Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Schizophrenia Schizoaffective

Intervention / Treatment
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* Other: Education Sessions
* Other: No Education Session


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will compare an educational intervention between participant prescribers located at the randomized clinic sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education sessions<br>Project ECHO (Extension for Community Healthcare Outcomes) based intervention sessions for improving the use of clozapine in people with treatment-resistant schizophrenia. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes. | Other: Education Sessions<br>* Project ECHO (Extension for Community Healthcare Outcomes) based intervention sessions for improving the use of clozapine in people with treatment-resistant schizophrenia. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes.<br>|
| Placebo Comparator: No education sessions<br> | Other: No Education Session<br>* No Education Session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in clozapine prescriptions using Medicaid claims data | The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to clozapine prescriptions. The outcome is the increase in the proportion of patients treated with clozapine for those in the care of prescribers randomized to the CHAMPION relative to the ETAU condition. | Baseline and endpoint changes after 12 month intervention | 
| Change in prescriber knowledge of clozapine use | A 52 item Multiple Choice Questionnaire will be used to assess knowledge. The knowledge-based test questions will consist of 2 questions per 26 topic areas and will conform to best practices and guidelines for design of the questions. The total mean score will range from 0-52. The questions were developed and validated by the team. | Baseline and endpoint changes after 12 month intervention | 
| Change in self-reported competence for clozapine use | We will use a mean score on a Visual Analog Scale (VAS) (0-100 mm). We will have one for overall competence and then one for each of the 26 topic areas. Overall, self report scores and the global self report scores will be used. | Baseline and endpoint changes after 12 month intervention |