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.
|Effective start/end date||4/1/22 → 3/31/23|
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