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 这款R01符合PAS-20-160(小型R01)，用于针对特派团内疾病的临床试验 NIDDK，支持“短期探索性临床试验”，以收集试点数据，以“全面支持更大的未来” 影响重要健康结果的动力试验“)。此应用程序的目标是测试早期效果 和实施增强的社区卫生工作者(CHW)模式(T1DTechCHW)，以鼓励 并支持来自代表不足的少数族裔群体(YA-URM)的年轻人使用糖尿病技术 1型糖尿病(T1D)。YA-URM是美国T1D患者中增长最多的人群，而且 在血糖、住院和死亡结果方面表现出广泛的种族不平等。新兴 我们小组和其他人的证据表明，糖尿病技术的使用存在种族不平等， 例如胰岛素泵疗法和连续血糖监测仪(CGM)，这可能会导致不良 结果，并代表一个潜在的干预目标。我们的工作还突出了独特的患者、提供者和 系统层面的技术使用障碍超出了保险覆盖范围。社区卫生服务是以证据为基础的， 经济高效、可扩展的劳动力，可以解决在YA-URM中使用糖尿病技术的多个层面的障碍 使用T1D，但之前未在此能力下进行过测试。社区卫生工作者在分享生活的能力上是独一无二的 为来自服务不足社区的患者提供经验和倡导，充当社区和社区之间的桥梁 卫生系统，而不是YA-URM信任程度较低的系统的一部分。建立在我们之前的基础上 基于自我决定理论的研究，以及我们对患有T1D的YA-URM的丰富临床经验 在支持新兴成人糖尿病(SEAD)计划中，我们的中心假设是CHWS将 通过成为T1D基于团队的护理方法的一部分，使用其独特的 建立信任，增加YA-URM的自主性、能力和社会支持，同时也填补 提供商的劳动力缺口。YA年龄较大的CHW将通过提供 具有T1D技术教育、目标设定、同伴支持和社会需求管理的YA-URM，同时 将保险审批工作从提供者转移到更好地协调患者和提供者的优先事项。我们将进行一项 为期6个月的随机对照试验，YA-URM将随机接受T1DTechCHW或常规护理。我们 将从纽约州布朗克斯区一个大型安全网卫生系统的内分泌学和初级保健诊所招聘。 我们的具体目标是：1)评估T1DTechCHW对技术启动和持续使用的影响 月和2)使用Proctor的实施分类评估T1DTechCHW的实施情况 结果：可行性、采用率、保真度和成本。为了加强严密性：我们利用已有的集成 CHW计划；吸引利益相关者以提高接受度和接受度；并通过以下方式提高普适性 从初级保健和内分泌诊所招募人才。这个小型R01试验是下一步测试 旨在解决差异根源的可持续模式，将推动T1D差异研究领域的发展。

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.