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实施多层次社区-临床联动干预以改善控制不佳的南亚糖尿病患者的血糖控制:DREAM 计划研究方案。

Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes: study protocol of the DREAM initiative.

机构信息

Department of Population Health, NYU Grossman School of Medicine, 180 Madison Avenue, New York, NY, 10016, USA.

Departments of Obstetrics and Gynecology and Medicine-Geriatrics, The University of Chicago, 5841 Maryland Avenue MC 2050, Chicago, IL, 60637, USA.

出版信息

BMC Endocr Disord. 2021 Nov 23;21(1):233. doi: 10.1186/s12902-021-00885-5.

Abstract

BACKGROUND

A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes.

METHODS

The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%.

DISCUSSION

Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings.

TRIAL REGISTRATION

This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

摘要

背景

许多研究已经确定了南亚裔美国人在有效管理糖尿病方面存在患者、提供者和社区层面的障碍,他们是 2 型糖尿病的高发人群。然而,还没有利用健康信息技术 (HIT) 开发出多层面、综合社区卫生工作者 (CHW) 模式来减轻这一人群的疾病。本文介绍了一项多层面、社区-临床联系干预措施的方案,旨在改善控制不佳的南亚裔糖尿病患者的血糖控制。

方法

该研究包括三个部分:1)提高初级保健机构 (PCP) 使用电子健康记录 (EHR) 登记册识别未控制糖尿病患者的能力;2)提供文化和语言适应的 CHW 干预措施,以改善糖尿病自我管理;3)通过 HIT 实现与相关社区资源的联系。CHW 干预部分包括一项随机对照试验,包括关于糖尿病管理、体育活动和饮食/营养的小组教育课程。从纽约市的 20 个 PCP 招募 2 型糖尿病的南亚裔个体,并在每个 PCP 站点内按个体进行随机分组。共有 886 名个体将被随机分为治疗组或对照组;EHR 数据采集在筛查、6、12 和 18 个月时进行。我们假设接受多层面糖尿病管理干预的个体在 6 个月时达到血红蛋白 A1c(HbA1c)降低≥0.5%的可能性比对照组高 15%。次要结局包括体重、体重指数和 LDL 胆固醇的变化;更多地利用社区和社会服务;以及提高健康自我效能。此外,成本效益分析将侧重于实施和医疗保健利用成本,以确定每实现 HbA1c 变化≥0.5%的个人的增量成本。

讨论

最终结果将提供有关在小型 PCP 环境中实施多层面、综合 EHR-CHW 干预措施以促进服务不足的南亚裔人群糖尿病控制的有效性证据。该研究利用了多部门伙伴关系,包括当地卫生部门、医疗支付方和 EHR 供应商。研究结果将对将综合循证策略转化为其他少数族裔社区和资源匮乏的初级保健环境具有重要意义。

试验注册

该研究于 2017 年 11 月 6 日在 clinicaltrials.gov 注册:NCT03333044。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bca6/8609752/549e7f146bf3/12902_2021_885_Fig1_HTML.jpg

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