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Assessing Your Clients for Adherence: A Real World Approach. Sharon Mannheimer, MD Harlem Hospital Center Treatment Adherence Network Meeting February 27, 2001. Adherence. A complex behavioral process involving progression through various stages

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assessing your clients for adherence a real world approach

Assessing Your Clients for Adherence:A Real World Approach

Sharon Mannheimer, MD

Harlem Hospital Center

Treatment Adherence Network Meeting

February 27, 2001

adherence
Adherence
  • A complex behavioral process
  • involving progression through various stages
  • working toward the goal of maintaining 100% adherence with all doses all of the time
  • ultimate goal of improved quality of life and survival
it is difficult to identify who will and won t adhere to medications
It is difficult to identify who will and won’t adhere to medications
  • No test available
  • No single patient characteristic 100% predictive
  • Physicians are poor predictors
assessing for adherence
Assessing for adherence
  • complex
  • involves assessing clients’ progression toward full adherence to therapy
  • as well as assessing for a variety of barriers known to be associated with poorer adherence
steps toward adherence to antiretroviral therapy art
Steps Toward Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take and adhere to ART

3. Maintenance of adherent behavior

adherence behavior theoretical models
Adherence Behavior: Theoretical models
  • Theoretical models can provide a framework for assessing for behaviors such as adherence
    • Health Belief Model
    • Prochaska’s Transtheoretical Model of Change (TTM or TMC)
    • Information, Motivation and Behavioral Skills (IMB)
assessing clients progression toward adherence to antiretroviral therapy art
Assessing Clients’ Progression Toward Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take ART

3. Maintenance of adherent behavior

assessing for acceptance of art
Assessing for Acceptance of ART

1. Ask the patient

  • e.g., “Do you feel that you can take HIV medications two times a day, every day?”

2. Assess for barriers to acceptance

  • recent HIV diagnosis
  • denial of diagnosis
  • lack of knowledge
  • lack of trust in provider
  • lack of trust in medications
  • beliefs
slide9
Acceptance of and Adherence to ART

Importance of Trust

Altice, et al. 4th Conf. onRetrovirus and OIs, 1997

A O R p value

Acceptance

TRUST in Physician Scale 0.08 <0.0001

MISTRUST Medications 0.30 <0.001

* There is an 8% increase in adherence for each unit increase in the 11-55 item Trust in Physician Scale

assessing clients progression toward adherence to antiretroviral therapy art10
Assessing Clients’ Progression Toward Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take ART

3. Maintenance of adherent behavior

assessing client s ability to take adhere to art
Assessing client’s ability to take & adhere to ART

Assess for:

1. Barriers to adherence

2. Motivation for adherence

3. Skills needed for adherence

assessing barriers to adherence
Assessing Barriers to Adherence:

Adherence barriers can be classified as being related to:

  • Patient characteristics
  • Provider
  • Treatment regimen
  • Clinic/office characteristics
  • Disease characteristics
patient characteristics associated with lower adherence levels
Patient characteristics associated with lower adherence levels
  • Demographics
    • African American race
  • Social/environmental:
    • Lack of insurance or access
    • Active substance use
    • Homelessness
    • Poor social support
    • Doubt efficacy of medication
    • Confidentiality concerns
patient characteristics 2
Patient characteristics -2
  • Lack of Knowledge
    • HIV treatment regimen
    • CD4
    • Resistance
  • Psychological factors
  • beliefs:
    • Poor self-efficacy
    • 2 aspects of the Health Belief Model [Becker 1974]:

1) having greater perceived benefits from therapy

2) having fewer perceived barriers to treatment

race and adherence
Race and Adherence
  • Lower adherence rates noted among African Americans in several studies
    • Ostrow. 8th CROI 2001; Mannheimer, XIII Int’l AIDS Conf. 2000; Gifford, JAIDS 2000; Kleeberger, XIII Int’l AIDS Conf. 2000; Singh, Clin Infect Dis1999; Wenger, 6th CROI 1999; Muma, AIDS Care 1995; Moore, NEJM 1994; Besch, Int’l AIDS Conf. 1992
  • independent of education and drug use history in some studies
  • Nonwhite race may be a marker for other factors such as low literacy
substance use su and adherence mannheimer et al hats data 2 01 updated from durban n 164 p 005
Substance Use (SU) and AdherenceMannheimer, et al, HATS data 2/01, updated from DurbanN= 164p = .005
substance use adherence 2 hats data 2 01
Substance Use & Adherence - 2HATS data 2/01
  • Active substance users were:
    • less likely to report 100% adherence (p = 0.06)
    • less likely to report > 90% adherence (p < .04)
    • less likely to believe that ART was helpful in fighting HIV (fewer perceived benefits) (p = .03)
    • more likely to report stressful life events

(p = .02)

slide20
Barriers to Adherence to ART

Altice, et al. 4th Conf. onRetrovirus and OIs, 1997

Adherence OR p value

SOCIAL ISOLATION 0.08 0.0001

SIDE EFFECTS 0.09 0.0001

COMPLEXITY

of Antiretroviral Regimen 0.33 0.01

psychological factors
Psychological factors
  • Depression

(Singh 1996, Broers 1994, Burack 1993)

