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

Scripps Whittier Diabetes Institute

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Behavioral: Medical Assistant Health Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT02643797

R18DK104250-01A1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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602 participants in 2 patient groups

Intervention Group: MA Health Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Medical Assistant Health Coaching

Usual Care

No Intervention group

Description:

Patients in this group will receive "treatment as usual" during their primary care visits.