NCT04325386Completed
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 266 (actual)
- First submitted
- 11 Feb 2020
- Start date
- 1 Feb 2020
- Primary completion date
- 7 Jun 2023
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Schizophrenia
- NCT number
- NCT04325386
What you commit to
- Study type: Interventional
- Participants enrolled: 266
- From 1 Feb 2020 to the primary completion date, 7 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not willing to participate in CHAMPION Sessions
Who the study is looking for
- Located at a site in the State of Maryland with at least 3 prescribers at the site.
- Prescribers/clinical team should be licensed in the State of Maryland and have prescribed antipsychotics previously.
- Between the ages of 22 and 85 years old
- Willing to participate in pre- and post-testing
- Willing to agree to try to participate in the CHAMPION sessions
Age in the registry: 22 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) Coordinator of this site? Confirm its status | Catonsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.