- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02782143
Testing the Validity of the "Modified Confusion Assessment Method for the Emergency Department" (mCAM-ED)" (Val_mCAM-ED)
September 12, 2016 updated by: University Hospital, Basel, Switzerland
Testing the Validity of the "Modified Confusion Assessment Method for the Emergency Department" (mCAM-ED)" for the Recognition of Delirium in Elderly Patient Admitted to the Emergency Department
The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department
Study Overview
Status
Completed
Conditions
Detailed Description
Delirium is a complex neuropsychiatric syndrome with sudden change in cognition such as disturbance in orientation or memory particularly in elderly patients in the context of acute illness.
Multiple complications such as falls or increased duration of hospitalisation may result in delirium.
Long-term consequences may result in increased mortality rates and higher admissions rates to nursing homes.
In 2012, delirium prevalence in the Emergency Department (ED) of the University Hospital Basel was 9.5% in patients with 65 years and over.
Although a systematic delirium management was introduced in 2012, without systematic screening delirium detection rates varies between 20 and 40% only.
The risk of non-detection over the complete hospitalisation is high when early delirium detection did not occur in the ED.
In a preliminary evaluation we could show the usefulness of the mCAM-ED
Study Type
Observational
Enrollment (Actual)
289
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 to 115 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to the emergency department being 65 years and over
Description
Inclusion Criteria:
- Age >= 65 years
Exclusion Criteria:
- patients under resuscitation or fatal illness
- not speaking German
- being aphasic
- being deaf
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delirium measured by geriatricians using Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria
Time Frame: once during the stay at the emergency department which lasts an average of 24 hours
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acute confusional states in patients
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once during the stay at the emergency department which lasts an average of 24 hours
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Delirium measured by geriatricians using DSM-5 criteria
Time Frame: once during the stay at the emergency department which lasts an average of 24 hours
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acute confusional states in patients
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once during the stay at the emergency department which lasts an average of 24 hours
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Delirium measured by advanced practice nurses using the mCAM-ED
Time Frame: once during the stay at the emergency department which lasts an average of 24 hours
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acute confusional states in patients
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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
Time Frame: once during the stay at the emergency department which lasts an average of 24 hours
|
once during the stay at the emergency department which lasts an average of 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Wolfgang Hasemann, PhD, USB
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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
November 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
December 16, 2015
First Submitted That Met QC Criteria
May 20, 2016
First Posted (Estimate)
May 25, 2016
Study Record Updates
Last Update Posted (Estimate)
September 13, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ-2015-123
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.
Clinical Trials on Delirium
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Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
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Menoufia UniversityCompleted
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Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
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Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
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Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
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Mayo ClinicCompletedPost-Operative DeliriumUnited States
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Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
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University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland