Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Behavioral: Medical Assistant Health Coaching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group: MA Health Coaching<br>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<br>* One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.<br>* Other names: MAC;|
| No Intervention: Usual Care<br>Patients in this group will receive treatment as usual during their primary care visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, medical assistant, health coach, glycemic control, pragmatic trial