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

Sponsor

Scripps Whittier Diabetes Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02643797

Collaborator

San Diego State University (Other)

602

Enrollment

Location

Arms

49.4

Actual Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus (T2DM)	Behavioral: Medical Assistant Health Coaching	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

602 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

Actual Study Start Date :

Mar 7, 2016

Actual Primary Completion Date :

Apr 19, 2020

Actual Study Completion Date :

Apr 19, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be a patient at selected Scripps or Neighborhood Healthcare clinic,
Must be age 18 years or older,
Must have a T2DM diagnosis,
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Whittier Diabetes Institute	La Jolla	California	United States	92121

Sponsors and Collaborators

Scripps Whittier Diabetes Institute
San Diego State University

Investigators

Principal Investigator: Athena Philis-Tsimikas, MD, Scripps Whittier Diabetes Institute
Principal Investigator: Linda Gallo, PhD, San Diego State University