T1DTechCHW: Enhancing the Community Health Worker (CHW) Model to Promote Diabetes Technology Use in Young Adults from Underrepresented Minority Groups (YA-URMs) with Type 1 Diabetes (T1D)

项目摘要 本R 01响应PAS-20-160（针对以下使命内疾病的临床试验的小型R 01） NIDDK，支持“短期探索性临床试验”，以收集试点数据，“支持未来更大的全面- 影响重要健康结果的动力试验”）。本申请的目的是测试早期效果 加强社区卫生工作者（CHW）模式（T1 DTechCHW），鼓励 并支持糖尿病技术在来自代表性不足的少数群体（YA-URM）的年轻人中的使用， 1型糖尿病（T1 D）。YA-URM是美国T1 D患者中增长最多的人群， 在血糖、住院和死亡率结果方面显示出广泛的种族-种族不平等。新兴 我们小组和其他人的证据表明，在使用糖尿病技术方面存在种族-民族不平等， 例如胰岛素泵治疗和连续葡萄糖监测仪（CGM），这可能导致不良的 这是一个潜在的干预目标。我们的工作还突出了独特的病人，提供者， 系统层面的技术使用障碍超出了保险范围。CHW是一种基于证据的， 具有成本效益、可扩展的工作队伍，可以解决YA-URMs中糖尿病技术使用的多层次障碍 T1 D，但以前没有测试过这种能力。CHW在分享生活的能力方面是独一无二的 为来自服务不足社区的患者提供经验和倡导，作为社区和 卫生系统，而不是作为系统的一部分，其中YA-URMs具有低信任度。根据我们的前科 基于自我决定理论的研究，以及我们对T1 D患者YA-URM的广泛临床经验 在支持新兴成人糖尿病（SEAD）计划中，我们的中心假设是，CHW将 通过成为T1 D团队护理方法的一部分，利用其独特的 位置，以产生信任，并增加YA-URM的自主权，能力和社会支持，同时也填补 供应商的劳动力缺口。青年老年人社区卫生工作者将通过提供以下服务来解决常见的技术使用障碍： YA-URMs与T1 D技术教育，目标设定，同伴支持和社会需求管理，而 将保险审批工作从供应商转移，并更好地调整患者-供应商的优先事项。我们将进行 6-一项为期一个月的随机对照试验，其中YA-URM将随机分配至T1 DTechCHW或常规治疗组。我们 将从纽约布朗克斯一个大型安全网卫生系统的内分泌和初级保健实践中招募。 我们的具体目标是：1）评估T1 DTechCHW对技术启动和持续使用的影响超过6 2）使用普罗克特的实施分类法评估T1 DTechCHW的实施 结果：可行性，采用，保真度和成本。为了加强严谨性：我们利用预先存在的集成 CHW计划;让利益相关者参与进来，以提高可接受性和吸收率;并通过以下方式提高普遍性 从初级保健和内分泌实践中招募。这个小型R 01试验是测试 这是一个可持续的模式，旨在消除差距的根源，并将推动T1 D差距研究领域的发展。

PROJECT ABSTRACT This R01 responds to PAS-20-160 (Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK, supporting “short-term exploratory clinical trials” to gather pilot data to “support a future larger fully- powered trial affecting important health outcomes”). The objective of this application is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1DTechCHW) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). YA-URMs are the largest growing population with T1D in the United States, and demonstrate wide racial-ethnic inequity in glycemic, hospitalization, and mortality outcomes. Emerging evidence by our group and others has demonstrated racial-ethnic inequity in use of diabetes technologies, such as insulin pump therapy and continuous glucose monitors (CGM), which may be contributing to poor outcomes and represents a potential intervention target. Our work also highlights unique patient, provider, and system-level barriers to technology use that go beyond insurance coverage. CHWs are an evidence-based, cost-effective, scalable work force that can address multi-level barriers to diabetes technology use in YA-URMs with T1D, but have not previously been tested in this capacity. CHWs are unique in their ability to share lived experiences and advocate for patients from underserved communities, acting as links between community and health system instead of being a part of the system in which YA-URMs have low trust. Building off our prior research, grounded in self-determination theory, and our extensive clinical experience with YA-URMs with T1D in the Supporting Emerging Adults with Diabetes (SEAD) program, our central hypothesis is that CHWs will increase technology use by becoming part of the T1D team-based care approach, using their unique position to engender trust, and increase YA-URM autonomy, competence, and social support, while also filling provider workforce gaps. YA-aged CHWs will address commonly cited barriers to technology use by providing YA-URMs with T1D technology education, goal-setting, peer support, and social needs management, while shifting insurance approval work from providers and better aligning patient-provider priorities. We will conduct a 6-month randomized controlled trial in which YA-URMs will be randomized to T1DTechCHW or usual care. We will recruit from endocrinology and primary care practices in a large safety-net health system in the Bronx, NY. Our specific aims are to: 1) evaluate T1DTechCHW effects on technology initiation and continued use over 6 months and 2) evaluate T1DTechCHW implementation using Proctor’s Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost. To strengthen rigor: we leverage a preexisting integrated CHW program; engage stakeholders to increase acceptability and uptake; and boost generalizability by recruiting from primary care and endocrinology practices. This small R01 trial is the next step to test a sustainable model aimed at root causes of disparities and will advance the field of T1D disparities research.