My Interprofessional Care Team for Adherence and Research Engagement Disparities

Last updated: June 10, 2025
Sponsor: University of Arizona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Stress

Treatment

My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)

Clinical Study ID

NCT05470439
R01HL151772
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age ≥ 18 years;

  2. self-report cultural identity as African-American, or Latino;

  3. speak English, or Spanish;

  4. have medication-treated hypertension;

  5. use ≥5 chronic medications;

  6. have hypertension medication adherence <85%; and

  7. able to provide informed consent.

Exclusion

Exclusion Criteria:

  1. if project staff conclude that a candidate participant is unable to comprehend theinformed consent process (because he/she offers an inappropriate response to consentquestions); or

  2. if the candidate is hostile or unwilling to follow project protocols.

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)
Phase:
Study Start date:
August 30, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

The investigators will follow an intention-to-treat randomized design using a waitlist control with 230 African-American, and Latino patients with hypertension and low (<85%) medication adherence. Data collection via pill count, self-report, electronic health record, and clinical measures will assess medication adherence, BP, and other factors at baseline (pre-intervention) and at 6 months post-intervention.

Connect with a study center

  • Caring Health Center, Inc.

    Springfield, Massachusetts 01103
    United States

    Active - Recruiting

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