Integrated Community-Clinical Linkage Model to Promote Weight Loss Among

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03188094
Study type	Observational
Source	NYU Langone Health
Contact
Status	Active, not recruiting
Phase
Start date	December 17, 2018
Completion date	June 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms