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Active, Not Recruiting

NCT Number: NCT05470439

My Interprofessional Care Team for Adherence and Research Engagement Disparities

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Medication Adherence Behavior Cardiovascular Diseases Health Behavior Hypertension Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caring Health Center, Inc.

Springfield, Massachusetts, 01103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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)

  3. Blood Pressure

    Time frame: Month 6

    Systolic and diastolic blood pressure measured by a calibrated, automated sphygmomanometer

Secondary outcomes

  1. HgbA1c

    Time frame: Month 6

    Hemoglobin A1c for participants with concurrent diabetes will be collected from electronic health record

  2. Weight

    Time frame: Month 6

    Participant's weight will be collected from electronic health record

  3. Body Mass Index (BMI)

    Time frame: Month 6

    BMI calculated using participant's height and weight will be collected from electronic health record

  4. Lipid

    Time frame: Month 6

    Lipid panel including low-density lipoprotein (LDL) cholesterol level will be collected from electronic health record

  5. Statin use

    Time frame: Month 6

    Use of statin medication for participants with dyslipidemia or clinical atherosclerotic cardiovascular disease (or risk >7.5%) will be collected from electronic health record

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • University of Massachusetts, Amherst

Registry information

Official study title

Pharmacist-CHW Team to Improve Medication Adherence and Reduce Hypertension

Acronym: MI-CARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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