Stroke Unit Care Combined With Early Supported
Discharge Improves 5-Year Outcome
A Randomized Controlled Trial
Hild Fjærtoft, PT, PhD; Gitta Rohweder, MD; Bent Indredavik, MD, PhD
Downloaded from http://stroke.ahajournals.org/ by guest on June 18, 2017
Background and Purpose—Early supported discharge (ESD) seems to be a promising alternative to conventional follow-up
care after acute stroke. We have previously shown that stroke unit care combined with ESD has beneficial effects on
functional outcome and the use of resources for up to 1 year. The aim of this trial was to evaluate outcome after 5 years.
Methods—We performed a randomized controlled trial with 320 acute stroke patients allocated to ordinary stroke unit care
(160 patients) or stroke unit care with ESD (160 patients). The ESD service consisted of a mobile team that
co-coordinated hospital discharge and further rehabilitation during 1 month of follow-up in cooperation with the primary
health care. Mortality, residence, and functional outcome including modified Rankin scale were registered after 5 years.
All assessments were blinded.
Results—There was no difference between the groups with modified Rankin scale score ⱕ2 (P⫽0.213), but there was a
trend toward greater improvement in modified Rankin scale score in the ESD group from onset of stroke (38% versus
30%; P⫽0.106). More patients were dead or institutionalized in the ordinary stroke unit care group (P⫽0.032); 158
patients were alive, 84 were in ESD, and 74 were in ordinary stroke unit care. Of the 158 patients alive, a greater
proportion were living at home in ESD (86%/70%; P⫽0.019).
Conclusions—Stroke unit care combined with ESD seems to reduce death and institutional care and to improve patients’
chances of living at home 5 years after stroke compared to traditional stroke care. There is a trend toward improved
functional outcome in the ESD group. (Stroke. 2011;42:1707-1711.)
Key Words: organized stroke care 䡲 outcomes 䡲 rehabilitation 䡲 stroke delivery 䡲 stroke recovery 䡲 stroke units
T
he organization of inpatient stroke care was, for the first
time, seriously considered and addressed in the 1950s.1 It
was important, despite the lack of scientific evidence. Today,
we know that organizing the care of acute stroke patients is
essential, and the effectiveness of stroke unit care as the first
link in the chain of care is documented by scientific evidence.2 Stroke unit care is a widely accepted component of
stroke care and is recommended in many official guidelines.
The optimal organization of stroke care after discharge has
been undergoing discussion during the past 15 years. Randomized controlled trials of early supported discharge (ESD)
and further rehabilitation at home have documented great
benefits, mostly in reduced length of hospital stay (8 days).3,4
Some trials also have documented improved functional outcome, improved quality of life, and reduced costs3– 8 up to 1
year after stroke. The current recommendation from the ESD
trialists group, based on a meta-analysis on 12 randomized
controlled trials,3,4,9 is an ESD service consisting of a coordinating multidisciplinary team, because this is the most effective
form of organization in follow-up and rehabilitation. The service
is useful for most patients with mild to moderate disability, ie,
for 30% to 50% of stroke patients. Our previous publications are
a part of this systematic review. The long-term effects of ESD
after 1 year are not well-documented in the literature. Whether
ESD has a long-term effect surpassing 1 year of follow-up is a
question not yet answered by the literature.
This analysis is based on methods and results from a
randomized controlled trial of ESD service for patients at the
Stroke Unit at St. Olavs University Hospital, Trondheim,
Norway, in which we compared extended stroke unit service
(ESD) with traditional treatment (ordinary stroke unit service
[OSUS]) after stroke. The benefits attributed to the ESD
group consisted of improved functional ability,4,8 healthrelated quality of life,6 resource use, and reduced costs7
during the first year after a stroke, as presented. We have also
previously explored the association between stroke severity
and benefit of ESD versus OSUS.8
The primary focus of this analysis was to assess and compare
patients’ functional outcomes, survival, and place of residence 5
years after stroke for the patients treated in the 2 groups.
Received August 30, 2010; accepted December 23, 2010.
From the Stroke Unit (H.F., G.R., B.I.), St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Neuroscience (G.R.,
B.I.), Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Correspondence to Hild Fjærtoft, The Stroke Unit, St. Olavs Hospital, Trondheim University Hospital, Medisinsk klinikk, Pb. 3250, 7006 Trondheim,
Norway. E-mail [email protected]
© 2011 American Heart Association, Inc.
Stroke is available at http://stroke.ahajournals.org
DOI: 10.1161/STROKEAHA.110.601153
1707
1708
Stroke
June 2011
Secondarily, we also examined other measures of social function
and cognition. Finally, we tried to define baseline predictors for
good and bad outcomes 5 years after stroke.
Materials and Methods
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This 5-year follow-up study was performed based on a randomized
controlled trial of 320 acute stroke patients; 468 acute stroke patients
admitted to the Stroke Unit at St. Olav University Hospital of
Trondheim, Norway, during a 2-year period from 1995 to 1997 were
assessed for inclusion in the trial and 320 fulfilled the inclusion
criteria and were randomly allocated either to the extended stroke
unit service (ESD) or to the OSUS. The time of follow-up was 1 year
after inclusion. We recorded the baseline characteristics of age, sex,
severity of stroke, medical history, and functional status before
entrance into the trial.
During the acute phase in the stroke unit (eg, the first 2 weeks),
both groups received identical evidence-based stroke unit care with
a standardized medical treatment combined with a focus on early
mobilization/rehabilitation.
The follow-up service for the ESD group was organized by a
coordinating mobile team that followed-up the patient for the first
month after discharge from the hospital. They established a program
and support system that allowed the patient to live at home as soon
as possible and to continue rehabilitation at home or in a day
clinic. The mobile team consisted of a physiotherapist, an
occupational therapist, a nurse, and the part-time service of a
physician. One of the therapists acted as a case manager for the
patient.
The follow-up for the OSUS group after discharge from the stroke
unit was organized by the primary health care service with further
inpatient or outpatient rehabilitation on discharge. Details regarding
the study design, the method of randomization, the inclusion criteria,
and the intervention have been reported previously.5– 8 The Regional
Committee for Medical Research approved the study protocol.
Evaluation
As the primary outcome, we have used the modified Rankin scale
(mRS)10 and improvement of mRS score from stroke onset to 5
years. Because this is a long-term follow-up of a randomized trial,
we also decided to have the proportion of patients deceased, at home,
and in an institutions after 5 years as the primary outcome.
Secondary outcomes were the results of the following assessment
scales: Frenchay Activity Index,11 Scandinavian Stroke scale
(SSS),12 Mini Mental Status Examination,13 and Barthel Index.14 The
Frenchay Activity Index has been developed specifically for measuring disability in stroke patients. It measures complex physical
activities and social functioning with a separate score for each of the
15 items (maximum score, 60). The Mini Mental Status Examination
is a simplified scored form of the cognitive status examination and
includes 11 questions with a maximum total score of 30.
Finally, a subgroup analysis examining independence at 5 years
(mRS score ⱕ2) was performed for patients with mild to moderate
stroke, defined as baseline SSS score ⱖ30.15 We also tried to define
baseline predictors for good and bad outcomes 5 years after stroke
measured by mRS. A blinded external assessor performed these
clinical evaluations during a visit of the patients at their place of
residence. Informed consent was obtained before the examination.
The same assessments measures were used at baseline, 6 months, 12
months, and 5 years after stroke.
Statistics
Pearson ␹2 test was used to investigate the difference between the
groups regarding baseline characteristics and place of residence
(death, home, or institution) The intention-to-treat population was
used in the main analysis. To investigate differences between the
groups in the other primary and secondary outcomes, we used the
Mann–Whitney U test. Logistic regression was performed with
the use of mRS score (ⱕ2) as the dependent variable and treatment,
age, sex, SSS score, and cohabiting status as predictor variables.16 To
answer the question about whether the direct analysis of original
ordered data is more efficient and more likely to yield reliable results
in this kind of trials,17 we performed different analyses of mRS as
outcome using both the entire ordinal scale and dichotomization
(independent score 0 –2 versus dependent or dead score 3– 6). The
significance level was set at 0.05. In the secondary outcomes, the
on-treatment population (patients alive) was used.
Results
Four hundred sixty-eight patients were screened for inclusion
in the trial, and 320 patients fulfilled the inclusion criteria.
After 5 years, 5 patients were missing in the ESD group and
9 patients were missing in the OSUS group. Respectively,
155 and 151 patients were evaluated (Figure 1).
Table 1 shows the baseline characteristics of the 2 groups.
No significant differences existed concerning age, sex, living
conditions, or comorbidities. The functional status assessments within 24 hours after randomization were almost
identical in the groups.
The primary outcome of independence was measured by mRS
score ⱕ2 and showed no statistically significant difference
between the groups 5 years after stroke (35% versus 29%;
P⫽0.213; Table 2). Adjusted for potentially confounding independent variables (treatment, SSS score, sex, age, and cohabiting
status), the analysis showed a strong trend toward a larger
proportion of patients with mRS score ⱕ2 in ESD (P⫽0.079;
Table 3). Our analyses showed no difference between outcomes
using the entire ordinal scale or dichotomization. No significant
interaction between the independent variables was found.
There was a strong trend toward a larger proportion of
patients with improvement in mRS score from onset of stroke
to 5 years after stroke in ESD (38% versus 30%; P⫽0.106).
Additionally, a larger proportion of patients in ESD versus
OSUS also showed improvement in mRS score from 1 year to
5 years (16% versus 9%; P⫽0.048; Table 2). There were no
differences in mortality between ESD (46%) and OSUS
(51%) at 5 years (P⫽0.364), but a significantly larger group
of patients was dead or institutionalized in the OSUS group
(P⫽0.032). The odds ratio for living at home in the ESD
group (versus the OSUS group) was 1.699 (95% CI, 1.08 –
2.68; P⫽0.022). One hundred fifty-eight patients (84 ESD/74
OSUS) were alive after 5 years; of those, a larger proportion
of patients was living at home versus at an institution in ESD
(86%) versus OSUS (70%; P⫽0.019; Figure 2).
The secondary outcomes SSS, Barthel Index, Frenchay
Activity Index, and Mini Mental Status Examination showed
no differences between the groups at 5 years (Table 4). The
subgroup analysis for patients with mild to moderate stroke
(SSS score ⱖ30) showed no significant differences between
the groups in mRS after 5 years, but a trend toward more
independent patients (mRS score ⱕ2) in the ESD group (37%
versus 29%; P⫽0.126).
A subgroup analysis of the ESD group with regard to
predictors for good outcome (mRS score ⱕ2) versus bad
outcome (mRS score ⬎2) after 5 years yielded lower age at
stroke onset (median age, 69.0 years for good outcome/76.6
years for bad outcome), a lower mRS score (mean score, 2.8
for good outcome/3.5 for bad outcome), and cohabitation
(living alone 26.4% for good outcome/48.5% for bad outcome) at baseline.
Fjærtoft et al
Follow-Up of Early Supported Discharge
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Figure 1. Flow diagram for the extended
stroke unit service (early supported discharge [ESD]) and the ordinary stroke unit
service (OSUS).
Discussion
We have previously shown that extended stroke unit service
combined with ESD reduces length of institutional stay,
improves clinical outcome, and reduces costs up to 1 year
after stroke compared to traditional stroke care.5– 8 This is in
accordance with other trials.3 In this 5-year follow-up, we
show that ESD can reduce death and institutional care and
can improve patients’ chances of living at home up to 5 years
after a stroke compared to traditional follow-up care. There is
a strong statistical trend toward improved functional outcome
assessed by mRS in the ESD group, as was shown at the
1-year follow-up. After 4 years, the difference between the
groups in the proportion of patients living at home had
increased in favor of the ESD group. The early supported
discharge regime also seems to be effective in the long-term.
The findings with increased improvement in the mRS score from
1 to 5 years in the ESD group are interesting, because no formal
interventions were performed in this period. It is possible that the
initial intervention during ESD leads to a process that caused the
patients and their immediate networks to better-manage life after
stroke. Our result is based on a long-term follow-up of a
randomized trial with a relatively short term of intervention. A
weakness of the trial is that we do not know what services the
patients received from the health care service in the period
between 1 year and 5 years after their stroke. This time period
carries within it the possibility of confounding factors for the
results of the trial. However, we have no evidence that specific
interventions, such as therapy-based rehabilitation services at
ⱖ1 year after a stroke, influence outcome.18 It also might have
been interesting to know the hospital readmission rate during
this time, because few stroke patients seem to survive 5 years
without readmissions.19 Unfortunately, we do not have these
data available.
To our knowledge, just 1 other trial20 has published data from
a 5-year follow-up of a randomized trial on ESD, in which the
initial treatment for all patients was stroke unit care. It found
beneficial effects on measures of extended activities of daily
living for patients with mild and moderate stroke.
1710
Stroke
June 2011
Table 1. Baseline Characteristics of the Patients Allocated to the
Extended Stroke Unit Service and to Ordinary Stroke Unit Service
Characteristic
Age, years (mean/median)
ESD (n⫽160)
OSUS (n⫽160)
Table 3. Binary Logistic Regression Model for Modified Rankin
Scale Score <2 at 5 Years and Effect of the Extended Stroke Unit
Service Versus the Ordinary Stroke Unit Service Adjusted for
Severity of Stroke, Sex, Cohabiting Status, and Age
74.0/74.5
73.8/74.0
Male (%)
54
44
Living alone (%)
41
43
TIA
13
14
SSS
Stroke
12
16
Sex
Hypertension
33
35
Living alone
Myocardial infarction
19
16
Atrial fibrillation
17
15
Diabetes
15
12
SSS* (mean/median)
43.6/48.0
43.2/47.0
BI† (mean/median)
60.4/65.0
58.5/60.0
RS‡ (mean/median)
3.3/4.0
3.4/4.0
95% CI for OR
Values
Medical history (%)
Treatment
As given
Cohabiting
P
OR⫽Exp(B)
Lower
Upper
0.539
0.079
1.714
0.940
3.125
⫺0.095
0.000
0.909
0.879
0.941
1.109
0.001
3.032
1.547
5.943
0.846
0.014
2.330
1.188
4.571
1.093
1.192
Living alone
Age
Constant
Functional state
Downloaded from http://stroke.ahajournals.org/ by guest on June 18, 2017
BI indicates Barthel Index; ESD, early supported discharge; OSUS, ordinary
stroke unit service; RS, Rankin scale; SSS, Scandinavian Stroke scale; TIA,
transient ischemic attack.
*SSS was assessed at inclusion before randomization.
†BI was assessed within 24 h after randomization.
‡RS was assessed within 24 h after randomization.
The strengths of our trial are the randomized controlled
design from the beginning and the enrollment of an unselected hospitalized stroke population. All included patients
received the best available care in the acute phase (stroke unit
treatment).2 Our stroke unit has previously shown beneficial
results not only in the short-term but also in the long-term,21
which makes the additional long-term effects of the ESD
even more impressive.
There were no statistically significant differences in mortality.
The drop-out rate was 3% over the course of 5 years in the ESD
group and 5.6% in the OSUS group. The low number of
drop-outs should not influence the results. Blinding is always a
challenge in this kind of trial and was performed as best as
Table 2. Number and Proportion at Home, in an Institution, and
Deceased After 5 Years and Number, Proportion of Patients With
Modified Rankin Scale Score <2, and Patients With Improvement
in Modified Rankin Scale Score From Onset of Stroke Up to 5
Years and From 1 Year to 5 Years in the Extended Stroke Unit
Service Versus the Ordinary Stroke Unit Service
ESD (n⫽155)
OSUS, ESD
B
Years
0.132
0.000
1.141
⫺6.156
0.001
0.002
CI indicates confidence interval; ESD, early supported discharge; OR, odds
ratio; OSUS, ordinary stroke unit service; SSS, Scandinavian Stroke scale.
possible. The evaluation after 5 years was conducted by a
physiotherapist previously not involved in the study and with no
knowledge about the groups. He visited the patients in their
homes and was specially trained in the use of the assessment
scales.
One of the questions this kind of trial raises is which
components of the present service cause it to be so successful.
We know that well-coordinated multidisciplinary teams with
weekly meetings are the most effective,9 but measuring the
specific parts of the service is difficult.
Trials have documented reduction in short-term and longterm mortality22–24 for stroke patients treated in stroke units.
This finding of increased survival brings forth the need for
effective care of stroke patients after discharge. ESD seems to
be the most useful component of an integrated stroke service
for a large proportion of stroke patients up to 1 year after
stroke, and 2 randomized trials have now shown benefits up
to 5 years after stroke.20 There is definitely a need for more
research to confirm the long-term benefits.
It is a challenge to integrate ESD in clinical practice, because
the service depends on available resources in the community and
some difficult financial barriers have to be overcome. A few
trials25–27 have documented that ESD is a cost-effective alterna-
OSUS (n⫽151)
n
%
n
%
P
Dead
71
45.8
77
51.0
0.364
At home
72
46.5
52
34.4
0.032
In institution
12
7.7
22
14.6
0.057
mRS ⱕ2
54
34.8
43
28.5
0.213
Improvement in mRS*
from onset to 5 y
58
37.5
45
29.8
0.106
Improvement in mRS*
from 1 to 5 y
24
15.5
13
8.6
0.048
ESD indicates early supported discharge; mRS, modified Rankin scale;
OSUS, ordinary stroke unit service.
*Improvement in mRS score of 1 step or more.
Figure 2. Subgroup analysis for patients alive after 5 years.
Place of residence 5 years after stroke in extended stroke unit
service (early supported discharge [ESD]) vs the ordinary stroke
unit service (OSUS). Pl of residence 5 years after stroke for
patients alive in the extended stroke unit service (early supported discharge) vs the ordinary stroke unit service (OSUS).
Fjærtoft et al
Table 4. Secondary Outcomes of Scandinavian Stroke Scale,
Frenchay Activity Index, and Mini Mental Status Examination
and Dichotomized Scandinavian Stroke Scale and Barthel Index
Assessed by 5 Years in the Extended Stroke Unit Service and
the Ordinary Stroke Unit Service
ESD (n⫽84)
OSUS (n⫽74)
Mean (SD)
51.9 (10.7)
51.4 (8.7)
Median (range)
57.0 (50)
55.0 (32)
Mean (SD)
33.5 (11.3)
31.3 (12.2)
Median (range)
33.0 (38)
32.0 (39)
Mean (SD)
25.9 (4.8)
25.0 (5.9)
Median (range)
27.5 (25)
27.0 (24)
SSS
P
0.346
FAI
0.256
MMSE
0.458
SSS ⱖ52, n (%)
62 (73.8)
50 (67.6)
0.389
BI ⱖ95, n (%)
48 (57.1)
38 (51.4)
0.285
Downloaded from http://stroke.ahajournals.org/ by guest on June 18, 2017
BI indicates Barthel Index; ESD, early supported discharge; FAI, Frenchay
Activity Index; MMSE, Mini Mental Status Examination; OSUS, ordinary stroke
unit service; SD, standard deviation; SSS, Scandinavian Stroke scale.
tive to usual care, and a systematic review concludes with
“moderate evidence” that ESD provides care at lower total costs
than usual care.28 There are several methodological challenges in
this area. Because long-term follow-up studies of randomized
trials have weaknesses, these results should be treated with
caution. Further trials in different cultural settings are necessary
to confirm the results.
We have previously defined the balance of cost and benefit
of ESD up to 1 year after stroke.7 However, more research on
the economic consequences of ESD is also required.
In this trial, we have been able to show that our extended
stroke unit service combined with ESD increases the patients’
chances of living at home with improved function up to 5
years after a stroke compared to traditional follow-up after
stroke. Together with the other evidence of stroke unit care,
ESD seems today to be the best-documented and most
effective alternative for follow-up after stroke.
Acknowledgments
The authors extend their gratitude to Physiotherapist Rune Furutangvik for performing the assessments of the patients, and Secretary
Margareth von Ibenfeldt for help in preparation of the data files. The
authors also thank the patients who agreed to take part in this
follow-up trial.
Sources of Funding
This publication has been financed by the Stroke Unit, St. Olavs
Hospital, Trondheim University Hospital, Trondheim, Norway.
Disclosures
None.
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Stroke Unit Care Combined With Early Supported Discharge Improves 5-Year Outcome:
A Randomized Controlled Trial
Hild Fjærtoft, Gitta Rohweder and Bent Indredavik
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Stroke. 2011;42:1707-1711; originally published online April 7, 2011;
doi: 10.1161/STROKEAHA.110.601153
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