My Interprofessional Care Team for Adherence and Research Engagement Disparities

Hypertension Clinical Trial

— MI-CARE  

Official title:

Pharmacist-CHW Team to Improve Medication Adherence and Reduce Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470439
• Other study ID #: R01HL151772
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Vrinda Prakash, MPH
• Phone: 413-739-1100
• Email: vprakash[@]caringhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

Intervention

Behavioral:
• My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)
MI-CARE is an innovative, tailored coordinated care intervention by pharmacist-community health worker (CHW) team derived from a previous research and a clinical pilot implementation. MI-CARE will identify and address individual, clinical, social-cultural and structural barriers to medication adherence and hypertension management. MI-CARE consists of an initial individualized needs assessment (Baseline). During Months 1-2, pharmacist-CHW team will deliver a tailored intervention including an individualized medication chart, preferred adherence aids, hypertension therapy optimization, tailored education based on medication beliefs, tools to combat social stressors, and referrals for structural barriers such as food insecurity, transportation and drug costs. Tailored family/care partner participation and telehealth visits will be provided when needed during this time. A booster visit to assess patient progress and reinforce intervention components will occur at Month 2.

Locations

Country	Name	City	State
United States	Caring Health Center, Inc.	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objectively measured medication adherence (pill count)	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.	Month 6
Primary	Self-reported medication adherence (survey)	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)	Month 6
Primary	Blood Pressure	Systolic and diastolic blood pressure measured by a calibrated, automated sphygmomanometer	Month 6
Secondary	HgbA1c	Hemoglobin A1c for participants with concurrent diabetes will be collected from electronic health record	Month 6
Secondary	Weight	Participant's weight will be collected from electronic health record	Month 6
Secondary	Body Mass Index (BMI)	BMI calculated using participant's height and weight will be collected from electronic health record	Month 6
Secondary	Lipid	Lipid panel including low-density lipoprotein (LDL) cholesterol level will be collected from electronic health record	Month 6
Secondary	Statin use	Use of statin medication for participants with dyslipidemia or clinical atherosclerotic cardiovascular disease (or risk >7.5%) will be collected from electronic health record	Month 6