Challenges in end-stage heart failure: Compliance

1. Challenges in end-stage heart failure: Compliance Fabienne Dobbels, PhD

2. Heart failure: A chronic disease • Requires ongoing management over a period of years • Cannot be cured • May lead to disability, or the short- or long-term reduction of a person’s activity • Goal of treatment: = to improve patients’ ability to live a productive and pain free life  to get rid of the disease!!!

3. Treatment of heart failure:A complex therapeutic regimen

4. Management of patient with heart failure: Psychological Dimension Behavioral Dimension Physical Dimension Goal = to optimize outcomes!

5. Non-adherence: the Achilles heel of heart failure treatment • Definition • Prevalence • Consequences • Risk factors • Interventions Peter Paul Rubens 1630

6. Eve and the Apple in the Garden of Eden.... ...the first case of nonadherence?

7. Compliance = adherence = concordance = “The extent to which a person’s behavior corresponds with the agreedrecommendations from a health care provider” (Sabate. WHO report 2003) = “Is a behavioral process, strongly influenced by the environment in which the patient lives, including the healthcare practices and system. Adherence assumes that a patient has the knowledge, motivation, skills and resources required to follow the recommendations of a healthcare professional. (AHA expert panel. Miller et al. 1997)

8. Age 65 - 74 years: 8.5 medications daily Age 75 – 84 years: 7.9 medications daily Age > 84 years: 7.0 medications daily (Soumerai et al. Arch Int Med 2006; 166: 1829)

9. Prevalence of non-adherence (NA) in elderly with heart failure • Medication taking: 1 - 90% • Fluid restrictions: 27 - 77% • Sodium restrictions: 27 – 87% • Daily weighing: 21 – 88% Large variation depending on operational definition and measurement method used (van der Wal et al. Int J Cardiol 2008; 125: 203)

10. Prevalence of adherence * Numbers for hypertension similar to other cardiovascular diseases (DiMatteo MR. Med Care 2004; 42(3): 200-209)

11. Estimated NA of elderly patients with heart disease in Belgium • Estimations (2004): • 10 318 000 inhabitants • 1 754 060 (17%) > 65 years • 261 355 (14.9%) serious heart • disease or heart attack in past • 12 months • - 23.4% non-adherent 61 680 PATIENTS WITH HEART DISEASE NONADHERENT!!! (Belgian Health Interview Survey 2004, www.iph.fgov.be) (DiMatteo MR. Med Care 2004; 2: 200) (Wetenschappelijk Instituut Volksgezondheid, 2001)

12. NA is a prevalent problem: so what???

13. “Drugs don’t work in patients who don’t take them”(C Everett Koop M.D.) Clinical consequences Economic consequences

14. NA associated with poor clinical outcomes in heart failure • Absence of the intended effect of the drugs • Higher number of hospitalizations • More visits to the emergency department • Adverse effects (rebound effect) (Hope et al. Am J Health-Syst Pharm 2004; 61: 2043) (Vinson et al. Am J Geriatr Soc 1990; 38: 1290)

15. NA and outcome of medical treatment: A meta-analysis (63 studies) OVERALL Risk difference (DiMatteo et al. Med Care 2002; 40: 794)

16. 0.2 2 5 0.5 1 Good adherence reduces mortality riskin chronic illness populations OR= 0.56 [0.50 – 0.63] TOTAL (Simpson et al. 2006; 333: e-pub June 21)

17. % of prescribed doses taken % of doses taken on schedule (within 25% of prescribed time interval) % of days the correct number of prescribed doses were taken Median= 95.4% Median= 90.3% Median= 76.0% Impact of NA assessed by MEMS on event-free survival (N= 137) (Wu et al. J Cardiac Fail 2008; 14: 203)

18. Economic consequences

19. Economic consequences of NA Direct costs • cost of non-taken medication •  cost for treatment of morbidity •  cost of avoidable hospitalizations Indirect costs • Missed work days • Cost for transportation, household, home care •  quality of life •  cost of evolving more potent medications

20. Non-drug medical costs within 1 year One study in heart failure: No difference in costs (Muzbek et al. Int J Clin Pract 2008; 62: 338)

21. Noncompliance: a major and important problem Can / will health care provider do something... Or will we expel patients from Paradise?

22. Identifying patients at risk for NA Implementation of interventions Randomized controlled trials Determinants of NA What can be done to improve adherence ?

23. Measurement of nonadherence Clinical nonadherence Sub-clinical nonadherence • Direct methods • - observation • - assay • - objective tests B.Indirect methods – pill count – prescription refill – clinical judgement – electronic monitoring – self-report No gold standard: combine measures to increase accuracy (Osterberg et al. N Engl J Med 2005;353)

24. Socio-economic factors Condition related factors Health professional and setting-related Patient related factors Treatment related factors 5 interrelated categories of determinants (Sabate E. WHO report 2003)

25. Determinants in patients with HF (van der Wal et al. Int J Cardiol 2008; 125: 203)

26. Impact of the health care providerand setting related factors • reimbursement and insurance policy • no funding for chronic disease • management programs or prevention Macro levelPolicy Meso levelHealth care organizations and community • Short consultations • Lack of follow-up / cooperation with • community services • Uni-disciplinary treatment • Poor knowledge about adherence • lack of trust • poor communication style Micro levelpatient-provider interaction

27. Interventions…

28. Effectiveness of adherence-enhancing interventions: RCT’s ES= .20 ES= .22 ES= .20 ES= .35 Absolute difference (%) (Roter et al. Med Care 1998; 36: 1138-1161)

29. Typical reaction if treatment is not working: the radar syndrome The patient appears… Find the problem and fix it, by: - increasing the dose - switching to another drug - adding another drug But nonadherence frequently ignored!

