Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

— MAC  

Official title:

Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643797
• Other study ID #: R18DK104250-01A1
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2016
• Est. completion date: April 19, 2020

Study information

• Verified date: September 2021
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: April 19, 2020
• Est. primary completion date: April 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Scripps Whittier Diabetes Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute	San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model		12 months
Primary	Glycosylated Hemoglobin (Hba1c); % units		12 months
Primary	Low-density lipoprotein-cholesterol (LDL-c); mg/dL units		12 months
Primary	Systolic blood pressure (SBP); mmHg units		12 months
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome		12 months
Secondary	Patient Activation Measure (PAM) - patient-reported outcome		12 months
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome		12 months
Secondary	Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome		12 months
Secondary	Morisky Medication Adherence Scale (MMAS) - patient-reported outcome		12 months