Medical Assistant Health Coaching for Diabetes in Diverse Primary Care Settings
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/14/2018 |
Start Date: | March 7, 2016 |
End Date: | June 2020 |
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).
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).
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.
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.
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.
We found this trial at
1
site
La Jolla, California
Principal Investigator: Athena Philis-Tsimikas, MD
Phone: 858-678-7046
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