NCT02782143

Brief Summary

The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

December 16, 2015

Last Update Submit

September 12, 2016

Conditions

Keywords

delirium detection

Outcome Measures

Primary Outcomes (4)

  • Delirium measured by geriatricians using Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria

    acute confusional states in patients

    once during the stay at the emergency department which lasts an average of 24 hours

  • Delirium measured by geriatricians using DSM-5 criteria

    acute confusional states in patients

    once during the stay at the emergency department which lasts an average of 24 hours

  • Delirium measured by advanced practice nurses using the mCAM-ED

    acute confusional states in patients

    once during the stay at the emergency department which lasts an average of 24 hours

  • degree of concordance between nurses' delirium measurement versus geriatricians' delirium measurement assessed in a four field matrix

    once during the stay at the emergency department which lasts an average of 24 hours

Eligibility Criteria

Age65 Years - 115 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the emergency department being 65 years and over

You may qualify if:

  • Age \>= 65 years

You may not qualify if:

  • patients under resuscitation or fatal illness
  • not speaking German
  • being aphasic
  • being deaf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

Related Publications (3)

  • Trzepacz, P. T., & Meagher, D. J. (2008). Neuropsychiatric Aspects of Delirium. In S. C. Yudofsky & R. E. Hales (Eds.), Neuropsychiatry and Behavioral Neurosciences (5 ed., pp. 445-518). Washington, DC: American Psychiatric Publishing, Inc.

    BACKGROUND
  • Han JH, Zimmerman EE, Cutler N, Schnelle J, Morandi A, Dittus RS, Storrow AB, Ely EW. Delirium in older emergency department patients: recognition, risk factors, and psychomotor subtypes. Acad Emerg Med. 2009 Mar;16(3):193-200. doi: 10.1111/j.1553-2712.2008.00339.x. Epub 2009 Jan 20.

    PMID: 19154565BACKGROUND
  • Ryan DJ, O'Regan NA, Caoimh RO, Clare J, O'Connor M, Leonard M, McFarland J, Tighe S, O'Sullivan K, Trzepacz PT, Meagher D, Timmons S. Delirium in an adult acute hospital population: predictors, prevalence and detection. BMJ Open. 2013 Jan 7;3(1):e001772. doi: 10.1136/bmjopen-2012-001772.

    PMID: 23299110BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Wolfgang Hasemann, PhD

    usb

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

May 25, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

September 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations