Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Improving Diabetes Equity and Advancing Care Study
The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.
Sinai Health System is Illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large Medicaid-eligible populations in Chicago. In response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. This study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the Center to define the ideal sequence for improving patient outcomes. Grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim 2); comparing the effectiveness and determine optimization of intervention components (Aim 3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze Aims 2 & 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. We will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities. ;
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