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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 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. 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. 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.

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

Conditions
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Pre Diabetes, Weight Loss

Intervention / Treatment
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* Other: community health worker (CHW)-led health coaching for patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provider Assessment Surveys clinicians employed by independent primary care practice that are members of HealthFirst's network and have enrolled into the study. Key Informant Interviews must be a provider, clinic manger, Healthfisrt staff, or community health worker. Exclusion Criteria: Provider Assessment Surveys Exclusion criteria include the following: participants who are unable to complete the survey in the English language.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| South Asians with Prediabetes<br> | Other: community health worker (CHW)-led health coaching for patients<br>* Using a stepped-wedge design, investigators will implement the study in 25 NYC PCP sites enrolling 2,840 South Asian patients at- risk for T2DM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probability of eligible patients at a practice site to lose 5% or more of their body weight six months following the index office visit. |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average reduction in HbA1c |  | 12 Months | 
| % sustained >5% weight loss at 12 months |  | 12 Months | 
| improved lipids following the index office visit |  | 6 Months, 12 Months | 
| improved blood pressure following the index office visit |  | 6 Months, 12 Months |