Pharmacist-CHW Team to Improve Medication Adherence and Reduce Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Arizona
- Enrollment
- 217
- Locations
- 1
- Primary Endpoint
- Self-reported medication adherence (survey)
Study Overview
Brief Summary
MI-CARE is an innovative coordinated care team intervention to improve medication adherence and blood pressure derived from research findings that build on existing clinical practice. Designed with an eye toward sustainability, MI-CARE incorporates billable pharmacist and CHW services for patients with low medication adherence and high burdens of chronic illness and preventable consequences. MI-CARE offers interprofessional team care with comprehensive expertise and complementary skill sets that mitigate the silo effect of specialized medicine to deliver primary care to diverse, high-risk populations experiencing disparities in hypertension.
Detailed Description
MI-CARE is a practice-based randomized controlled trial (RCT) to test the effectiveness of a comprehensive, individually- and culturally-tailored intervention for high-risk patients with hypertension, polypharmacy, and low adherence. MI-CARE leverages the specialized expertise of a clinical pharmacist together with a community health worker (CHW) who will serve as a cultural broker and patient navigator to address individual, clinical, social-cultural, and structural barriers to adherence.
This comprehensive and tailored, coordinated care intervention aims to improve medication adherence and hypertension outcomes among African-American, Latino, and Vietnamese immigrant patients. The proposed practice-based RCT is designed to meet the following specific aims:
Aim 1: Implement MI-CARE, an innovative, tailored adherence intervention delivered by a pharmacist and CHW team.
Aim 2: Determine the short- and long-term effectiveness of MI-CARE by assessing pre- to post-intervention changes in a) medication adherence (proximal outcome) and blood pressure (BP, distal outcome), and b) other comorbid health outcomes (e.g., HbA1c, BMI) using a randomized controlled trial.
Aim 3: Identify factors associated with MI-CARE effectiveness including a) tailored intervention features, b)medication beliefs, c) barriers to adherence, d) intervention dose, e) health literacy and f) cultural group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 18 years;
- •self-report cultural identity as African-American, or Latino;
- •speak English, or Spanish;
- •have medication-treated hypertension;
- •use ≥5 chronic medications;
- •have hypertension medication adherence <85%; and
- •able to provide informed consent.
Exclusion Criteria
- •if project staff conclude that a candidate participant is unable to comprehend the informed consent process (because he/she offers an inappropriate response to consent questions); or
- •if the candidate is hostile or unwilling to follow project protocols.
Arms & Interventions
MI-CARE Intervention
Pharmacist-community health worker team providing coordinated care tailored to high-risk patients with hypertension. MI-CARE intervention participants will meet with the pharmacist-CHW team for medication optimization and tailored case management. Pill counts will be completed to assess adherence and BP will be measured at each visit to guide antihypertensive medication optimization and provide feedback to participants about their adherence and BP control. Intervention visits will be followed by a booster one month later.
Intervention: My Interprofessional Care team for Adherence and Research Engagement (MI-CARE) (Behavioral)
Waitlist Control
Participants enrolled in this arm will receive usual medical care
Outcomes
Primary Outcomes
Self-reported medication adherence (survey)
Time Frame: Month 6
Medication Adherence Report Scale-5 (MARS-5) with 5-point Likert scale will be used (Minimum Value: 1; Maximum Value 5); Range of score (cumulative): 5(worst) - 25(best)
Objectively measured medication adherence (pill count)
Time Frame: Month 6
The investigators will use dosage information from the pill bottle and refill history to calculate percentage adherence (the number of pills taken / the number of pills that should have been taken x 100). All chronic oral medications in current use will be counted. Percent adherence rates for each medication will be calculated as well as the mean adherence averaged across all chronic oral medications.
Blood Pressure
Time Frame: Month 6
Systolic and diastolic blood pressure measured by a calibrated, automated sphygmomanometer
Secondary Outcomes
- HgbA1c(Month 6)
- Weight(Month 6)
- Body Mass Index (BMI)(Month 6)
- Lipid(Month 6)
- Statin use(Month 6)