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Emergency PsychiatricNCT06357195

DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients

An observational study of Emergency Psychiatric and Cognition Disorder, run by Ohio State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 54 years and older
How many people
1,000 participants
Where
1 siteUnited States
Study dates
1 Jul 2024to 1 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 54 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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?
Read the 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.

Medical subject headings
Cognition Disorders, Movement Disorders, Lewy Body Disease, Behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antipsychotic/Benzodiazepine

    Name of medication used

    Measured: From admission to discharge, up to 30 days

  2. Clinical Indication

    Reason for antipsychotic or benzodiazepine administration

    Measured: From admission to discharge, up to 30 days

Secondary outcomes (3)

  1. Length of Stay

    Number of hours spent in the ED, number of days spent during hospital admission

    Measured: From admission to discharge, up to 30 days

  2. Disposition

    Discharge location order

    Measured: From admission to discharge, up to 30 days

  3. Code Status

    Resuscitation orders at the time of admission and discharge

    Measured: From admission to discharge, up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start1 Jul 2024
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357195
Sponsor's protocol ID
2024H0075
Status last verified
Jul 2025
First submitted
4 Apr 2024
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taylor JP, McKeith IG, Burn DJ, Boeve BF, Weintraub D, Bamford C, Allan LM, Thomas AJ, O'Brien JT. New evidence on the management of Lewy body dementia. Lancet Neurol. 2020 Feb;19(2):157-169. doi: 10.1016/S1474-4422(19)30153-X. Epub 2019 Sep 10.

    PubMed 31519472

  • Weintraub D, Chen P, Ignacio RV, Mamikonyan E, Kales HC. Patterns and trends in antipsychotic prescribing for Parkinson disease psychosis. Arch Neurol. 2011 Jul;68(7):899-904. doi: 10.1001/archneurol.2011.139.

    PubMed 21747029

  • Spears CC, Besharat A, Monari EH, Martinez-Ramirez D, Almeida L, Armstrong MJ. Causes and outcomes of hospitalization in Lewy body dementia: A retrospective cohort study. Parkinsonism Relat Disord. 2019 Jul;64:106-111. doi: 10.1016/j.parkreldis.2019.03.014. Epub 2019 Mar 23.

    PubMed 30930058

  • Hill JD, Schmucker AM, Siman N, Goldfeld KS, Cuthel AM, Chodosh J, Bouillon-Minois JB, Grudzen CR. Emergency and post-emergency care of older adults with Alzheimer's disease/Alzheimer's disease related dementias. J Am Geriatr Soc. 2022 Sep;70(9):2582-2591. doi: 10.1111/jgs.17833. Epub 2022 May 25.

    PubMed 35612546

  • Russek NS, Skappak C, Scheuermeyer F, Brousseau AA, McLeod SL, Melady D, Spencer M. Pharmacological Management of Agitation and Delirium in Older Adults: a Survey of Practices in Canadian Emergency Departments. Can Geriatr J. 2023 Sep 1;26(3):405-409. doi: 10.5770/cgj.26.666. eCollection 2023 Sep.

    PubMed 37662063

  • McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.

    PubMed 28592453

Questions about this trial

What is this clinical trial studying?

An observational study of Emergency Psychiatric and Cognition Disorder, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antipsychotic/Benzodiazepine (time frame: From admission to discharge, up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357195, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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