Clinical trial NCT04325386: Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Schizoaffective
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will compare an educational intervention between participant prescribers located at the randomized clinic sites.
Primary purpose: OTHER

Brief 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 60 outpatient mental health clinics (OMHCs) and other treatment sites; approximately half the OHMCs will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).


Eligibility criteria: 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

Primary outcomes:
measure: change in clozapine prescriptions using Medicaid claims data
timeFrame: Baseline and endpoint changes after 12 month intervention
measure: Change in prescriber knowledge of clozapine use
timeFrame: Baseline and endpoint changes after 12 month intervention
measure: Change in self-reported competence for clozapine use
timeFrame: Baseline and endpoint changes after 12 month intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
state: Maryland
Study officials:
References: