Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use. (CHAMPION)
Primary Purpose
Schizophrenia Schizoaffective
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education Sessions
No Education Session
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia Schizoaffective
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
Sites / Locations
- Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Education sessions
No education sessions
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04325386
First Posted
February 11, 2020
Last Updated
September 25, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT04325386
Brief Title
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
Acronym
CHAMPION
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Schizoaffective
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will compare an educational intervention between participant prescribers located at the randomized clinic sites.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education sessions
Arm Type
Experimental
Arm Description
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.
Arm Title
No education sessions
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Education Sessions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Education Session
Intervention Description
No Education Session
Primary Outcome Measure Information:
Title
change in clozapine prescriptions using Medicaid claims data
Description
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.
Time Frame
Baseline and endpoint changes after 12 month intervention
Title
Change in prescriber knowledge of clozapine use
Description
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.
Time Frame
Baseline and endpoint changes after 12 month intervention
Title
Change in self-reported competence for clozapine use
Description
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.
Time Frame
Baseline and endpoint changes after 12 month intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
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