Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2025-12-17 @ 9:49 AM
Study NCT ID:
NCT06251323
Status:
None
Last Update Posted:
2025-09-03 00:00:00
First Post:
2024-02-01 00:00:00
Brief Title:
Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)
Status:
None
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iPATH
Brief 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. 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.
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.
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 373 million Americans have type 2 diabetes and significant racial and socioeconomic disparities persist in care quality and patient safety FQHCs serve 1 in 7 US racialethnic minorities and shoulder a higher prevalence of diabetes 21 FQHC 11 US 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 A1c9 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 US 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
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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MD017870-01A1 | NIH | None | httpsreporternihgovquickSearch1R01MD017870-01A1 |