DeliriumVal_mCAM-EDNCT02782143
Testing the Validity of the "Modified Confusion Assessment Method for the Emergency Department" (mCAM-ED)"
An observational study of Delirium, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department Read more about this study
- Who is it for?
- Ages 65 to 115 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- How many people
- 289 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 115 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients admitted to the emergency department being 65 years and over
Who may be able to join
- Age >= 65 years
Who cannot join
- patients under resuscitation or fatal illness
- not speaking German
- being aphasic
- being deaf
Trial locations and contacts
1 site in 1 country.
About this study
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
The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department
Read the 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
- Conditions
- Delirium
- Keywords
- delirium detection
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium measured by geriatricians using Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria
acute confusional states in patients
Measured: once during the stay at the emergency department which lasts an average of 24 hours
Delirium measured by geriatricians using DSM-5 criteria
acute confusional states in patients
Measured: once during the stay at the emergency department which lasts an average of 24 hours
Delirium measured by advanced practice nurses using the mCAM-ED
acute confusional states in patients
Measured: 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
Measured: once during the stay at the emergency department which lasts an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Hasemann, PhD, Study chair, usb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782143
- Sponsor's protocol ID
- EKNZ-2015-123
- Acronym
- Val_mCAM-ED
- Status last verified
- Sep 2016
- First submitted
- 16 Dec 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19154565Ryan 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.
PubMed 23299110
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02782143
- Acronym / sponsor ID
- Val_mCAM-ED / EKNZ-2015-123
- Conditions
- Delirium
- Keywords
- delirium detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 115 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the emergency department being 65 years and over
Key inclusion criteria (1 listed)
- Age >= 65 years
Key exclusion criteria (4 listed)
- patients under resuscitation or fatal illness
- not speaking German
- being aphasic
- being deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- BackgroundTrzepacz, 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.
- Background: PubMed 19154565Han 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.
- Background: PubMed 23299110Ryan 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.
Related trials for Delirium
Active, not recruiting
TaVNS for Delirium
Delirium
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Hasemann, PhD study chair
usb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782143, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.