Clinical trial NCT06251323: Implementing Scalable, PAtient-centered Team-based Care for Adults With Type 2 Diabetes and Health Disparities (iPATH)
Official title: Implementing Scalable, PAtient-centered Team-based Care for Adults With Type 2 Diabetes and Health Disparities (iPATH)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Harvard School of Public Health (HSPH)
name: Impactivo, LLC.
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-02-09
Enrollment: 119680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Sixteen institutions will be selected from a HRSA uniform data system and have data collected for up to 3 years. Eight institutions will begin the iPATH practice transformation during year one, the other eight institutions will begin iPATH in year two. FQHC administrators, clinicians and staff will be enrolled to participate in the iPATH transformation in their clinic and will participate in qualitative interviews. Patient HbA1c data from the clinics will be collected for comparative data analysis during each year of the study.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Before and after 1-year practice transformation period
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Board of Trustees of the Leland Stanford Junior University
state: California
city: Boston
country: United States
facility: President and Fellows of Harvard College, T.H. Chan School
state: Massachusetts
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: San Juan
country: Puerto Rico
facility: Impactivo, LLC.
Study officials:
References: