Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes

NYU Langone Health

Status: Completed

Conditions: Weight Loss; Pre Diabetes

Treatments: Other: EHR Alerts; Behavioral: CHW-Led Health Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03188094

17-00693

1R01DK110048 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The proposed study will inform efforts to prevent diabetes and promote weight loss in a high-risk population and generate a reproducible, scalable, and sustainable model for use with other insurer groups and clinical settings that work in immigrant populations with a high burden of chronic disease.

Full description

The study "Integrated Community-Clinical Linkage Model to Promote Weight Loss among South Asians with Pre-Diabetes" aims to test the effectiveness and assess the implementation process of an integrated intervention to support weight loss for South Asian patients at-risk for type-2 diabetes mellitus (T2DM) in primary care settings. The integrated intervention involves:

1. An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI >23 kg/m2 and registries to track outcomes: and
2. Registry-driven community health worker (CHW)-led health coaching for patients. Using a stepped-wedge design, we will implement the study in 25 New York City PCP sites enrolling 2,840 South Asian patients at- risk for T2DM.
3. Provider Surveys (n=40) to capture data on satisfaction with workflow before and after intervention, information sources for EHR-CHW initiatives before and after intervention, acceptability of and satisfaction with the integrated EHR-CHW intervention, and barriers and facilitators of point-of-care use of the tools.
4. Key Informant Interviews (n=35) with physician champions at each site and/or administrator of each site, Health first representatives, and CHWs. At baseline, the interviews will be incorporated into the workflow analysis to assess current satisfaction and usage of EHR and health coaching. At follow-up, the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated EHR-CHW intervention, fidelity to the interventions, and to solicit recommendations for the replication and scalability of the intervention to other sites and insurer organizations.

Enrollment: 974 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• self identify as South Asian;
• are at least 21 years of age and younger than age 75,
• had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months;
• have a BMI of >23; and
• have incident pre-diabetes as determined by HbA1c test (last A1c test date in the last 12 months).

Exclusion criteria

• Patients under the age of 21 and older than 75 will be excluded.
• Individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded.
• Pregnant women and all visits with an obstetrician gynecologist are excluded.
• No children or vulnerable subjects will be enrolled in this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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974 participants in 2 patient groups

Alert + CHW-Led Coaching

Experimental group

Description:

Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.

Treatment:

Behavioral: CHW-Led Health Coaching

Other: EHR Alerts

Usual Care - Wait-List Control

No Intervention group

Description:

All participants waitlisted during the first round will be randomized to the control group. Control group participants will be offered the full CHW group education sessions during the second round. The control participants will receive usual care during the first round.