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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title: Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

• NCT number: NCT02643797
• Study type: Interventional
• Source: Scripps Whittier Diabetes Institute
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2016
• Completion date: April 19, 2020