Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)
NCT ID: NCT06251323
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
119680 participants
INTERVENTIONAL
2025-09-30
2028-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Wave 1 Clinics
Clinics will have data evaluated for up to 3 years. Wave 1 clinics will begin the iPATH practice transformation in Year 1.
iPATH implementation approach
A multi-level, multi-component, customized, standardized, technology enabled, person-centered, and team-based care practice transformation strategy.
Wave 2 Clinics
Clinics will have data evaluated for up to 3 years. Wave 2 clinics will begin the iPATH practice transformation in Year 2.
iPATH implementation approach
A multi-level, multi-component, customized, standardized, technology enabled, person-centered, and team-based care practice transformation strategy.
Interventions
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iPATH implementation approach
A multi-level, multi-component, customized, standardized, technology enabled, person-centered, and team-based care practice transformation strategy.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Ohio State University
OTHER
Harvard School of Public Health (HSPH)
OTHER
Impactivo, LLC.
UNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Stanford University
OTHER
Responsible Party
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Sara Singer
Professor of Health Policy, of Medicine (Primary Care & Population Health), by courtesy, of Organizational Behavior at the Graduate School Of Business and Senior Fellow, by courtesy, at The Freeman Spogli Institute For International Studies
Locations
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Board of Trustees of the Leland Stanford Junior University
Stanford, California, United States
President and Fellows of Harvard College, T.H. Chan School
Boston, Massachusetts, United States
The Ohio State University
Columbus, Ohio, United States
Impactivo, LLC.
San Juan, Puerto Rico, Puerto Rico
Countries
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Facility Contacts
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Other Identifiers
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72410
Identifier Type: -
Identifier Source: org_study_id