Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)

NCT06251323 | Recruiting

• 2 other identifiers: 724101R01MD017870-01A1
• Study Type: interventional
• Target: 119,680
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Percent poorly controlled diabetes (A1c\>9%)

  Before and after 1-year practice transformation period

Study Arms (2)

Wave 1 Clinics

EXPERIMENTAL

Clinics will have data evaluated for up to 3 years. Wave 1 clinics will begin the iPATH practice transformation in Year 1.

Other: iPATH implementation approach

Wave 2 Clinics

EXPERIMENTAL

Clinics will have data evaluated for up to 3 years. Wave 2 clinics will begin the iPATH practice transformation in Year 2.

Other: iPATH implementation approach

Interventions

iPATH implementation approach OTHER

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

Wave 1 Clinics; Wave 2 Clinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Impactivo, LLC.: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Stanford University: lead

Study Sites (4)

Board of Trustees of the Leland Stanford Junior University

Stanford, California, 94305, United States

RECRUITING

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

Boston, Massachusetts, 02115, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Impactivo, LLC.

San Juan, Puerto Rico, 00907, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Policy, of Medicine (Primary Care & Population Health), by courtesy, of Organizational Behavior at the Graduate School Of Business and Senior Fellow, by courtesy, at The Freeman Spogli Institute For International Studies

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

PR (1); US (3)