Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings (MAC)

This study is a cluster (clinic level) randomized pragmatic trial to compare the effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals with poorly controlled type 2 diabetes mellitus (T2DM).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Medical Assistant Health Coaching

Detailed Description

The study will be conducted in the primary care environments of two distinct, yet representative healthcare systems in San Diego County: Neighborhood Healthcare (a San Diego County FQHC system and designated Patient-Centered Medical Home, serving predominantly ethnic minority, low income patients) and Scripps (a large, non-profit, private insurance-based health system, serving predominantly Caucasian, middle-to-higher income patients). Six hundred patients at intervention (n=2; patient N=300) and control (n=2; patient N=300) clinics, aged 18 and older, with T2DM, and glycosylated hemoglobin (HbA1c) ≥ 8.0%, and/or low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL, and/or systolic blood pressure (SBP) ≥ 140 within the last 60 days, will be identified and enrolled using electronic health records (EHRs). Primary clinical outcomes of HbA1c, LDL-C, and SBP assessed as part of quarterly (or annual, for LDL-C), standard-of-care medical visits will be extracted from EHRs over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (quality of life, patient activation) outcomes will be evaluated via telephone assessment in a subset of intervention and control (N=300 total) participants at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient, MA, and primary care provider perspectives. Cost-effectiveness will also be examined from the health system perspective. Principles of community engaged research were incorporated in intervention and study planning and will be sustained throughout the research period.

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92121
      • Scripps Whittier Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must be a patient at selected Scripps or Neighborhood Healthcare clinic,
2. Must be age 18 years or older,
3. Must have a T2DM diagnosis,
4. Must show evidence of poor clinical control, defined as HbA1c ≥ 8% and/or LDL-C ≥ 100 mg/dL, and/or SBP ≥ 140 mmHg.

Exclusion Criteria:

None as this is a pragmatic trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group: MA Health Coaching; Patients in the intervention group will receive the "MA Health Coaching" intervention during their primary care visits, as well a follow-up calls to encourage/monitor progress and offer support.	Behavioral: Medical Assistant Health Coaching; One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.; Other Names: MAC
No Intervention: Usual Care; Patients in this group will receive "treatment as usual" during their primary care visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycosylated Hemoglobin (Hba1c); % units	12 months
Low-density lipoprotein-cholesterol (LDL-c); mg/dL units	12 months
Systolic blood pressure (SBP); mmHg units	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome	12 months
Patient Activation Measure (PAM) - patient-reported outcome	12 months
Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome	12 months
Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome	12 months
Morisky Medication Adherence Scale (MMAS) - patient-reported outcome	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model	12 months

Collaborators and Investigators

• Sponsor: Scripps Whittier Diabetes Institute
• Collaborators: San Diego State University
• Investigators: Principal Investigator: Linda Gallo, PhD, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2016
• Primary Completion (Actual): April 19, 2020
• Study Completion (Actual): April 19, 2020

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: diabetes; pragmatic trial; glycemic control; health coach; medical assistant
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: R18DK104250-01A1 (U.S. NIH Grant/Contract)