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Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)

NCT06251323 · Stanford University
In plain English

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About this study
A collaborative network of research teams from Stanford, Harvard, The Ohio State University, and Impactivo, LLC propose practice-relevant research focused on diabetes care in federally qualified health centers (FQHCs). Some 37.3 million Americans have type 2 diabetes. FQHCs are an important source of diabetes care for one in ten Americans and shoulder a higher prevalence of diabetes (21% FQHC, 11% U.S.), 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 demonstrated significant decreases (average 31% reduction) in poorly controlled diabetes (A1c\>9%) among patients at 7 clinics affiliated with an FQHC in Puerto Rico in 2017-20. Improvements in patients' diabetes control were sustained pre- to post- Covid-19 pandemic. Aim 1. Refine the iPATH implementation approach by identifying organizational conditions and processes at FQHCs that promoted or impeded the effectiveness of type 2 diabetes care. Research teams will simultaneously conduct 12 in-depth regional case studies, enabling contrast between FQHCs considered high-performing and low-performing for diabetes control. Teams will identify actionable, how-to implementation factors for ensuring chronic, preventive, and acute care for patients with diabetes. Employing an innovative Rapid Data Collection and Reporting methodology, teams 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. Aim 2. Implement a multi-level, multi-component, technology-enabled practice transformation strategy to improve type 2 diabetes for patients at 8 multi-clinic FQHCs. Teams will adapt, tailor, implement, test, and spread our practice transformation strategy across FQHCs located in California, Massachusetts, Ohio, and Puerto Rico. The iPATH implementation approach will be modularized and customizable to accommodate organizational readiness, patient needs, and social contexts, tailoring practice transformation efforts to each unique FQHC. Aim 3. Comprehensively evaluate the iPATH implementation approach with a hybrid type 2 study, including a stepped wedge cluster randomized trial. Including formative, process, and summative evaluation elements guided by the Exploration-Preparation-Implementation-Sustainment model, the study will evaluate impact of practice transformation and identify process elements affecting implementation effectiveness. Analyses will leverage the unique advantage of FQHC data.
Eligibility criteria
Inclusion Criteria: * Two largest clinic sites in multi-clinic FQHCs operating in or near Massachusetts, Ohio, California, Puerto Rico * We will prioritize FQHCs performing in the lower half of the distribution for A1c control, as these FQHCs have greater room for improvement. Exclusion Criteria: * FQHCs that have a patient population comprised of more than 80% children * FQHCs that have a patient population multiplied by the FQHC's diabetes prevalence in the lowest 10% of all the clinics * FQHCs that have fewer than 5,000 or more than 50,000 patients.
Study design
Enrollment target: 119680 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-09-30
Estimated completion: 2028-01-31
Last updated: 2026-05-01
Interventions
Other: iPATH implementation approach
Primary outcomes
  • Hemoglobin A1c (Before and after 1-year practice transformation period)
Sponsor
Stanford University · other
With: Ohio State University, Harvard School of Public Health (HSPH), Impactivo, LLC., National Institute on Minority Health and Health Disparities (NIMHD)
All locations (4)
Board of Trustees of the Leland Stanford Junior UniversityRecruiting
Stanford, California, United States
President and Fellows of Harvard College, T.H. Chan SchoolRecruiting
Boston, Massachusetts, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
Impactivo, LLC.Recruiting
San Juan, Puerto Rico, Puerto Rico
Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH) · TrialPath