Development and validation of the 4AT: a new rapid screening tool for delirium

Development and validation of the 4AT- a new rapid screening tool for delirium: a multicentre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53388093

Enrollment

900

Registered

2014-06-02

Start date

2015-04-01

Completion date

Unknown

Last updated

2019-09-09

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

Conditions

Delirium/geriatric/acute admissions Mental and Behavioural Disorders Delirium

Interventions

Patients on the study will be randomised into one of 2 groups. One group will be screened for delirium using the 4AT screening tool while the other group will be screened using the CAM (Confusion Asse

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject > 70 years old 2. Subject admitted to hospital via: 2.1. Emergency Department (ED) 2.2. Acute general medical and geriatric unit

Exclusion criteria

Exclusion criteria: 1. Acute life-threatening illness 2. Communication difficulties

Design outcomes

Primary

Measure	Time frame
Primary objective: 4AT vs reference standard (binary): the diagnostic screening performance of 4AT versus the reference standard will be assessed using the positive and negative predictive values, sensitivity and specificity. The exact binomial 95% confidence interval will be reported for each measure. An ROC curve will be constructed to verify that the proposed cut point on the 4AT score is appropriate. The area under the ROC curve and its 95% confidence interval will be reported.	—

Measure

Time frame

Primary objective: 4AT vs reference standard (binary): the diagnostic screening performance of 4AT versus the reference standard will be assessed using the positive and negative predictive values, sensitivity and specificity. The exact binomial 95% confidence interval will be reported for each measure. An ROC curve will be constructed to verify that the proposed cut point on the 4AT score is appropriate. The area under the ROC curve and its 95% confidence interval will be reported.

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Secondary

Measure	Time frame
1. 4AT vs short CAM: differences in each of sensitivity, specificity, positive and negative predictive values between 4AT and short CAM will be tested by Fisher's exact test and quantified by the difference in the two proportions (4AT-CAM) and its 95% confidence interval. To aid comparison of 4AT and CAM, the overall performance of each will also be summarised using Youden's Index (sensitivity minus false positive rate) and the odds ratio of sensitivity to specificity. 2. Performance of the 4AT cognitive screening items: is the 4AT an adequately sensitive tool for detecting general cognitive impairment as judged against a documented history of dementia and/or the Informant Questionnaire for Cognitive Decline in the Elderly? Methods as per primary objective. 3. 4AT vs clinical outcomes: as assessment of criterion validity, the performance of the 4AT in predicting length of stay, institutionalisation, and mortality, up to 12 weeks. Descriptive statistics of clinical outcomes (continuous variables: mean, median, standard deviation, minimum, maximum; categorical variables, number and percentage of participants) will be presented for the groups with and without 4AT scores above the cut point of 3.	—

Measure

Time frame

1. 4AT vs short CAM: differences in each of sensitivity, specificity, positive and negative predictive values between 4AT and short CAM will be tested by Fisher's exact test and quantified by the difference in the two proportions (4AT-CAM) and its 95% confidence interval. To aid comparison of 4AT and CAM, the overall performance of each will also be summarised using Youden's Index (sensitivity minus false positive rate) and the odds ratio of sensitivity to specificity. 2. Performance of the 4AT cognitive screening items: is the 4AT an adequately sensitive tool for detecting general cognitive impairment as judged against a documented history of dementia and/or the Informant Questionnaire for Cognitive Decline in the Elderly? Methods as per primary objective. 3. 4AT vs clinical outcomes: as assessment of criterion validity, the performance of the 4AT in predicting length of stay, institutionalisation, and mortality, up to 12 weeks. Descriptive statistics of clinical outcomes (continuous variables: mean, median, standard deviation, minimum, maximum; categorical variables, number and percentage of participants) will be presented for the groups with and without 4AT scores above the cut point of 3.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026