NCT02054169

Brief Summary

Delirium is common in older emergency department (ED) patients and often remains unrecognized. Existing instruments to detect delirium are often time consuming and therefore not feasible in the busy ED setting In this study the investigators tested the feasibility of the newly developed modified confusion assessment method (mCAM-ED).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

Same day

First QC Date

January 31, 2014

Last Update Submit

February 3, 2014

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • delirium

    Delirium was assessed by research assistants using the mCAM-ED. Patients with a positive delirium diagnosis were presented to a senior emergency physician (PI) who served as the reference standard. The final delirium diagnosis was based on the DSM IV criteria

    two hours after ED admission

Secondary Outcomes (1)

  • adherence of ED staff to mCAM-ED algorithm

    At patient discharge or transfer from ED (average 4 hours after presentation)

Study Arms (2)

pre-test group

All patients aged 65 or older presenting to the ED during the pre-test period

post-test period

All patients aged 65 or older presenting to the ED in the post-test period

Eligibility Criteria

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

The samples consisted of consecutive ED patients.

You may qualify if:

  • patients aged 65 or older

You may not qualify if:

  • patients treated in the resuscitation room
  • patients transferred or discharged within 2 hours of arrival
  • patients with insufficient proficiency in the German language
  • patients with an inability to communicate (e.g. aphasic patients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christian H Nickel, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 4, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

CH(1)