- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02054169
Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)
February 3, 2014 updated by: Christian Nickel, University Hospital, Basel, Switzerland
Pilot Study on the Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
340
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
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Basel, Switzerland, 4031
- University Hospital Basel
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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
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The samples consisted of consecutive ED patients.
Description
Inclusion Criteria:
- patients aged 65 or older
Exclusion Criteria:
- 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)
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
Cohorts and Interventions
Group / Cohort |
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pre-test group
All patients aged 65 or older presenting to the ED during the pre-test period
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post-test period
All patients aged 65 or older presenting to the ED in the post-test period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delirium
Time Frame: two hours after ED admission
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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
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two hours after ED admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence of ED staff to mCAM-ED algorithm
Time Frame: At patient discharge or transfer from ED (average 4 hours after presentation)
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Adherence was achieved when the mCAM-ED result was documented by the ED nurses.
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At patient discharge or transfer from ED (average 4 hours after presentation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian H Nickel, MD, University Hospital, Basel, Switzerland
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
August 1, 2013
Primary Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
January 31, 2014
First Submitted That Met QC Criteria
February 3, 2014
First Posted (ESTIMATE)
February 4, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2014
Last Update Submitted That Met QC Criteria
February 3, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mCAM-ED
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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