DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients

August 6, 2025 updated by: Douglas Scharre, Ohio State University

Implementation of DIAMOND-Lewy Guidelines for Emergency Department Antipsychotic Use in Older Patients With Cognitive and Movement Disorders

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?

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Older adults >54 years old who receive antipsychotics or benzodiazepines in the ED and older adults >54 years old who have underlying neurocognitive disorders and receive antipsychotics or benzodiazepines in the ED.

Description

Inclusion Criteria:

  • Patients over the age of 54
  • Received antipsychotic/benzodiazepine in the ED
  • Have clinical signs or symptoms of underlying cognitive or movement disorders

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antipsychotic/Benzodiazepine
Time Frame: From admission to discharge, up to 30 days
Name of medication used
From admission to discharge, up to 30 days
Clinical Indication
Time Frame: From admission to discharge, up to 30 days
Reason for antipsychotic or benzodiazepine administration
From admission to discharge, up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: From admission to discharge, up to 30 days
Number of hours spent in the ED, number of days spent during hospital admission
From admission to discharge, up to 30 days
Disposition
Time Frame: From admission to discharge, up to 30 days
Discharge location order
From admission to discharge, up to 30 days
Code Status
Time Frame: From admission to discharge, up to 30 days
Resuscitation orders at the time of admission and discharge
From admission to discharge, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024H0075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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