Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000648426
Ethics application status
Approved
Date submitted
2/06/2025
Date registered
19/06/2025
Date last updated
19/06/2025
Date data sharing statement initially provided
19/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a new digital screening tool to identify persons suffering from delirium in an emergency department
Scientific title
A validation study of a novel and digital Delirium scREening tool in An eMergency department (DREAM): Bringing the diagnosis and management of delirium into the 21st century
Secondary ID [1] 314527 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
DREAM
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Delirium 337689 0
Condition category
Condition code
Mental Health 334024 334024 0 0
Other mental health disorders
Public Health 334130 334130 0 0
Health service research
Emergency medicine 334131 334131 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The presence / absence of delirium will be assessed using three different test methods consecutively:
• electronic Delirium Screening tool DREAM
• validated routine Delirium Screening tool 4AT
• Expert-administered delirium assessment based on the DSM-V-TR diagnostic criteria

The order of assessments will be randomised, and all three tests will be completed within 1 hour of commencement of the first test by three different assessors. Each assessor will be blinded to the outcomes of concurrent test results. Completion of all three assessments should take no more than 20 minutes. Any protocol deviations regarding the administration of tests, including non-adherence to order randomisation, will be documented by research staff to ensure adherence to the intervention.

DREAM is administered by an ED research nurse. The tool is accessed via a weblink on a study dedicated iPAD at the bedside. Test outcomes produce a score of 0 – 5 and will be recorded on a secured, cloud-based database resulting in scores of 0 (no delirium), 1 (possible delirium), and 2 or more (delirium) in addition to the participants study number, age, and data and time of test administration. Results will be downloaded at the conclusion of the study and entered into the study database.

The 4AT is a standard delirium screening tool that has been validated for use in the ED and is routinely used at TPCH. It is administered by an ED nurse or FRAIL team member and recorded using a routine paper chart, as per standard ED procedure, resulting in an outcome score of 0 – 12, which will be recorded in the study database (0 = no delirium, 1-3 = likely cognitive impairment, 2-4 = delirium with or without cognitive impairment).

A study participating clinician trained in the assessment of delirium conducts a standard clinical evaluation applying DSM-5-TR standards. This assessment includes cognitive evaluation using standard measures of attention plus potential caregiver interview depending on availability. A routine practitioner will apply a consensus-based decision-making approach to formulating a diagnosis.
Intervention code [1] 331204 0
Early detection / Screening
Intervention code [2] 331206 0
Treatment: Devices
Comparator / control treatment
The comparator / control is the expert-administered delirium assessment based on the DSM-V-TR diagnostic criteria. Both DREAM and 4AT will be assessed against the comparator to determine diagnostic accuracy.

A study participating clinician trained in the assessment of delirium conducts a standard clinical evaluation applying DSM-5-TR standards. This assessment includes cognitive evaluation using standard measures of attention plus potential caregiver interview depending on availability. A routine practitioner will apply a consensus-based decision-making approach to formulating a diagnosis.
Control group
Active

Outcomes
Primary outcome [1] 341681 0
Diagnostic accuracy measured by the area under the receiver operating curve (AUC) for DREAM when compared to a reference gold standard diagnosis for delirium
Timepoint [1] 341681 0
At completion of recruitment and data clean-up
Primary outcome [2] 341682 0
Non-inferiority of DREAM measured by the percentage assessments correctly classified by DREAM compared to standard care 4AT
Timepoint [2] 341682 0
At completion of recruitment and data clean-up
Secondary outcome [1] 448326 0
Prevalence of delirium over the observation period in adults aged 65 years or older presenting to TPCH ED
Timepoint [1] 448326 0
At completion of recruitment and data clean-up
Secondary outcome [2] 448327 0
Other measures of diagnostic accuracy (sensitivity and specificity) of the DREAM, 4AT delirium screening tools compared to the reference gold standard diagnosis will be assessed as a composite outcome.
Timepoint [2] 448327 0
At completion of recruitment and data clean-up

Eligibility
Key inclusion criteria
• Patients presenting to The Prince Charles Hospital Emergency Department
• Patients aged 65 years or older
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients identified as medically unstable (e.g. requiring significant organ support defined as ED triage category 1)
• Patients deemed “unconscious” (defined as Glasgow Coma Scale <8)
• Patients identified as “end of life” or “for comfort cares only”
• Patients presenting with a mental health condition or confirmed mental health diagnosis
• Patients received as inter-hospital-transfer
• Patients for direct admission to a ward

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27996 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 44196 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 319078 0
Charities/Societies/Foundations
Name [1] 319078 0
The Common Good / The Prince Charles Hospital Foundation
Country [1] 319078 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Common Good / The Prince Charles Hospital Foundation
Address
Country
Australia
Secondary sponsor category [1] 321538 0
Hospital
Name [1] 321538 0
The Prince Charles Hospital
Address [1] 321538 0
Country [1] 321538 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317675 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 317675 0
Ethics committee country [1] 317675 0
Australia
Date submitted for ethics approval [1] 317675 0
19/03/2025
Approval date [1] 317675 0
23/05/2025
Ethics approval number [1] 317675 0
HREC/2025/MNH/109885

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

Contacts
Principal investigator
Name 141778 0
Dr Jordan Faye
Address 141778 0
Department of Emergency, The Prince Charles Hospital, Chermside QLD 4032
Country 141778 0
Australia
Phone 141778 0
+61 7 3139 5419
Fax 141778 0
Email 141778 0
[email protected]
Contact person for public queries
Name 141779 0
Dr Barbara Zangerl
Address 141779 0
Department of Emergency, The Prince Charles Hospital, Chermside QLD 4032
Country 141779 0
Australia
Phone 141779 0
+61 7 3139 6830
Fax 141779 0
Email 141779 0
[email protected]
Contact person for scientific queries
Name 141780 0
Dr Barbara Zangerl
Address 141780 0
Department of Emergency, The Prince Charles Hospital, Chermside QLD 4032
Country 141780 0
Australia
Phone 141780 0
+61 7 3139 6830
Fax 141780 0
Email 141780 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No individual, identifying data will be collected for this trial. All data analysis and interpretation will be conducted from de-identified data.



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
No additional documents have been identified.