Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

NCT ID: NCT02643797

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 602 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-07
• Study Completion Date: 2020-04-19

Brief Summary

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).

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Medical Assistant Health Coaching

Intervention Type: BEHAVIORAL

One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MAC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego State University

OTHER

Sponsor Role: collaborator

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Athena Philis-Tsimikas

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Whittier Diabetes Institute

Linda Gallo, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

Scripps Whittier Diabetes Institute

La Jolla, California, United States

Countries

United States

Other Identifiers

R18DK104250-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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