Condition category
Mental and Behavioural Disorders
Date applied
03/02/2020
Date assigned
21/02/2020
Last edited
21/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Delirium is one of the most common and serious neuropsychiatric conditions affecting specialist palliative care (hospice) inpatients. Delirium is associated with increased morbidity and mortality. Patients' ability to communicate may be impaired, as may their decision-making ability and quality of life. If delirium is detected earlier or more accurately, it can result in better treatment for patients. However, delirium often goes unrecognised because of the lack of quick and simple ways to detect it. The ‘4AT’ is a short and simple bedside test for detecting delirium. Previous research studies have shown it to be an effective test in hospitalised patients. The 4AT is already used in hospices, however, it has not been proven in this setting. The aim of this study is to explore how accurately the 4AT can diagnose delirium in hospice inpatients.

Who can participate?
Patients aged 18 and over who are admitted to hospice inpatient units

What does the study involve?
Two sets of tests of thinking, memory and concentration will be done by the participant’s bedside by two different healthcare professionals (a nurse or a doctor). One set of tests will last around 2 minutes (the 4AT), and the other set (the reference standard delirium assessment) lasts up to 15-20 minutes. There are no treatments or invasive investigations. The researcher will also seek the participant’s permission to examine their medical notes, and speak to the hospice team looking after them and/or someone who knows them well.

What are the possible benefits and risks of participating?
The hospice team looking after the patient will be informed of the results of the assessments. It may help the patient’s care if they have this information. It is hoped that the results of the study will help nurses and doctors decide if they should use the 4AT test in hospice settings. The only disadvantage of taking part in the study is that the participant might find the questions irritating – however the participant can choose to stop at any point if they wish. There are no significant risks in this study.

Where is the study run from?
The study is being held at Marie Curie Hospices in Edinburgh and Glasgow, and St Columba’s hospice in Edinburgh (UK)

When is the study starting and how long is it expected to run for?
January 2019 to August 2020

Who is funding the study?
Marie Curie (UK)

Who is the main contact?
Dr Elizabeth Arnold
liz.arnold@mariecurie.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Arnold

ORCID ID

Contact details

Marie Curie Hospice
45 Frogston Road West
Edinburgh
EH10 7DR
United Kingdom
+44 (0)131 470 2201
liz.arnold@mariecurie.org.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

AC19073, IRAS 262658

Study information

Scientific title

Preliminary validation study of the 4AT delirium assessment tool in specialist palliative care inpatients

Acronym

Study hypothesis

To determine the validity or accuracy of the 4AT for delirium detection versus a reference standard delirium assessment in specialist palliative care inpatient (hospice) populations.

Ethics approval

Approved 15/10/2019, Scotland A Research Ethics Committee (Scotland A REC) (2nd Floor Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5680; Manx.neill@nhslothian.scot.nhs.uk), ref: 19/SS/0091

Study design

Multicentre randomized cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Delirium

Intervention

Participants will undergo two assessments for detecting delirium:
1. The 4AT, a quick, easy to use test, which takes around 2 min to complete
2. A reference standard delirium assessment, which takes up to 15-20 min to complete. The reference standard delirium assessment will be based on the core diagnostic criteria for delirium as documented in the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.

The two assessments will be completed independently by two clinicians. The order of the tests will be a randomised in a 1:1 ratio. The randomisation process will occur immediately after consent is obtained. During the assessment period, there will be no direct communication about the participant between the two clinicians, until both assessments are completed (other than to schedule the order of the tests). This is to ensure blinding of the assessment results. Given the fluctuating nature of delirium, the assessments will be completed within a maximum time period of 3 h, with a target time interval of 15 min.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. The accuracy of the 4AT in detecting delirium amongst hospice inpatients compared to the reference standard assessment centred on the DSM-5 criteria for delirium
2. The diagnostic accuracy of the 4AT assessed using specificity, sensitivity, positive and negative predictive values
Measured at a single study visit

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/01/2019

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Acutely admitted to a specialist palliative care inpatient unit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200-240 participants: the researchers are aiming to recruit 240 participants, across the 3 sites, allowing for two hundred participants with complete data suitable for analysis.

Participant exclusion criteria

1. Acute life-threatening illness requiring time-critical intervention
2. Coma
3. Unable to communicate in English. (The cognitive tests used have not been validated in non-English speakers, hence the study only includes patients who can communicate fluently in English.)
4. Severe dysphasia
5. Combined severe hearing and visual impairment, which would limit participation in the study’s tests
6. High level of patient and family distress, as judged by the clinical team

Recruitment start date

17/10/2019

Recruitment end date

31/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Marie Curie Hospice Edinburgh
45 Frogston Road West
Edinburgh
EH10 7DR
United Kingdom

Trial participating centre

Marie Curie Hospice Glasgow
Balornock Road
Glasgow
G21 3US
United Kingdom

Trial participating centre

St Columba's Hospice
15 Boswall Road
Edinburgh
EH5 3RW
United Kingdom

Sponsor information

Organisation

University of Edinburgh

Sponsor details

ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 3326
resgov@accord.scot

Sponsor type

University/education

Website

http://www.accord.scot

Funders

Funder type

Charity

Funder name

Marie Curie Cancer Care

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to submit the protocol for publication and plan to publish information from the study in a peer-reviewed medical journal and/or present at a conference.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/02/2020: Trial's existence confirmed by Scotland A Research Ethics Committee.