Addressing Social Determinants of Health in Young Adults with Type 1 Diabetes Through Comprehensive Assessment, Responsiveness, and Engagement (T1CARE) - ABSTRACT Adverse social determinants of health constitute major barriers to type 1 diabetes (T1D) management and drive disparities in diabetes outcomes. Young adults with T1D tend to have the worst glycemic control levels of all age groups, with Black and Hispanic young adults experiencing the highest complication rates and mortality. While social risk factor screening-and-referral services could improve health outcomes, convincing data on their effectiveness are largely lacking. Results from the Accountable Health Communities Model found this intervention ineffective with respect to addressing social needs. As opposed to classifying people by social risk factors and assisting them in accessing generic services, a personalized intervention, fully responsive to the complex, problematic situation of each person may be required, especially to address the unique needs of young patients with T1D. However, such an approach remains untested against care as usual. To fill this knowledge and care gap, we propose a pilot randomized trial to test the feasibility and preliminary efficacy of T1CARE: Comprehensive Assessment Responsiveness and Engagement. T1CARE includes in-depth assessment of social and clinical needs and a hybrid community health worker-patient navigator approach to address social and clinical needs of young patients with T1D. We have partnered with a community-based organization (Project Access-New Haven), which has an established record of removing barriers to clinical care and addressing social needs for underserved populations. Our specific aims are: Aim 1: Determine the feasibility of implementing screening for adverse social determinants of health (SDOH) for young patients with T1D and randomly linking patients who report ≥1 adverse SDOH to either T1CARE or usual care: (1.1): Characterize what is the usual care these patients receive during the experimentation period to determine what aspects of the intervention are present usually, including “dose” and intensity. (1.2): Evaluate the feasibility of recruitment and retention of trial participants, rates of SDOH screening and identification of adverse SDOH, acceptability of the intervention, completion of study procedures, and collection of clinical outcome data. (1.3): Assess the extent to which screening for SDOH and T1CARE can be integrated into clinical practice routines using Normalization Process Theory and its Toolkit. Aim 2: Estimate preliminary signals of the efficacy of T1CARE vs. usual care for the following outcomes at 6 months post intervention: (2.1) resolution of adverse SDOH; (2.2) patient-reported outcomes, including diabetes distress (measured using the Diabetes Distress Scale), illness intrusiveness (Illness Intrusiveness Scale), and global quality of life (evaluated using a 1-item analogue scale); and (2.3) clinical outcomes, specifically changes in HbA1c levels. This study will establish a robust partnership model with Project Access-New Haven, and estimate feasibility, normalization, and efficacy of an innovative approach, T1CARE, for testing in future larger hybrid effectiveness-implementation trials.
