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

• ClinicalTrials.gov Identifier: NCT02782143
• Recruitment Status: Completed
• First Posted: May 25, 2016
• Last Update Posted: September 13, 2016
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Study Description

Brief Summary:

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

Condition or disease
Delirium

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 Design

• Study Type: Observational
• Actual Enrollment: 289 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: November 2015
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: September 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   acute confusional states in patients
2. 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 ]
   acute confusional states in patients
3. 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 ]
   acute confusional states in patients
4. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 115 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Patients admitted to the emergency department being 65 years and over

Criteria

Inclusion Criteria:

• Age >= 65 years

Exclusion Criteria:

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

Contacts and Locations

Locations

Switzerland

University Hospital Basel

Basel, Switzerland, 4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

• Study Chair: Wolfgang Hasemann, PhD; usb

More Information

Publications:

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.

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.

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.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT02782143
• Other Study ID Numbers: EKNZ-2015-123
• First Posted: May 25, 2016
• Last Update Posted: September 13, 2016
• Last Verified: September 2016

Keywords provided by University Hospital, Basel, Switzerland:

delirium detection

Additional relevant MeSH terms:

Delirium; Confusion; Emergencies; Disease Attributes; Pathologic Processes; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders