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Ned Ferguson, M.D. Professor of Medicine Preventive Cardiology Section of Cardiovascular Medicine

Patient and Provider Non-Adherence to Therapy in Prevention and Treatment of Disease: Problems and Solutions. Ned Ferguson, M.D. Professor of Medicine Preventive Cardiology Section of Cardiovascular Medicine. Definitions.

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Ned Ferguson, M.D. Professor of Medicine Preventive Cardiology Section of Cardiovascular Medicine

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  1. Patient and Provider Non-Adherence to Therapy in Prevention and Treatment of Disease: Problems and Solutions Ned Ferguson, M.D. Professor of Medicine Preventive Cardiology Section of Cardiovascular Medicine

  2. Definitions • Adherence: The extent to which a person’s behavior corresponds with agreed recommendations from a healthcare provider; also called compliance • Persistence: The duration of treatment (ie, the length of time a patient fills his/her prescriptions) Benner JS et al. JAMA. 2002;288:255-261.Insull W. J Intern Med. 1997;241:317-325. World Health Organization. World Health Organization; Geneva, Switzerland. 2003.

  3. Nonadherence to Therapy: A Major Challenge • Nonadherence (aka noncompliance, nonpersistence, etc) is a major problem • Within 1 year, ~50% of patients overall discontinue use of drugs • An additional ~35% discontinue treatment within 2 years National Council on Patient Information and Education, 1997.

  4. Statin Adherence to Chronic Therapy 100 90 80 70 60 50 Patients (%) 40 30 20 10 0 1 2 3 4 5 6 7 8 9 10 11 12 Month ACE-Inhibitor Courtesy: Ockene IS; Source: IMS Health data, 1996.

  5. Lisinopril/HCTZ combination pill (n=1644) Lisinopril and diuretic in separate pills (n=624) Combining 2 Antihypertensive Agents In 1 Pill Enhances Persistence 100 90 80 Persistence (%) 69% 70 19%* 60 58% 50 0 1 2 3 4 5 6 7 8 9 10 11 12 Months *P<0.05 vs. fixed-dose combination Dezii C. Managed Care. 2000;(Suppl 2):6-10.

  6. Persistence* with Diabetes Therapy Declines When Patients Are Prescribed 2 Pills Instead of 1 100 75 58% Persistence (%) 55% 50 29%** 25 0 1 2 3 4 5 6 7 8 9 10 11 12 Months Metformin alone Sulfonylurea alone Metformin and sulfonylurea in separate pills *Defined as continuous months of drug use. **P<0.05 vs. monotherapies.Data on file. Bristol-Myers Squibb Company.

  7. Adherence Lowest When Therapy Was Preventive 100 90 80 70 Patients taking statins (%) 60 50 40 30 20 10 0 Cohort study using linked population-based administration data from Ontario, Canada (N=143,505). Jackevicius CA et al. JAMA. 2002;288:462-467.

  8. Initial Therapy Choice InfluencedLong-term Persistence Patients continuing therapy at 48-month follow-up (%) b-Blocker Retrospective, records-based, cohort study of patients on antihypertensive medication using the Merck-Medco Managed Care LLC Research Convenience Sample database (N=15,175). Conlin PR et al. Clin Ther. 2001;23:1999-2010.

  9. Patient Reasons for Nonadherence Don’t think it’s necessary all the time Just forget Don’t think it’s necessary all the time Hate taking Don’t like being dependent Drugs give me side effects Don’t think drugs are working Too expensive Don’t like being told what to take Supply will last longer Other Prospective, open-label, interview-based study in metropolitan New York area pharmacies (N=821). Cheng JWM et al. Pharmacotherapy. 2001;21:828-841.

  10. What Research Shows About Patterns of Adherence • Remember, nonadherence begins early and persists • Patients must actively decide to adhere • Many factors influence adherence

  11. More Frequent Physician Visits Improved Adherence Adherence ≥80% (OR) Retrospective study of elderly (aged 65 to 99 years) members of the New Jersey Medicaid and Medicare populations (N=8643). Monane M et al. Am J Hypertens. 1997;10:697-704.

  12. Number of Concurrent Medications Influenced Adherence P<.0001 P<.0001 P<.0001 P<.0002 Adherence ≥80% (OR) Retrospective cohort study in a large managed care population (N=8406). Data on file. Pfizer Inc., New York, NY.

  13. Concurrently Starting 2 Medications Improved Adherence Adherence ≥80% (OR) Retrospective cohort study in a large managed care population (N=8406). Data on file. Pfizer Inc., New York, NY.

  14. Using Multiple Pharmacies Negatively Affected Adherence 1.10 1.00 0.90 0.80 Adherence ≥80% (OR) 0.70 0.60 0.50 0.40 0.30 1 >1 Pharmacies used in last 120 days Retrospective study of elderly (aged 65 to 99 years) members of the New Jersey Medicaid and Medicare populations (N=8643). Monane M et al. Am J Hypertens. 1997;10:697-704.

  15. The Case for Improving Adherence • Improved adherence can lead to: • Higher rates of treatment success • Fewer diagnostic procedures • Fewer hospitalizations • Lower mortality rates Benner JS et al. JAMA. 2002;288:255-261. Insull W. J Intern Med. 1997;241:317-325. World Health Organization. World Health Organization; Geneva, Switzerland. 2003.

  16. Strategies for Success

  17. Adherence: A Multilevel Problem • The Individual/Patient • The Healthcare Provider • The Healthcare System • The Social-Environmental Context Adapted from: Miller NH, Hill M, Kottke T, Ockene IS. Circulation. 1997;95:1085-1090.

  18. Summary of Implications for Adherence Intervention Programs • Intervene EARLY in therapy • Interact OFTEN • KNOW your patient • TARGET interventions • EDUCATE patients • PRESCRIBE regimens with a high probability of adherence • ENCOURAGE close relationships

  19. Adherence: Patient Factors • Knowledge, attitudes, skills • Organic factors (memory, cognitive-information processing) • Self-efficacy • Decision-making processes – discounting • Co-morbidities/complexity of therapeutic regimen • Individual resources

  20. Recommended Strategies From Several Studies: Prescribing Practices 1 • Prescribe: • Regimens with the lowest appropriate pill burden • Drugs with reduced dose frequencies • Drugs with favorable side-effect profiles • Drugs with a lower cost • Before hospital discharge • Remind patients by letter and/or phone to refill prescriptions Aronow HD et al. Arch Intern Med. 2003;163:2576-2582. Avorn J et al. JAMA. 1998;279:1458-1462. Bloom BS. Clin Ther. 1998;20:671-681. Dezii CM. Manag Care. 2000;9(suppl):S2-S6. Monane M et al. Am J Hypertens. 1997;10:697-704. Newell SA et al. Prev Med. 1999;29:535-548.

  21. Medicaid Study: Time Interventions to the Advantage of Adherence 2 • Reach patients within the first 3 months of therapy or sooner, if possible • After 6 months, attitudes about therapy are formed Retrospective claims analysis of elderly members of the New Jersey Medicaid and Pharmaceutical Assistance to the Aged and Disabled programs (N=34,501). Benner JS et al. JAMA. 2002;288:255-261.

  22. Adherence: Provider Factors • Counseling skills • Involvement of patients in decision-making/plan of care • Time constraints • Knowledge, awareness, adherence to clinical practice guidelines • Individual vs. team-provider approach

  23. Provider Level – Problems • Problem-solving skills • Self-monitoring • Relapse prevention strategies • Prompts/reminder systems • Mail/telephone • Medication containers • Social support • Realistic/appropriate goals • Reward system

  24. Provider Level – Problems • Number of daily doses • Number of medications • Occurrence and severity of side effects • Incompatibility with patient’s daily routine • Inadequate physician-patient communication • Cost Russell M. Behavioral Counseling in Medicine: Strategies for Modifying At-Risk Behavior. New York, NY: Oxford Press; 1986.

  25. Provider Level – Problems • Studies show clinicians generally cannot reliably predict which patients will be adherent • Clinicians consistently overestimate patient adherence • Physicians tend to believe adherence is solely the patient’s responsibility

  26. Adherence: Societal Factors Example: Obesity • Food used to be expensive – now it’s cheap • Physical activity used to be cheap – now it’s expensive

  27. Social Learning Theory: Albert Bandura • Behavior is learned and can be unlearned • People learn best by active participation • People need to believe they can change (self-efficacy) Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice Hall; 1986.

  28. Health Belief Model • People are more likely to take action if they believe: • They’re vulnerable or susceptible to consequence of a behavior • They’re capable of change • Benefits of change will outweigh costs Rosenstock I, in Glanz K et al, eds. Health Behavior and Education: Theory, Research and Practice. San Francisco: Jossey-Bass; 1990.

  29. Precontemplation Contemplation Relapse Action Maintenance Stages of Change Adapted from: Prochaska J, DiClemente CC. J Consulting Clin Psych. 1983;51:390.

  30. Summary of Principles from Theories and Models of Change • Individuals need to have adequate information • Individuals need to believe in their ability to make changes and have positive expected outcomes • Individuals need skills, support, resources • Interventions need to be tailored to the individual or organization and its social context

  31. Patient Level – Solutions Counseling • Use questions related to 5 content areas: • Desire and motivation to change behavior • Past experiences with the behavioral change • Factors that inhibit the change (barriers) • Resources for change (strengths) • Plan for change and follow-up Courtesy: Ockene IS. Ockene IS, et al. J Am Coll Cardiol; 2002;40:630-638.

  32. Provider Level – Solutions • Simplify the regimen • Ask about adherence at every visit • Look at the refill dates!! • Tailor regimen to patient’s lifestyle and needs, and to patient’s willingness/desire to be challenged • Involve patient as partner in treatment • Provide clear written and oral instructions • Use behavioral strategies (reminder systems, cues, self-monitoring, feedback, reinforcement) Courtesy: Ockene IS. Ockene IS, et al. J Am Coll Cardiol; 2002;40:630-638.

  33. Physician Adherence Management Clinician uses problem-solving approach based on questioning the patient in a nonjudgmental manner • “How do you remember to take your medicine?” • “As is the case with many patients, do you ever miss or forget a dose?” • “How do you remember to take your medication on weekends or while traveling?” • “What do you think you could do to avoid missing doses?” • “Might any future events interfere with taking your medication?” Insull W. J Intern Med. 1997;241:317.

  34. Self-reported Adherence • Level of adherence reported by patient, in interview or questionnaire • Frequently overstated • Sample questions: • Do you ever forget to take your medicine? • Are you careless at times about taking your medicine? • When you feel better, do you sometimes stop taking your medicine? • Sometimes if you feel worse when you take the medicine, do you stop taking it? Choo PW et al. Med Care. 1999;37:846-857. Morisky DE et al. Med Care. 1986;24:67-74. Wang PS et al. Pharmacoepidemiol Drug Saf. 2004;13:11-19.

  35. Adherence: System-Based Factors • Extent to which the healthcare system facilitates or impedes provider’s adherence-related activities • Organizational structures and processes • Organizational priorities • Need to extend financial horizon – 5-year vs. 6-12 month outlook

  36. Systems Level – Solutions • Create an environment/office system supportive of preventive interventions • Establish tracking and reporting systems • Optimize multidisciplinary team approach • Implement education, training programs for provider • Establish appropriate reimbursementfor providers Courtesy: Ockene IS. Ockene IS, et al. J Am Coll Cardiol. 2002;40:630-638.

  37. Midwest Heart Specialists’ Experience • Cardiology practice in Naperville, Illinois started physician-directed, nurse-managed lipid clinic in 1985 • All new patients see medical director, then lipid nurse • Lipid nurse reviews lab results, educates patient on NCEP lipid goals and step II diet • After diet trial, patient has repeat lipid profile and appointment with lipid physician for individualized treatment plan • Electronic medical record tracks patients • Nurses provide ongoing education, phone consultation • Intense compliance effort through phone calls, postcards Brown AS, et al. Am J Cardiol. 2000;85:18A-22A.

  38. Midwest Heart Specialists’ Experience • 97% of patients have LDL-C level in their charts • 71% are at their LDL-C goal • 29% not at goal have average LDL-C of 105 mg/dL Brown AS, et al. Am J Cardiol. 2000;85:18A-22A.

  39. Easily Implemented Steps for All Practices • Have nurse flag date of last lipid measurement on Post-It atop patient’s chart • Measure lipids upon diagnosing a patient with hypertension, diabetes, other conditions • Designate 1 nurse or other staffer to handle basic lipid and hypertension education and phone calls, clearly defining what issues warrant notifying physician • Use paper or electronic methods for quick calculation of Framingham 10-year risk • Use preprinted index cards or other form to provide each patient with his or her lipid and blood pressure levels and goals

  40. Specific Challenges in Adherence to Long-Term Medication Regimens • Most effective interventions are complex and labor intensive: • Usually require multiple approaches and follow-up supervision • Even effective interventions may have only modest effects • Full benefits of long-term medications cannot be realized at currently achievable levels of adherence: • More innovative approaches are needed McDonald HP, et al. JAMA. 2002;288:2868-2879.

  41. In-Hospital Initiation of Lipid-Lowering Therapy for Patients CHD: The Time is NOW • Therapy more likely to be • Initiated by physician • Continued by physician long term • Patients • Less likely to be concerned about side effects and monitoring • More likely to view therapy as essential (heart medication) • More likely to adhere (lower discontinuation rates) • More likely to achieve LDL-C<100 mg/dL • Early event reduction in ACS patients not missed Fonarow GC, et al. Circulation. 2001;103:2768-2770.

  42. In-Hospital Prescribing of Statin Improves Long-Term Compliance 3-year follow-up 100 P<0.0001 75 77% Taking statin at follow-up (%) 50 40% 25 0 No (n=278) Yes (n=65) Prescribed statin at discharge Muhlestein JB, et al. Am J Cardiol. 2001;87:257-261.

  43. Prevention Clinic Approach Improves Lipid Profiles † † † † Change at Follow-up from Baseline * * * * ‡ * * * * • All drugs/combinations: >80% success to reach goal ATP III • Success rate with statins: 97% • Success rate with statin and niacin: 100% † † *P<0.001; †P=NS; ‡P=0.001. Thomas HD, et al. NC Med J. 2003;6:263-266.

  44. Other Successful Prevention Clinic Models Ryan MJ Jr, et al. Am J Cardiol. 2003;91:1427-1431; Cording MA, et al. Ann Pharmacother. 2002;36:892-904; Brown AS, Cofer LA. Am J Cardiol. 2000;85:18A-22A; Sueta CA, et al. Am J Cardiol. 1999;83:1303-1307.

  45. A Prevention Clinic Offers: • Enhanced patient compliance with therapy • Aggressive treatment and follow-up, including combination therapy • Aggressive lifestyle and risk factor modification • Multifaceted team approach (diet, exercise, medication) • Continuous patient education (handouts, tapes, classes) • Constant reinforcement (frequent visits, calls, mailers) A Prevention Clinic’s Keys to Success Are:

  46. Summary

  47. Patient Barriers to Adherence with Treatment Recommendations • Lack of access to care • Psychological dysfunction, such as depression, alcohol abuse • Cognitive impairment • Societal issues (lack of education, cultural beliefs and habits) • Failure to recognize severity of condition • Failure to recognize the need for chronic therapy • Distrust of long-term medication safety • Lack of understanding goals and benefits of therapy • Asymptomatic nature of dyslipidemia • Lack of immediate benefits from medication regimen • Polypharmacy (costs, complexity, fear of side effects)

  48. Strategies for Improving Patient Adherence • Seeking continuing education of health care professionals on principles and implementation of evidence-based guidelines • Implement a team approach to preventive care • Ask about patient adherence at every visit • Be aware of pharmacy refill dates • Simplify the regimen if possible (fewest number of pills and simplest dosing schedule, tailored to the patient’s lifestyle) • Involve patient as active partner in treatment goals and regimen • Use proven behavioral modification tools (reminder systems, prompts for health care professionals; in-office and home educational tools for patients; clear verbal and written instructions)

  49. Physician Barriers to Adherence with Guidelines • Time pressure/constraints • Reimbursement issues • Overestimation of patient adherence • Underestimation of the consequences of undertreatment • Belief that adherence is solely the patient’s responsibility • Discomfort in discussing risk factors with patients • Lack of knowledge of evidence-based practice guidelines (awareness differs by physician type: primary care, OB/GYN, cardiologists) • Delay in rapid and effective dissemination of new clinical trial results to health care professionals

  50. Physician Barriers to Adherence with Guidelines (cont’d) • Focus on single risk factors, not the global picture • Gender issues (risk prevention is driven by misperceived lower risk in women even though calculated risk is equivalent to men) • Underdeveloped counseling skills • Failing to involve patients in decision-making and care plan • Lack of perceived effectiveness of attempts to change lifestyle • Individual vs. team-provider care • Lack of referral to specialty care, eg, preventive cardiology clinic, cardiac rehabilitation program, diabetes nurse educator, smoking cessation program

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