跳至主要内容
临床试验/NCT03188094
NCT03188094已完成不适用

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

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 974 人开始时间: 2018年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
974
试验地点
1
主要终点
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Provider Assessment Surveys
  • Exclusion criteria include the following: participants who are unable to complete the survey in the English language.

结局指标

主要结局

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

时间窗: Baseline, Month 6

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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