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

University of Arizona

Status: Enrolling

Conditions: Hypertension; Medication Adherence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05470439

R01HL151772

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

1. 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
2. if the candidate is hostile or unwilling to follow project protocols.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

MI-CARE Intervention

Experimental group

Description:

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.

Treatment:

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

Waitlist Control

No Intervention group

Description:

Participants enrolled in this arm will receive usual medical care