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
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2025 |
| Est. completion date |
June 30, 2028 |
Study information
| Verified date |
June 2024 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
