Implementing Scalable, PAtient-centered Team-based Care for Adults With Type 2 Diabetes and Health Disparities (iPATH)

Diabetes Mellitus, Type 2 Clinical Trial

— iPATH  

Official title:

Implementing Scalable, PAtient-centered Team-based Care for Adults With Type 2 Diabetes and Health Disparities (iPATH)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06251323
• Other study ID #: 72410
• Secondary ID: 1R01MD017870-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2025
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 and significant racial and socioeconomic disparities persist in care quality and patient safety. FQHCs serve 1 in 7 U.S. racial/ethnic minorities and shoulder a higher prevalence of diabetes (21% FQHC, 11% U.S.), offering a promising venue for innovating in equity-focused 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 for NIH-designated U.S. health disparity populations pre- and post-pandemic. 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 an equity-focused 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 FQHC data by race and ethnicity to examine health disparities.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Two largest clinic sites in multi-clinic FQHCs operating in or near Massachusetts, Ohio, California, Puerto Rico
• Clinics performing in the 3rd quartile for percentage of patients with poorly controlled diabetes (A1c>9%).

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• iPATH implementation approach
A multi-level, multi-component, technology-enabled practice transformation strategy.

Locations

Country	Name	City	State
Puerto Rico	Impactivo, LLC.	San Juan
United States	President and Fellows of Harvard College, T.H. Chan School	Boston	Massachusetts
United States	The Ohio State University	Columbus	Ohio
United States	Board of Trustees of the Leland Stanford Junior University	Stanford	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Harvard School of Public Health (HSPH), Impactivo, LLC., National Institute on Minority Health and Health Disparities (NIMHD), Ohio State University

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Percent poorly controlled diabetes (A1c>9%)	Before and after 1-year practice transformation period