NCT06552923

Brief Summary

The Project ECHO model is currently used in 180 countries to address chronic disease care through a provider empowerment, tele-education approach using a "hub" and "spoke" learning model. Few studies have rigorously evaluated the impact of the program on patient outcomes using randomized designs. This study evaluated implementation of an ECHO Diabetes program on patient-level, provider-level, and center-level outcomes in underserved populations receiving diabetes care from primary care providers. Participants: Twenty Federally Qualified Health Centers (FQHCs) and FQHC "look alikes" across CA and FL were recruited to participate as spokes in the ECHO Diabetes trial. A stepped-wedge trial design was used with randomized, phased-in intervention entry for participating health centers (or "spokes"). Interventions: Spokes were provided access to 6-months of tele-education sessions with continuing medical education credits, access to real-time support for complex medical decision making with hub subspecialty teams, and access to a diabetes support coach. Main outcomes and Measures: Participating FQHCs ("spokes") provided aggregate data including Healthcare Effectiveness Data and Information Set (HEDIS) reporting on the % of patients with HbA1c \>9%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32,796

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 8, 2024

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    The percent of patients with HbA1c greater than 9 percent

    6-months

Study Arms (2)

ECHO Intervention Immediate

EXPERIMENTAL

9 FQHC were randomized to start the ECHO program June 2021. The providers at participating FQHCs joined tele-education one hour sessions and received CME for learning about diabetes care-related topics. They attended sessions twice monthly for 6-months

Other: ECHO Tele-Education

ECHO Intervention Delayed

EXPERIMENTAL

11 FQHC were randomized to start the ECHO program in December 2021. The providers at participating FQHCs joined tele-education one hour sessions and received CME for learning about diabetes care-related topics. They attended sessions twice monthly for 6-months

Other: ECHO Tele-Education

Interventions

A common curriculum was developed that covered best practices in multidisciplinary diabetes care for the primary care setting that was guided by the ADA Clinical Care. guidelines. FQHCs attended one-hour tele-ECHO sessions twice a month for 6-months.

ECHO Intervention DelayedECHO Intervention Immediate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Seen for routine care at participating FQHC
  • Diagnosis of Type 1 Diabetes or Type 2 Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CommuniCare Davis Family Health Center

Davis, California, 95616, United States

Location

St Agnes Medical Center

Fresno, California, 93720, United States

Location

La Clinica

Multiple Locations, California, 94601, United States

Location

Santa Rosa Community Health Centers

Multiple Locations, California, 95403, United States

Location

Shasta Community Health Centers

Multiple Locations, California, 96001, United States

Location

Health Service Alliance

Rancho Cucamonga, California, 91730, United States

Location

Hill Country Community Clinic

Redding, California, 96001, United States

Location

CommuniCare Salud Family Health

West Sacramento, California, 95605, United States

Location

CommuniCare Hansen Family Center

Woodland, California, 95695, United States

Location

Premier Community Health

Dade City, Florida, 33525, United States

Location

Community Health of South Florida (CHI)

Homestead, Florida, 33190, United States

Location

Banyan Health Systems

Miami, Florida, 33134, United States

Location

Borinquen Medical Center

Miami, Florida, 33137, United States

Location

Orange Blossom Family Health

Orlando, Florida, 32805, United States

Location

Evara Health System

Pinellas Park, Florida, 33718, United States

Location

Tampa Family Health Center

Tampa, Florida, 33610, United States

Location

Treasure Coast Community Health

Vero Beach, Florida, 32960, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • David Maahs, PhD, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Michael Haller, MD

    University of Florida

    PRINCIPAL INVESTIGATOR
  • Ashby F Walker, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not used
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Federally Qualified Health Centers were randomized to start in 6-month phased entry and large, aggregate data for participating health centers was collected pre and post ECHO program
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 14, 2024

Study Start

June 1, 2021

Primary Completion

June 30, 2022

Study Completion

December 31, 2023

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations