Clinical trial NCT06552923: Extension for Community Health Outcomes (ECHO) Diabetes Program
Official title: Extension for Community Health Outcomes (ECHO) Diabetes Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 32796
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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%.

Detailed description: The recruitment of spokes for the ECHO Diabetes program was accomplished by focusing on FQHC (and FQHC look-alikes) through use of the Neighborhood Deprivation Index coupled with provider geocoding. This novel approach ensured recruitment of spokes that deliver care for communities in medically underserved areas. Over 30 million people in the U.S. receive primary care in FQHCs. Federal funding requirements for FQHCs mandate that no one is turned away for care based on insurance status, that need-based sliding scales are used for payment, and that the healthcare providers must be representative of the communities they serve (i.e., language needs, race, and ethnicity).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Not meeting all inclusion criteria

Primary outcomes:
measure: HbA1c
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: CommuniCare Davis Family Health Center
state: California
city: Fresno
country: United States
facility: St Agnes Medical Center
state: California
city: Multiple Locations
country: United States
facility: La Clinica
state: California
city: Multiple Locations
country: United States
facility: Santa Rosa Community Health Centers
state: California
city: Multiple Locations
country: United States
facility: Shasta Community Health Centers
state: California
city: Rancho Cucamonga
country: United States
facility: Health Service Alliance
state: California
city: Redding
country: United States
facility: Hill Country Community Clinic
state: California
city: West Sacramento
country: United States
facility: CommuniCare Salud Family Health
state: California
city: Woodland
country: United States
facility: CommuniCare Hansen Family Center
state: California
city: Dade City
country: United States
facility: Premier Community Health
state: Florida
city: Homestead
country: United States
facility: Community Health of South Florida (CHI)
state: Florida
city: Miami
country: United States
facility: Banyan Health Systems
state: Florida
city: Miami
country: United States
facility: Borinquen Medical Center
state: Florida
city: Orlando
country: United States
facility: Orange Blossom Family Health
state: Florida
city: Pinellas Park
country: United States
facility: Evara Health System
state: Florida
city: Tampa
country: United States
facility: Tampa Family Health Center
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Community Health
state: Florida
Study officials:
affiliation: Stanford University
name: David Maahs, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Michael Haller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Ashby F Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: