Testing the Validity of the "Modified Confusion Assessment Method for the Emergency Department" (mCAM-ED)"

Delirium Clinical Trial

— Val_mCAM-ED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782143
• Other study ID #: EKNZ-2015-123
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: September 12, 2016
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 115 Years

Eligibility

Inclusion Criteria:

• Age >= 65 years

Exclusion Criteria:

• patients under resuscitation or fatal illness

• not speaking German

• being aphasic

• being deaf

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Confusion
• Delirium
• Emergencies

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

Ryan DJ, O'Regan NA, Caoimh RÓ, 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). pii: e001772. doi: 10.1136/bmjopen-2012-001772. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No