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Trial registered on ANZCTR


Registration number
ACTRN12622000220763
Ethics application status
Approved
Date submitted
20/10/2021
Date registered
8/02/2022
Date last updated
10/11/2022
Date data sharing statement initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
eDIS-ICU - An international validation study to assess accuracy of a new screening tool for delirium in the intensive care unit
Scientific title
eDIS-ICU - An international validation study to assess accuracy of a new screening tool for delirium in the intensive care unit
Secondary ID [1] 305495 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 323882 0
Condition category
Condition code
Mental Health 321393 321393 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once consent is given, the presence / absence of delirium will be assessed by consecutively using three different test methods:
• electronic Delirium Screening in the ICU (eDIS-ICU)
• Confusion Assessment Method for the ICU (CAM-ICU)
• Expert-administered delirium assessment as per the DSM-V diagnostic criteria

CAM-ICU is a delirium assessment tool comprising standardised non-verbal assessments for mechanically ventilated and non-ventilated ICU patients. It assesses four features: (1) the acute onset of mental status changes, or a fluctuating course, (2) inattention, (3) altered levels of consciousness, and (4) disorganised thinking. It takes approximately 1-2 minutes to complete, and will be a paper-based assessment.

eDIS-ICU is an electronic delirium screening tool designed specifically for minimally responsive patients in the ICU setting. It is an app containing a bank of 60 questions that test attention, divided attention, and organisation of thinking. Questions are randomised, with up to six questions asked in each assessment with true or false answers. The time required to complete the test is approximately 60 seconds per assessment.

eDIS-ICU will be accessed via a weblink which will be sent to the investigators at each recruiting site. The three tests will be administered by three different people at any given time point. The DSM-V assessment will be performed or confirmed (after assessment performed by an appropriately trained and certified psychiatric nurse) by a designated psychiatrist. Patients will be assessed twice within 24 hours (morning and afternoon) immediately following recruitment. The order in which tests are administered (e-DIS-ICU, CAM-ICU and DSM-V assessment) and the clinician administering the CAM-ICU and eDIS-ICU tests will be randomised. A randomisation schedule will be created using statistical software (e.g. the "ralloc" package in Stata), which will then be implemented using the randomisation module in REDCap (the electronic database used for data management – see below). The three tests will all be completed within 1 hour of commencement of the first test to increase the reliability of the comparable data. Assessors will be blinded to previous test results.

The time of test commencement and completion will be recorded. Administration of the CAM-ICU and eDIS-ICU tests will be timed (in seconds) and a record will be kept of tests not able to be completed at all assessment timepoints (and reasons for inability to complete).
Intervention code [1] 321897 0
Early detection / Screening
Intervention code [2] 322741 0
Treatment: Devices
Comparator / control treatment
The control comparator will be expert-administered delirium assessment as per the DSM-V diagnostic criteria. The DSM-V assessment is paper-based and will be performed or confirmed (after assessment performed by an appropriately trained and certified psychiatric nurse) by a designated psychiatrist. The order in which tests are administered (e-DIS-ICU, CAM-ICU and DSM-V assessment) will be randomised. The time of test commencement and completion will be recorded, and a record will be kept of tests not able to be completed at all assessment timepoints (and reasons for inability to complete). The expected time required to complete the DSM V assessment is approximately 5-10 minutes per patient.
Control group
Active

Outcomes
Primary outcome [1] 329165 0
Sensitivity of eDIS-ICU compared to CAM-ICU.
Timepoint [1] 329165 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [1] 401697 0
Prevalence of delirium using the eDIS-ICU.
Timepoint [1] 401697 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [2] 401698 0
Prevalence of delirium using the CAM-ICU.
Timepoint [2] 401698 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [3] 401699 0
Prevalence of delirium using the DSM-V.
Timepoint [3] 401699 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [4] 401700 0
Diagnostic concordance between eDIS-ICU and DSM V.
Timepoint [4] 401700 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [5] 401701 0
Diagnostic concordance between CAM-ICU and DSM V.
Timepoint [5] 401701 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [6] 401704 0
Time taken (in seconds) to administer eDIS-ICU (using a stopwatch).
Timepoint [6] 401704 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [7] 401707 0
Time taken (in seconds) to administer CAM-ICU (using a stopwatch).
Timepoint [7] 401707 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [8] 402055 0
Specificity of eDIS-ICU compared to CAM-ICU.
Timepoint [8] 402055 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [9] 405646 0
Positive predictive value (PPV) - the probability that patients diagnosed with delirium via eDIS-ICU are also diagnosed as delirious via DSM V.
Timepoint [9] 405646 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [10] 405647 0
Negative predictive value (NPV) - the probability that patients diagnosed with delirium via eDIS-ICU are not diagnosed as delirious via DSM V.
Timepoint [10] 405647 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [11] 405648 0
Diagnostic odds ratio - the ratio of odds of eDIS-ICU diagnosing delirium in patients who are also delirium positive as diagnosed by DSM V, relative to the odds of eDIS-ICU diagnosing delirium in patients who are not delirium positive as diagnosed by DSM V.
Timepoint [11] 405648 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [12] 405649 0
Completion rate of eDIS-ICU tests (by audit of study database).
Timepoint [12] 405649 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [13] 405650 0
Completion rate of CAM-ICU tests (by audit of study database).
Timepoint [13] 405650 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.
Secondary outcome [14] 405651 0
Overall delirium prevalence (using collected DSM V data).
Timepoint [14] 405651 0
Twice within 24 hours (morning and afternoon) immediately following enrolment.

Eligibility
Key inclusion criteria
• Anticipated ICU length of stay of >24 hours from time of enrolment.
• Greater than or equal to 18 years.
• Able to communicate ‘Yes’ and ‘No’ consistently (verbal or non-verbal).
• Informed consent obtained by participant / their legal representative.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pre-existing severe cognitive impairment preventing them from comprehending / answering assessment questions (as determined by the treating clinical team in consultation with the research team).
• Insufficiently fluent in the language in use at the participating hospital to complete consent processes and/or follow instructions.
• Patients with visual / hearing impairment preventing them from hearing verbal assessment instructions or visualising the app screen.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
16/02/2022
Date of last participant enrolment
Anticipated
10/02/2023
Actual
Date of last data collection
Anticipated
17/02/2023
Actual
Sample size
Target
700
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21600 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 36523 0
4032 - Chermside
Recruitment outside Australia
Country [1] 24196 0
Estonia
State/province [1] 24196 0
Country [2] 24197 0
Japan
State/province [2] 24197 0

Funding & Sponsors
Funding source category [1] 309854 0
Other Collaborative groups
Name [1] 309854 0
Critical Care Research Group
Country [1] 309854 0
Australia
Funding source category [2] 310662 0
Charities/Societies/Foundations
Name [2] 310662 0
The Prince Charles Hospital Foundation
Country [2] 310662 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service
Address
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country
Australia
Secondary sponsor category [1] 311878 0
None
Name [1] 311878 0
Address [1] 311878 0
Country [1] 311878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309591 0
The Prince Charles Hospital HREC
Ethics committee address [1] 309591 0
Ethics committee country [1] 309591 0
Australia
Date submitted for ethics approval [1] 309591 0
Approval date [1] 309591 0
11/10/2021
Ethics approval number [1] 309591 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114698 0
Mr Oystein Tronstad
Address 114698 0
Critical Care Research Group,
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country 114698 0
Australia
Phone 114698 0
+61 422 212 452
Fax 114698 0
Email 114698 0
[email protected]
Contact person for public queries
Name 114699 0
Oystein Tronstad
Address 114699 0
Critical Care Research Group,
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country 114699 0
Australia
Phone 114699 0
+61 422 212 452
Fax 114699 0
Email 114699 0
[email protected]
Contact person for scientific queries
Name 114700 0
Oystein Tronstad
Address 114700 0
Critical Care Research Group,
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country 114700 0
Australia
Phone 114700 0
+61 422 212 452
Fax 114700 0
Email 114700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results will be shared upon reasonable request to the Principal Investigator.
When will data be available (start and end dates)?
Available for 5 years after publication.
Available to whom?
Data will be available to fellow researchers who provide a methodologically-sound proposal who are approved by the Principal Investigator
Available for what types of analyses?
Data will only be available to achieve the aims of the approved proposal.
How or where can data be obtained?
Data can be obtained through email request to the Principal Investigator, Oystein Tronstad ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA protocol of an international validation study to assess the clinical accuracy of the eDIS-ICU delirium screening tool.2023https://dx.doi.org/10.1016/j.aucc.2023.02.003
N.B. These documents automatically identified may not have been verified by the study sponsor.