Evaluating CVD Medication Adherence Program in Low SES



Status:Completed
Conditions:High Blood Pressure (Hypertension), Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 85
Updated:8/13/2016
Start Date:January 2015
End Date:August 2016

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The investigators propose to evaluate the implementation of an efficacious medication
adherence program in a group at high risk for CVD. The program involves patients
receiving/responding to e-reminders to take CVD medications via patient-selected technology
[mobile/web-based applications, short message service (SMS; text messaging), interactive
voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program
administered by either research staff or a case manager staff member from the Duke
Outpatient Clinic via the telephone. This is a hybrid type II implementation science study.

The investigators propose to evaluate the implementation of a medication adherence program
among patients who attend Duke Outpatient Clinic (DOC). It is anticipated that, among the
providers' patient panels, at least 100 and up to 300 with CVD risk and poor CVD medication
adherence (<0.08 medication possession ratio) will consent to the program.

Using procedures from the investigators previous studies, the investigators will identify
potential patients from the EHR, and will identify a pool of potential patients using
electronic health records, with the goal of administering the program to at least 100
patients. Patients will be mailed letters, signed by their own provider or medical director
of DOC, requesting their participation in the programs. The RA will contact patients via
telephone to explain the study, screen for eligibility, and determine what mode of
administration individuals prefer to receive the program (SMS, IVR, or email).

The primary outcome will be that the effectiveness/impact of the proposed adherence program
will be a 10% improvement in MPR and CVD outcomes (anticipate reducing SBP by 5 mmHg, Hgb
a1c by 0.5%, LDL-C by 20 mg/dl).

Inclusion Criteria:

1. Medicaid recipient (preferred); however the investigators will include those patients
with other types of insurance or those who are uninsured

2. Enrolled in Duke Outpatient Clinic for at least one year

3. Outpatient diagnostic code for hypertension and/or hypercholesterolemia and/or
diabetes

4. Poorly controlled BP levels (>140/90) and/or LDL-C (>130mg/dl) and/or HbA1c of >8
within last 6 months

Exclusion Criteria:

1. No access to cell phone

2. Not proficient in English

3. Nursing home/long-term care facility resident or receiving home health care

4. Impaired hearing/ speech/ vision

5. Participating in another trial (pharmaceutical or behavioral)

6. Planning to leave the area in the next 12 months

7. Pregnancy (or planning)

8. Diagnosis of life-threatening disease with death probable within 1 year

9. Active Diagnosis of psychosis or dementia (has been hospitalized in the last 30 days)

10. Diagnosis of ESRD
We found this trial at
1
site
Durham, North Carolina 27705
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Durham, NC
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