NCT06357195

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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 11, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

April 4, 2024

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Antipsychotic/Benzodiazepine

    Name of medication used

    From admission to discharge, up to 30 days

  • Clinical Indication

    Reason for antipsychotic or benzodiazepine administration

    From admission to discharge, up to 30 days

Secondary Outcomes (3)

  • Length of Stay

    From admission to discharge, up to 30 days

  • Disposition

    From admission to discharge, up to 30 days

  • Code Status

    From admission to discharge, up to 30 days

Eligibility Criteria

Age54 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

  • 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.

    PMID: 31519472BACKGROUND
  • 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.

    PMID: 21747029BACKGROUND
  • 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.

    PMID: 30930058BACKGROUND
  • 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.

    PMID: 35612546BACKGROUND
  • 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.

    PMID: 37662063BACKGROUND
  • 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.

    PMID: 28592453BACKGROUND

Related Links

MeSH Terms

Conditions

Cognition DisordersMovement DisordersLewy Body DiseaseBehavior

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersCentral Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesDementiaSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Neurology and Psychiatry, Division Director of Cognitive Neurology

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

July 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations