Clinical trial NCT02643797: Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
Official title: Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: diabetes
medical assistant
health coach
glycemic control
pragmatic trial
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2015-12-31
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Glycosylated Hemoglobin (Hba1c); % units
timeFrame: 12 months
measure: Low-density lipoprotein-cholesterol (LDL-c); mg/dL units
timeFrame: 12 months
measure: Systolic blood pressure (SBP); mmHg units
timeFrame: 12 months
Secondary outcomes:
measure: Summary of Diabetes Self-Care Activities (SDSCA) - patient-reported outcome
timeFrame: 12 months
measure: Patient Activation Measure (PAM) - patient-reported outcome
timeFrame: 12 months
measure: Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome
timeFrame: 12 months
measure: Patient Assessment of Care for Chronic Conditions (PACIC) - patient-reported outcome
timeFrame: 12 months
measure: Morisky Medication Adherence Scale (MMAS) - patient-reported outcome
timeFrame: 12 months
Other outcomes:
measure: Cost-effectiveness using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model
timeFrame: 12 months
Locations:
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Linda Gallo, PhD
role: PRINCIPAL_INVESTIGATOR
References: