Schizophrenia Schizoaffective
Conditions
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 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).
Interventions
OTHERECHO Intervention
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.
OTHEReTAU
Consultation Line and ATHELAS device only
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The investigators will compare an educational intervention between prescribers who individually enrolled from participating clinics.
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clozapine Prescriptions Using Medicaid Claims Data | Baseline and endpoint changes after 12 month intervention | The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to percent of clozapine prescriptions. |
| Change in Prescriber Knowledge of Clozapine Use | Baseline and endpoint changes after 12 month intervention | 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 with higher scores being better outcome. The questions were developed and validated by the team. |
| Change in Self-reported Competence for Clozapine Use | Baseline and endpoint changes after 12 month intervention | We will use a mean score on a Visual Analog Scale (VAS) (0-100 mm) for overall competence with higher scores being better outcome. |
Countries
United States
Participant flow
Recruitment details
As per grant and protocol all outcomes are by participant level no analysis by site.
Participants by arm
| Arm | Count |
|---|---|
| Education Sessions 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.
Education Sessions: 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. | 126 |
| No Education Sessions No Education Session: No Education Session | 140 |
| Total | 266 |
Baseline characteristics
| Characteristic | Education Sessions | No Education Sessions | Total |
|---|---|---|---|
| Age, Customized 39 year or less | 47 Participants | 58 Participants | 105 Participants |
| Age, Customized 40-49 years | 39 Participants | 33 Participants | 72 Participants |
| Age, Customized 50-59 years | 16 Participants | 33 Participants | 49 Participants |
| Age, Customized 60 years or more | 24 Participants | 16 Participants | 40 Participants |
| Race/Ethnicity, Customized Black | 32 Participants | 32 Participants | 64 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 27 Participants | 47 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 71 Participants | 79 Participants | 150 Participants |
| Region of Enrollment United States | 126 participants | 140 participants | 266 participants |
| Sex: Female, Male Female | 93 Participants | 100 Participants | 193 Participants |
| Sex: Female, Male Male | 33 Participants | 40 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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 percent of clozapine prescriptions.
Time frame: Baseline and endpoint changes after 12 month intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECHO Intervention | Change in Clozapine Prescriptions Using Medicaid Claims Data | Mean percent of Clozapine prescriptions among antipsychotic prescribing Pre Intervention | 9.4 Mean percent of Clozapine prescriptions | Standard Error 0.7 |
| ECHO Intervention | Change in Clozapine Prescriptions Using Medicaid Claims Data | Mean percent of Clozapine prescriptions among antipsychotic prescribing Post intervention | 11.8 Mean percent of Clozapine prescriptions | Standard Error 0.92 |
| eTAU | Change in Clozapine Prescriptions Using Medicaid Claims Data | Mean percent of Clozapine prescriptions among antipsychotic prescribing Pre Intervention | 10.8 Mean percent of Clozapine prescriptions | Standard Error 0.79 |
| eTAU | Change in Clozapine Prescriptions Using Medicaid Claims Data | Mean percent of Clozapine prescriptions among antipsychotic prescribing Post intervention | 9.5 Mean percent of Clozapine prescriptions | Standard Error 0.9 |
Primary
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 with higher scores being better outcome. The questions were developed and validated by the team.
Time frame: Baseline and endpoint changes after 12 month intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECHO Intervention | Change in Prescriber Knowledge of Clozapine Use | Pre Intervention | 63 Percentage of Correct responses reported | Standard Deviation 12 |
| ECHO Intervention | Change in Prescriber Knowledge of Clozapine Use | Post Intervention | 71 Percentage of Correct responses reported | Standard Deviation 17 |
| eTAU | Change in Prescriber Knowledge of Clozapine Use | Pre Intervention | 66 Percentage of Correct responses reported | Standard Deviation 11 |
| eTAU | Change in Prescriber Knowledge of Clozapine Use | Post Intervention | 67 Percentage of Correct responses reported | Standard Deviation 12 |
Primary
Change in Self-reported Competence for Clozapine Use
We will use a mean score on a Visual Analog Scale (VAS) (0-100 mm) for overall competence with higher scores being better outcome.
Time frame: Baseline and endpoint changes after 12 month intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ECHO Intervention | Change in Self-reported Competence for Clozapine Use | Pre Sessions | 55.3 score on a scale | Standard Deviation 21 |
| ECHO Intervention | Change in Self-reported Competence for Clozapine Use | Post Sessions | 68.4 score on a scale | Standard Deviation 22.3 |
| eTAU | Change in Self-reported Competence for Clozapine Use | Pre Sessions | 59.0 score on a scale | Standard Deviation 20.5 |
| eTAU | Change in Self-reported Competence for Clozapine Use | Post Sessions | 71.4 score on a scale | Standard Deviation 19.2 |