Recruiting

iPATH

Sponsor:

Stanford University

Code:

NCT06251323

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

iPATH implementation approach

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT06251323

Start date

Sep 30, 2025

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Two largest clinic sites in multi-clinic FQHCs operating in or near Massachusetts, Ohio, California, Puerto Rico
  • 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 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.

Study Design

Enrollment

119680 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

iPATH implementation approach

A multi-level, multi-component, customized, standardized, technology enabled, person-centered, and team-based care practice transformation strategy.

Primary outcome measure

  • Hemoglobin A1c [ Time Frame: Before and after 1-year practice transformation period ]

Central Contacts and Locations

Locations

Board of Trustees of the Leland Stanford Junior University

Recruiting

Stanford, California, United States, 94305

Contacts

Sara Singer, PhD

650-498-5354ssinger@stanford.edu

President and Fellows of Harvard College, T.H. Chan School

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michaela Kerrissey, PhD

617-432-4520mkerrissey@hsph.harvard.edu

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Daniel Walker, PhD

614-293-2428daniel.walker@osumc.edu

More Information

Sponsor

Stanford University

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-01.