A Practical Approach to HIV Adherence Issues

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  • More recently, the term adherence rather than compliance has been used to reflect a change in our approach to patients; it connotes the element of patient choice involved in deciding whether or not to follow medical advice.
    Miller has nicely defined five ways in which patients may not adhere to medication prescriptions that I think are helpful in recognizing that this is not just an issue of “do” or “don’t”. This can be helpful to keep in mind in discussing medication-taking with your patients
    Not filling the prescription, Studies have shown that approximately 20% of prescriptions are never filled.
    Taking a different dose or taking at a different time, note the use of the word “different” rather than “wrong” again reflecting this element of patient choice.
    Missing of skipping doses
    Or discontinuing early
  • Although exact results vary with the way adherence is measured, as Wright suggests, many, many studies have shown that it is quite common that patients on chronic medical therapy do not take all of their medications all of the time. In other chronic illness, we know that on average patients take 50% of prescribed doses.
  • But short of that rather labor and cost intensive approach, there is no gold standard for measuring adherence although several ways exist; each has advantages and disadvantages; some are generally more accurate than others.
    Thus, one approach is to measure blood levels or urinary excrection levels, this is obviously influenced by other pharmacokinetic factors. Other approaches involve asking people—either patients, providers, or family members—these may be subject to recall or social desirability bias but give information about people’s perceptions. Many RCTs use prescription refill records and/or pill counts to assess compliance. These are more objective but don’t give an information about patterns of adherence. More recently studies of compliance use electronic pill bottle caps that contain a microchip which records the exact date and time that a medication was taken. Our group has developed a method of combining pill counts, self-report and electronic data into one measure.
  • This study by Paterson published in the Annals of Internal Medicine in 2000 was the first to shed light on the question of how much adherence affects virologic outcomes. To orient you to this graph, the horizontal axis represents the percent of prescribed doses taken ranging from over 95% sown to less than 70%. These results showed that among patients taking over 95% of their pills 80% of them maintained an undetectable viral load over six moths. But, as patients dropped below 95% adherence, 50% of them failed therapy in only six months.
  • As one would expect, given the relationship with viral load, adherence affects other more clinical outcomes including hospitalization rates, disease progression and mortality.
  • In terms of patients factors that have been pretty consistently identified in studies to be associated with worse adherence, have less severe asymptomatic disease, active psychiatric illness especially depression, poor medication taking skills, lack of understanding of the regiment, cognitive impairment, low literacy and active substance abuse all make it more difficult for patients to take their medication.
  • This shows that in a nationally representative sample of nearly 2,000 HIV+ patients in the US, the greater the regimen fit into the patients’ daily lifestyle, the more adherent they were.
  • Another study measured literacy among Medicare recipients and clearly showed that inadequate literacy increased with age. This is a cross-sectional study, so we cannot say whether literacy actually declined in individuals or whether the effect was related to less educational exposure among older beneficiaries. That is a question that still needs to be sorted out.
    Regardless, we know that older populations are at greater risk for having low literacy skills.
  • A recent systematic review of the literature found studies showing a relationship between low literacy and worse outcomes for all of the areas listed on this slide. I will point your attention to a few including worse general health status, increased risk of hospitalization, worse depression, worse diabetes control and worse control of hiv infection.
  • Update with more recent meta-analysis
    Add newer trials by DeBusk + DIAL
  • Check paper to make sure these are the final numbers
  • Again, make sure these are the final numbers in the paper
  • A Practical Approach to HIV Adherence Issues

    1. 1. Literacy and Adherence Michael Pignone, MD, MPH University of North Carolina-Chapel Hill Department of Medicine
    2. 2. A Clinic Visit • 54 y.o. woman with DM and HTN returns to clinic 3 months after your last visit • At the last visit, her A1C was 11.2% and her BP was 164/82. She was taking Glipizide 10 QD and Enalapril 10 mg QD. • You added Metformin 500mg bid and HCTZ 25 mg QD • Today she returns to clinic and her A1C is 11.3%; BP is 160/85.
    3. 3. Goals • Review importance of adherence for managing chronic conditions • Review relationship between low literacy and adverse health outcomes • Examine the complex relationship between literacy and adherence • Describe a successful intervention for patients with low literacy and heart failure
    4. 4. Key Messages • Adherence can be difficult, but it is essential for realizing treatment benefits • Low literacy is associated with a variety of adverse health outcomes, including increased morbidity and mortality • To date, it is not clear if, and how much, adherence mediates the relationship between low literacy and adverse outcomes • Interventions that build self-care skills can overcome literacy-related health disparities
    5. 5. Adherence • What is Patient Adherence? • Why does adherence matter? • What factors affect adherence? • Literacy and adherence • How Can We Improve Adherence?
    6. 6. What is Adherence?  Compliance: “the extent to which a person’s behavior coincides with medical or health advice” -Haynes, 1979  Adherence: “the extent to which the patient continues an agreed-upon mode of treatment (under limited supervision) when faced with conflicting demands” -American Heritage Medical Dictionary 2007
    7. 7. Types of Medication Non-adherence • Not filling the prescription • Taking a different dose • Taking at a different time • Missed, skipped, or extra doses • Early discontinuation
    8. 8. • On Average, Patients with Chronic Illness Take Only 50% of Prescribed Doses • TB: 48% pts miss Rx > 2 mos. Pablos-Mendez, Am J Med, 1997. • Hypertension: 50-60% near-optimal adherence. Rudd P, Am H J. 1995. • Antilipidemics: 50% of patients took 1/4 to 1/2 dose. LRCP. JAMA 1984. • ART: Patients take 53%-79 % of prescribed doses. - Bangsberg AIDS 2000 - Gross AIDS 2001 - Arnsten CID 2001 - Liu Annals Int Med 2001 - McNabb CID 2001 - Paterson Annals Int Med 2000 • Metaanalysis: 40% of patients take all of prescribed doses. Roter et al.Roter et al. Medical Care.Medical Care. 1998; 36: 1138 - 1161.1998; 36: 1138 - 1161. Prevalence of Non-adherence
    9. 9. Adherence Measures No “Gold Standard” • Blood levels or Urinary excretion • Outcome measures (e.g. A1C) • Patient or family member report • Provider estimate • Prescription refill records • Pill counts • Electronic caps (e.g. MEMS)
    10. 10. Morisky Score • 4-question patient survey • Do you ever forget to take your medication? • Are you careless at times about taking your medication? • When you feel better, do you sometimes stop taking your medication? • Sometimes if you feel worse when you take your medication, do you stop taking it? • Non-adherence = “yes” to 2 or more questions (61% sensitivity c/w claims data) • “Positive” response linked with poorer A1C
    11. 11. How much Adherence is Enough? Adherence to HAART measured for 6 mos (%) % undetectable viral load Paterson DL et al. Ann Intern Med. 2000;133:21-30. N =91 79% 48% 32% 29% 18% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% >=95 90-94.9 80-89.9 70-79.9 <70
    12. 12. ART Adherence Matters • Lower adherence associated with: • higher viral loads / lower CD4 counts • increased risk of hospitalization • increased progression to AIDS • increased mortality Arnsten J, et al. 7th CROI, 2000; Bangsberg DR, et al. AIDS 2000; Bangsberg et al., 8th Conf on Retroviruses, 2001; Hogg, et al, 7th CROI, 2000; Patterson, An Inter Med, 2000; Singh N, et al. Clin Infect Dis 1999.
    13. 13. Factors Affecting Adherence: 4“P”s  PPATIENTATIENT:: lack of symptoms, psychiatric illness, poor skills, poor understanding, cognitive impairment, literacy, substance misuse / abuse..  PPOTION:OTION: side effects, complexity, costside effects, complexity, cost  PPROVIDER:ROVIDER: trust, relationship, beliefs, knowledge  PPLACELACE:: daily activities, pharmacy access, housing, social support, reminders
    14. 14. Correlation of Adherence With Regimen Fit with Patient’s Daily Life* 70 60 50 40 30 20 10 0 % Patients Adherent to Therapy† *P < .001. † Patients who reported no missed doses in the past week. Data from Wenger et al. Poster presented at: 6th Conference on Retroviruses and Opportunistic Infections; January 31–February 4, 1999; Chicago, Ill. Poster 98. Not at all well A little bit Somewhat Very well Extremely well Patients who responded that regimen fits in N = 1910
    15. 15. Prescribing Recommendations • Ask preferences; tailor regimen to pt needs • Assess readiness (prior experience with medicine) • Assess / treat depression and substance misuse • Inform (what and why) using literacy-sensitive “teach back” methods • Assess comprehension • Give them someone to call with questions
    16. 16. At Return Visits • Ask open-ended, non-judgmental questions “What’s it been like for you taking your medicine?” “How well does the regimen fit in your daily routine?” “How confident are you that you can take these the way I am recommending in the next 30 days?” • Help them identify barriers and facilitators “What gets in the way for you? What helps you remember?” • Assess and manage/address side effects • Help them identify available social support • Enhance self-efficacy with goal setting, reinforcement, cues and reminders
    17. 17. Vulnerable Populations • Elderly • Low income • Poor social support • Lack of patient/family knowledge about disease • Depression • Lack of transportation • No access to medications • English as a second language  Low literacy
    18. 18. Literacy
    19. 19. National Assessment of Adult Literacy (NAAL)  Most up to date portrait of US literacy  Scored on 4 levels  Lowest 2 levels cannot: ◦ Use a bus schedule or bar graph ◦ Explain the difference in two types of employee benefits ◦ Write a simple letter explaining an error on a bill National Center for Education Statistics, U.S. Department of Education
    20. 20. 2003 National Assessment of Adult Literacy Intermediate Basic Below Basic Proficient 14%13% 44% 29% 93 Million Adults have Basic or Below Basic Literacy Basic or Below Basic 52% of H.S. Grads 61% of Adults ≥ 65
    21. 21. Inadequate Literacy Increases with Age Slide by Terry Davis, PhD 0 10 20 30 40 50 60 70 80 65-69 70-74 75-79 80-84 >=85 Marginal Inadequate Baker et al. J Gerontol B Psychol Sci Soc Sci. Nov 2000;55(6):S368-374.
    22. 22. Health Outcomes Associated with Literacy Health Outcomes/Health Services • General health status • Hospitalization • Prostate cancer stage • Depression • Asthma • Diabetes control • HIV control • Mammography • Pap smear • Pneumococcal immunization • Influenza immunization • STD screening • Cost • Mortality Behaviors Only • Substance abuse • Breastfeeding • Behavioral problems • Adherence to medication • Smoking Knowledge Only • Birth control knowledge • Cervical cancer screening • Emergency department instructions • Asthma knowledge • Hypertension knowledge • Prescription labels DeWalt, et al. JGIM 2004;19:1228-1239
    23. 23. Patients with Diabetes and Low Literacy Less Likely to Know Correct Management 0 20 40 60 80 100 Percent Need to Know: symptoms of low blood sugar (hypoglycemia) Need to Do: correct action for hypoglycemic symptoms Williams et al., Archive of Internal Medicine, 1998 Low Moderate High Low Moderate High
    24. 24. Williams et al. Chest 1998, 114(4):1008-1015. Asthma Patients with Low Literacy have Poorer Metered Dose Inhaler (MDI) Skills 0.7 1.2 1.5 1.7 0 1 2 3 4 3rd≤ 4th-6th 7th-8th 9th≥ Mean MDI Score 0 - 4
    25. 25. Adult Hospitalization  People with low literacy have 30-70% increased risk of hospitalization  RR = 1.29 (1.07-1.55) Medicare Managed Care  RR = 1.69 (1.13-2.53) Urban Public Hospital *Adjusted for age, gender, socioeconomic status, health status, and regular source of care. Baker et al. AJPH. 2002. 92:1278. Baker et al. JGIM. 1998. 13:791.
    26. 26. Literacy and Mortality Sudore et al. JGIM 2006; 21: 806-812 Health, Aging, and Body Composition Study
    27. 27. Literacy and Adherence
    28. 28. Relationship Between Literacy and Adherence is Complex • Mixed findings for ART adherence and diabetes • No effect for anticoagulation • Low literacy may make initial adoption harder, but may have neutral or positive effects once a behavior is in place • Effect may differ across conditions Fang JGIM 2006; 21: 841-6; Golin JGIM 2002; 17:756-65; Kalichman JGIM 1999; 14: 267; Rothman Annals 2008; 148:737-46; Schillinger JAMA 2002: 288: 475-82; Pignone and DeWalt JGIM 2006; 21: 896-7.
    29. 29. Literacy and Heart Failure
    30. 30. Heart Failure Epidemiology • 4.8 million people in U.S. have heart failure • Leading cause of hospitalization in elderly • Of those hospitalized, 25% to 50% are re-admitted within 3-6 month • Half of all admissions are preventable • Self-care, including adherence, essential • 13% of Medicare enrollees, 37% of Medicare expenditures
    31. 31. Individuals with lower literacy are more likely to: • Be diagnosed with HF • Experience hospitalization due to HF • Die due to HF complications
    32. 32. Heart Failure Organized Care Programs • 29 randomized trials29 randomized trials • Three types:Three types: • Multidisciplinary team care (n =15)Multidisciplinary team care (n =15) • Telephone-based care (n = 10)Telephone-based care (n = 10) • Self-care training (n = 4)Self-care training (n = 4) • All types reduced HF-related hospitalizationsAll types reduced HF-related hospitalizations • 15 of 18 studies reported cost savings15 of 18 studies reported cost savings • No information on the role of participantNo information on the role of participant education or literacyeducation or literacy McAlister JACC 2004; 44:810
    33. 33. Components of Successful Heart Failure Programs • Multidisciplinary teams • Defined follow-up procedures • Treatment algorithms based on best available evidence • Information systems for tracking patients • Patient education for self-care
    34. 34. Self-care Training • 4 trials • Number of participants 88-192 • Mean age 71-76 • Follow-up 1 week – 12 months • HF hospitalizations: RR 0.66 (0.52, 0.83) • All hospitalizations: RR 0.73 (0.57, 0.93) McAlister JACC 2004; 44:810
    35. 35. Recent Studies: Sisk trial • 406 adults in NYC followed for 12 months • 78% minority • mean age 59 • 30% low literacy • All with systolic HF (EF < 40%) • Nurse-led self-care training • Regular phone follow-up • Facilitation of medication changes • 12 month outcomes: • Reduced hospitalization rate (- 0.13 / person-yr) • Improved QOL (3.1 points on SF-12; 4.7 on MLHF)
    36. 36. Murray Trial • 314 adults with HF • Intervention vs. usual care • Multi-disciplinary team approach • Intervention improved adherence (79% vs. 68%, measured by MEMS) • 18% reduction in incidence of ED visits and hospitalizations • $3000/year reduction in direct costs Murray et al Annals of Internal Medicine 2007; 146:714
    37. 37. Our Research at UNC
    38. 38. Our Intervention • 1-hour individual education session • Education booklet <6th grade level • Digital bathroom scale • Scheduled follow-up phone calls • Easy access to care team
    39. 39. Development of Educational Materials • Distilled to essential information • Collaborated with medical illustrator • Focus group feedback • Cognitive interviews • Revised materials
    40. 40. Information Recommended by Guidelines • General topics • Explanation of heart failure • Expected symptoms vs. symptoms of worsening heart failure • Psychological responses • Self-monitoring with daily weights • Action plan in case of increased symptoms • Prognosis • Advanced directives • Dietary recommendations • Sodium restriction • Fluid restriction • Alcohol restriction • Activity and exercise • Work and leisure activities • Exercise program • Sexual activity • Medications • Nature of each drug and dosing and side effects • Coping with a complicated regimen • Compliance strategies • Cost issues Grady et al. Circulation. 2000;102(19):2443-2456.
    41. 41. Information We Included DeWalt et al. Patient Ed Coun. 2004; 55: 78 • General topics • Explanation of heart failure • Expected symptoms vs. symptoms of worsening heart failure • Psychological responses • Self-monitoring with daily weights • Action plan in case of increased symptoms • Prognosis • Advanced directives • Dietary recommendations • Sodium restriction • Fluid restriction • Alcohol restriction • Activity and exercise • Work and leisure activities • Exercise program • Sexual activity • Medications • Nature of each drug and dosing and side effects • Coping with a complicated regimen • Compliance strategies • Cost issues
    42. 42. Randomized Trial • UNC Internal Medicine and Cardiology • Self-care training vs. usual care/ booklet • 1 year duration • Primary Outcome: incidence of hospitalization or death • Secondary Outcomes: • HF-related quality of life • HF knowledge • HF specific self-efficacy • HF self-care (adherence to daily weight)
    43. 43. Enrollment and Follow-up Enrolled and randomized 129 Control 65 Intervention 64 Withdrawal: 2 58 (95%) 56 (95%) Withdrawal: 6 50 (85%)56 (93%) 6 month 12 month Death: 5 Death: 5
    44. 44. Baseline Characteristics Variable Control (n=65) Intervention (n=64) Mean Age, years 62 63 African American, % 55% 56% Male, % 42% 58% Education, years 9.8 + 2.8 9.1 + 3.2 Income <15K/yr, % 68% 69% Medicaid, % 32% 36% Medicare, % 73% 72% Literacy (S-TOFHLA) Inadequate, % 40% 45%
    45. 45. Improved HF Knowledge, Self-Efficacy, and Self-Care Behavior 6 Month Outcome Control Intervention Difference (CI) Knowledge change -2 10 12 (4, 19) Self-efficacy change -0.5 1.3 2 (0.5, 3.1) Daily weight measurement, % 21 88 67 (53, 81)
    46. 46. Reduced Incidence of Hospital Admission or Death • Overall: 0.56 [0.32, 0.95] • Low literacy sub-group: 0.38 [0.16, 0.88] DeWalt et al BMC Health Serv Res. 2006 13:30
    47. 47. How Well did Patients do with Materials? • 56 patients completed 6 months of intervention • Low literacy patients more likely to use the log sheets: 92% vs. 71%, p=0.05
    48. 48. Adherence to Instructions -- Errors Inadequate Literacy Adequate/Marginal Literacy Weeks 3-7 Mean errors 6.7 3.6 Weeks 18-22 Mean errors 3.6 4.2
    49. 49. Conclusions of Adherence Analysis • Low literacy patients more likely to use materials • Low literacy patients are less successful early after instruction, but improve over time • Learning requires multiple sessions!
    50. 50. The End Last updated 12.09.08 Individuals are welcome to use the slides in this presentation. Please credit authors and the presentation creators. Thank you.

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