Transcript 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
• 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
• No test available
• No single patient characteristic
100% predictive
• Physicians are poor predictors
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)
1. Acceptance of ART (Readiness)
2. Ability to take and adhere to ART
3. Maintenance of adherent behavior
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)
1. Acceptance of ART (Readiness)
2. Ability to take ART
3. Maintenance of adherent behavior
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
Acceptance of and Adherence to ART
Importance of Trust
Altice, et al. 4th Conf. onRetrovirus and OIs, 1997
AOR
p value
TRUST in Physician Scale
0.08
<0.0001
MISTRUST Medications
0.30
<0.001
Acceptance
* 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 (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
Assess for:
1. Barriers to adherence
2. Motivation for adherence
3. Skills needed for 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
• 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
• 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
• 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
100
N= 164
90
80
70
60
Mean Adherence
Level, %
50
40
30
20
10
0
Active SU
No active SU
p = .005
Substance Use & Adherence - 2
HATS 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)
Active Substance Use and
HIV RNA
(HATS data 2/01, N = 164)
50
45
40
35
30
25
20
15
10
5
0
% with nondetectable
(<400) HIV RNA
Active SU
No active SU
p < .05
Social support and adherence
Gifford, et al. JAIDS 2000
N = 133
70
60
50
% of pts reporting
they had support for
using medications
40
30
20
10
0
<80%
80-99%
100%
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
• 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
• Mistrust of provider
• Provider’s interpersonal skills
• Provider’s experience/expertise
Predictors of Adherence
Montessori, et al (CROI 2000)
(N=886)
Variable
AOR
Male
1.96
Increased age (@10 yr) 1.33
AIDS at baseline
2.28
Physician experience
1.45
(per 100 pts)
History IDU
0.50
CI
1.28 - 3.01
1.2 - 1.57
1.44 - 3.61
1.20 - 1.74
0.36 - 0.71
Medication-related barriers
to adherence
•
•
•
•
•
fit with lifestyle
complexity / pill burden
dose frequency
side effects
duration
Correlation With How Well
Regimen Fits Patients’ Daily Life*
(N = 1910)
70
60
50
Patients 40
% of
Adherent to
Therapy†
Patients
responded that
regimen fits in:
Not at all well
A little bit
Somewhat
30
Very well
20
Extremely well
10
0
*P < .001.
† Patients who reported no missed doses in the past week.
Wenger et al., 6th Conf. on Retroviruses and OIs; 1999
Fit with daily activities and
Adherence
Gifford, et al. JAIDS 2000
N = 133
70
60
50
% reporting that
regimen fits well with
daily activities
40
30
20
10
0
<80%
80-99%
100%
Perceived fit and HIV RNA
Gifford 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
Patients with plasma HIV RNA
50 copies/ml at 48 weeks (%)
90
(r=–0.57, P=0.0085)
80
70
60
50
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
Number of antiretroviral pills prescribed per day
Bartlettt J. XIII IAC, Durban, 2000. Abstract 4998
20
Disease-related barriers to
adherence
Health Status
– AIDS, h/o OI
• (Samet 1992, Singh 1996)
– symptomatic
• (Eldred 1997a)
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 Med 1989; Haynes
1979
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
•
•
•
•
Pill taking - difficulty swallowing pills
keeping to a schedule
forgetfulness
use of pillbox
Assessing Clients’
Progression Toward
Adherence to Antiretroviral
Therapy (ART)
1. Acceptance of ART (Readiness)
2. Ability to take ART
3. Maintenance of adherent behavior
Adherence Scores Over Time
Mannheimer, XIII int’l AIDS conf., 2000
data from 2 large CPCRA clinical trials of ART (N = 732)
80
70
60
50
40
30
20
10
0
100
80-100
0-80
1 mo
4 mo
8 mo
12 mo
follow-up visit
P < .001 for difference between mos 1 and 4 and
mos 1 and 8
Consistency of 100% adherence
and virologic outcome
Mannheimer et al., data from participants in 2 CPCRA
ART clinical trials
90
N = 205
80
70
60
50
%non40
detectable
30
20
10
0
0
1
2
3
Number of follow-up visits with
self-reported 100% adherence
4
Assessing for Maintenance of
Adherence in the field
• Self-report
– nonjudgmental
– give permission to “miss”
• Important to assess at every followup visit/encounter if possible
• high risk of relapse even if in
“maintenance”
• Frequent follow-up
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
120
100
80
% of pts with
undetectabe HIV RNA
(<400 copies/mL)
60
40
20
0
I
II
N= 1
N=4
III
N=45
IV
V
N=34
N=76
p< .001
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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