Clinical trial NCT05470439: My Interprofessional Care Team for Adherence and Research Engagement Disparities
Official title: Pharmacist-CHW Team to Improve Medication Adherence and Reduce Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
Hypertension
Keywords: Pharmacist, CHW, Hypertension, Adherence, FQHC
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Amherst
First posted: 2022-07-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 Month 1 and Month 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objectively measured medication adherence (pill count)
timeFrame: Month 6
measure: Self-reported medication adherence (survey)
timeFrame: Month 6
measure: Blood Pressure
timeFrame: Month 6
Secondary outcomes:
measure: HgbA1c
timeFrame: Month 6
measure: Weight
timeFrame: Month 6
measure: Body Mass Index (BMI)
timeFrame: Month 6
measure: Lipid
timeFrame: Month 6
measure: Statin use
timeFrame: Month 6
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Caring Health Center, Inc.
state: Massachusetts
Study officials:
affiliation: University of Arizona College of Pharmacy
name: Jeannie K Lee, PharmD
role: PRINCIPAL_INVESTIGATOR
References: