Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04325386
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2020-02-11
Brief Title:
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAMPION
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None