The 95% confidence interval of the ICER was
calculated by using the upper and lower confidence levels of incremental costs and utilities obtained
with the probabilistic sensitivity analysis programmed within the UKPDS Outcomes Model. In
addition to the basecase 40 years time horizon, ICERs were calculated at 1, 2, 5 years and further at
each 5 year interval.
Handling missing data and analysis of uncertainty
The RCT loss to follow-up at 6 and 18 months was 11% and 16% in the intervention group and 9%
and 14% in the control group respectively (13). For the missing clinical data, a single imputation
technique was applied using Statistics Analysis System (SAS, version 9.2), i.e. for each of the
variables: smoking status, total cholesterol, HDL cholesterol, systolic blood pressure, HbA1c, age and
diabetes duration, the mean value was imputed conditional on the other observed values, assuming
a multivariate normal distribution. There were no missing claims data.
The parameter – and methodological uncertainty was handled by one-way sensitivity analysis and
presented in a Tornado diagram illustrating the impact of different scenarios on the value of ICER. The
70
following scenarios were explored: 1) the program costs varied by 50%; 2) the costs of complications
varied by 50%; 3) the upper and lower confidence levels of utility decrements; 4) discount rates for
costs and effects set to 0% and to 5%; 5) the effect of the intervention disappearing beyond 18 months,
or staying unchanged for lifetime; 6) the intervention repeating bi-annually for 20 years, to sustain the
achieved effect.
Presentation of results
The results of the base case analysis are presented on a cost-effectiveness plane and probability of
willingness to pay by the Belgian health care system in a cost-effectiveness acceptability curve. The
results of the one-way sensitivity analysis are shown in a Tornado diagram.
Results
In the base case scenario analysis of the entire cohort data, the UKPDS Outcomes Model (further
“Model”) calculated a mean Life Expectancy (95% CI) of 10.52 (9.61; 11.44) years in the intervention
group versus 10.26 (9.36; 11.16) in the control group, corresponding with Quality Adjusted Life
Expectancy of 8.04 (7.36; 8.71) versus 7.83 (7.17; 8.49) respectively and implying 0.21 (0.13; 0.28)
QALYs gained with the COACH Program. At 40 years horizon, the Model forecasted a cumulative
decrease in the event rate in the intervention group by 0.2% for IHD, 0.9% for MI, 1.3% for heart
failure, 0.8% for stroke and 0.3% for all-cause death (Table 5). The long-term treatment cost of
diabetes and complications computed by the Model was respectively €57,226 (50,408; 64,044) and
€56,649 (49,939; 63,358). After adding the incremental within-trial costs and the cost of the
intervention, the mean total incremental long-term cost in the intervention group was €1,147 (188;
2,107). The mean ICER (95% CI) was €5,569 per QALY (€677; €15,679), with a 2.0% probability that
the intervention is cost-saving and a 98.2% probability that the ICER lies below the threshold of
€10,000 per QALY (Figures 1, 2).
In the elevated HbA1c subgroup, the Model predicted a Life Expectancy of 10.05 (9.15; 10.96) in the
intervention and 9.33 (8.47; 10.19) in the control group and the Quality Adjusted Life Expectancy of
7.66 (6.99; 8.33) and 7.10 (6.47; 7.74) respectively, meaning a QALY gain of 0.56 (0.43; 0.68)
achieved with The COACH Program. The modelled long-term treatment costs were €55,876 (48,947;
62,805) in the intervention and €53,855 (47,095; 60,614) in the control group, resulting in an
incremental total long-term costs of €2,565 (654; 4,474) and an ICER of €4,615 (1,207; 9,969). The
probability that the intervention would be cost-saving in people with poorly controlled HbA1c was
0.3%, while the chance that the ICER lies below the threshold of €10,000 per QALY equalled 100%
(Figures 1, 2).
An inverse relationship was observed between the ICER values and the applied time horizon in the
entire cohort, with €811,250 per QALY in the first year after the program delivery and a steep fall to
€84,455 in year five, €30,868 in year ten; €9,880 and €6,212 in year twenty and thirty respectively. In
the elevated HbA1c subgroup, the ICER was €52,680 per QALY in the first year after the trial, €10,201
in the second year, and did not exceed the value of the 40-time horizon, at any of other simulated
years (Figure 3).
71
Table 5. Cumulative event rates from modelling simulation at 5, 10, 20, 30 and 40 years.
Complications
Ischaemic
heart disease
Year
5
10
20
30
40
Myocardial
5
infarction
10
20
30
40
Heart failure
5
10
20
30
40
Stroke
5
10
20
30
40
Amputation
5
10
20
30
40
Blindness
5
10
20
30
40
Renal Failure
5
10
20
30
40
All cause death 5
10
20
30
40
Intervention group
Entire
Subgroup
cohort
0.0193
0.0213
0.0400
0.0448
0.0657
0.0700
0.0723
0.0762
0.0735
0.0779
0.1140
0.1316
0.1988
0.2207
0.2820
0.3005
0.3009
0.3212
0.3041
0.3246
0.0365
0.0398
0.0720
0.0756
0.1139
0.1197
0.1230
0.1303
0.1245
0.1317
0.0464
0.0525
0.0863
0.0925
0.1281
0.1338
0.1370
0.1423
0.1379
0.1432
0.0032
0.0036
0.0075
0.0102
0.0153
0.0186
0.0186
0.0221
0.0193
0.0224
0.0246
0.0288
0.0451
0.0446
0.0648
0.0615
0.0692
0.0652
0.0695
0.0658
0.0023
0.0028
0.0062
0.0060
0.0118
0.0118
0.0141
0.0144
0.0147
0.0155
0.2705
0.3010
0.4894
0.5274
0.8160
0.8267
0.9539
0.9490
0.9951
0.9945
Control group
Entire
Subgroup
cohort
0.0220
0.02453
0.0451
0.0499
0.0690
0.0730
0.0747
0.0763
0.0752
0.0772
0.1142
0.1276
0.2025
0.2118
0.2921
0.2955
0.3108
0.3088
0.3129
0.3095
0.0415
0.0469
0.0799
0.0873
0.1262
0.1317
0.1362
0.1398
0.1373
0.1401
0.0506
0.0557
0.0917
0.0999
0.1357
0.1429
0.1453
0.1505
0.1461
0.1508
0.0028
0.0044
0.0070
0.0095
0.0152
0.0182
0.0178
0.0210
0.0184
0.0213
0.0256
0.0270
0.0456
0.0467
0.0656
0.0671
0.0698
0.0706
0.0702
0.0712
0.0024
0.0025
0.0059
0.0063
0.0115
0.0111
0.0140
0.0130
0.0145
0.0130
0.2762
0.3141
0.4943
0.5411
0.8251
0.8673
0.9673
0.9836
0.9981
0.9998
Difference (I-C)
Entire
Subgroup
cohort
-0.0028
-0.0032
-0.0051
-0.0051
-0.0033
-0.0031
-0.0024
-0.0001
-0.0017
0.0007
-0.0002
0.0040
-0.0038
0.0089
-0.0101
0.0051
-0.0099
0.0125
-0.0088
0.0152
-0.0050
-0.0071
-0.0079
-0.0117
-0.0123
-0.0120
-0.0132
-0.0095
-0.0128
-0.0084
-0.0042
-0.0032
-0.0054
-0.0075
-0.0076
-0.0090
-0.0083
-0.0082
-0.0082
-0.0076
0.0003
-0.0008
0.0005
0.0007
0.0002
0.0004
0.0008
0.0010
0.0009
0.0011
-0.0009
0.0017
-0.0006
-0.0021
-0.0008
-0.0057
-0.0006
-0.0055
-0.0007
-0.0054
-0.0001
0.0003
0.0003
-0.0003
0.0003
0.0008
0.0001
0.0014
0.0002
0.0025
-0.0056
-0.0132
-0.0050
-0.0137
-0.0092
-0.0407
-0.0135
-0.0346
-0.0030
-0.0052
Abbreviations: C=Control group; I-Intervention group; NNT=Number Needed to Treat
72
NNT
Entire
cohort
357
196
303
417
588
5000
263
99
101
114
200
127
81
76
78
238
185
132
120
122
179
200
109
74
333
Figure 1. Cost-effectiveness plane based on 999 bootstraps of costs and QALYs.
Bootstrapping results of the entire cohort and the elevated HbA1c subgroup, basecase analysis with
40 years time horizon.
Figure 2. Cost-effectiveness acceptability curves for the COACH Program based on the Monte Carlo
simulation of data from the entire cohort and the subgroup with poorly controlled HbA1c at
baseline. Baseline analysis with 40 years time horizon.
73
Figure 3. ICER of The COACH Program as a function of the applied time horizon. Results for the entire
cohort and the elevated HbA1c subgroup.
The one-way sensitivity analysis demonstrated a lifetime QALY gain in the intervention group in all
applied scenarios, with a variability of the ICER between €4,168 and €13,034 per QALY in the entire
cohort and between €2,629 and €7,858 per QALY in the elevated HbA1c subgroup. With the
assumption that the effect of the intervention disappeared beyond 18 months, the calculations
showed a mean incremental QALY of 0.14 in the entire cohort and 0.53 in the elevated HbA1c
subgroup, with the respective ICERs of €4,556 and €3,336 per QALY. Assuming that the effect stayed
unchanged for lifetime, the QALY gained with telecoaching were 0.32 and 0.67, and the ICERs €5,198
and €5,586 per QALY, respectively. The hypothesis that the intervention needs to be repeated biannually for lifetime, to sustain the achieved effect, had the greatest impact on the cost-effectiveness,
followed by varying the cost of diabetes complications (Figures 4A and 4B).
Discussion
The cost-effectiveness analysis of The COACH Program adapted to the Belgian primary care setting
and performed by populating the UKPDS Outcomes Model with the data of the randomized clinical
trial participants, showed a mean QALY gain of 0.21 in the entire cohort and 0.56 in the subgroup
with poorly controlled HbA1c at baseline. The mean ICER in the respective study cohorts was €5,569
and €4,615 per QALY, with 2.0% and 0.3% respective probabilities for telecoaching to be cost-saving
and 98.2% and 100% probabilities that the value of ICER lies below the threshold of €10,000 per
QALY. A gain in QALYs was demonstrated in all scenarios. The assumption that the telecoaching
program needs to be repeated bi-annually for lifetime, to sustain the achieved effect, had the
greatest impact on the ICER: €13,034 and €7,858 in the entire cohort and the elevated HbA1c
subgroup respectively. A greater QALY gain in patients with a poor glycaemic control had little
74
impact on the ICER in this subgroup, as higher incremental QALYs were associated with higher
incremental treatment costs.
Figure 4. One-Way Sensitivity Analysis showing the influence of changing different parameters on
the long-term cost-effectiveness.
A. In the entire cohort
B. In the subgroup with poorly controlled HbA1c at baseline.
Though application of a single ICER threshold in the national reimbursement decisions is not
common (35), the World Health Organization recommends to consider health technologies with the
75
ICER below the value of the gross domestic product (GDP) per capita as very cost-effective (36). With
the GDP above €43,000 (37), the target-driven nurse-led telecoaching of people with type 2 diabetes
has a high potential of being considered cost-effective within the Belgian healthcare system.
The results are comparable with those obtained in the cost-effectiveness study of diabetes group
education in the UK, where a lifetime prediction with the Sheffield diabetes model was applied and
the ICER of £5,387 (€6,700) per QALY was reported (38). Other identified economic evaluations of
diabetes education schemes did not apply a long-term analytic horizon, which complicated
interpretation of the results (39-41). The meaningfulness of short-term cost-effectiveness analysis of
diabetes self-management programs is questionable, as it has been shown that the greatest costs
occur in the year of the delivery and decrease in the subsequent years, while most of the benefits
occur after several years of follow-up (42). The analysis of ICER in the entire cohort at different time
points confirmed this observation, showing a consistent improvement of the cost-effectiveness over
time. A key question for policy makers therefore is whether they are prepared to consider a longer
time horizon in their decision-making (43). The ICER in the subgroup with inadequate glycemic
control reached values below €10,000 per QALY after a time horizon of two years, a finding that
needs to be confirmed in larger studies.
Some limitations of the study have to be mentioned. While no significant between-group differences
were observed in patient baseline characteristics, the baseline costs in the intervention group were
higher than in the control group due to a greater number of hospitalizations. Though participants of
the telecoaching program demonstrated an increase in utilization of the guidelines recommended
ambulatory diabetes care, the overall health care costs in the year of the trial decreased by 1% in the
intervention group. The control group showed an opposite trend: a decrease in the guideline
recommended care consumption and an increase of overall healthcare costs by 16%. In both groups
these changes were strongly associated with the change in hospitalization costs, however, it was
difficult to attribute these changes to the intervention due to insufficient insights in the
hospitalization causes and the cost imbalances at baseline. Diabetes education has been previously
shown to have a positive impact on the number of hospital admissions in the short to medium term,
based on retrospective studies (44,45), - a hypothesis that requires further testing in a randomized
setting.
Each health economic model has its limitations. Differences between patient baseline characteristics
and the clinical setting underlying the model, and those used to populate the model, may result in
varying long-term disease progression patterns (45). However, given the scarcity of appropriate data
and resources, it is not feasible to develop new models specific for each setting (46). From at least
thirteen available predictive diabetes models, the UKPDS Outcomes Model has undergone the most
extensive external validation of its ability to predict the incidence of cardiovascular disease through a
comparison with the results of large cohort studies in people with type 2 diabetes. It showed to
consequently overestimate the risk of coronary heart disease and stroke (46-50). The Model thus
should be used with caution for the prediction of the absolute risk of diabetes complications, but is
believed to provide a reasonable prediction of the incremental event rate and be a suitable method
for resource prioritization (49-51). The Model performance in estimating the risk of microvascular
76
complications should be further investigated. Introduction of electronic patient records at the
national level and their structural use in epidemiological research should be of great importance for
the development of well performing models in different patient subgroups. Recently, the second
version of the UKPDS Outcomes Model was released, however the validation of its equations is still
ongoing (52).
Considering a fair heterogeneity of the study population and the pragmatic nature of the clinical trial,
the results of the study are potentially transferrable to other primary care settings in the Western
countries. The critical factors of the program success, - an appropriate training of the coaches, quality
assurance measures and a constructive interaction with the involved physicians, have to be considered
in the implementation phase (13). Limitations to the overall generalizability of the study results include
possible positive self-selection of patients recruited into the study, exclusion of people with
debilitating medical conditions, the Belgian-specific cultural, organizational and economic context and
lack of data to consider the societal perspective.
More economic evaluations of healthcare programs are needed to support the policy makers in their
decisions on budget allocation. Currently, patient self-management support programs are structurally
underfinanced, while relevant health economic research is strongly underrepresented compared to
evaluations of medicines. However, results of the cost-effectiveness analyses is not the only criterion
to consider in the reimbursement decisions (53). Severity of disease, size of the target population,
budget impact, and availability of treatment alternatives may also play a role next to legal, ethical and
organizational issues (54). At present, reimbursement decisions in healthcare frequently lack a
systematic approach (55). Policy tools such as priority setting and multi-criteria decision making
approaches are being explored and have potential to increase transparency of reimbursement
decisions (54, 56-58).
77
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80
Chapter 5. Patient and provider acceptance of telecoaching in type 2
diabetes: a mixed-method study embedded in a randomized clinical trial.
Odnoletkova I, Buysse H, Nobels F, Goderis G, Aertgeerts B, Annemans L, Ramaekers D. Patient and provider
acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomized clinical trial.
Submitted.
81
Abstract
Background: Despite advances in diagnosis and treatment of type 2 diabetes, suboptimal metabolic
control persists. Patient education in diabetes has been proved to enhance self-efficacy and
guidelines-driven treatment, however many people with type 2 diabetes do not have access to or do
not participate in self-management support programs. Tele-education has a potential to improve
accessibility and efficiency of care, but shows a slow uptake in Europe. Patient and provider
acceptance in a local social and organizational context is an important pre-condition for a successful
implementation. The aim of the study was to explore the perceptions of patients, nurses and general
practitioners (GPs) regarding diabetes education delivered by phone.
Methods: Mixed-method study embedded in a pragmatic clinical trial, in which a nurse-led targetdriven telecoaching program was offered to 287 people with type 2 diabetes in Belgian primary care.
Intervention attendance and satisfaction about the program were analysed along with qualitative
data obtained during post-trial semi-structured interviews with a purposive sample of patients and
general practitioners (GPs) and nurses involved into the trial. The perceptions of patients and care
providers about the intervention were coded and the themes interpreted as barriers or facilitators
for adoption.
Results: Of 252 patients available for a follow-up analysis, 97.5% reported to be satisfied. Interviews
were held with 16 patients, 17 general practitioners (GPs) and all involved nurses (n=6). Themes
associated with adoption facilitation were: 1) improved diabetes control; 2) need of more tailored
patient education programs offered from the moment of the diagnosis; 3) comfort and flexibility; 4)
evidence-based nature of the program; 5) established cooperation between GPs and diabetes
educators; and 6) efficiency gains. Most potential barriers were derived from the provider views: 1)
poor patient motivation and suboptimal compliance to “faceless” advice; 2) GPs’ reluctance in
patient referral and information sharing; 3) lack of legal, organizational and financial framework for
telecare.
Conclusions: Nurse-led telecoaching of people with type 2 diabetes was well-accepted by patients
and providers, whereby providers were overall more critical in their reflections. A well elaborated
implementation plan is needed for upscaling of telecare.
82
Background
About 382 million people worldwide have diabetes and its prevalence is expected to increase by
more than 50% in the coming twenty years [1]. Despite significant advances in diagnosis and
treatment, inadequate metabolic control persists. Poor risk factor control may be reflected by both
the failure of diabetes self-management by patients as well as inadequate intervention strategies by
clinicians [2]. Patient education proved to enhance self-care and guidelines-driven diabetes
treatment [3].
In Belgium, patient education was initially introduced in 1988 for people with advanced diabetes in a
hospital setting and extended to primary care in 2009, where it has been delivered by certified
diabetes educators, mostly in individual sessions at the patient’s home. Diabetes education is still not
reimbursed to patients in the early stage of diabetes – those on lifestyle and/ or oral antidiabetics
therapy. Alternative less costly approaches are needed to ensure a better patient inclusion.
Patient education and coaching by phone has a potential to improve quality and accessibility of
chronic care [4,5]. However, in Europe, distant care solutions have shown a slow uptake [6,7].
Adoption of evidence-based patient support interventions in daily clinical practice depends on the
social and organizational context in which they are introduced and used [2]. This paper explores
the patient and provider perceptions about diabetes education by phone in Belgian primary care
setting. The study participants were involved in a randomized clinical trial (RCT) which was the first
to test a nurse-led telecoaching program in Belgium and showed sustainable improvement in the
glycemic control [8].
The objectives of this research were 1) to explore the perceptions of patients, nurses and general
practitioners (GPs) involved into the RCT, with regard to diabetes self-management education
delivered by phone; 2) to hypothesize the barriers and facilitators for adoption of nurse-led
telecoaching in Belgian primary care.
Methods
Intervention and Setting
Between April 2012 and January 2014, 3115 people on glycemia lowering agents were invited into
the study by the Independent Health Insurance Fund of Belgium. Two-hundred-eighty-seven patients
with type 2 diabetes were randomized to the intervention group and received the COACH Program
(TCP), delivered by certified diabetes nurse educators after an additional training [9]. The
intervention consisted of 5 monthly telephone sessions of 30 minutes on average and was focused
on achieving guideline-recommended diabetes treatment targets through regular control of diabetes
risk factors including self-monitoring of blood glucose, appropriate lifestyle adjustments and
intensification of medication therapy upon a patient consultation with GP [8].
83
The novel features of TCP compared to usual diabetes education were: 1) focus on closing the
“treatment gaps”, i.e. failure to achieve the guideline recommended goals, through systematically
covering each diabetes risk factor based on the clinical guidelines; 2) analysing patient risk profile
based on recent lab results and a standard intake interview; 3) delivering the coaching entirely by
phone; 4) sharing a written patient progress report with the patient and his GP; 5) using a special
software for patient administration.
Research design
Patient attrition and associated reasons were registered by nurses who delivered the intervention. A
program satisfaction questionnaire was filled out during a nurse home visit upon graduation from
TCP, by all patients who were available for the RCT follow-up assessment. The survey was a fivepoint Likert scale questionnaire developed for TCP evaluation (Table 1) [9]. It was translated in Dutch
and piloted for intelligibility with several patients.
Semi-structured individual face-to face interviews were held with the trial participants: all nurses and
a purposive sample of patients and GPs. Patients and GPs were randomly selected from the trial
participant list and invited for an interview by phone by a trial assistant. The respondents were
recruited and interviewed until a theoretical saturation point was achieved, i.e. no new themes
could be derived from additional interviews.
The interviews
The interviews were designed and performed by IO and HB. A flexible topic guide was used
(Appendix A). Challenges in diabetes management, perceptions about telecouselling and the COACH
Program were consistently discussed with all respondents. The purpose of the interviews was to let
the respondent talk freely about a subject in order to be able to capture as much information as
possible. To encourage a discussion, “reflective listening” techniques were applied [10]. HB and IO
agreed on the conduct of the interviews and used specific tutorials in the preparation phase [11].
The interviews were piloted with one respondent from each target group. All conversations were
audio-taped and transcribed verbatim.
Data analysis
To process the qualitative data, consensual analytic techniques were used [12-15] . NVivo 10
software was employed to assist the data coding. Directed content analysis was applied, i.e. a priory
developed topic guide was used as initial coding scheme. The analysis was performed in four stages:
1) interview transcription; 2) assigning quotes to the discussion topics; 3) compressing quotes and
extracting the content core (themes); 4) interpreting themes as associated with barriers or
facilitators for adoption. A multiple coding approach was used, i.e. IO and HB performed the coding
exercise and cross-revised the transcriptions and interpretation of data. Upon a consensus, the
results were reviewed by and discussed within the research team.
84
To present the results, the “menu” of the Consolidated Framework for Implementation Research
(CFIR) was used [16]. Three domains were selected based on their relevance and supported by
applicable constructs. These include: Intervention characteristics (Benefit for patient and Key
features of the intervention); Implementation process (Engaging of GPs & Patient recruitment;
Executing & Quality assurance); and Broader context (Current practice of patient education in type 2
diabetes and Personal beliefs about telecounselling). The themes associated with barriers and
facilitators are discussed per respondent group and supported by the most representative quotes.
The intervention attendance rate and the COACH Program satisfaction questionnaire results were
analyzed with IBM SPSS Statistics 22 software.
Results
Intervention fidelity and patient satisfaction
Of 287 patients enrolled in the telecoaching group, 252 (87.8%) were available for the RCT follow-up
assessment. Patients reported a high level of satisfaction with The COACH Program in general
(97.5%). 92.1% were content with the telephone as medium for communication with the coach
(Table 1).
Table 1. Results of the questionnaire about patient satisfaction with the COACH Program, based on
the responses of 252 participants of the intervention group.
5
4
3
2
1
Score
Questionnaire dimension
Strongly
agree
Strongly
disagree
The telephone was an effective form of
communication between me and my coach.
70.5%
21.6%
6.2%
1.7%
0%
I feel better informed about my diabetes risk
factors than before I joined The COACH
Program.
68.5%
24.5%
5.8%
1.2%
0%
The coach listened to me and gave advice
that was relevant to my needs.
78.3%
17.5%
3.8%
0.4%
0%
The written progress reports were useful.
69.3%
21.6%
7.9%
0.4%
0.8%
Sending a copy of the progress reports to my
treating doctor was useful.
72.4%
15.9%
7.1%
2.9%
1.7%
The time interval between coaching sessions
was appropriate.
74.5%
19.2
5.4%
0.4%
0.4%
Overall, I was satisfied with The COACH
Program.
78.4%
19.1%
1.7%
0.4%
0.4%
85
Interview participants
Between April and July 2014, 6 nurses, 16 patients and 17 GPs were interviewed (Table 2). Twentynine percent of initially contacted patients and 57% of GPs refused to participate in the study with
lack of time as the most frequently reported reason.
Table 2. Characteristics of the interview participants
N
Men, n (%)
Age, median
Years, median
(min-max)
(min-max)
Patients
16
7 (44%)
68 (37 – 77)
11 (3 – 20)*
GPs
17
12 (71%)
51 (33 – 69)
25 (7 – 46)**
Nurses
6
2 (33%)
37 (32 – 51)
5 (3 – 11)***
*with diagnosis type 2 diabetes; ** GP experience (65% working in a solo practice); ***experience as diabetes educator
Interview results
Themes associated with the barriers and facilitators for implementation of nurse-led telecoaching in
type 2 diabetes in Belgian primary care are summarized below per respondent group and in Table 3
(submitted as “Additional file”) per applied CFIR domain.
Potential facilitators for adoption
Views shared by patients, nurses and GPs:
Overall, the respondents found TCP a benefit for patient and mentioned at least one of the following
improvements: understanding of diabetes, motivation, discipline in diet habits and physical activity,
more regular check-ups and better risk factor control. There was a general acknowledgment of the
fact that GPs don’t have enough time to provide diabetes education. Most interviewees seemed to
be convinced of the importance of diabetes education from the moment of the diagnosis and
emphasized the need of a variety of education programs tailored to patient needs. Inequalities in the
reimbursement of diabetes education were criticized by most.
Nurse 1: “Diabetes education should start from the moment of the diagnosis and maybe even earlier,
in the prediabetes stage. The patients must be directly informed how they can self-manage diabetes,
in first place through adjustments in the eating habits, physical activity. It is essential that the patient
understand the possible complications, so he/she can react more quickly on certain symptoms.
Apparently, today there are not enough resources for that.”
The majority of respondents believed that telecounselling may help to achieve an efficiency gain and
better care accessibility through partial substitution of face-to-face contacts.
Perception of patients:
86
Patient told to be satisfied about TCP. A regular repetition and monitoring by coach was perceived by
most as an important vehicle for lifestyle change.
Patient 15 “I started to pay more attention to my diet. You know that they’re going to call and it is like
a big stick, - you try to do your best. I lost several kilos and am glad about it… I have learned a lot
about self-monitoring. Diet advice and glucose monitoring were the most important things.”
Patients found communication by phone comfortable, time saving and offering flexibility.
Patient 1: “You don’t need to travel and yet you can ask questions and directly receive an answer… I
have to visit the hospital regularly because of more different problems. That’s why I think: Let me once
stay at my own place.”
About a half of the interviewed patients found that the program should not have stopped after six
months, but continue with lower intensity, or re-launched at the moment of a treatment
adjustment, such as initiation of insulin therapy.
Patient 14: “A repetition is welcome. The program is finished now and the self-monitoring device is
dusting on the shelf. If it was possible to continue, maybe less frequently, for example twice a year, I
would be satisfied.”
Perceptions of GPs:
Based on the experience of cooperation with diabetes educators in previous years, the majority of
GPs expressed trust in their performance. They thought that the educators facilitate their work.
GP 5 “ Diabetes educators are a great added value. It should have been introduced long ago. What a
patient needs to know (self-injections, diet) and where we miss time or knowledge, they come inbetween.”
Most found information about the launch of TCP sufficient. The fact that the program did not require
much additional time investment, was valued by GPs.
GP 13: “If the goals of the project are clear and we don’t have the feeling that it will ask more of our
time, then it’s OK. In this case I have not experienced that additional work was required.”
GPs found it important to receive the written patient progress reports and were overall satisfied
about the quality of the advice. Most of them told to have integrated the electronic copies of the
progress reports in the patient medical records. All but one GP thought that a motivated nurse
advice on therapy adjustment was acceptable.
GP 10: “All reports are integrated into the electronic records of my patients…The advice was correct,
absolutely…. It was fine receiving these letters.”
GP 6: “A diabetes educator advice on medication adjustment is perfectly all right. In the end it is my
decision, but the more people are contributing to the better diabetes control, the better…”
Perception of nurses:
87
All nurses thought that the current concept of diabetes education needs to be revised. They
complained about underfinancing due to high transport costs.
Nurse 3: “ We have to travel from patient to patient and these costs are barely covered. Ideally, I
would start the education with a home visit and do the rest via the telephone or via Internet, if
possible.”
All found that TCP and associated software offer a clear structure. The one-week training in
individual risk factor targets and medication management was perceived as a knowledge
advancement.
Nurse 6: “Looking back at the training, I see that I have grown in my profession. The training also
covered the medication therapy and when/ how it should be adjusted. I use this knowledge in my work
also outside of The COACH Program.”
Discussing with patients the blood glucose levels based on the self-monitoring results was
considered by all as important guidance for an appropriate advice. All nurses mentioned that
observing improvements in patient diabetes control was rewarding to them. They appreciated
receiving the results of patient baseline clinical assessment at the start of the program and the
follow-up results. Some admitted that comprehensive patient information is frequently missing in
their usual education practice.
Potential barriers for adoption
Views shared by patients, nurses and GPs:
Lack of discipline and commitment, particularly in lifestyle recommendations, was identified by most
interviewees as the major challenge of leveraging the effect of diabetes treatment in general and
educational programs in particular.
GP 17: “Motivation of the patient is the biggest concern. I keep on harping but the patients do not
appreciate it, some totally ignore my advice… The problem is: diabetes does not hurt. It starts hurting
when it is already too late...”
Perceptions of patients:
Patients found it overall challenging to remember and understand the targets for all risk factors
associated with diabetes. The patient who was not satisfied with TCP, mentioned that he dislikes
communication by phone in general and that he participated in the program just to please his wife.
Perceptions of GPs:
Some GPs admitted to be reluctant about the program in the beginning, because they are
overwhelmed with initiatives and have difficulty keeping track on the source, goals and quality of
different pilot projects.
Several GPs regretted that the patient progress reports were not sent electronically for a direct
integration into the patient medical record. Some missed a direct interaction with the coach,
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particularly on an appropriate therapy adjustment. One GP had a negative perception about
diabetes education in general because of a limited availability of diabetes educators. Several
complained about the administrative burden associated with the current referral procedure.
According to most GPs, work still needs to be done to identify the groups of patients who would
benefit from consultations or coaching by phone. Some expressed concerns about inclusion of older
patients because of fading perceptive capabilities. All GPs thought that such interventions could not
entirely substitute a personal contact and emphasized the current lack of a legal, financial and
organizational framework.
GP 7 “A telephone support is perfectly possible. My patients who stay abroad, call me regularly for a
consultation. For me, this is a voluntary work, because today I cannot make an invoice for a teleconsultation. This should not be difficult to organize because many people are open for this...”
In addition, most GPs thought that the current fee-for-service payment system has a poor fit with
chronic and multidisciplinary care.
Perceptions of nurses:
While recognizing certain benefits of telecoaching, the nurses also brought up some limitations.
Diabetes education entirely by phone was perceived as a barrier by most nurses. All would have
preferred starting the program with a face-to-face contact with the patient. They thought that such
contact would create more trust and increase patient commitment. Moreover, meeting the patient
at home would have provided important information on the patient living environment and lifestyle
which they missed now.
Nurse 2 “I thought, it was not easy to do the entire program by phone. What I always missed was
being able to observe the direct reaction of the patient… I think, if they once met me personally, they
would have sometimes done more effort. For the future, I would see a combination of a home visit and
the telephone sessions as the ideal solution.”
The nurses were not used to make extensive patient progress reports with specific advice and were
sometimes uncertain about the acceptance of their recommendations by GPs. Overall, they found
GPs reluctant in up-titrating medications, even when they thought it was necessary. They also
complained about the postponing attitude of patients in visiting their GPs.
Nurse 1: “The reports included advice on a medication adjustment that the patient had to discuss with
the GP. We have never done this before… It was important for me to be sure that the program is
scientifically validated. Sometimes I thought it was necessary to adjust the medications, but the
decision needed to be made by the GP. In some cases they postponed it too long.”
In the beginning, the coaches found it difficult to adopt a new way of working. Getting used to the
TCP software and preparing the progress reports was experienced as time consuming. Sometimes
occurring technical issues, time pressure through other regular nursing tasks, occasional failure of
patients to keep their appointment caused frustrations of the nurses. However, their attitude
towards the program improved with accrued experience.
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Nurse 4: “Making reports was time consuming. We are not used to make these kind of detailed
reports. On the other hand, it was a good thing that both the patient and the GP received them. This
reinforced the responsibility of the patient.”
In general, diabetes educators think that there is room for improvement in their cooperation with
GPs. They criticize lack of readiness for cooperation and information exchange among some GPs and
their selective referral behaviour.
Nurse 2: “Communication with GPs – we invest a lot of time in it… First, they are not easy to reach. If
you reach them, they do not take time to look up the information we need. But there are GPs who are
more cooperative, I have the feeling that it’s improving… You need to be very patient with them.”
Nurse 5: “The referral procedure should improve. GPs are supposed to introduce a diabetes educator
to his patient. However, today not all patients entitled to reimbursed diabetes education and selfmonitoring, can benefit from it. It’s a pity...”
Discussion
Based on the observed attendance rate of 87.8% and high patient satisfaction about the
telecoaching program (97.5%), a good acceptance by patients can be concluded. Qualitative data
confirm these findings and show perceived added-value by most patients, GPs and all nurses. The
COACH Program resulted in improved diabetes understanding and control in view of most interview
participants. Patients associated telecoaching with increased comfort and flexibility, and nurses with
efficiency gain. Most providers valued the quality of The COACH Program, particularly the evidencebased advice within the patient progress reports.
Delivering education entirely by phone was perceived as a barrier by nurses. Nurses were convinced
that at least one face-to-face contact was necessary at the beginning of the program and expected
such a contact to be informative and improve patient trust and commitment. At the same time, the
nurses thought that patient education by phone is possible and would help solving the current
problem of underfinancing.
Based on the context analysis, most Belgian GPs seem to have built up trust in the competence of
diabetes educators in the past years. However, the cooperation between GPs and educators may
need a further improvement, particularly in the perception of educators who sometimes experience
GPs reluctance in patient referrals or sharing patient information. The reasons for such reluctance
may include increased administrative burden, uncertainty about the program benefit, fear to lose
control, or a general limited readiness for innovations, as analysed in previous studies [17,18]. Lack
of a legal, financial and organizational framework for telecounselling was recognized as an important
barrier for implementation by most providers.
Differences in perceptions between patients and providers whereby patients show a higher
readiness to use telecare, were found in previous research [19]. Providers show more scepticism
about the “faceless counselling” and assume a lower patient compliance to tele-nurse advice [20,21].
Provider scepticism about telecare might be caused by limited local evidence of the (cost-)
90
effectiveness and usually project-based financing, altogether explaining a slow uptake of telecare.
With growing evidence, more attention should be paid by policy makers to the implementation
issues. Lack of a global implementation plan that includes consultations with the stakeholders and
introduction of appropriate organizational and financial measures, is believed to limit the adoption
of telecare solutions [22,23].
Previous implementation research identified several factors influencing integration of selfmanagement support programs in daily practice: engagement of general practitioners, patient
recruitment methods and quality assurance of the program delivery [24-26]. Local organization and
financing of primary care also seem to influence the adoption of patient support programs. While a
trend towards strengthening the role of nurses in chronic care delivery has been observed in most
European countries, nurse-led approaches remain challenging in systems where primary care is
traditionally provided by doctors in solo practices with few support staff [27]. These findings need to
be taken into account while working out a local implementation strategy for patient selfmanagement education by phone.
The strength of our study is in the combination of qualitative and quantitative research methods,
allowing for a methodological triangulation [28]. A potential of personal bias was methodologically
resolved through parallel coding with subsequent consensus-based interpretation of the interview
data.
The self-selection and the purposive sampling of the interview respondents may limit the
representativeness of the results. The unique nature and an evolving character of the study context
and participants may make the findings not transferable to other settings or to the future [15].
Further, a positive self-selection of the trial participants might have taken place during the
recruitment of patients in the clinical study. Further research should explore the reasons of nonparticipation. It will help to identify alternative recruitment techniques and those groups of patients
who might benefit from diabetes education through alternative delivery modes.
Conclusions
Nurse-led telecoaching of people with type 2 diabetes as part of a clinical trial in Belgium was wellaccepted by patients, nurses and GPs, whereby providers were overall more critical in their
reflections. A number of specific preconditions for a successful implementation can be assumed
based on the findings of this study and previous international research:
 Legal, financial and organizational framework for self-management support programs
delivered by means of Information – and Communication Technologies;
 An agreed communication protocol between the healthcare providers;
 A personal contact between patient and nurse at enrolment;
 An on-going quality assurance and content update based on the emerging evidence;
 Multiple strategies for the program promotion to providers and for patient enrolment.
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Discussion
What this thesis adds to science
In view of the uncertainty of evidence regarding the clinical and cost-effectiveness of diabetes
education, this doctoral thesis contributes to a better understanding of the success factors in the
organization of self-management education programs in type 2 diabetes.
Therapeutic patient education in diabetes and prediabetes is believed to be an essential element of
chronic care. However, the appropriate approaches to the provision of patient education are in
general not well-established. Our systematic review suggests that when offered in prediabetes stage,
patient education programs are potentially cost-saving or highly cost-effective, as they have been
shown to reduce the incidence of type 2 diabetes compared to usual care by 51% to 58% in the short
term and by 34% to 43% over a follow-up period of between 7 and 20 years (109). In type 2 diabetes,
the results were mixed and varied from cost-saving to not cost-effective, reflecting the uncertainty of
the clinical effect. Re-consideration of public health priorities in the direction of earlier prevention of
diabetes might be therefore appropriate.
As most cost-effectiveness studies in prediabetes were based on the clinical effect observed within
the Diabetes Prevention Program, U.S. (110), the idea to reconfirm these clinical and costeffectiveness results in Belgium, was tempting. However, identification of people with prediabetes
was challenging. Patients with diagnosed diabetes, instead, were recognizable through the health
insurance claims database, based on the consumption of glucose lowering medications.
Our field research demonstrated that target-driven nurse-led telecoaching by diabetes nurse
educators in people with type 2 diabetes in Belgian primary care resulted in sustainable improvements
in the glycaemic control, disregarded the level of HbA1c at baseline. Telecoaching appeared to be costeffective within the Belgian healthcare system, and was well-accepted by the trial participants. With
the current controversy on the effectiveness of diabetes education, particularly in well-controlled
patients (73, 77), it is quite remarkable that in our study, a positive sustainable effect was achieved
with an intervention delivered entirely by phone.
Brief overview of the methodologies and results
To analyse the effectiveness of therapeutic education in type 2 diabetes in Belgium, we have chosen
a well-established nurse-led target driven telecoaching program, originally from Australia, and
adapted it to the Flemish context. The randomized controlled trial enrolled 574 individuals with type
2 diabetes, selected from the database of the Independent Health Insurance Fund of Belgium based
on the utilization of hypoglycaemic agents.
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The intervention group demonstrated improvements in glycaemic control, BMI and total cholesterol
at 6 months’ follow-up compared to usual care. Although the study population was already quite well
controlled at baseline for most diabetes risk factors, telecoaching resulted in a clinically modest HbA1c
reduction by 2 mmol/mol (0.2%) in the total sample and a clinically significant reduction by 4
mmol/mol (0.4%) in the subgroup of patients with HbA1c≥53 mmol/mol (7%) at baseline. These
improvements in glycaemic control were still observed at 12 months after the completion of the
intervention, sustainably lowering the mean HbA1c in the intervention group to the recommended
target below 53 mmol/mol. Clinically modest improvements in total cholesterol and BMI did not
sustain at 18 months follow-up, neither did the difference in the proportion of patients who achieved
the guideline recommended treatment targets for the composite of HbA1c, systolic and diastolic blood
pressure and LDL-Cholesterol at 6 months: an increase by 8.9% in the intervention and a decrease by
1.3% in the control group.
Current evidence suggests that diabetes education improves glycaemic control only in subgroups with
HbA1c ≥ 8% at baseline, not in all patients, and that this effect disappears one to three months after
the completion of the program (73, 77). Moreover, until now, most nurse-led telecoaching programs
have been unsuccessful in improving glycaemic control, even in those with poorly controlled HbA1c
(101, 104). Our trial positively contrasts with the previous findings, demonstrating that telecoaching
by diabetes nurse educators can have a positive effect on the glycaemic control in all people with type
2 diabetes, not only in poorly controlled patients, and that the sustainability of this effect can last for
at least 12 months.
To analyse the lifelong cost-effectiveness of nurse-led telecoaching compared to usual care in people
with type 2 diabetes from the perspective of the Belgian healthcare system, we populated the UKPDS
Outcomes Model with patient-level data from the clinical trial described above, and analysed the
results for the entire cohort and the subgroup with elevated HbA1c at baseline. At the time horizon of
40 years, the cumulative mean Quality Adjusted Life Year (QALY) gain (95% CI) was 0.21 (0.13; 0.28)
overall and 0.56 (0.43; 0.68) in the elevated HbA1c subgroup. The respective incremental costs were
€1,147 (188; 2,107) and €2,565 (654; 4,474) and the Incremental Cost-Effectiveness Ratios (ICERs)
€5,569 (€677; €15,679) and €4,615 (1,207; 9,969) per QALY, with 98.2% and 100% probabilities that
the value of ICER lies below the threshold of €10,000 per QALY. In the scenario analysis, repeating the
intervention bi-annually for lifetime had the greatest impact on the cost-effectiveness and resulted in
the ICERs of €13,034 in the entire cohort and €7,858 in the elevated HbA1c subgroup. Given
conventional thresholds of cost-effectiveness in Western economies (€40K to €80K per QALY gained)
(111), nurse-led target driven telecoaching of people in type 2 diabetes may be considered very costeffective within the Belgian healthcare system, disregarded the level of glycaemic control at the
enrolment.
Based on the analysis of the health insurance data in the year before and after randomisation,
participants of the telecoaching program demonstrated increased costs for guideline recommended
outpatient care, such as endocrinologist consultations, laboratory tests and consumption of lipid
modifying agents, and a decrease in the number and costs of hospital admissions compared to
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controls, however the difference in the change of hospitalization costs cannot with certainty be
attributed to the intervention.
To investigate the patient and provider acceptance of diabetes education delivered by phone, we have
analysed the intervention attendance, satisfaction about the program, and performed interviews with
a purposive sample of patients, general practitioners (GPs) and all nurses involved into the clinical trial.
In the intervention group, 97.5% of those available for the follow-up assessment, reported to be
satisfied about the COACH Program. Qualitative data confirmed these findings and showed perceived
added-value by patients, GPs and all nurses, however, providers were overall more critical in their
reflections. The patients associated telecoaching with improved diabetes understanding and control,
comfort and flexibility. Providers valued the guidelines-based structure of the program and expected
tele-counselling to generate efficiency gains. The concerns raised by the providers included perceived
suboptimal compliance to “faceless” advice and lack of legal, organizational and financial framework
for telecare in Belgium. The nurses found that the current concept of diabetes education needs to be
revised. They complained about underfinancing due to high transport costs. With regard to the current
diabetes educators’ training, the nurses regretted its overemphasis on the glucose control and
undermining of other diabetes risk factors. Overall, providers asserted the need for more patient
education programs offered from the moment of the diagnosis, or already in prediabetes stage.
Research limitations
The clinical trial setting implies certain limitations to the generalizability of the results. The enrolment
rate based on an invitation of the Health Insurance Fund Partena, did not exceed twenty-two percent,
potentially implying a positive self-selection of the trial participants. The same is true for our
qualitative research, where the participation rate was 71% and 43% among the contacted patients and
GPs respectively. Further research should explore the reasons of non-participation, in order to identify
complimentary recruitment strategies and those groups of patients who might benefit from diabetes
education through alternative delivery modes. Particularly socially disadvantaged people and those
with limited language skills may present challenges to goal-based care and require more intensive
modes of support. Having said that, there is, however, much to suggest a reasonable generalizability
of the observed results among type 2 diabetes patients capable of self-care, because a) the baseline
characteristics of the trial participants were comparable to those of the general Belgian population
with type 2 diabetes, in terms of clinical, biomedical and demographic data (112); b) a similar
therapeutic effect of The COACH Program was observed in patients with type 2 diabetes in another
cultural context, i.e. Australia (113).
Whereas randomized controlled trials, when appropriately conducted, offer the highest level of
evidence, the economic evaluations in healthcare, representing a young field of research, still miss
the golden standards. Recent reporting guidelines have partly solved certain disagreements (114),
however, many methodological debates remain unresolved. To overcome common methodological
limitations, we combined the clinical outcomes of a randomized controlled trial with the claims data
from the reimbursement database, ensuring the data input of highest possible quality. Prospective
data modelling for the purpose of a lifelong cost-effectiveness analysis introduced uncertainty, which
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was addressed by using a model with the most extensive validation record and a comprehensive
sensitivity analysis.
Practice and policy implications
Currently, in most countries therapeutic education programs lack documented consensus on the
design, objectives and relevant outcomes, even though reimbursement schemes for diabetes
education have been increasingly introduced. The need for better quality patient education with a
therapeutic intent is recognized (32). In Belgium, a better conceptualization of patient selfmanagement education would support the planned chronic care reform. The distinguishing features
of diabetes education programs, which proved effective, offer an important source of knowledge for
policy makers and could guide designers of such programs and inspire diabetes educators.
From this perspective, the COACH Program (TCP) merits special attention, as in the past 15 years it
proved effective in different chronic conditions and in diverse cultural contexts. Delivery by phone is
not likely to be the unique success factor of the program. The whole concept of target-driven
motivational counselling differentiates this program from usual diabetes education. The main
objective is making the patient aware of the individual risk factor targets associated with diabetes and
empower the patient to take the responsibility for achieving and maintaining these individual targets.
Motivational interviewing and goal setting focused on incremental achievable improvements have
been previously shown effective in optimizing diabetes control (115). The program integrity and
replicability are ensured through a documented training course for coaches, on-going supervision, and
content update following a revision of the relevant guidelines.
The role of self-monitoring of blood glucose (SMBG) as part of the coaching intervention, may not be
underestimated. Until now, SMBG in patients not treated with insulin was predominantly analysed as
stand-alone intervention and demonstrated mixed results (116). Evaluating effectiveness of SMBG as
part of a self-management support programme in type 2 diabetes might be more meaningful, as
patients need to be appropriately advised on the monitoring frequency, interpretation of results and
adequate actions. Adding SMBG to a telephone support program has previously shown to significantly
improve glycaemic control when compared to telephone support without self-monitoring (117).
Emerging novel SMBG solutions, such as flash glucose monitoring give promise in terms of patient
comfort, but raise yet unresolved questions on their clinical rationality, cost-effectiveness and patient
acceptance in type 2 diabetes, particularly in primary care, where most patients are not treated with
injectables (22).
To transfer the therapeutic value of TCP, observed within our clinical trial, into clinical practice, a
particular attention needs to be paid to the replication integrity. The effectiveness of TCP in type 2
diabetes in Australia was evaluated in different organizational settings in a past few years, and
demonstrated conflicting results (101, 113). While a population-based audit of prospectively collected
data in Queensland, showed significant improvements in serum lipids, blood glucose and lifestyle
habits (113), a randomized controlled trial did not confirm effectiveness of TCP in type 2 diabetes
(101). The purpose of the latter was to test TCP when implemented in general practice, i.e. the
program was not delivered as usual by the employees of the health insurance funds, but instead by
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practice nurses. The analysis of the intervention integrity revealed, that the median number
of coaching sessions actually delivered, did not exceed three sessions per patient, whereby 25% of
patients did not receive any coaching sessions at all. Moreover, the medication intensification was not
adequately addressed. The authors note that the practice nurses received a much shorter training
compared to the TCP coach training standard, and had difficulties to combine the telecoaching of the
assigned patients with their regular tasks within the practice (101).
These findings demonstrate that deviations from the initial concept in staff training, contact hours or
curriculum of an evidence-based program, may result in waste of resources. Absence of measurable
goals and outcomes in the existing concept of diabetes education in Belgium, represents a structural
risk of resource waste. An additional risk to consistent quality of diabetes education is the lack of a
standard curriculum for diabetes educators’ training. The principles of TCP have a good potential to
be introduced into Belgian healthcare system, as much work has been done in the previous years to
implement diabetes education in primary care. The necessary infrastructure, such as training and
certification facilities for paramedical staff, and dedicated services within home care organizations,
are currently available in Belgium. At the same time, there is an unmet need for patient selfmanagement support in other chronic conditions, both in primary and in hospital care. It has been
reported that about 55% of patients with cardiovascular diseases (CVD) in Belgium do not undergo
any rehabilitation program after their discharge from hospital (118), with the main reasons for nonattendance being distance to the hospital, patients' belief that they could handle their own problems,
and lack of time (119). The evidence of cardiac tele-rehabilitation has been growing (106, 120, 121)
and may offer a solution for some patient groups. However, for a large-scale introduction of telecounselling for self-management education, a commitment of the national health authorities is
essential. A framework is still missing to support the necessary changes and needs to be developed.
Firstly, it might be appropriate to conceptualise patient education provision in a consensus
/guideline paper, e.g. by a special Taskforce, composed of relevant experts and under leadership by a
scientific policy-oriented institution, such as e.g. Belgian Healthcare Knowledge Centre. Such paper
would ideally consist of recommendations for good practice in self-management education, based
on the available evidence and with consideration of the local care organization. Documentation of
the goals of patient education, the required skills and knowledge of the educator, the process of
providing education and its evaluation, and on the scope of interaction with the care team, including
the minimal dataset on process and patient outcomes to be shared, might offer a solid basis for
guidelines based, easy-to-replicate patient counselling (32, 63, 72, 122). The program curriculum has
to consider tailoring to individual’s needs and adapted as necessary for age (123), type of diabetes
(including prediabetes and diabetes in pregnancy), cultural factors (124, 125), health literacy (126),
and comorbidities.
Dealing with barriers such as income, health literacy, diabetes-related distress may require alternative
strategies of diabetes management including (culturally) adapted programs with more intensive
personal contact between patients and educators (61).
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Extending recommendations to common comorbidities and/ or conditions with similar risk factor
management, such as CVD, would be desirable. Current training of diabetes educators does not
sufficiently cover the management of cardiovascular and other diabetes risks. The evidence from TCP,
which trains nurses and dieticians in risk factor management in multiple pathologies, may support
establishment of the next-generation multi-morbidity coaches, who might better meet the needs of
patients with chronic diseases in Belgium. Guidelines for self-management education would help to
standardize curricula and certification principles for the future educators.
The goals of self-management education should derive from the overall strategic goal of chronic care
provision. Following the U.S. and the Netherlands, Belgium has adopted a “triple aim” to improve
chronic care: better care for individuals, better health for populations, more efficient use of resources
(127). Further practical implication of the triple aim in daily practice needs to be elaborated, including
a consensus on specific measurable goals, relevant for patients, healthcare providers and the
healthcare system overall. Some conceptual papers have been advocating for a distinction between
active chronic patients and those with multiple conditions, severe disability, or short life expectancy.
The latter may benefit from a new paradigm of “goal-oriented care”, wherein the individual functional
and/ or emotional goals would be more relevant to the patient than the traditional treatment goals,
such as survival and tight control of disease specific risk factors (128, 129). The support needs of such
patients may be completely different than support offered by target-driven self-management
education, and may require particular staff training. For all groups of chronically ill patients, relevant
metrics eliciting perceived quality of care must be developed, in order to be able to monitor healthcare
providers – and healthcare system performance (129).
Secondly, using telephone – or Internet based technologies for counselling and data processing,
requires legal clarity on information security and privacy, professional liability and remuneration of
providers’ performance. As technological developments will inevitably increase patient demand for
mobile and remote services in healthcare, appropriate (regulatory) actions of the national healthcare
authorities are needed to ensure feasibility and minimal quality standards for such services in chronic
care, in first place where their effectiveness has been proved (130). Ideally, introduction of
telecounselling and telemedicine should be a part of the national eHealth plan. Countries as Denmark,
where a national eHealth platform was launched in 2003, within nine months after the completion of
a European tendering procedure, might serve as an example (131). According to a report, all Danish
GPs are trained to use eHealth while all citizens are required to use the platform for booking GP
appointments, request prescription renewal, home monitoring, if appropriate etc.; researchers may
request access to the anonymized data upon an approval of an ethical committee (80). As our research
has demonstrated, combining information from health records and insurance databases creates an
additional value, ensuring accurate data analysis for the purposes of health economic research.
Integration of technology in healthcare services, such as required in software-supported
telecounselling, needs special expertise, and has to take into account at least current technical
standards and future trends, potential for interoperability, user friendliness, upscalability and price.
Tendering has been increasingly used in government-funded service procurement and has potential
to improve the price-quality ratios.
99
Thirdly, alternative approaches to healthcare financing may be needed. The current system of
nomenclature-driven budget allocation has been criticized as limiting prospects for innovation, service
improvement and patients' choices. It is not sufficiently based on the analysis of the actual need for
healthcare services, their quality or evidence, and not designed to provide integrated services (132).
Important preconditions for a shift from supply-driven towards performance-based culture in
integrated chronic care delivery, are: 1) outlining care standards (where patient education may be a
part of), with prospective estimation of required budgets (i.e. a lump sum per patient); 2) identifying
entities accountable for the procurement, coordination and quality monitoring of integrated services;
and 3) organizing structural data collection related to process and outcome indicators, to make such
monitoring possible.
Distinguishing between the procurer and provider roles in healthcare provision may offer a solution
for a continuous improvement in return on investment in healthcare. Federal procurement and
financing of healthcare services for support of people with chronic conditions may be challenged by
the variety of local contexts and needs. Management of people with multimorbidity in
community settings is supported by some evidence (133-135). After the Sixth State Reform in Belgium,
the regional governments now have the full authority for the organization of primary health care
services. However, a local organization of multidisciplinary chronic care in Belgium is inhibited by
absence of entities capable of procurement of integrated services, according to their mandate and
expertise. Whereas in other countries, local healthcare procurement is the responsibility of
community administrations (e.g. Denmark), or of health insurance funds (e.g. the Netherlands), a
solution has yet to be worked out for Belgium. The budget holders of integrated care programs may
become, for example, trusted local groups of general practitioners (‘huisartsenkring’ or ‘cercle de
médecins généralistes’); or the sickness funds, provided appropriate reconsideration of their financial
responsibilities; or municipalities, provided a required capacity building; or hospitals in collaboration
with the local primary care health care providers. Furthermore, any local healthcare provision should
be supervised by means of a government-monitored benchmark system, increasing accountability and
setting performance standards. Such performance standards may include the number of patients
served, health outcomes and quality indicators achieved, e.g. patient satisfaction etc., per invested
amount. This will require well dovetailed political decisions both at the federal and the regional
governmental level.
Overall, current high-cost health care delivery system, which places greater emphasis on acute
hospital care than on primary and preventive care, encourages to re-think the budgeting of healthcare
services, particularly in chronic care (136, 137). Nevertheless, so far, little is known about the influence
of the principles of healthcare organization and financing on the provision of chronic care and patient
self-management education (61, 138). To increase the applicability of academic research in this field,
it is important that policy makers communicate clearly about their short- and long term goals.
Innovation would also be enhanced by more consistency and transparency on the criteria the policy
makers are willing to use for the reimbursement decisions, such as reimbursement thresholds and the
time horizon they are prepared to consider in the evaluation of the effect of therapeutic interventions
on health and healthcare costs. The priorities of the healthcare system need to be made explicit, as
difficult ethical and budgetary choices are being made by the policy makers, such as paying for
100
expensive cancer medicines, potentially prolonging life by several months in a limited number of
patients; or investing in prevention of future complications in a larger group at risk, or….. In order to
be able to explain such choices to the broad public, citizen engagement in policy and decision making
seems crucial. In this context, priority setting and multi-criteria decision making approaches seem
promising tools in publically financed healthcare systems and are being actively explored in Belgium
(139-141).
Currently, healthcare policy makers are generally concerned about the budgetary impact associated
with the reimbursement of new healthcare interventions. Estimation of the budgetary impact of fullscale implementation of telecoaching for type 2 diabetes patients in Belgium, was, however, outside
of the scope of this thesis. Assuming that winning healthy life years per number of patients treated
should be the primary focus of a healthcare system, our finding, that, applied in 100,000 patients
with type 2 diabetes in Belgium, the COACH Program would be able to gain about 21,000 QALYs in
total, must provide a valuable support to the policy makers. Taken into account that patient
education in prediabetes stage could offer even a better value for money, as demonstrated in our
systematic review, further analysis of implementation of such interventions are recommended.
Identifying less cost-effective educational interventions may support disinvestments within current
restricted financial resources.
Conclusion
This thesis shows that patient education aimed at lifestyle adjustment is potentially cost-saving or
highly cost-effective if offered in the prediabetes stage. In people with type 2 diabetes in Belgian
primary care, a structured target-driven nurse-led telecoaching resulted in short-term improvements
in total cholesterol and body mass index and sustainable improvements in the glycaemic control. The
intervention proved to be cost-effective and well-accepted by the trial participants.
The scope of this thesis was limited to therapeutic education in type 2 diabetes, but the findings of
our research could be useful for the development of self-management education programs in other
chronic conditions.
101
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Appendix A. Example of the COACH Program patient progress report.
Geachte,
Welkom bij het COACH Programma
Hartelijk dank dat u tijd vrij maakt om deel te nemen aan het COACH Programma. Bijgaand treft u een schema
aan waarin u uw meetresultaten, de streefwaarden en uw bereikte doelen kunt bekijken. Het advies is gebaseerd
op het intakegesprek en het resultaat van uw recente bloedname rekening houdend met uw individuele
risicofactoren (zie het overzicht in bijlage).
Ik heb een samenvatting gemaakt van de belangrijkste informatie – en actiepunten waarover wij hebben
gesproken: Deze bestaat uit het overzicht van de biomedische doelen (diabetes, lipiden, bloeddruk) en
leefstijl doelen (gewicht, lichaamsbeweging, voeding, roken en alcohol).
Een brief met uitleg samen met bijkomende informatie over het COACH Programma werd naar uw
behandelende arts gestuurd. Ik beveel u aan om tijdens het volgende bezoek, met uw arts te overleggen over
uw doelstellingen voor diabetes, voor de cardiovasculaire risicofactoren en voor uw inname van
geneesmiddelen.
We hebben een volgende afspraak gepland op dinsdag 19 februari 2013 om 19:00 om het COACH Programma
voort te zetten. Mocht u ondertussen nog vragen hebben over het COACH Programma of over uw
vorderingen dan kunt u mij bellen.
Met vriendelijke groet,
108
Te bereiken biomedische doelen:
Diabetes - Op dit moment gebruikt u de volgende diabetesmedicatie:
Generieke naam
Merk naam
INSULINE GLARGINE LANTUS
INSULINE LISPRO
HUMALOG
METFORMINE,
HYDROCHLORIDE
GLUCOPHAGE
Dosis
Ochtend Middag
Avond
5 patronen 3 ml
suspensie voor injectie,
3,64 mg/ml
5 patronen 3 ml
suspensie voor injectie,
100 U/ml
850 mg
6
6
6
1
1
1
v.d.
nacht
46
Uw HbA1c waarde van 9,5% (80 mmol/mol) gemeten op 20/11/2012 is boven de algemene streefwaarde
van 7% (53 mmol/mol).
Bespreek met uw arts uw individuele streefwaarde voor HbA1c.
Wat is HbA1c ?:
De rode bloedcellen in ons bloed zijn opgebouwd uit hemoglobine. De glucose in ons bloed kleeft aan
hemoglobine en vormt zo een versuikerde hemoglobinemolecule. Die wordt ‘hemoglobine A1c’ of ‘HbA1c’
genoemd. Hoe meer glucose in het bloed, hoe meer HbA1c aanwezig zal zijn in het bloed. HbA1c is dus een
maatstaf voor de hoeveelheid (percentage) suiker in de rode bloedcellen.
Uw HbA1c op streefwaarde houden is belangrijk en geeft de beste kansen op het voorkomen van complicaties
van de kleine bloedvaten (=microvasculaire complicaties = schade aan de nieren, ogen en zenuwen), en helpt
ook om complicaties van de grote bloedvaten (=macrovasculaire complicaties = hartaanval, beroerte en
slechte circulatie in de benen) te voorkomen.
HbA1c is de beste manier om te checken of uw glucoseregeling onder controle is. De HbA1c test moet om de
drie maanden worden uitgevoerd, zelfs al heeft u de streefwaarde bereikt. Dit betekent dat uw volgende
HbA1c controle rond 20/02/2013 moet gebeuren.
Vraag dat uw arts het laboratorium aan u een kopie van de resultaten laat bezorgen of vraag het resultaat van
uw HbA1c meting aan uw arts. Zo weet u of u de streefwaarde al dan niet bereikt heeft.
Glucoseconcentraties schommelen voortdurend. Voor de dagelijkse controle is de vingerpriktest de beste
methode. Aangezien u insuline inspuit volgens een basaal bolusschema, meet u vier maal per dag uw
glycaemie.
Als u de HbA1c waarde van maximum 7% wil blijven bereiken, dan liggen de streefwaarden voor de vingerprik
voor de maaltijd tussen 70 en 125 mg/dl. Na de maaltijd is de streefwaarde maximum 180 mg/dl.
Het is belangrijk dat u verder uw diabetesmedicatie inneemt zoals werd voorgeschreven.
Glucofage 850 mg (Methformine) werkt door de gevoeligheid van het lichaam voor insuline te verhogen.
Werk samen met uw geneesmiddelen en neem ook maatregelen met betrekking tot de levensstijl. Beperk
calorieën (beperk verzadigde vetten, alcohol, snelle koolhydraten) en zorg voor voldoende beweging.
Uw bloedsuiker onder controle houden is erg belangrijk, maar diabetes is meer dan suiker. Het is minstens
even belangrijk dat u uw andere risicofactoren (bloeddruk, cholesterol, gewicht enz.) onder controle houdt.
109
Lipiden - Op dit moment gebruikt u de volgende lipidenverlagende medicatie:
Generieke naam
Merk naam
Dosis
Ochtend Middag
Avond
v.d.
nacht
SIMVASTATINE
SIMVASTATINE
20 mg
1
MYLAN
Uw LDL- cholesterol van 112 mg/dl gemeten op 20/11/2012 is iets hoger dan de streefwaarde van
maximaal 100 mg/dl.
Laat daarom uw nuchtere lipiden terug controleren samen met uw HbA1c rond 20/02/2013.
Wat zijn lipiden:
Lipiden zijn verschillende soorten vet in uw bloed. Deze verschillende vetten moeten gecontroleerd en zo
nodig gecorrigeerd worden om u gezond te houden. Het nuchtere lipidenprofiel bestaat uit 4 analysen: totaal
cholesterol, triglyceriden, HDL- cholesterol en LDL- cholesterol. Van de 4 analysen van uw nuchtere
bloedvetten is de eerste prioriteit het bereiken van de streefwaarde voor LDL- cholesterol, namelijk maximaal
100 mg/dl.
Als ons bloed meer LDL- cholesterol bevat dan we nodig hebben, zal de overtollige LDL- cholesterol zich
afzetten op de wand van de slagaders en vettige plaques vormen. Hierop zetten zich gemakkelijk
bloedklonters vast. Zo kunnen de slagaders die het hart, de hersenen en andere lichaamsdelen bevloeien
vernauwen of verstoppen.
-
Als u uw LDL- cholesterolconcentratie verlaagt, maakt u uw bloedvaten gezonder. Zo maakt u de kans kleiner
op een hartaanval, een beroerte of verstopping van de bloedvaten in de benen.
Aanpassingen aan uw levensstijl verbeteren uw lipiden:
Beperk verzadigde vetten en transvetten; eet meer vezels en minder cholesterol. Kies voedingsmiddelen met
een lage glykemische index, bijv. volkorenbrood, peulvruchten, havervlokken, fruit.
Eet minimum 2 maal per week vette vis (zalm, makreel, sardines, tonijn, heilbot,...) en gebruik koolzaadolie of
druivenpitolie in de voeding, deze bevatten omega-3 en zullen uw HDL-cholesterol (goede cholesterol) doen
stijgen.
HDL- cholesterol staat bekend als de ‘goede cholesterol’ – u kunt denken aan de ‘H’ van “heilzaam” – HDLcholesterol moet zo ‘hoog’ mogelijk zijn. Terwijl LDL de cholesterol naar de bloedvaten voert, haalt HDL juist
de overtollige cholesterol terug op en brengt hem terug naar de lever om te verwerken. Zo verkleinen hoge
HDL- cholesterolconcentraties de kans dat er LDL- cholesterol wordt afgezet in de slagaders, en verminderen
dus de kans op hart- en vaatlijden.
Zorg ook voor voldoende beweging minstens 30 minuten per dag, liefst elke dag.
Van zodra u dan de streefwaarde voor LDL- cholesterol heeft bereikt, wordt aanbevolen het nuchtere
lipidenprofiel om de 6 maanden te testen om zeker te zijn dat u onder de streefwaarde blijft.
Bloeddruk - Op dit moment gebruikt u geen bloeddrukverlagende medicatie.
Gefeliciteerd, uw bloeddruk van 130/80 mmHg gemeten op 20/11/2012 ligt onder de streefwaarde van
maximaal 140/80 mmHg. U heeft gemeld dat uw normale bloeddruk meestal 120/70 mmHg bedraagt.
Hoge bloeddruk maakt deel uit van het diabetesprobleem. Om diabetes goed aan te pakken is het belangrijk
de streefwaarde voor de bloeddruk te blijven bereiken.
Overmatige krachtsuitoefening op de slagaderwanden door een herhaaldelijk hoge bloeddruk beschadigt de
slagaders en organen in het lichaam.
110
Dat kan gevaarlijke gevolgen hebben, met name ziektes van grote bloedvaten (beroertes en
hartaandoeningen) en kleine bloedvaten (schade aan nieren, ogen en zenuwen).
-
-
De enige manier om hoge bloeddruk tijdig op te sporen, is door regelmatige controle.
Het is aanbevolen dat telkens wanneer u uw arts raadpleegt, hij uw bloeddruk controleert. Schrijf het
resultaat op zodat u weet of u de streefwaarde al dan niet bereikt hebt.
Zorg voor een gezond dieet, zout en alcohol beperking, matig gewichtsverlies en regelmatige
lichaamsbeweging:
Het is bewezen dat vermindering van de zoutinname de bloeddruk kan doen dalen. Zoutinname moet beperkt
worden tot maximaal 4 gram per dag door het eten te bereiden zonder toevoeging van zout en door voedsel
te kopen waarop staat dat er geen zout werd toegevoegd. Vermijd voedingstoffen, snacks en fast food die
met zout werden bereid. Vermijd zout te gebruiken aan tafel.
Alcoholinname, zelfs gematigd, kan de bloeddruk verhogen. Beperking van alcohol kan de bloeddruk sterk
doen dalen. U heeft gemeld dat u zelden alcohol gebruikt.
Door gewichtsverlies zal uw bloeddruk dalen.
Ook voldoende regelmatige lichaamsbeweging kan de bloeddruk doen dalen.
Microvasculaire controle:
Nieronderzoek –
Diabetes en hoge bloeddruk zijn de twee belangrijkste risicofactoren voor beschadiging van uw nieren. De
vroege schade aan de nieren kan vastgesteld worden door de controle op aanwezigheid van eiwitten in de
urine.
Alle diabetespatiënten moeten jaarlijks microalbuminurie - de aanwezigheid van piepkleine hoeveelheden
eiwitten in de urine- laten testen om vroegtijdige tekens van nierschade te ontdekken. De beste test hiervoor
is het meten van de verhouding albumine/creatinine in de urine. Om de test uit te voeren is een
ochtendstaal urine nodig - liefst de eerste ochtendurine. Vraag uw arts om het juiste aanvraagformulier. Is
deze test dit jaar al uitgevoerd, geef dan de waarde door de volgende coach sessie.
Ook het creatinine en de eGFR (filtersnelheid van de nieren) moeten 1 maal per jaar getest worden en vaker
bij afwijkende waarden.
U heeft gemeld dat deze testen om de 6 maand gebeuren. Zoek indien mogelijk deze waarden op en geef ze
door bij de volgende coach sessie.
Oogonderzoek –
Mensen met diabetes lopen een risico op gezichtsverlies door beschadiging van de kleine bloedvaten aan de
achterzijde van de ogen. Goede bloedglucoseconcentraties, een goede bloeddruk en regelmatig nazicht
kunnen het risico op complicaties sterk verminderen.
Ga daarom ieder jaar op controle bij een oogarts of nog vaker als er al oogschade is.
U heeft gemeld dat u jaarlijks een oogonderzoek laat uitvoeren en dat er nog geen afwijkingen aanwezig
waren.
Voetonderzoek –
Als u diabetes hebt, moet u uw voeten elke dag goed verzorgen. Als u dat doet, kunt u ernstige complicaties
voorkomen.
Voeten lopen risico omdat diabetes schade kan toebrengen aan de zenuwen en de bloedtoevoer. De kans is
groter dat die beschadiging optreedt als: u al lang diabetes hebt, uw bloedglucoseconcentraties lang te hoog
111
zijn, u rookt, u inactief bent.
De symptomen zijn onder andere: een verdoofd gevoel, een koud gevoel in de benen, tintelingen, slapende
voeten, branderige pijn in de benen en voeten.
Die symptomen kunnen leiden tot gevoelsverlies in de voeten. Dat verhoogt het risico op letsels omdat u pijn
niet op tijd zult voelen. Een letsel aan de voeten kan zich ontwikkelen tot een etterwond op de voetzool die
tot het bot kan doordringen. Dat kan een chronische infectie in de botten en gewrichten veroorzaken.
Als een infectie niet behandeld wordt bij de eerste tekens, kan dat leiden tot een geïnfecteerde open zweer
en eventueel een amputatie (verwijdering van een teen, voet of lidmaat).
Om zweren en andere voetproblemen te vermijden, wordt aan patiënten met diabetes dan ook aanbevolen
hun voeten te laten controleren door een arts, een podoloog of door een diabetesverpleegkundige, en dit op
het moment dat diabetes wordt vastgesteld en verder om de 12 maanden.
U heeft gemeld dat uw voetonderzoek werd uitgevoerd op 1 december en er geen afwijkingen werden
vastgesteld.
Ken uw voeten goed- was, droog en controleer uw voeten elke dag. Controleer op roodheid, zwelling,
sneetjes, afscheiding van etter, splinters of blaren, en zorg er daarbij vooral voor om tussen de tenen, rond de
hielen en nagelhoeken en naar de voetzolen te kijken. Knip de teennagels recht af – niet rond – en vijl de
scherpe kantjes voorzichtig bij. Breng elke dag een vochtinbrengende crème aan op uw voeten om droge huid
te vermijden (maar niet tussen uw tenen). Win snel medisch advies in als u een verandering of probleem
opmerkt.
Bloedplaatjesremmers:
Op dit moment gebruikt u het volgende antistollingsmiddel:
Generieke naam
Merk naam
Dosis
Ochtend Middag
ACETYLSALICYLZUUR
ASAFLOW
80 mg
1
Avond
v.d.
nacht
Te bereiken leefstijldoelen:
Roken –
Gefeliciteerd! U bent niet-roker.
Roken brengt schade toe aan de bloedsomloop omdat ons hart sneller gaat kloppen en omdat de bloedvaten
vernauwen. Roken maakt het bloed dikker en de bloedvatwanden plakkeriger zodat er gemakkelijker
vetplakken worden gevormd in het bloedvat. Dit kan hartaanval, beroerte en andere vaatziekten veroorzaken.
Vermijd de aanwezigheid van rokers rondom u. Passief roken verhoogt de kans op hartaandoening.
Gewichtsmanagement –
Overgewicht maakt het goed beheren van diabetes moeilijker en verhoogt sterk de kans op hartziekte en
beroerte. Zelfs een beperkt gewichtsverlies (5-10% van uw totaal gewicht op 1 jaar tijd) maakt een groot
verschil voor uw gezondheid. Concreet betekent dit voor u een gewichtsverlies van 4,5 tot 9 kg.
Gewichtsvermindering verlaagt uw bloedsuikerspiegel.
Geleidelijke gewichtsvermindering is het beste. Een gewichtsverlies van 0.5 kg per week is haalbaar.
Gewichtscontrole kunt u bereiken door een goede voeding en door lichaamsbeweging. Het gaat over
eetgewoonten en lichaamsbeweging – NIET over dieet en sporten.
Wandelen is de meest praktische vorm van lichaamsbeweging, maar alles wat uw activiteitsniveau verhoogt
helpt.
112
In Het COACH Programma welkomstpakket vindt u een buikomtrekmeter. Meet uw buikomtrek precies ter
hoogte van uw navel. Geef uw buikomtrek en uw recent gewicht door bij de volgende coach sessie.
Zorg voor geleidelijk gewichtsverlies door uw porties te verkleinen, beperk uw energie en vetopname (vooral
verzadigde vetten), en doe gedurende 30 minuten per dag aan matige lichaamsbeweging, liefst elke dag,
zoniet dan toch minstens 150 minuten per week.
Alcoholgebruik –
Gefeliciteerd! Uw actueel alcoholgebruik komt overeen met de aanbevelingen, namelijk niet meer dan 2
standaard alcoholconsumpties per dag.
Onderzoek heeft aangetoond dat matig alcoholgebruik gepaard gaat met een lager cardiovasculair risico.
Gematigd alcoholgebruik betekent voor een man niet meer dan een consumptie per dag. Anderzijds weten
we dat 3 of meer consumpties leiden tot hoge triglyceridenspiegels (vetten in het bloed), hoge bloeddruk,
beroertes en hartspieraandoeningen.
Onthoud dat 1 glas niet altijd overeenkomt met een consumptie. Een glas wijn op restaurant of thuis van
ongeveer 150 ml, komt overeen met 1,5 consumptie. Ook een biertje van 375 ml is gelijk aan 1,5 consumptie.
Alle alcoholische dranken bevatten veel energie (calorieën) en dragen bij tot gewichtstoename.
Het is aan te bevelen alcohol te drinken bij het eten of bij koolhydraatbevattende snacks om eventuele
hypoglycaemie te vermijden.
Lichaamsbeweging –
Uw actuele fysieke activiteiten stemmen overeen met de aanbevelingen, namelijk dagelijks 30 minuten of
meer matig intense inspanning, liefst elke dag van de week. U doet het prima en hou zo vol!
Matige fysieke inspanning veroorzaakt slechts een matig diepere ademhaling die u toch nog toelaat op een
comfortabele manier een gesprek te voeren. Voorbeelden van matig fysieke inspanning zijn doelgericht
wandelen op vlakke ondergrond, zwemmen, water aerobics en fietsen voor je plezier.
Hou voor ogen dat de 30 minuten beweging kunnen samengesteld worden uit kortere periodes van 3 x 10
minuten of 2 x 15 minuten.
Bepaal voor uzelf haalbare doelstellingen. Start rustig en verhoog progressief de frequentie en de duur van
uw lichaamsbeweging. Wees elke dag op zoveel mogelijk manieren actief.
Lichaamsbeweging is essentieel om gewicht onder controle te houden. Het verbetert tevens uw
bloedglucosespiegel, uw lipiden, uw bloeddruk, en het verhoogt uw welzijnsgevoel.
Andere geneesmiddelen:
U neemt momenteel ook volgende geneesmiddelen:
Naam
Dosis
Ochtend Middag
L-thyroxine
Zyloric
150 microgr
300 mg
1
1
113
Avond
v.d.
nacht
114
- Leeftijd: 58 jaar
- Diagnose type 2 diabetes sinds: 2008
- Chronische aandoeningen : dyslipidemie
- Hypoglycaemie : Zelden
- Familie leden met cardiovasculaire aandoening: Nee
Risicofactoren in vergelijking met de te behalen doelen
Risicofactoren
Diabetes
Datum:
HbA1c
Lipiden
Datum:
Totaal cholesterol
Triglyceride
HDL-cholesterol
LDL-cholesterol
Bloeddruk
Datum:
Uw risicofactoren aan het begin van het Aanbevolen door de Wetenschappelijke
COACH Programma
vereniging van Vlaamse Huisartsen (Domus
Datum: 15/01/2013
Medica)
Bereikte doelen
20/11/2012
9,5 % (80 mmol/mol)
Minder dan 53 mmol/mol (7%)
Doel niet bereikt **
20/11/2012
167 mg/dL
62 mg/dL
43 mg/dL
112 mg/dL
Minder dan 100 mg/dL
Doel niet bereikt **
20/11/2012
130/80 mmHg
Minder dan 140/80 mmHg
Doel bereikt
114
115
Risicofactoren in vergelijking met de te behalen doelen
Roken
Nooit gerookt
Gewichtsmanagement
Gewicht
Body mass index
95,6 kg
29,5 kg/m²
Buikomtrek
Alcohol
Lichaamsbeweging
101 cm
1 glas alcohol, 4 keer per week
wandelen en lopen
30 minuten, 5 keer per week
Volledig stoppen
Doel bereikt
Bij BMI > 25 kg/m² en buikomtrek > 94 cm –
gewichtsverlies van 5 tot 10% per jaar
Doel niet bereikt **
Niet meer dan 2 standaard alcohol
consumpties per dag
30 minuten of meer matige inspanning op 5
of meer dagen per week (m.a.w. minimaal
150 min./week)
Doel bereikt
Aanbevolen door de Wetenschappelijke vereniging van Vlaamse Huisartsen (Domus Medica)
115
Doel bereikt
116
Controle voor microvasculaire risico’s
Microvasculaire controle
Nierfunctiecontrole
Datum:
albumine/creatinine
Datum:
Creatinine
eGFR
Uw resultaten aan het begin van
het COACH Programma
Datum: 15/01/2013
Aanbevolen door de Wetenschappelijke
vereniging van Vlaamse Huisartsen (Domus
Medica)
Bereikte doelen
Niet beoordeeld
Niet meer dan 30 mg/g
Niet beoordeeld *
Niet beoordeeld
Niet beoordeeld
meer dan 90 mL/min/1.73m²
Niet beoordeeld *
Aanbevolen door de Wetenschappelijke vereniging van Vlaamse Huisartsen (Domus Medica)
Microvasculaire controle
Uw resultaten aan het begin
van
The COACH Program
Datum: 15/01/2013
Oogcontrole
Datum controle:
03/01/2012
Volgende controle::
Volgende test op:
Voetcontrole
Datum controle:
01/12/2012
Volgende controle:
Volgende test op:
01/12/2013
Aanbevolen door de Wetenschappelijke vereniging van
Vlaamse Huisartsen (Domus Medica)
Bereikte aanbevelingen
Controle bij diagnose. Daarna eenmaal per jaar en vaker bij
problemen
Uitgebreid oogonderzoek bij een oogarts of optometrist om
blindheid te voorkomen.
Oogcontrole uitgevoerd
Controle bij diagnose en elke 12 maanden bij een diabetes
verpleegkundige, dokter of een podoloog.
Om zweervorming en amputatie van de onderste ledematen
te voorkomen
Voet controle uitgevoerd
Aanbevolen door de Wetenschappelijke vereniging van Vlaamse Huisartsen (Domus Medica)
116
117
Appendix B. Search Strategies within the Systematic Review
------------------------------------------------------------------------------------------------------I.
SEARCH STRATEGY MEDLINE VIA PUBMED (2002 – 17.04.2014) – 853 records
-------------------------------------------------------------------------------------------------------("Diabetes Mellitus, Type 2"[Mesh] OR "Prediabetic State"[Mesh] OR "Glucose Intolerance"[Mesh] OR
“Impaired Glucose Tolerance” OR TYPE 2 DIABETESM OR NIDDM OR IDDM2 OR MODY OR “Diabetes Mellitus
Type 2” OR “Diabetes Mellitus Type II” OR “Type 2 diabetes” OR “Ketosis-Resistant Diabetes Mellitus“ OR “NonInsulin-Dependent Diabetes Mellitus” OR “Stable Diabetes Mellitus” OR “Maturity-Onset Diabetes Mellitus” OR
“Adult-Onset Diabetes Mellitus” OR prediabetes OR Prediabetic State* OR Prediabetic Stage*)
AND
("Self Care"[Mesh] OR "Patient Education as Topic"[Mesh] OR "Counseling"[Mesh:NoExp] OR "Directive
Counseling"[Mesh] OR "Telenursing"[Mesh] OR "Telemedicine"[Mesh:NoExp] OR "Remote
Consultation"[Mesh] OR "Disease Management"[Mesh:NoExp] OR “disease management” OR "diabetes
management" OR “patient empowerment” OR ((“self care” OR “self management” OR “self treatment” OR
“self help” OR intervention) AND educat*) OR patient educat* OR “diabetes education” OR counsel* OR
telecounsel* OR teleconsult* OR telehealth OR ehealth OR telenursing OR telemedicine OR
(("Telephone"[Mesh] OR Telephone* OR phone* OR remote) AND (coach* OR counsel* OR educat* OR nursing
OR support OR consult*)))
AND
(cost OR costs OR economic*[tiab] OR "economics"[Subheading] OR "health technology assessment" OR HTA
OR "Models, Economic"[Mesh] OR ((economic OR cost OR costs) AND (model OR models OR modelling OR
modeling)) OR "Health Expenditures"[Mesh] OR "Quality-Adjusted Life Years"[Mesh] OR “life years”)
----------------------------------------------------------------------------------------------------------II.
