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Type 1 DiabetesECHONCT06552923

Extension for Community Health Outcomes (ECHO) Diabetes Program

A study testing ECHO Tele-Education in people with Type 1 Diabetes and Type 2 Diabetes, run by University of Florida at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes, Type 2 Diabetes
What is being tested?
ECHO Tele-Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32,796 participants
Where
17 sitesUnited States
Study dates
1 Jun 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Not meeting all inclusion criteria

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites
  • Premier Community Health

    Dade City, Florida, 33525

  • CommuniCare Davis Family Health Center

    Davis, California, 95616

  • St Agnes Medical Center

    Fresno, California, 93720

  • Community Health of South Florida (CHI)

    Homestead, Florida, 33190

  • Banyan Health Systems

    Miami, Florida, 33134

  • Borinquen Medical Center

    Miami, Florida, 33137

  • La Clinica

    Multiple Locations, California, 94601

  • Santa Rosa Community Health Centers

    Multiple Locations, California, 95403

  • Shasta Community Health Centers

    Multiple Locations, California, 96001

  • Orange Blossom Family Health

    Orlando, Florida, 32805

  • Evara Health System

    Pinellas Park, Florida, 33718

  • Health Service Alliance

    Rancho Cucamonga, California, 91730

  • Hill Country Community Clinic

    Redding, California, 96001

  • Tampa Family Health Center

    Tampa, Florida, 33610

  • Treasure Coast Community Health

    Vero Beach, Florida, 32960

  • CommuniCare Salud Family Health

    West Sacramento, California, 95605

  • CommuniCare Hansen Family Center

    Woodland, California, 95695

Other trials in United States

About this study

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").

Read more

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%.

Read the 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.

Being tested
ECHO Tele-Education
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECHO Tele-EducationOther

    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.

Study groups in NCT06552923
Study groupRoleWhat they receive
ECHO Intervention ImmediateExperimental9 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
Receives: Other: ECHO Tele-Education
ECHO Intervention DelayedExperimental11 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
Receives: Other: ECHO Tele-Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    The percent of patients with HbA1c greater than 9 percent

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start1 Jun 2021
  3. Primary completion30 Jun 2022
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
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
Masking
None (open label)
Enrolment
32,796 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06552923
Sponsor's protocol ID
IRB201903243
Acronym
ECHO
Status last verified
Aug 2024
First submitted
8 Aug 2024
Last updated
14 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ECHO Tele-Education in people with Type 1 Diabetes and Type 2 Diabetes, run by University of Florida at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.

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