Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Schizophrenia Schizoaffective

Treatments: Other: eTAU; Other: ECHO Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04325386

HP-00087399

Details and patient eligibility

About

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).

Enrollment: 266 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Not willing to participate in CHAMPION Sessions

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups, including a placebo group

ECHO Intervention

Experimental group

Description:

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.

Treatment:

Other: ECHO Intervention

eTAU

Placebo Comparator group

Description:

Consultation line and ATHELAS Device only

Treatment:

Other: eTAU