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Validation of a new digital screening tool to identify persons suffering from delirium in an emergency department

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000648426
Acronym
DREAM
Enrollment
100
Registered
2025-06-19
Start date
2025-07-01
Completion date
2025-11-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to embed a new technologically based approach for the screening of delirium into the Emergency Department with the goal of improving accuracy and timeliness of diagnosis of delirium in all patients presenting to ED over 65 years of age. The new tool, named DREAM, will be used in parallel to the current clinical screening standard, 4AT, and a diagnostic "gold standard" diagnosis in 100 patients above the age of 65 presenting to ED. Order of testing will be randomly assigned and prospective consent will be obtained from all participants or their primary decision makers. The primary study outcome is diagnostic accuracy of DREAM, which will subsequently lead to implementation into clinical practice. This implementation will provide future opportunities to combine DREAM with existing, electronic delirium aetiology tools to enhance clinical decision support for delirium diagnosis. Early and accurate diagnosis and treatment will significantly improve patient outcomes, such as shorter hospital length of stay, fewer re-hospitalisation, and reduced morbidity and mortality.

Interventions

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 t

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.

Sponsors

The Common Good / The Prince Charles Hospital Foundation
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients presenting to The Prince Charles Hospital Emergency Department • Patients aged 65 years or older

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026