Extension for Community Health Outcomes (ECHO) Diabetes Program
NCT ID: NCT06552923
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32796 participants
INTERVENTIONAL
2021-06-01
2023-12-31
Brief Summary
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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%.
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Detailed Description
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Any healthcare provider from the participating spoke sites were eligible for the ECHO Diabetes intervention. Healthcare providers at participating spokes were offered the opportunity to attend real-time, interactive, one-hour, bimonthly, tele-education sessions with continuing medical education credits provided. The curriculum was designed using the current standards of diabetes care and delivered by a team of multidisciplinary experts including adult endocrinologists, pediatric endocrinologists, clinical health psychologists, exercise physiologists, pharmacists, diabetes education and care specialists (CDCES), registered dietitians, and medical sociologists. Each tele-ECHO Diabetes session was recorded and available on-demand for healthcare providers at participating spoke sites, along with access to an online repository of diabetes resources and guidelines. Providers were also able to reach out to the hub team for real-time support with complex medical decision making, as needed. Finally, spokes also had access to Diabetes Support Coaches for their patients. A full description of the use of Diabetes Support Coaches in the ECHO Diabetes program has been published elsewhere and involved using a combination of a community health worker (CHW) and peer mentors to address social determinants of health (SDOH), and to create more community capacity within the spokes for people with diabetes.
ECHO Diabetes utilized a variation of a stepped-wedge study design, allowing for two phases of program kick-off and patient recruitment at spokes. Spoke sites provided basic metrics of their patient panels, including the number of clinic locations participating in the program, and adults with T1D and T2D. Covariate-constrained randomization was used to assign spokes to begin the ECHO Diabetes intervention in May or December of 2021. The randomization design specifications allowed for clinic arm totals to differ by no more than one, and the mean number of patients with diabetes to not differ by greater than 20% between arms. Final randomized intervention assignment was distributed to enrolled spokes in Spring of 2021. Spoke-level data capture incorporated the transfer of aggregate-level data by participating centers for calendar years 2020, 2021, 2022 including Health Effectiveness Data and Information Set (HEDIS) and Uniform Data System (UDS) diabetes-related measures.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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ECHO Intervention Immediate
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
ECHO Tele-Education
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 Delayed
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
ECHO Tele-Education
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.
Interventions
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ECHO Tele-Education
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.
Eligibility Criteria
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Inclusion Criteria
* Seen for routine care at participating FQHC
* Diagnosis of Type 1 Diabetes or Type 2 Diabetes
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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David Maahs, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Michael Haller, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Ashby F Walker, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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CommuniCare Davis Family Health Center
Davis, California, United States
St Agnes Medical Center
Fresno, California, United States
La Clinica
Multiple Locations, California, United States
Santa Rosa Community Health Centers
Multiple Locations, California, United States
Shasta Community Health Centers
Multiple Locations, California, United States
Health Service Alliance
Rancho Cucamonga, California, United States
Hill Country Community Clinic
Redding, California, United States
CommuniCare Salud Family Health
West Sacramento, California, United States
CommuniCare Hansen Family Center
Woodland, California, United States
Premier Community Health
Dade City, Florida, United States
Community Health of South Florida (CHI)
Homestead, Florida, United States
Banyan Health Systems
Miami, Florida, United States
Borinquen Medical Center
Miami, Florida, United States
Orange Blossom Family Health
Orlando, Florida, United States
Evara Health System
Pinellas Park, Florida, United States
Tampa Family Health Center
Tampa, Florida, United States
Treasure Coast Community Health
Vero Beach, Florida, United States
Countries
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Other Identifiers
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IRB201903243
Identifier Type: -
Identifier Source: org_study_id
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