Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-27 @ 4:18 AM
Study NCT ID:
NCT07043803
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Reduction of Anticholinergic Medications Project (RAMP) Among Persons With Schizophrenia or Other Psychiatric Disorders Across UPMC Behavioral Healthcare Partner Organizations Using a Stepped-wedge, Randomized Trial Study Design.
Status:
RECRUITING
Status Verified Date:
2025-07
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:
RAMP
Brief Summary:
The goal of this study is to reduce Anticholinergic Medication (ACM) in persons with psychoses or serious mental illness, when these medications are no longer needed.
Detailed Description:
Based on the investigator's preliminary work, the investigators will utilize a combination of administrative, prescriber and patient buy-in to reduce Anticholinergic Medication (ACM), when these medications are no longer needed, as evidence-based practice. Previously developed materials and tools from the investigator's earlier work include an ACM side-effect scale (the Pittsburgh Anticholinergic Symptoms Scale, PASS v2.0), a patient-facing information leaflet reviewing the risks of long-term ACM use, and a Clinical Guide for deprescribing. These, as well as education on the Anticholinergic Medication Burden (ACMB) reduction protocol will be provided to prescribers at initiation of each site. The clinical pharmacist on the team will train staff at each site to compute and record the Anticholinergic Cognitive Burden and use the PASS to assess ACM side effects. The investigators will train the staff members to administer the Memory Impairment Screen, a verbal working memory task.
The Principal Investigator (PI) and members of the study team will work with the healthcare teams at each site using case examples of 'how to reduce and/or stop anticholinergic medications" and maintain office hours on a scheduled basis to problem-solve, trouble-shoot and/or manage the medication reduction process and clinical issues that emerge. The PI and members of the study team will train the healthcare teams at each site to examine eligible patients for extra pyramidal symptoms and in the use of a shared decision-making approach in this effort to reduce anticholinergic medications.
Based on considerable interest from our healthcare partners, and in the absence of any randomized studies, the investigators intend to use a stepped-wedge, randomized trial study design to implement this protocol for eligible patients in each of the participating clinics. In addition to affirming earlier positive clinical outcomes in the preliminary work, the investigators intend to assess barriers to and facilitators of anticholinergic medication burden reduction implementation to inform the emerging evidence-based practice.
The Principal Investigator (PI) and members of the study team will work with the healthcare teams at each site using case examples of 'how to reduce and/or stop anticholinergic medications" and maintain office hours on a scheduled basis to problem-solve, trouble-shoot and/or manage the medication reduction process and clinical issues that emerge. The PI and members of the study team will train the healthcare teams at each site to examine eligible patients for extra pyramidal symptoms and in the use of a shared decision-making approach in this effort to reduce anticholinergic medications.
Based on considerable interest from our healthcare partners, and in the absence of any randomized studies, the investigators intend to use a stepped-wedge, randomized trial study design to implement this protocol for eligible patients in each of the participating clinics. In addition to affirming earlier positive clinical outcomes in the preliminary work, the investigators intend to assess barriers to and facilitators of anticholinergic medication burden reduction implementation to inform the emerging evidence-based practice.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UL1TR001857 | NIH | None | https://reporter.nih.gov/quic… | View |