Trial Summary

More than 37 million people in the United States have type 2 diabetes, and federally qualified health centers (FQHCs) shoulder a high prevalence of diabetes (21% in FQHCs vs 11% overall), offering a promising venue for innovating in diabetes care. The iPATH project will refine and implement an approach to practice transformation originally conceived to support FQHCs’ pursuit of National Committee for Quality Assurance recognition as patient-centered medical homes. A pilot study demonstrated significant decreases (average 31% reduction) in poorly controlled diabetes among patients at 7 clinics affiliated with 1 FQHC in 2017 to 2020. Improvements in patients’ diabetes control were sustained. For aim 1 of the iPATH project, the study team will refine the iPATH implementation approach by identifying organizational conditions and processes at FQHCs that promoted or impeded the effectiveness of type 2 diabetes care. They will conduct 12 in-depth regional case studies to differentiate between high-performing and low-performing FQHCs for diabetes control. Employing an innovative Rapid Data Collection and Reporting methodology, the study team will rapidly collect, analyze, and share data to accelerate dissemination of customized feedback to FQHC leaders and to inform adaptation and implementation of the iPATH practice transformation. For aim 2, the study team will implement a multilevel, multicomponent, technology-enabled practice transformation strategy to improve type 2 diabetes for patients at 8 multi-clinic FQHCs in California, Massachusetts, Ohio, and Puerto Rico. The implementation approach will be modularized and customizable to accommodate organizational readiness, patient needs, and social and environmental factors affecting patients’ health (such as transportation, employment, and nutrition), tailoring practice transformation efforts to each unique FQHC. For aim 3, the study team will evaluate the implementation approach using a stepped-wedge, cluster randomized, hybrid type 2 effectiveness-implementation trial. Using formative, process, and summative evaluation elements guided by the Exploration-Preparation-Implementation-Sustainment model, the trial will evaluate the impact of practice transformation and identify process elements affecting implementation effectiveness.

NIH Project Information