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Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.

NCT04325386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2025-08-12

Study results available
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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

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

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2023-06-07
Completion
2024-09-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325386 on ClinicalTrials.gov