SEARCH STRATEGY EMBASE via EMBASE.COM (2002 – 17.04.2014) - 655 records
----------------------------------------------------------------------------------------------------------'non insulin dependent diabetes mellitus'/exp OR 'impaired glucose tolerance'/exp OR 'glucose
intolerance'/exp OR ('impaired glucose tolerance' AND [embase]/lim) OR (type 2 diabetesm OR niddm OR
iddm2 OR mody AND [embase]/lim) OR ('diabetes mellitus type 2' OR 'diabetes mellitus type ii' OR 'type 2
diabetes' AND [embase]/lim) OR ('ketosis-resistant diabetes mellitus' OR 'non-insulin-dependent diabetes
mellitus' OR 'stable diabetes mellitus' OR 'maturity-onset diabetes mellitus' OR 'adult-onset diabetes mellitus'
AND [embase]/lim) OR (prediabetes OR (prediabetic AND state*) OR (prediabetic AND stage*) AND
[embase]/lim) AND ('self care'/exp OR 'patient education'/exp OR 'diabetes education'/exp OR 'counseling'/exp
OR 'telenursing'/exp OR 'telemedicine'/exp OR (counsel* AND [embase]/lim) OR (ehealth AND [embase]/lim)
OR ('diabetes management' OR 'patient empowerment' AND [embase]/lim) OR ('self care' OR 'self
management' OR 'self treatment' OR 'self help' OR intervention AND educat* AND [embase]/lim) OR ((diabetes
OR patient) NEAR/1 educat* AND [embase]/lim) OR (telecounsel* OR teleconsult* OR telehealth OR
telenursing OR telemedicine AND [embase]/lim) OR (telephone* OR phone* OR remote AND (coach* OR
counsel* OR educat* OR nursing OR support OR consult*) AND [embase]/lim)) AND ('cost'/exp AND
[embase]/lim OR (economic*:ab,ti AND [embase]/lim) OR ('economics'/exp AND [embase]/lim) OR (hta OR
'health technology assessment' AND [embase]/lim) OR 'mathematical model'/exp OR ((economic OR cost OR
117
118
costs) NEAR/1 (model OR models OR modelling OR modeling) AND [embase]/lim) OR 'health care cost'/exp OR
'quality adjusted life year'/exp OR ('life years' AND [embase]/lim)) AND [2002-2012]/py
#1 : 'non insulin dependent diabetes mellitus'/exp
#2: 'impaired glucose tolerance'/exp - 112,740
#3: 'glucose intolerance'/exp - 14,657
#4: 'impaired glucose tolerance' AND [embase]/lim - 9,500
#5: type 2 diabetesm OR niddm OR iddm2 OR mody AND [embase]/lim - 16,140
#6: 'diabetes mellitus type 2' OR 'diabetes mellitus type ii' OR 'type 2 diabetes' AND [embase]/lim - 15,440
#7: 'ketosis-resistant diabetes mellitus' OR 'non-insulin-dependent diabetes mellitus' OR 'stable diabetes
mellitus' OR 'maturity-onset diabetes mellitus' OR 'adult-onset diabetes mellitus' AND [embase]/lim - 65,681
#8: prediabetes OR (prediabetic AND state*) OR (prediabetic AND stage*) AND [embase]/lim - 95,437
#9: #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 - 4,551
#10: 'self care'/exp - 150,430
#11: 'patient education'/exp - 42,566
#12: 'diabetes education'/exp - 79,141
#13: 'counseling'/exp - 985
#14: 'telenursing'/exp - 94,097
#15: 'telemedicine'/exp – 97
#16: counsel* AND [embase]/lim - 14,583
#17: ehealth AND [embase]/lim - 103,562
#18: 'diabetes management' OR 'patient empowerment' AND [embase]/lim - 531
#19: 'self care' OR 'self management' OR 'self treatment' OR 'self help' OR intervention AND educat* AND
[embase]/lim - 2,732
#20: (diabetes OR patient) NEAR/1 educat* AND [embase]/lim - 62,323
#21: telecounsel* OR teleconsult* OR telehealth OR telenursing OR telemedicine AND [embase]/lim - 43,444
#22: telephone* OR phone* OR remote AND (coach* OR counsel* OR educat* OR nursing OR support OR
consult*) AND [embase]/lim - 10,220
#23: #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 - 30,500
#24: 'cost'/exp AND [embase]/lim - 321,982
#25: economic*:ab,ti AND [embase]/lim - 172,509
#26: 'economics'/exp AND [embase]/lim - 116,196
118
119
#27: hta OR 'health technology assessment' AND [embase]/lim - 15,941
#28: 'mathematical model'/exp - 4,729
#29; (economic OR cost OR costs) NEAR/1 (model OR models OR modelling OR modeling) AND [embase]/lim 180,897
#30: 'health care cost'/exp - 2,477
#31: 'quality adjusted life year'/exp - 179,434
#32: 'life years' AND [embase]/lim 9,354
#33: #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 - 5,479
#34: #9 AND #23 AND #33- 496,811
#35: #34 AND [2002-2012]/py - 673
-----------------------------------------------------------------------III.
SEARCH STRATEGY COCHRANE LIBRARY via WILEY (2002 – 17.04.2014) - 182 records
-----------------------------------------------------------------------HTA: 9 records; Economic evaluations: 57 records; Clinical tirals (met cost): 116 records
#1 MeSH descriptor: [Diabetes Mellitus, Type 2] explode all trees
7261
#2 MeSH descriptor: [Prediabetic State] explode all trees
100
#3: #1 or #2
7325
#4 MeSH descriptor: [Self Care] explode all trees
3133
#5 MeSH descriptor: [Disease Management] explode all trees
1480
#6 MeSH descriptor: [Telemedicine] explode all trees
910
#7 MeSH descriptor: [Telenursing] explode all trees
13
#8 MeSH descriptor: [Remote Consultation] explode all trees
267
#9 MeSH descriptor: [Directive Counseling] explode all trees
183
#10 MeSH descriptor: [Patient Education as Topic] explode all trees
5602
#11: #4 or #5 or #6 or #7 or #8 or #9 or #10
9933
#12: #3 and #11
545
#13 MeSH descriptor: [Models, Economic] explode all trees
1442
#14 MeSH descriptor: [Quality-Adjusted Life Years] explode all trees
2664
119
120
#15 MeSH descriptor: [Health Expenditures] explode all trees
227
#16 “life years”:ti,ab,kw (Word variations have been searched)
14678
#17 cost or costs or economic*:ti,ab,kw (Word variations have been searched)
34224
#18 ((economic or cost or costs) and (model or models or modelling or modeling)):ti,ab,kw (Word variations
have been searched)
4654
#19: #13 or #14 or #15 or #16 or #17 or #18
44582
#20: #12 and #19
112
-----------------------------------------------------------------------IV.
SEARCH STRATEGY CINAHL via EBSCOHOST (2002 – 17.04.2014) - 296 records
-----------------------------------------------------------------------S1
(MH "Diabetes Mellitus, Type 2")
19724
S2
(MH "Prediabetic State")
525
S3
(MH "Glucose Intolerance")
1212
S4
TX “Impaired Glucose Tolerance” OR TYPE 2 DIABETESM OR NIDDM OR IDDM2 OR MODY
2413
S5
TX “Diabetes Mellitus Type 2” OR “Diabetes Mellitus Type II” OR “Type 2 diabetes”
22772
S6
TX “Ketosis-Resistant Diabetes Mellitus“ OR “Non-Insulin-Dependent Diabetes Mellitus” OR
“Stable Diabetes Mellitus” OR “Maturity-Onset Diabetes Mellitus” OR “Adult-Onset Diabetes
Mellitus”
433
S7
TX prediabetes OR Prediabetic State* OR Prediabetic Stage*
695
S8
(MH "Self Care+")
20737
S9
(MH "Diabetes Education")
3754
S10 (MH "Counseling+")
14530
S11 (MH "Telehealth+")
6485
S12 (MH "Remote Consultation")
490
S13 (MH "Disease Management")
5022
S14 TX “disease management” OR "diabetes management" OR “patient empowerment”
9124
120
121
S15
TX ((“self care” OR “self management” OR “self treatment” OR “self help” OR intervention) AND
34067
educat*)
S16
TX patient educat* OR “diabetes education” OR counsel* OR telecounsel* OR teleconsult* OR
telehealth OR ehealth OR telenursing OR telemedicine
89239
S17
TX ((Telephone* OR phone* OR remote) AND (coach* OR counsel* OR educat* OR nursing OR
support OR consult*))
20294
S18 TX cost OR costs
86355
S19 (MH "Economics+")
392329
S20 TX eonomics OR economic
32330
S21 TX "health technology assessment" OR hta
1514
S22 TX ((economic OR cost OR costs) AND (model OR models OR modelling OR modeling))
14415
S23 (MH "Quality-Adjusted Life Years")
632
S24 TX "Life Years"
1436
S25 S1 or S2 or S3 or S4 or S5 or S6 or S7
24254
S26 S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17
147705
S27 S18 or S19 or S20 or S21 or S22 or S23 or S24
434664
S28
S25 and S26 and S27. Limiters - Published Date from: 20020101-; Peer Reviewed; Exclude
MEDLINE records
-----------------------------------------------------------------------V.
SEARCH STRATEGY ECONLIT via CSA/ProQuest (2002 – 17.09.2012) - 198 records
-----------------------------------------------------------------------(diabetes OR prediabetes) AND (cost* OR economic*)
121
241
122
Appendix C. A tool for quality assessment of economic evaluations within the Systematic Review
Consensus Health Economic Criteria List (CHEC) extended with guideline-based interpretations and question 5) on the model assumptions and validation.
Checklist question
1.Is the study population clearly described?
2.Are competing alternatives clearly
described?
3.Is a well-defined research question posed
in answerable form?
4.Is the economic study design appropriate
to the stated objective?
Guidelines to support the value judgment
The study population should be described in terms of
geography, patient characteristics such as age, sex, ethnicity
(Higgins et al.), co-morbid conditions, and disease
stage/previous treatments, each of which should be
appropriate to the decision problem. (Caro et al.)
Specific guidelines for the models
The patient population to which the economic evaluation
applies should be consistent with the patient population
defined in the clinical part of the study.(Cleemput et al.)
The competing alternatives should be clearly defined in terms
of frequency, component services, dose or intensity, duration,
and any variations required for target subgroups It should be
mentioned whether people involved in delivery of the
intervention need to be trained (adapted from Higgins et al. and
Caro et al.).
The choice of the comparator(s) should always be justified. The
comparator should be the most cost effective alternative
intervention currently available1.
The research question should specify the type of population
(participants), type of interventions (and comparisons), the type
of outcomes and the type of study that was performed (Higgins
et al.) including the chosen perspective and the applied analytic
time horizon.
Trial based economic evaluations are appropriate when the
available data are sufficient to allow a full assessment of the
cost-effectiveness or cost-utility of an Intervention. That means:
122
Modeling should be applied if the available data are
insufficient to allow a full assessment of the costeffectiveness or cost-utility of an
intervention. That means:
123


the effect of the treatment cannot go beyond the
duration of the trial;
the intermediate outcome parameters do not have
potential impact on the clinical endpoints such as longterm mortality, quality adjusted life years gained or life
years gained on a long term.
(adapted from Cleemput et al.)
5. Are the structural assumptions and the
validation methods of the model properly
reported?
123

the effect of the treatment might go beyond
the duration of the trial;
 the intermediate outcome parameters have
potential impact on the clinical endpoints
such as long-term mortality, quality adjusted
life years gained or life years gained on a long
term.
Modeling is also appropriate:
 to simulate the real life application of an
intervention based on the data available
from clinical trials. This can be done e.g. by
adjusting for differences in baseline risk
between the trial population and the realworld target population and adjusting for
protocol-driven costs or events;
 to account for possible externalities
associated with the disease or treatment
(e.g. transmission of infections, bacterial
resistance…) that were not part of the
original study design and therefore not
captured during clinical trial;
 to compare the intervention with the
relevant comparator if the respective
interventions have never been directly
compared in a clinical trial.
(adapted from Cleemput et al.)
For models, the following information should be
presented:
Structure
the structural hypotheses/ assumptions
the uncertainty around these assumptions;
sources of information for these assumptions
(systematic reviews preferred).
(adapted from Cleemput et al.)
Validity
Methods to verify the model’s
124
structure (face) validity,
performance (technical/internal) validity
outcomes validity
should be discussed.
(adapted from Weinstein et al. and Caro et al.)
6.Is the chosen time horizon appropriate in
order to include relevant costs and
consequences?
7.Is the actual perspective chosen
appropriate?
8.Are all important and relevant costs for
each alternative identified?
9.Are all costs measured appropriately in
physical units?
10.Are costs valued appropriately?
The chosen time horizon should be long enough to capture
relevant differences in outcomes across strategies. (Caro et al.)
Treatments of chronic diseases mostly have consequences over
a patient’s lifetime. (Cleemput et al.)
The perspective of the analysis should be stated and defined.
Analyses which take a perspective narrower than the societal
perspective should report and justify the included and excluded
outcomes. (Caro et al.)
The identification of costs should be consistent with the chosen
perspective and the assessed area of disease and treatments.
For the perspective of the health care payer, at least all direct
health care costs associated with or influenced by the
competing alternatives must be included.
For the societal perspective, also direct and indirect costs
outside the health care sector, such as productivity loss, should
be included.
(adapted from Cleemput et al.)
Validated sources should be used for the measurement of the
resource – and material use, such as observations from clinical
trials, prospective observational studies, databases and patient
charts, or derived from literature. If derived from literature or
studies from other countries, resource use estimates should be
validated for the local context. (Cleemput et al.)
All costs should be expressed in values by using prices of a
particular year indicated in the study. (adapted from Cleemput
et al.)
Adjustment for inflation should be based on the Consumer
Price Index (CPI) or its health-care component.
The method of choice for making adjustments across countries
is to use purchasing power parity. However, a simple currency
124
125
11.Are all important and relevant outcomes
for each alternative identified?
12.Are all outcomes measured
appropriately?
13.Are outcomes valued appropriately?
conversion would be appropriate if there is an international
market for an input at a fixed price.
(Weinstein et al.)
Outcomes in economic evaluations should be expressed in
terms of final endpoints instead of intermediary outcomes, i.e.
in life years gained, in quality adjusted life years (QALYs) gained
(Cleemput et al.), or in disability-adjusted life-years. (Caro et al.)
Intermediate outcomes (useful for outcomes validation) can of
course be reported and may include number of events,
incidence of disease, mortality, adverse events … (Caro et al.)
Differences in outcomes between subgroups should be stated if
appropriate. (Cleemput et al.)
Quality of the clinical evidence from which the differences in
health outcomes were derived , should be critically appraised.
QALYs should be derived from the utility weights obtained from
the self-reported health status of the study participants.
Validated generic health-related quality-of-life instruments
should be used.
The generic health-related quality of life instruments used
should correspond with pre-specified scoring systems based on
“forced-choice” methods (standard gamble, time trade-off)
reflecting the preferences of the general public. (Weinstein et
al.)
Only if measured with the same instrument and in a similar
patient population are the values comparable and can they be
used in one and the same economic evaluation.
If the primary data are not available but only health-related
quality-of-life results from trials from another country are used,
index values from that country should be used for consistency.
Adjustment for baseline (age- and gender-specific) healthrelated quality of life is required in estimating the incremental
utility of an intervention.
(Cleemput et al.)
Life expectancy should be estimated by using national life
tables based on all-cause mortality
(Weinstein et al. and Cleemput et al.)
125
126
14.Is an appropriate incremental analysis of
costs and outcomes of alternatives
performed?
15.Are all future costs and outcomes
discounted appropriately?
16.Are all important variables, whose values
are uncertain, appropriately subjected to
sensitivity analysis?
The difference in the relevant health outcomes should be
compared to the difference in all relevant costs associated with
the alternative treatments (i.e. not only the additional costs of
the intervention). Consistency in the perspective and the time
horizon of the clinical and the economic outcomes should
thereby be pursued.
Incremental cost-effectiveness ratios should only be presented
if the treatment is NOT dominant (lower costs and better
effectiveness) or dominated (higher costs and lower
effectiveness). (Cleemput et al.)
The method for discounting costs and health effects to present
value should be stated and justified. (Weinstein et al.)
For all economic evaluations, uncertainty should be analysed
using appropriate statistical techniques.
For within-trial economic evaluations:
 The sample uncertainty should be presented through
deterministic sensitivity analysis methods (point
estimate and range).

Methodological uncertainty coming from the analytical
methods chosen such as the discount rate/ missed
data imputation etc. should be handled by one-way
sensitivity analyses.
The incremental costs and incremental outcomes should be
presented with the 95% confidence or credibility interval.
(Adapted from Cleemput et al.)
For all economic evaluations:
To assess the sensitivity of the results to the discount rate
applied, different scenarios should be presented. For all
analyses of data, methods to handle missing data should be
described.
It is recommended to show the most important contributors to
the uncertainty of the estimated incremental costeffectiveness/cost-utility ratio (e.g. by means of a Tornado
diagram).
126
For models:
 The parameter uncertainty should be tested
through probabilistic sensitivity analyses, e.g.
by means of Monte Carlo simulations.
Beta distributions are a natural match for binomial
data; gamma or log normal for right skew parameters;
log normal for relative risks or hazard ratios; logistic
for odds ratios)
(Caro et al.)
 The structural uncertainty should be tested
through presenting different scenarios to
show the impact of different extrapolation
approaches on the results.
Possible scenarios:
1) the treatment effect disappears immediately
in the extrapolated phase (stop-and-drop
approach);
2) the incremental treatment effect stays the
same as during the observed phase;
3) the initial treatment effect fades out in the
long term.
127
17.Do the conclusions follow from the data
reported?
18.Does the study discuss the
generalizability of the results to other
settings and patient/client groups?
19.Does the article/report indicate that
there is no potential conflict of interest of
study researcher(s) and funder(s)?
20.Are ethical and distributional issues
discussed appropriately?
The cost-effectiveness plane, with the results of the uncertainty
analysis (such as Monte Carlo simulations or bootstrapping),
should always be presented. In addition, if simulations are
spread over different quadrants of the cost-effectiveness plane,
the percentage of simulations in each quadrant should be
reported.
(adapted from Cleemput et al.)
A cost-effectiveness plane should be displayed. The
acceptability curve should be presented in order to show the
probability that the treatment is cost-effective, given varying
theoretical threshold values for the cost-effectiveness ratio.
(Cleemput et al.)
Do the authors critically discuss the quality of health economic
evidence considering the study limitations and uncertainties?
Generalisability refers to applicability of the results to other
populations (e.g. non-trial populations with different baseline
risk). Transferability refers to the applicability of the results
from other countries. These two aspects should be assessed
separately. (Cleemput et al.)
No value judgment implied.
The morally relevant issues and moral conflicts related to
implementing or not implementing the technology have to be
synthesized and reported. This includes potential impact on the
traditional values such as human equality, autonomy, dignity,
the principles of solidarity and justice etc. Summarizing the
benefits and harms of introducing/ refraining from the
technology for different groups of stakeholders, such as
patients, families, care providers, society etc. might be
appropriate. The ethical analysis should allow a judgment on
their transferability.
(adapted from The HTA Core Model)
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Summary
Background
Type 2 diabetes is a chronic condition associated with a high risk of developing micro-and
macrovascular complications, which result in loss in life expectancy and health related quality
of life. In absence of means to cure diabetes, an adequate diabetes management is crucial to
reduce the risk of diabetes complications. Despite improvements in glycaemia, lipids and
blood pressure control, only about 15% of people with diabetes reach the guidelines
recommended targets for all three risk factors.
It has been estimated that about ninety-five percent of daily care in diabetes is related to
patient self-care. Diabetes education, particularly when designed as behavioural change
counselling, has been shown to improve diabetes knowledge, body weight, blood pressure
and glycaemic control in poorly controlled patients. Despite proven benefits, the numbers of
patients who are referred to and receive diabetes education, are small. Overall, the healthcare
systems have been found to be poorly designed to provide patients with tailored selfmanagement support.
A better patient inclusion and up-scaling of education schemes to other pathologies is a
financial and organizational challenge and urges to enhance our understanding of the
predictors of its clinical and cost-effectiveness. The clinical and cost-effectiveness of
therapeutic patient education in diabetes has not been investigated in Belgium until now.
Research objectives
The objectives of this doctoral thesis were: 1) to update current evidence on the costeffectiveness of therapeutic education in prediabetes and type 2 diabetes by means of a
systematic literature review; 2) to investigate the clinical effectiveness of a nurse-led targetdriven diabetes education program delivered by phone, compared to usual care, through
completing a randomized controlled trial in Belgian primary care setting; 3) to analyse the
long-term cost-effectiveness of this program applying a Markov model and using the trial
outcomes and the claims data of the reimbursement database to populate the model; and 4)
to explore the patient and provider acceptance of the program in Belgian primary care,
engaging questionnaires and interviews.
Results
The systematic review revealed a great variety of approaches to deliver therapeutic patient
education and demonstrated, that it can be cost-effective in prediabetes and type 2 diabetes,
but offers a better value for money when offered already in prediabetes stage, as therapeutic
education aimed at lifestyle modifications of people with prediabetes showed to significantly
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reduce the incidence of type 2 diabetes. In type 2 diabetes, there was a greater variability of
the clinical and cost-effectiveness results.
The randomized controlled trial showed improvements in glycaemic control, body mass
index and total cholesterol at 6 months’ follow-up in the group allocated to telecoaching
delivered by diabetes nurse educators, compared to usual care. The improvements in
glycaemic control were still observed at twelve months after the completion of the
intervention, sustainably lowering the mean HbA1c in the intervention group to the
recommended target below 53 mmol/mol (7%). The program was well-accepted by the trial
participants. The lifelong cost-effectiveness analysis demonstrated that the telecoaching
would be cost-effective within the Belgian healthcare system, disregarded the level of
glycaemic control at the enrolment, with the mean Incremental Cost-Effectiveness Ratio
(ICER) of €5,569 per Quality Adjusted Life Year Gained (QALY). In West-European countries,
interventions with an ICER below €40,000 per QALY are generally considered cost-effective.
Conclusions
Patient education aimed at lifestyle adjustment is potentially cost-saving or highly costeffective if offered in in prediabetes stage. In people with type 2 diabetes in Belgian primary
care, target-driven nurse-led telephone education resulted in short-term improvements in
total cholesterol and body mass index and sustainable improvements in the glycaemic
control. The intervention is cost-effective and well-accepted by the trial participants. These
research findings contribute to the development of patient self-management education
programs in (pre)diabetes and other chronic conditions.
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Samenvatting
Achtergrond
Type 2 diabetes is een chronische aandoening, geassocieerd met een hoog risico op microen macrovasculaire complicaties, die leiden tot verlies in levensverwachting en -kwaliteit.
Aangezien er geen middelen zijn om diabetes te genezen, is adequaat diabetes management
cruciaal, met focus op het reduceren van het risico op complicaties. Ondanks verbeteringen
in de controle van glycemie, lipiden en bloeddruk, haalt slechts ongeveer 15% van de
mensen met diabetes de door de klinische richtlijnen aanbevolen streefwaarden voor deze
drie risicofactoren.
Er wordt geschat dat ongeveer vijfennegentig procent van de dagelijkse zorg bij diabetes uit
de zelfzorg van de patiënt bestaat. Het is aangetoond dat diabeteseducatie, vooral
programma’s gebaseerd op gedragsverandering theorie, het diabetesmanagement kunnen
verbeteren, en een effect hebben op diabetes kennis, lichaamsgewicht, bloeddruk, en
glycemiecontrole bij slecht gecontroleerde patiënten. Echter, ondanks bewezen voordelen,
wordt slechts een klein aantal patiënten naar een diabetes educator doorverwezen. Over
het algemeen biedt de organisatie van onze gezondheidszorg geen optimaal kader om
patiënten met chronische aandoeningen zelfmanagementondersteuning op maat te bieden.
Een betere inclusie van patiënten in zelfmanagement educatieprogramma’s en de
uitbreiding ervan naar andere pathologieën vormen een financiële en organisatorische
uitdaging. Om dit goed te kunnen organiseren, hebben we kennis nodig omtrent de
voorspellers van de klinische- en kosteneffectiviteit van deze programma’s. De klinische- en
kosteneffectiviteit van therapeutische patiënteneducatie in diabetes is tot nu toe nog niet
onderzocht geweest in België.
Onderzoeksdoelstellingen
De doelstellingen van dit proefschrift waren: 1) update van de kennis omtrent de
kosteneffectiviteit van therapeutische educatie in prediabetes en type 2 diabetes door het
uitvoeren van een systematisch literatuuroverzicht; 2) onderzoek van de klinische
effectiviteit van telefonische doel-gedreven diabeteseducatie door
diabetesverpleegkundigen, vergeleken met gewone zorg, door middel van een
gerandomiseerde gecontroleerde klinische studie in de Belgische eerstelijnszorg; 3) analyse
van de lange-termijn kosteneffectiviteit van dit programma met behulp van een
Markovmodel, en gebruik makend van de resultaten van de klinische studie en de
terugbetalingsgegevens van het ziekenfonds; en 4) exploratie van de acceptatie van het
programma door patiënten en zorgverstrekkers in Belgische eerstelijnszorg door middel van
vragenlijsten en interviews.
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Resultaten
Het systematische literatuuroverzicht liet zien dat er een grote variëteit van
organisatiemethodes bestaat voor therapeutische patiënteneducatie. De
educatieprogramma’s kunnen kosteneffectief zijn zowel in prediabetes als in type 2
diabetes, maar leveren meer waar voor hun geld indien aangeboden in de prediabetes fase.
Therapeutische educatie gericht op het veranderen van de levensstijl van mensen met
prediabetes blijkt inderdaad de incidentie van type 2 diabetes aanzienlijk te doen dalen. Bij
type 2 diabetes werd een hogere variabiliteit van de klinische- en kosteneffectiviteit
vastgesteld.
De gerandomiseerde gecontroleerde klinische studie toonde verbeteringen aan in de
controle van glycemie, BMI en totaalcholesterol in de telecoaching groep, vergeleken met de
controlegroep, na 6 maanden opvolging. De verbeteringen in de glycemiecontrole werden
nog steeds waargenomen op twaalf maanden na de voltooiing van de interventie. Hierdoor
werd in de interventiegroep een duurzame daling van de gemiddelde HbA1c onder de
aanbevolen waarde van 53 mmol/mol (7%) bereikt. Het programma werd goed
geaccepteerd door de deelnemers van de studie.
De kosteneffectiviteitsanalyse maakte een simulatie van de levenslange gevolgen van de
interventie waaruit bleek dat telecoaching binnen de Belgische gezondheidszorg
kosteneffectief zou zijn, ongeacht het niveau van de glycemiecontrole bij het begin van de
educatie, met een gemiddelde incrementele kosteneffectiviteit ratio (IKER) van € 5,569 per
gewonnen gezond levensjaar (QALY). In West-Europese landen worden interventies met een
IKER onder €40,000 per QALY over het algemeen als kosteneffectief beschouwd.
Conclusies
Patiënteneducatie gericht op aanpassing van de levensstijl is potentieel kostenbesparend of
zeer kosteneffectief als aangeboden in de prediabetes fase. Bij mensen met type 2 diabetes
in Belgische eerstelijnszorg, resulteerde de doel-gedreven telefonische coaching door
diabetes educatoren in korte termijn verbeteringen van totaalcholesterol en BMI, en
duurzame verbeteringen in de glycemiecontrole. De interventie is kosteneffectief en werd
goed aanvaard door de deelnemers van de studie. Deze thesis levert een bijdrage tot het
verder werk aan de ontwikkeling van “patient empowerment” programma's in (pre)diabetes
en andere chronische aandoeningen.
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