  • Active psychiatric illness

(Paterson Ann Intern Med 2000)

  • Stress

(Gifford 2000, Singh 1996)

  • Poor coping skills

(Singh 1996)

  • HIV “burnout”

(Ostrow 8th CROI 2001)

provider related barriers to adherence
Provider-related barriers to adherence
  • Mistrust of provider
  • Provider’s interpersonal skills
  • Provider’s experience/expertise
slide23
Predictors of AdherenceMontessori, et al (CROI 2000)

(N=886)

Variable AOR CI

Male 1.96 1.28 - 3.01

Increased age (@10 yr) 1.33 1.2 - 1.57

AIDS at baseline 2.28 1.44 - 3.61

Physician experience 1.45 1.20 - 1.74

(per 100 pts)

History IDU 0.50 0.36 - 0.71

medication related barriers to adherence
Medication-related barriers to adherence
  • fit with lifestyle
  • complexity / pill burden
  • dose frequency
  • side effects
  • duration
slide25
Correlation With How Well Regimen Fits Patients’ Daily Life* (N = 1910)

Patients responded that regimen fits in:

70

60

Not at all well

50

A little bit

% of PatientsAdherent toTherapy†

40

Somewhat

30

Very well

Extremely well

20

10

0

*P < .001.

†Patients who reported no missed doses in the past week.

Wenger et al., 6th Conf. on Retroviruses and OIs; 1999

perceived fit and hiv rna gifford jaids 2000
Perceived fit and HIV RNAGifford JAIDS 2000

Patients having a good perceived fit of their regimens with their routine and daily activities (“high regimen convenience scores”) had lower viral loads (1.04 log copies/mL lower) than persons having “low regimen convenience scores”

virologic response by pill burden
Virologic response by pill burden

90

(r=–0.57, P=0.0085)

80

70

60

50

Patients with plasma HIV RNA

50 copies/ml at 48 weeks (%)

40

30

PI

NRTI

NNRTI

20

10

Size of symbol is directly proportional to weight of the data point in the analysis.

0

5

10

15

20

Number of antiretroviral pills prescribed per day

Bartlettt J. XIII IAC, Durban, 2000. Abstract 4998

disease related barriers to adherence
Disease-related barriers to adherence

Health Status

  • AIDS, h/o OI
    • (Samet 1992, Singh 1996)
  • symptomatic
    • (Eldred 1997a)
clinical setting related barriers to adherence
Clinical setting-related barriers to adherence
  • long waiting times
  • inconvenient clinic hours
  • unfriendly staff
  • lengthy delays between contact and appointments
  • substantial travel costs

Cramer 1991; Cuneo, Clin Chest Med1989; Haynes 1979

motivation
Motivation
  • Belief in efficacy of pills
    • greater perceived benefits from treatment(Balestra 1996, Eldred 1997, Ferris 1996, Mossar 1993, Muma 1995, Samet 1992, Smith 1997)
  • Self-efficacy
    • Gifford JAIDS 2000; Eldred 1997; Muma AIDS Care 1995
  • Support
    • Morse 1991
assess for behavioral skills helpful with adherence
Assess for Behavioral skills helpful with adherence
  • Pill taking - difficulty swallowing pills
  • keeping to a schedule
  • forgetfulness
  • use of pillbox
assessing clients progression toward adherence to antiretroviral therapy art34
Assessing Clients’ Progression Toward Adherence to Antiretroviral Therapy (ART)

1. Acceptance of ART (Readiness)

2. Ability to take ART

3. Maintenance of adherent behavior

slide35

Adherence Scores Over TimeMannheimer, XIII int’l AIDS conf., 2000data from 2 large CPCRA clinical trials of ART (N = 732)

P < .001for difference between mos 1 and 4 and mos 1 and 8

slide36
Consistency of 100% adherenceand virologic outcomeMannheimer et al., data from participants in 2 CPCRA ART clinical trials N = 205

Number of follow-up visits with

self-reported 100% adherence

assessing for maintenance of adherence in the field
Assessing for Maintenance of Adherence in the field
  • Self-report
    • nonjudgmental
    • give permission to “miss”
  • Important to assess at every follow-up visit/encounter if possible
  • high risk of relapse even if in “maintenance”
  • Frequent follow-up
assessing for consistency of adherence
Assessing for consistency of adherence
  • Assess Stage of Behavioral Change (Precontemplation, Contemplation, Preparation, Action, Maintenance)
    • e.g. for Maintenance:

“Have you been taking medications against the HIV/AIDS virus regularly for the last 6 months?”

correlation of stage of behavioral change with hiv rna n 1 n 4 n 45 n 34 n 76 p 001
Correlation of Stage of Behavioral Change with HIV RNAN= 1 N=4 N=45 N=34 N=76 p< .001
summary
Summary
  • Assessing for adherence is complex
  • Adherence should be assessed frequently
  • Involves assessing for:
    • acceptance of treatment
    • barriers to adherence
    • motivation and behavioral skills for adherence
    • stage of behavioral change
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