My Interprofessional Care Team for Adherence and Research Engagement Disparities
MI-CARE
Pharmacist-CHW Team to Improve Medication Adherence and Reduce Hypertension
1 other identifier
interventional
217
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
August 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 13, 2026
June 1, 2025
2.6 years
July 14, 2022
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Blood Pressure
Systolic and diastolic blood pressure measured by a calibrated, automated sphygmomanometer
Month 6
Secondary Outcomes (5)
HgbA1c
Month 6
Weight
Month 6
Body Mass Index (BMI)
Month 6
Lipid
Month 6
Statin use
Month 6
Study Arms (2)
MI-CARE Intervention
EXPERIMENTALPharmacist-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.
Waitlist Control
NO INTERVENTIONParticipants enrolled in this arm will receive usual medical care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- University of Massachusetts, Amherstcollaborator
Study Sites (1)
Caring Health Center, Inc.
Springfield, Massachusetts, 01103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeannie K Lee, PharmD
University of Arizona College of Pharmacy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
July 22, 2022
Study Start
August 30, 2023
Primary Completion
March 31, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 13, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share