- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417865
ECHO Diabetes FQHC
Extension for Community Health Outcomes (ECHO) Diabetes Federally Qualified Health Centers (FQHCs)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We will implement a national ECHO Diabetes FQHC program by offering a 6-month tele-education intervention that includes: (1) a virtual orientation and onboarding for FQHCs (2) one-hour tele-ECHO sessions twice monthly with continuing medical education (CME) credits provided (3) real-time support with complex medical decision-making and (4) access to an online repository of diabetes resources for PCPs. The 'hub' team delivering the ECHO Diabetes FQHC program are a nationally recognized multidisciplinary team of adult and pediatric endocrinologists, a clinical health psychologist, Certified Diabetes Care and Education Specialists (CDCES), a registered dietitian, a Certified Exercise Physiologist (CEP), a medical sociologist, PCPs, and health services researchers.
We will evaluate the ECHO Diabetes FQHC program with a stepped-wedge design. This proposal will leverage and expand on key community partnerships established through ECHO Diabetes with two Health Center Controlled Networks (HCCNs), HealthChoiceNetwork (HCN) and AllianceChicago (AC) to accomplish both specific aims. These two Health Center Controlled Networks (HCCNs) have over 100 FQHCs in 29 different states and hold a central data repository for over 7 million unduplicated patients seen for care across these locations. 18 new "spokes" will be recruited from HCN and AC's national network. Covariate-constrained randomization will be used to assign spokes to three cohorts that will have staggered and phased entry into the program in 6-month intervals. Pre- and post-intervention data will be collected at the provider-level and center-level (i.e., "spoke-level") and housed using REDCap® as a central data repository. Provider-level data will include pre and post surveys assessing confidence and knowledge in diabetes care as well as self-reported diabetes care practices. Spoke-level data will include aggregate Health Effectiveness Data and Information Set (HEDIS) metrics for diabetes, Uniform Data System (UDS) metrics for diabetes, mean HbA1c for demographic subgroups, diabetes technology use (CGM and insulin pumps), and referrals for GLP1 and SGL2 medications.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ashby F Walker, Ph.D.
- Phone Number: 352-273-8278
- Email: afwalker@ufl.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33172
- Recruiting
- Health Choice Network
-
Contact:
- Crystal Walker, RMA, CPC
- Phone Number: 305-392-8093
- Email: Crwalker@hcnetwork.org
-
-
Illinois
-
Chicago, Illinois, United States, 60654
- Recruiting
- Alliance Chicago
-
Contact:
- Dana Bright, MSW
- Phone Number: 312-274-0068
- Email: dbright@alliancechicago.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Federally Qualified Health centers (spokes) are eligible to participate that are part of Health Choice Network (HCN) or Alliance Chicago (AC). All people living with diabetes 18 and older are included in aggregate data sharing to evaluate outcomes.
-
Exclusion Criteria:
- Non FQHC, not part of HCN or AC
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cohort 1
6-8 Federally Qualified Health Centers that participate in the ECHO Diabetes tele-education program for PCPs
|
All cohorts will be given the ECHO Diabetes tele-education program -- one hour sessions twice monthly for 6 months for PCP in FQHCs
|
|
Cohort 2
6-8 Federally Qualified Health Centers that participate in the ECHO Diabetes tele-education program for PCPs
|
All cohorts will be given the ECHO Diabetes tele-education program -- one hour sessions twice monthly for 6 months for PCP in FQHCs
|
|
Cohort 3
6-8 FQHCs that participate in the ECHO Diabetes tele-education program for PCPs
|
All cohorts will be given the ECHO Diabetes tele-education program -- one hour sessions twice monthly for 6 months for PCP in FQHCs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HEDIS >9% HbA1c
Time Frame: From baseline to 12-months following
|
Proportion of FQHC population with >9% HbA1c
|
From baseline to 12-months following
|
|
Technology Use
Time Frame: From baseline to 12-months following
|
CGM and Pump Use
|
From baseline to 12-months following
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashby F Walker, Ph.D., University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202501386
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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