Condition category
Mental and Behavioural Disorders
Date applied
30/05/2014
Date assigned
02/06/2014
Last edited
20/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Delirium (acute confusion) affects more than 15% of acute hospital patients. It is commonly due to acute illness, trauma or the side effects of drugs and can be very distressing for the patient and their families. Rapid detection of delirium is vital so that the patient can receive the appropriate treatment and support. Currently doctors use screening tools to help them assess whether a patient has delirium. However these are not suitable for all patients and can be time consuming to use. As a result it is estimated that two-thirds of acute hospital patients with delirium are not being diagnosed. A new quick, easy to use screening tool for delirium and cognitive impairment called the 4AT has been developed to help doctors diagnose delirium. It has 4 parts and is very quick to complete. In this study we compare the new 4AT screening tool against a reference standard assessment to show that it can be used to accurately diagnose delirium. The 4AT is compared with one of the most commonly used screening tools, the CAM (Confusion Assessment Method) to find out if it performs similarly whilst being potentially quicker to use. The study also includes a cost evaluation. The study's findings will improve the diagnosis of delirium allowing better management by the clinical team thereby improving both patient care and outcomes.

Who can participate?
Patients who are admitted to hospital via the emergency department or through acute general medical or geriatric units will be eligible. The 4AT study aims to recruit 900 patients over 70 years old from the 3 hospitals involved in the study.

What does the study involve?
Patients on the study are split into one of 2 groups at random. One group is screened for delirium using the 4AT screening tool while the other group is screened using the CAM screening tool. All patients on the study are screened using the reference standard assessment. Patients are screened within the first two days following admission. Information about their subsequent hospital stay will be collected from their medical records.

What are the possible benefits and risks of participating?
Patients on this study will be screened twice for delirium. There are no known risks to these assessments. A possible benefit of participation is that patients on this study in either group may be diagnosed with delirium more frequently which will mean that more can receive more appropriate care.

Where is the study run from?
The University of Edinburgh and NHS Lothian (UK)

When is study starting and how long is it expected to run for?
March 2015 to end of May 2017

Who is funding the study?
National Institute for Health Research; Health Technology Assessment Programme.

Who is the main contact?
Professor Alasdair MacLullich
A.MacLullich@ed.ac.uk

Trial website

http://www.the4at.com

Contact information

Type

Scientific

Primary contact

Prof Alasdair MacLullich

ORCID ID

Contact details

Professor of Geriatric Medicine
Edinburgh Delirium Research Group
Geriatric Medicine Unit
University of Edinburgh
Room F1424
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
-
A.MacLullich@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/143/01

Study information

Scientific title

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

Acronym

4AT

Study hypothesis

The diagnostic screening performance of 4AT will be assessed by comparing the diagnostic accuracy of the 4AT with the reference standard (Delirium Rating Scale-Revised-98) using the positive and negative predictive values, sensitivity and specificity.
In addition
1. The 4AT will be compared with one of the most commonly used screening tools, the short CAM (Confusion Assessment Method)
2. Performance of the 4AT cognitive screening assessment will be evaluated
3. Performance of the 4AT in predicting clinical outcomes will be evaluated

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1114301
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/113949/PRO-11-143-01.pdf

On 20/01/2015 the following changes were made to the trial record:
1. The overall trial start date was changed from 01/11/2014 to 01/03/2015.
2. The overall trial end date was changed from 31/07/2016 to 30/11/2016.

Ethics approval

1. Scotland A REC, 03/07/2015, ref: 15/SS/0071
2. Yorkshire & The Humber – Bradford Leeds REC, 16/09/2015, ref: 15/YH/0317

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Please use contact details to request a patient information sheet

Condition

Delirium/geriatric/acute admissions

Intervention

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 Assessment Method) screening tool. All patients on the study will also be screened using the reference standard assessment (Delirium Rating Scale-Revised-98). Patients will be screened within the first two days following admission. Information about their subsequent hospital stay will be collected from their medical records.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/03/2015

Overall trial end date

30/05/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

900

Participant exclusion criteria

1. Acute life-threatening illness
2. Communication difficulties

Recruitment start date

01/04/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Lothian
Royal Infirmary of Edinburgh Little France Edinburgh
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Weston Park Hospital Whitham Road
Sheffield
S10 2SJ
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom

Sponsor information

Organisation

University of Edinburgh and NHS Lothian - co-sponsors (UK)

Sponsor details

c/o M. Bucukoglu
Head of Research Governance
Research and Development
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
-
marise.bucukoglu@ed.ac.uk

Sponsor type

Other

Website

http://www.accord.ed.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research Health Technology Assessment Programme. Ref. No. - 11/143/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/10/2016: Recruitment end date changed from 31/07/2016 to 31/12/2016 24/03/2016: The overall trial dates have been updated from 01/03/2015 - 30/11/2016 to 01/03/2015 - 30/05/2017. Ethics approval information added.