Viewing Study NCT06357195


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Ignite Modification Date: 2025-12-26 @ 2:23 AM
Study NCT ID: NCT06357195
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-08-11
First Post: 2024-04-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients
Sponsor: Ohio State University
Organization:

Study Overview

Official Title: Implementation of DIAMOND-Lewy Guidelines for Emergency Department Antipsychotic Use in Older Patients With Cognitive and Movement Disorders
Status: ACTIVE_NOT_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: None
Brief Summary: The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are:

* How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits?
* Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits?
* How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder?
* What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders?
* Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations?
Detailed Description: Lewy Body Dementia (LBD) is the second most common type of dementia next to Alzheimer's Dementia, but many patients with this disease go undiagnosed or misdiagnosed. A clinical feature of this disease is sensitivity to certain medications such as antipsychotics and benzodiazepines, which can potentially worsen their symptoms and/or increase the risk of death. With neuropsychiatric symptoms being the leading cause for acute hospital visits in patients with LBD, over a third of patients receive antipsychotics in the hospital, a third end up needing a higher level of care after discharge, and a third of patients with dementia end up dying within the first year after an ED visit. Currently, there is not enough data for the best pharmacologic management of acute behavioral disturbances in older patients, but we do have international LBD guidelines that we can start to implement.

Since the ED is a place with high usage of antipsychotics/benzodiazepines, the purpose of this study is to measure the proportion of older patients who are receiving these medications during an ED visit. Of the older patients who received these medications, this study will measure which fraction of the patients might have an underlying diagnosis of dementia or movement disorder. The goal is to implement new hospital guidelines to help reduce the usage of these medications in older patients, thus the study will measure the proportion of older patients receiving these medications before and after the new hospital guidelines are implemented. The study will also directly measure the treatment knowledge of providers working in the ED by having them answer a clinical scenario/patient case question before and after the guidelines are presented to them. The ultimate goal of this study is to help improve patient outcomes in older people who visit the hospital by avoiding medications that could be potentially harmful to their health.

Study Oversight

Has Oversight DMC: False
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?: