med adherence and self efficacy

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SAFTINet Cardiovascular Cohort PRO: Medication Adherence

CER Team21 May 2012

+Overview

What medication adherence domains should we measure? Medication adherence: quantified Barriers Self-efficacy

What instruments should we use?

Who would be surveyed (PEC: all patients) and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Overview

What medication adherence domains should we measure? Medication adherence: quantified Barriers Self-efficacy

What instruments should we use?

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Medication Adherence Measures

Options in SAFTINet self-report: simple to obtain in real time

other real-time methods: more cumbersome and costly pill counts, drug levels, direct observation, etc.

prescription fulfillment data in SAFTINet: only for Medicaid patients only tells whether they filled the prescription

Patient(person)

Medication adherence(behavior)

Self-efficacyBarriers

+Medication Adherence Measures Feedback from PEC

Medication adherence would be helpful to know most clinicians ask this already the simpler the better

Barriers would be useful helped refine the list of domains to cover based on

clinical experience Self-efficacy—no clear direction yet from PEC

Patient(person)

Medication adherence(behavior)

Self-efficacyBarriers

+Overview

What medication adherence domains should we measure?

What instruments should we use? Medication adherence: quantified Barriers Self-efficacy

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Review of Self-Reported Medical Adherence Measures

Garfield S, et al. Suitability of measures of self-reported medication adherence for routine clinical use: A systematic review. BMC Med Res Methodol. 2011; 11: 149.

Inclusion Criteria: Studies that report development, reliability or validation of a retrospective self report adherence measure against a non-questionnaire measure

Exclusion Criteria: (excerpt) non-English no instrument available only relevant to single disease or medication med adherence questions not separable from other

questions

+Review findings

58 measures in 76 papers

Length: 1 to 21 questions

Formats: face to face interview, telephone interview, self administration and computer program

43/58 specified a time period

~half had a measure of barriers too, but these were usually not comprehensive or developed with patient feedback

54/58 had validation data

+Overview of studies by design

+Overview of studies by validation

+Narrowing down the field

Selected studies with only 1 question: 21/58

Selected studies with significant findings for validation study: 16/58

Selected studies not limited to an HIV positive or Mental Health population: 5/58 Rationale: focus on less symptomatic population

+Scale [Ref #] Scale type

Time period

Sample size

Population

Validated against

Validity Results

Adherence Self Report Questionnaire (ASRQ) [25-27] Likert

None Specified 245

Patients from GP practice taking antihypertensives MEMS

Significant association (p=0.0004)

216

Patients from GP Practices taking antihypertensives MEMS

Sensitivity= 46%; Specificity=66%

Gehi [41] Likert Previous month 1015

Outpatients with documented chronic heart disease

Develop-ment of CV events

Significant association (p=0.03) bivariate analysis, 0.06 multivariate analysis)

Inui [46]Dichotomous

Previous 2 months 241

Patients with HTN Pill count

Sensitivity = 55%; Specificity = 88%

+Scale [Ref #] Scale type

Time period

Sample size

Population

Validated against

Validity Results

Medical Outcomes Study Adherence question [57] Likert

Previous 4 weeks 139

Patients >18 with HTN, DM, hyper-cholesterolemia, hypo-thyroidism or requiring HRT

Pharmacy refill records

Spearman Rho= 0.261(p=0.05)

Visual Analogue Scale (VAS) six month version [89]

Continuous (visual analogue)

Previous 6 months 1985

Patients >18 with DM MEMS

VAS higher than MEMS adherence mean difference 15% (p value not reported)

+Adherence Self Report Questionnaire (ASRQ)

+Gehi Question

In the past month, how often did you take your medications as the doctor prescribed?

“All of the time” (100%) “Nearly all of the time” (90%) “Most of the time” (75%) “About half the time” (50%) “Less than half the time” (<50%)

+Medical Outcomes Study Adherence question

How often have you taken your prescribed medication in the past 4 weeks? (Select one) none of the time a little of the time some of the time a good bit of the time most of the time or all of the time

Similar to Gehi question

+Inui Question

Many patients find it difficult to take their medicines or stick to their diets as their doctors say they should. Over the past two months since you were last in clinic, do you think you have taken your medicine as you should, on schedule and regularly? Yes No

+Visual Analogue Scale (VAS) six month version

What percent of time over the past 6 months did you take your prescribed diabetes medication? Place an “x” on a horizontal line

anchored by 0% and100% demarcations provided for every 10th percentile

+Self-Reported Medical Adherence Measures

Recommendations on selecting a measure quantifying medication adherence? Adherence Self Report Questionnaire (ASRQ)

6 levels, more text per level Gehi Question

5 levels, brief text and percentages for each level Medical Outcomes Study Adherence question

5 levels, brief text for each level Inui Question

yes/no question Visual Analogue Scale (VAS) six month version

+Medication Adherence from Claims Fulfillment Data

Medication possession ratio (MPR) = (days of medication supplied) ÷ (# days between the first and last fills)

Proportion of days covered (PDC): the proportion of all days within a specified time period a patient had enough medication

Percentage of doses taken as prescribed: the percentage of prescribed doses taken as directed during a specified time period

Cumulative medication gap (CMG) = (# days in which a medication was not available) ÷ (# days between the first and last fills)

+Overview

What medication adherence domains should we measure?

What instruments should we use? Medication adherence: quantified Barriers Self-efficacy

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Medication Adherence Measures: Barriers Measure

Starting point for which barriers to ask about what barriers have been shown to matter in research

studies what barriers do you encounter in your own practices

(known to be very context dependent) emphasize barriers that are amenable to real-world

intervention (e.g., prescribe a daily rather than twice-daily medication)

Patient(person)

Medication adherence(behavior)

Self-efficacyBarriers

+Medication Adherence Measures: Barriers Measure

Starting point for which barriers to ask about what barriers have been shown to matter in research studies RAND Corporation systematic review of barriers found to

predict measured medication adherence regimen complexity cost-sharing (e.g., prescription copayments, formulary tiers,

coinsurance, pharmacy benefit caps or monthly prescription limits, formulary restrictions, and reference pricing)

depression (found effect only as comorbidity of diabetes) beliefs about medications (perceived risks of having a side

effect and perceived impact and need for the medication)

+Medication Adherence Measures: Barriers Measure

Based on the RAND list, and eliminating depression, here is a sample barriers measure, modified by PEC

Which of the following things make it harder for you to take your medication(s) as prescribed? I am worried about the side effects of the medication(s) I do not feel like I need the medication(s) for my health I do not feel like the medication(s) make me feel any better It is hard to take medication(s) more than once a day I have so many medications to take I cannot afford to pay for the medication(s) I sometimes forget to take my medication(s)

+Medication Adherence Measures: Barriers Measure

No systematic review of barriers measures

Per PubMed, the ASK-20 and ASK-12 are commonly cited not disease specific validated

ASK-12 contains the questions most often identified as barriers by

patients taking the ASK-20 Three domains – Inconvenience/forgetfulness, Treatment

beliefs, Behavior – each with a subscale

+Medication Adherence Measures: Barriers Measure

ASK-12 total score demonstrated adequate internal consistency reliability with a Cronbach’s alpha of 0.75

ASK-12 score correlates with self-report measures and objective measures Morisky Adherence Survey (-0.74) proportion of days covered as indicated by claims (r=-0.20;

P=0.059)

Score range 12-60 higher score = greater barriers

In a clinical setting it is not necessary to score the instrument, only review the items in the dark blue boxes

+Medication Adherence Measures: ASK-12

+Medication Adherence Measures: ASK-12

+Overview

What medication adherence domains should we measure?

What instruments should we use? Medication adherence: quantified Barriers Self-efficacy

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Medication Adherence Measures: Self-efficacy

Medication Adherence Self-Efficacy Scale (MASES) Ogedegbe et al 2003 Validated in African-American patients with hypertension

Please rate how sure you are that you can carry out the following tasks ALL OF THE TIME: (all answers are on a 3 point scale: Not at all sure, somewhat sure, very sure) Get refills for your medications before you run out Make taking your medications part of your routine Fill your prescriptions whatever they cost Always remember to take your blood pressure medications Take your blood pressure medications for the rest of your life

+Situations come up that make it difficult for people to take their medications as prescribed by their doctors. Below is a list of such situations. We want to know your opinion about taking your blood pressure medication(s) under each of them. Please indicate your response by checking the box that most closely represents your opinion. There are no right or wrong answers. For each of the situations listed below, please rate how sure you are that you can take your blood pressure medications ALL OF THE TIME

1. When you are busy at home

2. When you are at work

3. When there is no one to remind you

4. When you worry about taking them for the rest of your life

5. When they cause some side effects

6. When they cost a lot of money

7. When you come home late from work

8. When you do not have any symptoms

9. When you are with family members

10. When you are in a public place

11. When you are afraid of becoming dependent on them

12. When you are afraid they may affect your sexual performance

13. When the time to take them is between your meals

14. When you feel you do not need them

15. When you are travelling

16. When you take them more than once a day

17. If they sometimes make you tired

18. If they sometimes make you tired

19. When you have other medications to take

20. When you feel well

21. If they make you want to urinate while away from home

+Overview

What medication adherence domains should we measure?

What instruments should we use? Medication adherence: quantified Barriers Self-efficacy

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Options for Med Adherence PRO Administration

Easier to administer to all patients than to only those with select diagnoses

Having just one screening question is more practical

Administer medication adherence measure first then administer barriers +/- self-efficacy questions only administer barriers +/- self-efficacy questions to those

with non-adherence

Administer barriers +/- self-efficacy questions first and leave the medication adherence question for last

+Overview

What medication adherence domains should we measure?

What instruments should we use? Medication adherence: quantified Barriers Self-efficacy

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Research Utility

Which domains would we use? medication adherence barriers measure total score self-efficacy total score

How would we use these in an analytic model?

PCMH

Medication adherence

Self-efficacyBarriers

Disease control

+Research Utility

How would we use fulfillment data in an analytic model? Verify self-report data As an outcome or intermediate variable in the PCMH model

PCMH

Prescription fulfillment

Disease control

+Overview

What medication adherence domains should we measure?

What instruments should we use? Medication adherence: quantified Barriers Self-efficacy

Who would be surveyed and how?

How would we use the findings in our research?

How would our partners use the instruments?

+Utility to Practices

Which of the components of the proposed PRO would have clinical (and other use) utility to the practices?

What related activities are the practices already doing? Some clinicians are asking about medication adherence and

barriers but not documenting responses in a field Nurses check the list of active medications at intake, asking

which they are still taking and why they stopped those they are no longer taking

Meaningful use phase 2 will require goal-setting and a barriers format might meet these criteria

ACO activities related to identifying high-risk patients for hospitalization (next slide)

+Example of Medication Adherence Question Already In Use How many prescription medications are you currently taking

every day (H-8)?

None (0) (skip to Social Needs) 1-2 (0) 3 OR MORE (1)

In a TYPICAL WEEK how often did you forget to take or decide NOT to take one or more of your medications (H-8)?

NEVER (0) RARELY (0) SOMETIMES (1) USUALLY (1) ALWAYS (1)

How sure are you that you understand the reason you are taking your medications (H-8)?

VERY SURE (0) SOMEWHAT SURE (0) NOT VERY SURE (1)

How often do you get your medications at more than one pharmacy?

NEVER (0) RARELY (0) SOMETIMES (1) USUALLY (1) ALWAYS (1)