4/29/2014 CPAP Adherence (A.K.A. Compliance) Amy M. Sawyer, Ph.D., R.N. Assistant Professor The Pennsylvania State University College of Nursing IPA Behavioral Sleep Medicine & Pharmacological Interventions: Key Aspects to Treatment What do we know about our patients? • Obstructive sleep apnea (OSA) prevalence – Estimated to occur in 5% of the general population – Among obese adults and children, the estimated prevalence is 15‐25% (AHI criteria‐dependent & BMI dependent) • OSA is nearly 100% reversible with treatment – Reduction or elimination of apneas & hypopneas – Improvement in oxygenation, sleep fragmentation 1 4/29/2014 What do we know about our patients when fully treated? • Physiologic sequelae of intermittent nocturnal hypoxia and chronic sleep fragmentation are reduced or eliminated – Cardiovascular Disease – Metabolic Disease – Central Neural Injury and Cognitive Dysfunction • Daytime impairments improve or eliminated – Sleepiness, function and QOL, mood, intimacy What do we know about our patients after CPAP is prescribed? • 50% of adults prescribed CPAP do NOT adhere • At least 1/3 of adults prescribed CPAP use the treatment intermittently – CPAP use < 4hrs/night • Not cost‐effective • ↑ Cardiovascular risk & mortality • ↑ Motor vehicle accidents and deaths – Skipped nights of treatment result in cardiovascular and metabolic cellular‐level dysfunction – Persistent impairments in mood, cognitive function, and quality of life Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? 2 4/29/2014 Compliance is Important • Research on “compliance” has grown exponentially – Up to 1985 – 4,000 published papers on compliance – 1985 ‐ 1990 – 4,000 published papers addressing compliance on Medline only • Issues of compliance are important to health care industry and scientific basis of our practice • Summation of work to date across treatments and disorders – 50% of patients are non‐compliant Donovan, JL & Blake, DR (1992). Soc Sci Med 34(5), 507‐513 Words as Conscious Language Choices • Compliance: 1 a : the act or process of complying to a desire, demand, proposal, or regimen or to coercion b : conformity in fulfilling official requirements 2 : a disposition to yield to others Synonyms: acquiescence, biddability, compliancy, deference, docility, obedience, submissiveness • Adherence: : the act of adhering; especially : the act of doing what is required by a rule, belief, etc. Synonyms: loyalty, fidelity, faithfulness, obedience, constancy ʺCompliance.ʺ Merriam‐Webster.com. Merriam‐Webster, n.d. Web. 26 Apr. 2014. <http://www.merriam‐ webster.com/dictionary/compliance>. ʺAdherence.ʺ Merriam‐Webster.com. Merriam‐Webster, n.d. Web. 26 Apr. 2014. <http://www.merriam‐ webster.com/dictionary/adherence>. Words & Assumptions • Words are powerful – By definition – blind obedience – By juxtaposition – leader:follower – By relationship – provider:patient; scientist:subject • Assumptions that underlie how the problem of compliance is framed – Words corrupt thoughts (cognitive perceptions) – Thoughts (cognitive perceptions) influence behavior 3 4/29/2014 Words & Power Imbalance in the Delivery of Health Care • The term compliance is fraught with underlying concerns that may be important but likely corrupted – Dominance of health care providers – Costs of care • Selectively ignores the CORE – Patients as healthcare consumers – Patients as reasoning beings who make decisions – Patient decisions are made “in context” So Adherence Terminology Must Be An Improvement? • By definition, it’s simply a “softening of the edge” • There is no underlying assumption that the fulcrum is balanced with change in terminology • Or that we are meeting our patients in the “middle” to address the overall problem: Are we not simply addressing USAGE of treatment? • a : the action, amount, or mode of using • By disposing of underlying assumptions that are closely linked with our language, we can more clearly examine the problem of treatment of use – Places treatment use in the context of patients’ lives – Importantly acknowledging and seeking to understand lay beliefs that inform decisions to use/not use – Framing the problem in this way will advance practice, science, and policy ʺUsage.ʺ Merriam‐Webster.com. Merriam‐Webster, n.d. Web. 26 Apr. 2014. <http://www.merriam‐webster.com/dictionary/usage>. Donovan, JL & Blake, DR (1992). Soc Sci Med 34(5), 507‐513 4 4/29/2014 Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? So how much do I really have to use CPAP? Insights from Extant Literature • Two prospective, longitudinal observational studies have examined CPAP dose response and specific outcomes – Subjective sleepiness – Objective sleepiness – Functional outcomes of sleep – Generalized Functional outcomes, vitality and mental health – Cognitive outcomes, including verbal memory, vigilance, and short‐term memory Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30:711‐719. Antic NA, Catcheside P, Buchan C, et al. The effect of CPAP on normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011;34:111‐119. 5 4/29/2014 • Subjective sleepiness (ESS) was significantly improved post‐treatment in a dose response fashion; 4.2hrs CPAP use was identified as a “joint‐point” in piecewise regression • Objective sleepiness (MWT) did not demonstrate a CPAP dose response • Functional outcomes of sleep (FOSQ) significantly improved post‐treatment – Total scores and domain of activity levels demonstrated CPAP dose response • General functional outcomes (SF‐36) significantly improved post‐treatment at 5hrs – Vitality sub‐scale demonstrated a CPAP dose response • Neurocognitive outcomes of verbal memory and executive function significantly improved post‐treatment but did not demonstrate a CPAP dose response • NOTE: Across all outcomes assessed, residual deficits persisted Antic NA, Catcheside P, Buchan C, et al. The effect of CPAP on normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011;34:111‐119. What about other outcomes? • Cardiovascular morbidity and mortality – < 4hrs/night significantly increases long‐term CVD risks • MVAs – < 4hrs/night significantly increases risk of MVA • Cost‐effectiveness of CPAP in adults with OSA – > 4hrs/night is highly efficient use of health care resources – When quality of life, costs of therapy, and motor vehicle crashes are considered, CPAP use less than 4hrs per night on 70% of nights is not cost‐effective Ayas NT, FitzGerald JM, Fleetham JA, et al. Cost‐effectiveness of continuous positive airway pressure therapy for moderate to severe obstructive sleep apnea/hypopnea. Archives of Internal Medicine. 2006;166:977‐984. Billings ME, Kapur VK. Medicare long‐term CPAP coverage policy: a cost‐utility analysis. J Clin Sleep Med. Oct 15 2013;9(10):1023‐1029. Campos‐Rodriguez F, Pena‐Grinan N, Reyes‐Nunez F, et al. Mortality in obstructive sleep apnea‐ hypopnea patients treated with positive airway pressure. Chest. 2005;128:624‐633. How much CPAP is enough? • General Recommendation: Minimum use is 4hrs/night for all major bouts of sleep – CAVEAT: Sleep duration <6hrs/night confers significant health risks* • General Caution to Recommendation: Not all OSA‐specific outcomes improve at this “dose” of CPAP • Further General Caution: Not all adults with OSA have improvement across impairments across CPAP dose categories • Summary Recommendation: – Use of CPAP for duration of sleep bout permits clinical evaluation of response to treatment – Evaluate response to treatment on regular intervals after treatment initiation – Consider habitual sleep duration and hours of CPAP use/night *Grandner MA, Hale L, Moore M, Patel NP. Mortality associated with short sleep duration: The evidence, the possible mechanisms, and the future. Sleep Med Rev. Jun 2010;14(3):191‐ 203. 6 4/29/2014 Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? Policy & Practice Guidance • POLICY and PRACTICE GUIDELINES: – American Academy of Sleep Medicine Practice Parameters and Practice Guidelines (see http://www.aasmnet.org/) – CMS Coverage policy: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) • EVIDENCE‐BASED RECOMMENDATIONS: – No protocols or guidelines per Cochrane Collections – Cochrane Review identifies efficacy of CPAP in absence of usage recommendation – American College of Physicians Clinical Practice Guideline for CPAP in Adults with OSA (see National Guideline C. Management of obstructive sleep apnea in adults: a clinical practice guideline from the American College of Physicians; http://www.guideline.gov/content.aspx?id=47136&search=cpap) Giles TL, Lasserson TJ, Smith B, White J,Wright JJ, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults.CochraneDatabase of SystematicReviews 2006, Issue 3. Current Benchmarks and Benchmarking Sources • Average CPAP use ≥ 4hrs/night – Published research applies consistent cut‐points for analytic purposes – CMS and other third party payer reimbursement/payment policies – CPAP use tracking systems • Other benchmarks? – Published dose response research (≥4hrs/night, ≥6hrs/night, ≥7hrs/night) on limited set of outcomes 7 4/29/2014 Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? Evidence-based Factors of Influence • Since 2004, there has been a TREMENDOUS increase in the publication of papers that address CPAP use (i.e., adherence) • Suggesting interest and importance on the topic • Studies reporting “influential factors” on CPAP use have comprised much of the literature Crawford MR, Espie CA, Bartlett DJ, Grunstein RR. Integrating psychology and medicine in CPAP adherence ‐ New concepts? Sleep Medicine Reviews. 2013. What factors influence CPAP use? • Characteristic factors – Age, gender, race, SES • Disease factors – AHI, symptom improvement, nasal resistance (objective) – Insomnia and depression • Technological and titration factors and side effects – Flexible pressure, heated humidification – Poor titration night experience Crawford MR, Espie CA, Bartlett DJ, Grunstein RR. Integrating psychology and medicine – Claustrophobia in CPAP adherence ‐ New concepts? Sleep Medicine Reviews. 2013. Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: Clinical and empiric insights for developing CPAP adherence interventions. Sleep Medicine Reviews. 2011;15:343‐356. 8 4/29/2014 What factors influence CPAP use? • Psychological – Self‐efficacy, treatment expectancies, decisional balance, coping styles, etc. • Social – Spousal relationship, bed‐partner presence, spousal pressure, social support, bed partner sleep quality • 11‐58% of variance in CPAP use is explained by psychological and social factors of influence; typically measured after CPAP use for at least 1 week Crawford MR, Espie CA, Bartlett DJ, Grunstein RR. Integrating psychology and medicine in CPAP adherence ‐ New concepts? Sleep Medicine Reviews. 2013. Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: Clinical and empiric insights for developing CPAP adherence interventions. Sleep Medicine Reviews. 2011;15:343‐356. Clinical Observations Suggest Other Factors • • • • • • • Side effects Environmental barriers User experience with CPAP Household member responses to CPAP wearer and CPAP device Fears and beliefs relative to disease and sleep Complexity of CPAP use and routine Immediacy of assistance (provider, DME, family member) Studies that have closely examined the experience of using CPAP confirm clinical observations and extend quantitative findings Sawyer AM, Deatrick J, Kuna ST, Weaver TE. Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy among adherers and nonadherers. Qualitative Health Research. 2010;20:873‐892. Shaw R, McKenzie S, Taylor T, et al. Beliefs and attitudes toward obstructive sleep apnea evaluation and treatment among blacks. Journal of the National Medical Association. Nov‐Dec 2012;104(11‐12):510‐519. Making Sense of the Evidence • Most robust factors of influence emerge AFTER treatment exposure – Most studies have examined such factors after 1 wk or 1 mo of CPAP treatment • Is this too late in the course of establishing usage patterns to intervene? – LIKELY – Evidence suggests treatment patterns are established within first week • Day 2‐4 use predicts longer‐term use • Wk 1 predicts longer‐term use Weaver TE, Kribbs NB, Pack AI, et al. Night‐to‐night variability in CPAP use over first three months of treatment. Sleep. 1997;20:278‐283. Aloia MS, Arnedt JT, Stanchina M, Millman RP. How early in treatment is PAP adherence established? Revisiting night‐to‐night variability. Behavioral Sleep Medicine. 2007;5:229‐240. 9 4/29/2014 Utilizing Evidence-based Factors of Influence to Identify Non-users Sawyer AM, King TS, Hanlon A, et al. (2014). Risk assessment for CPAP nonadherence in adults with newly diagnosed obstructive sleep apnea: preliminary testing of the Index for Nonadherence to PAP (I‐NAP). Sleep & Breathing. http://dx.doi.org/10.1007/s11325‐014‐0959‐z. Logistic Regression Model for <4hrs/night CPAP Use (n=97) Variable† SEMSA Outcome Expectancy B Coefficient 3.80 Wald Chi‐square 3.20 p Value* OR (95% CI) 0.07 0.45 (0.17‐1.20) SCT Self‐efficacy ‐0.59 2.52 0.11 0.55 (0.27‐1.15) HLS1 ‐0.59 3.17 0.08 0.55 (0.29‐1.06) BMI 0.05 4.25 0.04 1.05 (1.00‐1.12) Marital Status (Married) ‐1.15 4.25 0.04 0.32 (0.11‐0.95) Sleepiness as presenting symptom ‐1.52 5.95 0.01 0.22 (0.07‐0.74) Restlessness in sleep 1.07 as presenting symptom 3.69 0.05 2.92 (0.98‐8.69) Gender (Female) 1.78 0.18 2.09 (0.71‐6.16) 0.74 *p value to remain in model defined a priori p≤ 0.20 †Variables excluded p>0.20: HLS2, HLS3, ESS, FOSQ sub‐scales, SEMSA risk perception, SEMSA self‐efficacy, SCT outcome expectancies, SCT knowledge, SCT social support; Variables excluded collinearity: Total FOSQ, Total HLS; Variables excluded insufficient cases: shift work I‐NAP Cut‐Point ≥ ‐4.8 Predictive Utility (n=97) Yes No Yes 32 True + 22 False + No I‐NAP4 Screening Index Cut‐Point ≥ ‐ 4.8† CPAP Adherence < 4hrs/night 5 False – 37 True – †Sensitivity = 87%; Specifi city = 63%; PPV = 60%; NPV = 88% Receiver Operating Characteristic AUC = 0.83 (95% CI 0.74‐0.91) 10 4/29/2014 INAP Items and Sub‐scales Item or Sub‐scale Format & Number of Items Source SEMSA Outcome Expectancies Sub‐scale 4‐point Likert scale; 9 items Available with permission from author* SCT Self‐efficacy sub‐scale 5‐point Likert scale; 5 items Publicly available† Health Literacy Scale Item 5‐point Likert scale; 1 item Publicly available‡ BMI 1 item Marital Status (Married or Not married) 1 item Presenting symptoms for seeking care for sleep problem Restless sleep (Y or N) Sleepiness during day (Y or N) 1 item Gender (Male or Female) 1 item *Weaver, TE, Maislin G, Dinges DF, et al. Sleep 2003;26:727‐32. †Stepnowsky CJ, Marler MR, Ancoli‐Israel S. Sleep Medicine 2002;3:239‐47. ‡Chew LD, Bradley KA, Boyko EJ. Family Med 2004;36:588‐94. Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? Intervention Trials: Progress to Date • Over past decade CPAP use intervention trials have emerged in the literature • To date, there has not been any large‐scale trials to establish intervention efficacy – Pilot trials to establish effect size of intervention – Preliminary trials to examine feasibility of intervention delivery – Constrained funding environment • The field may need to employ “alternative” designs/approaches to test CPAP use interventions 11 4/29/2014 Approaches • Interventions can be categorized by evidence‐based domains of influence on outcome behavior – Technological – Educational – Psychological – Psychosocial – Multi‐dimensional Technological Interventions Educational Interventions •OSA Diagnosis/Treatment •CPAP Skill Building •Troubleshooting •Health Risks •Outcome Expectancies Psychological – Psychosocial Interventions •Cognitive Perceptions •Motivation •Social support •Socialization Multi‐ dimensional Interventions Category Intervention Description •Laboratory Effect •Side Effects •Comfort •Convenience •Extensive laboratory support •Extended nursing support •Support for transition to home treatment Primary Outcome Overlapping Intervention Constructs Target Intervention Construct Rarely Measured Assessment of Intervention for Translation Technological PAP pressure mode Flexible pressure Humidification Mask Interface Titration procedure (‐) usage (+) sub‐groups Technological advancements for PAP treatment should be fully utilized across the adult OSA population ** Patients experiencing s/e ** Patients with demonstrated low use Educational Provider varied Video delivery PSG review (‐) usage Education is an essential component of behavior change but not an independent intervention variable ** Resource‐conserving approaches have been defined by this work ** Knowledge rarely measured with exposure; only usage measured Psychological – Psychosocial Motivational Interviewing CBT Tailored messaging Peer Buddies Staged‐approaches (+) usage (+) acceptability These approaches tap domains of influence of significant influence on adherence to CPAP ** Resource‐intensive ** Translational capacity in question for under‐resourced care sites Multi‐ dimensional Dx/titration in‐hospital Intensive homecare f/u by nurses Partner inclusion (+) usage Emphasis on disease perception and support for use of treatment in home environment ** Resource‐intensive ** Translation limited for clinical uptake 12 4/29/2014 Technological Interventions •Laboratory Effect •Side Effects •Comfort •Convenience Educational Interventions Innovative Approaches to Intervention Delivery Psychological – Psychosocial Interventions Multi‐ dimensional Interventions Overlapping Intervention Constructs •OSA Diagnosis/Treatment •CPAP Skill Building •Troubleshooting •Health Risks •Outcome Expectancies •Cognitive Perceptions •Motivation •Social support •Socialization •Extensive laboratory support •Extended nursing support •Support for transition to home treatment Target Intervention Construct Rarely Measured Moving Toward Translational Intervention Capacities – mTech Approaches • As we have seen, interventions to increase CPAP use are largely limited by translational capacity, even though effect sizes in pilot studies are considered moderate • Other notable trends and changes – The “clinic” is moving to the “community” – Specialized services are increasingly sparse – At risk populations are less likely to access traditional health care services, particularly specialized care services – Expertise availability is limited for FTF interface Evolving Area of Science for Interventions • Web‐based self‐management interventions* • CPAP tracking system apps† • Telephone‐delivered interventions and telemedicine approaches‡ Calls from federal agencies for design and testing of mobile technology intervention approaches will likely result in a “new generation” of interventions to address CPAP use ‡Sparrow D, Aloia MS, DeMolles DA, Gottlieb D. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010;65(12):1061‐1066. *Stepnowsky C, Edwards C, Zamora T, Barker R, Agha Z. Patient perspective on use of an interactive website for sleep apnea. International journal of telemedicine and applications. 2013;2013:239382. †Schwab RJ, Badr SM, Epstein LJ, et al. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. American journal of respiratory and critical care medicine. Sep 1 2013;188(5):613‐620. 13 4/29/2014 Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? To Support Translation… • Large RCTs – Sample heterogeneity – Multiple sites with adequate diversity – Secondary outcomes addressing target intervention variables – Efficacy evaluation • Comparative Effectiveness Research (CER) – Relative efficacy and relative effectiveness evaluation – Permits for considerations above PLUS conduct in less controlled environments (real world) Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? 14 4/29/2014 Practice Guidelines & CPAP Use Epstein LJ, Kristo D, Strollo PJ, Jr., et al. Clinical guideline for the evaluation, management and long‐term care of obstructive sleep apnea in adults. J Clin Sleep Med. Jun 15 2009;5(3):263‐276. CPAP Usage Components from Guidelines • Education Content • PSG findings, severity of OSA • Pathophysiology of OSA • Explanation of disease course and associated disorders • Risk factors and exacerbating factors • Treatment options • What to expect from treatment • Patient’s role in treatment, concerns, goal‐setting • Consequences untreated OSA • Drowsy driving/sleepiness • Compliance Program • ????? Epstein LJ, Kristo D, Strollo PJ, Jr., et al. Clinical guideline for the evaluation, management and long‐ term care of obstructive sleep apnea in adults. J Clin Sleep Med. Jun 15 2009;5(3):263‐276. CPAP Usage Components from Guidelines • Follow‐up Components • Re‐evaluate after treatment initiation within several weeks (Standard) • Assess treatment response (Consensus) • Monitor usage (Standard) • If CPAP usage low, “prompt and intensive efforts to improve are indicated or referral to alternative treatments 15 4/29/2014 Current Needs and Future Directions 1. Intervention studies of CPAP use are needed 2. Translational approaches to such empiric work is critical 3. Professional organizations responsible for guidelines – Inclusive across disciplines – Persistent evidence accrual – Set forth research agenda priority for translational studies that prioritize current gaps in guidelines 4. Research teams need to partner with clinical providers and patients to design and test “end‐user friendly” programs Compliance…Adherence…Usage…Does it really matter? CPAP Use Levels: How Much is Enough? CPAP Use Benchmarks: Research, Practice, and Policy What Evidence‐based Factors Influence CPAP Use? At the Patients “Compliance” Program Components for CPAP Use Translating CPAP Use Interventions to Real‐world Settings Interventions to ↑ CPAP Use: What Works in Ideal Settings? Return At the Core Teaming up with clinicians and researchers to enhance CPAP use to improve health and functional outcomes for adults with OSA 16
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