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Clinical Trials/NCT03188094
NCT03188094
Completed
N/A

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

NYU Langone Health1 site in 1 country974 target enrollmentDecember 17, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pre Diabetes
Sponsor
NYU Langone Health
Enrollment
974
Locations
1
Primary Endpoint
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2018
End Date
June 30, 2024
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6

Time Frame: Baseline, Month 6

Weight measured at baseline and 6 month survey via study scale.

Study Sites (1)

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