ONWARD: Optimizing Navigation for Wellness And Resource utilization in youth with prediabetes and type 2 Diabetes

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Linked publications, trials & patents

Abstract

Youth-onset type 2 diabetes (T2D) is an increasingly common, severe chronic disease. Health-related social needs (HRSN) including food insecurity, housing instability, and transportation barriers impact diabetes-related outcomes yet often go unaddressed despite recommendations by federal organizations to address HRSN in healthcare settings and the success of such interventions in general pediatric settings. Importantly, no healthcare-based interventions that effectively address HRSN in adolescents and young adults (AYA) with T2D exist, leaving AYA with T2D at high risk for severe complications. The objective of this proposal is to pilot-test ONWARD (Optimizing Navigation for Wellness And Resource utilization in type 2 Diabetes), an intervention to address HRSN for AYA with T2D. We will conduct a randomized pilot 2x2 factorial trial including 52 AYA and their caregivers to evaluate acceptability, feasibility, fidelity, and early HRSN and T2D outcomes for 2 different approaches to resource provision and resource connection. Resource provision will compare tailored in-clinic resource-offering based on disclosed HRSN, such as food bank information and food boxes for food insecurity, versus universal empowerment and resources, in which a brief clinician-delivered script and resources are shared with all families, regardless of disclosed needs. Resource connection will compare use of post-clinic text messages with an option to learn more about resources through links and warm referrals (once monthly for 3 months), versus assignment of a community health worker to serve as a personal resource navigator (15 hours over 3 months). Our use of a factorial trial will allow us to identify approaches that balance feasibility, acceptability, and fidelity (Aim 1) with preliminary impact on HRSN and T2D outcomes at 3- and 6-months (Aim 2), efficiently optimizing the intervention prior to evaluation in a fully powered trial (informed by implementation factors aligned with the PRISM framework elucidated through interviews in Aim 3). Our team has expertise in pediatric endocrinology, community-partnered research, human-centered design, qualitative research, addressing HRSN, factorial trials, and implementation science. AYA with T2D, their caregivers, and community collaborators are key partners in this work. Results will inform the design of a fully powered hybrid type 2 trial to test the effectiveness of ONWARD in improving metabolic outcomes and determining implementation strategies that best ensure intervention implementation and sustainability. This intervention has the potential to be transformative in addressing HRSN within healthcare systems, particularly in subspecialty pediatric settings. ONWARD’s use of a pilot optimization trial will guide further intervention development, with the ultimate goal of addressing HRSN in AYA with T2D to improve diabetes-related outcomes.