NCT04325386

Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.

Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network Using Extension for Community Healthcare Outcomes); Randomized Educational Study to Improve Clozapine Prescribing Through a Project ECHO Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

Summary

In a randomized controlled design with approximately 26 biweekly sessions over 12 months, the investigators propose to test the effectiveness of an ECHO-based intervention for improving the use of clozapine in people eligible for clozapine. The sessions will include: 1) active dissemination of knowledge and information by an expert "hub" followed by 2) clozapine case presentations and vignettes submitted by the "spokes". This intervention, Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network using Extension for Community Healthcare Outcomes, will be referred to as "CHAMPION" throughout.. To minimize ANC monitoring barriers and maximize recruitment, the investigators will provide Food and Drug Administration (FDA)-cleared ANC point of care (POC) monitoring devices to all study sites, including those in the control condition. The investigators will enroll at least 300 prescribers and additional clinical team members (up to 300) from up to 60 mental health clinics (MHCs) and other treatment sites; approximately half the participants will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).

Conditions

• Schizophrenia Schizoaffective

Interventions

Type	Name	Description
OTHER	ECHO Intervention	Project ECHO (Extension for Community Healthcare Outcomes) based intervention 26 CME educational sessions. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes. 1.25 hour long. Also consultation line and ATHELAS device.
OTHER	eTAU	Consultation Line and ATHELAS device only

Timeline

• Start date: 2020-02-01
• Primary completion: 2023-06-07
• Completion: 2024-09-20
• First posted: 2020-03-27
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

1 site across 1 country: United States