30. Disease management programs in heart failure populations • Integrated programs with focus on - detailed assessment of the patient - patient education about treatment regimen - optimizing medications - regular monitoring by health professionals (Health and health care 2010 – The Forecast – the Challenge Institute of the future 2003)

31. Efficacy of disease management programs: a meta-analysis * Risk Difference; negative value in favor of program ** significant difference with reference value; pooled relative risk 0.84 [0.77; 0.92] (Göhler et al. J Cardiac Fail 2006; 12: 554)

32. Cost-effectiveness of disease management programs • Mean age at onset 67 years (35% female) • Quality adjusted life expectancy: 2.64 years for standard care 2.83 years for disease management program • Additional lifetime cost for 84 days difference: 1700 Euro (i.e. 9800 Euro per QALY gained) Beneficial impact on clinical outcomes but expensive… (Göhler et al. Eur J Heart Failure 2008; e-pub)

33. 3o Providing professional patient care 20% 2o 1o Patient preferences Readiness for treatment Compliance Symptom management … Problem of disease management problems

34. 3o Providing professional patient care 20% 2o 1o Patient preferences Readiness for treatment Compliance Symptom management … 80% The majority of care is taking place outside the hospital setting Fostering patient self-management

35. “The most effective approaches have been shown to be multidimensional and multilevel – targeting more than one factor with more than one intervention” (Haynes et al. Cochrane Reviews 2008)

36. Social/economicfactors Healthsystem/HCT-factors Macro Meso Micro Patient Condition-relatedfactors Therapy-relatedfactors Patient-related factors Tackling Nonadherence: A Multidimensional and Multilevel Approach +

37. Health care system changes • allowing self-management support • and chronic care Macro levelPolicy • Multi-disciplinary treatment • follow-up organized with focus on • chronic illness • - Engagement of community resources Meso levelHealth care organizations and community • development of adherence • counseling toolkit • Training in fostering self-management • training in motivational interviewing Micro levelpatient-provider interaction Multilevel interventions

38. From disease management to self-management programs = A set of things patients can do for themselves to follow the prescribed therapy, to avoid health deterioration and preserve function

39. Remember the definition??? = “Is a behavioral process, strongly influenced by the environment in which the patient lives, including the healthcare practices and system. Adherence assumes that a patient has the knowledge, motivation, skills and resources required to follow the recommendations of a healthcare professional. (AHA expert panel. Miller et al. 1997)

40. Efficacy and cost of HF self-management programs Cost saving (3 studies) after subtracting the intervention cost: $ 1300 - $ 7515 saved per patient annually ONLY POSSIBLE IF YOU HAVE A TRAINED TEAM!!! (Jovicic et al. BMC Cardiovascular Disorders 2006; 6: 43)

41. Conclusion • HF is a chronic disease requiring a complex management • Nonadherence is a prevalent problem, resulting in poor clinical and economical outcomes • Risk factors are multi-factorial • Interventions should be multidimensional, targeting more than 1 risk factor with more than 1 intervention • A multilevel approach is mandatory, integrating interventions at the patient, health care professional, team and policy level

42. Take home message “Changing systems of care and applying multidimensional + multilevel adherence-enhancing interventions to improve self-management may have a far greater impact on the health of heart failure patients than any improvement in specific medical treatments” (Haynes et al. Cochrane review 2008)

43. IT IS NEVER TOO EARLY! HET IS NOOIT TE LAAT! Increasing adherence with heart failure treatment...

44. IT IS NEVER TOO LATE! KEEP ON BELIEVING THAT PEOPLE CAN CHANGE!

46. Some numbers… • 3.7% of the Belgian population reported with a serious heart problem or heart attack in the last 12 months (2004) • 21.9% treated by GP alone • 38.9% treated by specialist alone • 25.7% treated by both GP and specialist • 89.3% of these patients use medicines for this problem • Use of cholesterol reducing agents: 6.4% • Use of cardiac glycosides: 0.7% • Use of anti-arrhytmics: 0.8% • Use of ace-inhibitors: 3.8% • Use of diuretics: 4% • Use of beta-blocking agents: 8.7%

47. > 65 years: 3.4 drugs on average • 14.9% of > 65 years serious cardiac disease or heart attack in past 12 months • 22.3% cholesterol reducing agent • 3.9% cardiac glycosides • 4.2% anti-arrhytmics • 14.1% ace-inhibitor • 18.7% diuretics • 26.2% beta-blocking agents Belgian Health Interview Survey 2004, Scientific Institute for Public Health www.iph.fgov.be

48. Percentage of nonadherence for different therapeutic aspects (DiMatteo MR. Med Care 2004; 42(3): 200-209)