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

Primary Purpose

Medication Adherence, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Adherence focused on measuring Pharmacist, CHW, Hypertension, Adherence, FQHC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age ≥ 18 years;
  2. self-report cultural identity as African-American, Latino,or Vietnamese;
  3. speak English, Spanish, or Vietnamese;
  4. have medication-treated hypertension;
  5. use ≥5 chronic medications;
  6. have hypertension medication adherence <80%; 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.

Sites / Locations

  • Caring Health Center, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MI-CARE Intervention

Waitlist Control

Arm 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.

Participants enrolled in this arm will receive usual medical care

Outcomes

Primary Outcome Measures

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.
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)
Blood Pressure
Systolic and diastolic blood pressure measured by a calibrated, automated sphygmomanometer

Secondary Outcome Measures

HgbA1c
Hemoglobin A1c for participants with concurrent diabetes will be collected from electronic health record
Weight
Participant's weight will be collected from electronic health record
Body Mass Index (BMI)
BMI calculated using participant's height and weight will be collected from electronic health record
Lipid
Lipid panel including low-density lipoprotein (LDL) cholesterol level will be collected from electronic health record
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

Full Information

First Posted
July 14, 2022
Last Updated
September 6, 2023
Sponsor
University of Arizona
Collaborators
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT05470439
Brief Title
My Interprofessional Care Team for Adherence and Research Engagement Disparities
Acronym
MI-CARE
Official Title
Pharmacist-CHW Team to Improve Medication Adherence and Reduce Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 450 African-American, Latino, and Vietnamese patients with hypertension and low (<80%) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Hypertension
Keywords
Pharmacist, CHW, Hypertension, Adherence, FQHC

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MI-CARE Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Participants enrolled in this arm will receive usual medical care
Intervention Type
Behavioral
Intervention Name(s)
My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)
Intervention 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 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 Outcome Measure Information:
Title
Objectively measured medication adherence (pill count)
Description
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.
Time Frame
Month 6
Title
Self-reported medication adherence (survey)
Description
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)
Time Frame
Month 6
Title
Blood Pressure
Description
Systolic and diastolic blood pressure measured by a calibrated, automated sphygmomanometer
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
HgbA1c
Description
Hemoglobin A1c for participants with concurrent diabetes will be collected from electronic health record
Time Frame
Month 6
Title
Weight
Description
Participant's weight will be collected from electronic health record
Time Frame
Month 6
Title
Body Mass Index (BMI)
Description
BMI calculated using participant's height and weight will be collected from electronic health record
Time Frame
Month 6
Title
Lipid
Description
Lipid panel including low-density lipoprotein (LDL) cholesterol level will be collected from electronic health record
Time Frame
Month 6
Title
Statin use
Description
Use of statin medication for participants with dyslipidemia or clinical atherosclerotic cardiovascular disease (or risk >7.5%) will be collected from electronic health record
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18 years; self-report cultural identity as African-American, Latino,or Vietnamese; speak English, Spanish, or Vietnamese; have medication-treated hypertension; use ≥5 chronic medications; have hypertension medication adherence <80%; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vrinda Prakash, MPH
Phone
413-739-1100
Ext
1239
Email
vprakash@caringhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Susan J Shaw, PhD
Phone
413-545-7436
Email
sjshaw@umass.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie K Lee, PharmD
Organizational Affiliation
University of Arizona College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caring Health Center, Inc.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vrinda Prakash
Phone
413-739-1100
Ext
1239
Email
vprakash@caringhealth.org
First Name & Middle Initial & Last Name & Degree
Cristina Huebner Torres, PhD MA

12. IPD Sharing Statement

Plan to Share IPD
No

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