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临床试验/NCT07417865
NCT07417865招募中不适用

Extension for Community Health Outcomes (ECHO) Diabetes Federally Qualified Health Centers (FQHCs)

University of Florida2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
HEDIS >9% HbA1c

研究概览

简要总结

Extension for Community Health Outcomes Diabetes FQHC will provide tele-education to primary care providers (PCP) in Federally Qualified Health Centers in the U.S. using the "hub" and "spoke" training model established in the Project ECHO model. Participating FQHCs (called "spokes") will receive twice monthly tele-education sessions delivered by UF's "hub" team in a 6-month program. The program will be evaluated using pre/posttest provider-level surveys and center-level aggregate data in a stepped-wedge trial design with 3 cohorts of FQHCs. The primary outcomes are the proportion of people >9% HbA1c and technology use (CGM and insulin pump).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Non FQHC, not part of HCN or AC

研究组 & 干预措施

Cohort 3

6-8 FQHCs that participate in the ECHO Diabetes tele-education program for PCPs

干预措施: ECHO Diabetes tele-education (Behavioral)

Cohort 1

6-8 Federally Qualified Health Centers that participate in the ECHO Diabetes tele-education program for PCPs

干预措施: ECHO Diabetes tele-education (Behavioral)

Cohort 2

6-8 Federally Qualified Health Centers that participate in the ECHO Diabetes tele-education program for PCPs

干预措施: ECHO Diabetes tele-education (Behavioral)

结局指标

主要结局

HEDIS >9% HbA1c

时间窗: From baseline to 12-months following

Proportion of FQHC population with \>9% HbA1c

Technology Use

时间窗: From baseline to 12-months following

CGM and Pump Use

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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