Protocol for validation of the 4AT, a rapid screening tool for delirium: a multicentre prospective diagnostic test accuracy study

Introduction: Delirium is a severe neuropsychiatric syndrome of rapid onset, commonly precipitated by acute illness. It is common in older people in the emergency department and acute hospital, but greatly under-recognised in these and other settings. Delirium and other forms of cognitive impairment, particularly dementia, commonly co-exist. There is a need for a rapid delirium screening tool that can be administered by a range of professional level healthcare staff to patients with sensory or functional impairments in a busy clinical environment, which also incorporates general cognitive assessment. We developed the ‘4As Test’ (4AT) for this purpose.

This study’s primary objective is to validate the 4AT against a reference standard. Secondary objectives include (a) comparing the 4AT with another widely used test (the Confusion Assessment Method (CAM)); b) determining if the 4AT is sensitive for general cognitive impairment; c) assessing if 4AT scores predict outcomes; including d) a health economic analysis.

Methods and analysis: 900 patients aged 70 or over in Emergency Departments or acute general medical wards will be recruited in three sites (Edinburgh, Bradford, Sheffield) over 18 months. Each patient will undergo a reference standard delirium assessment and will be randomised to assessment with either the 4AT or the CAM. At 12 weeks outcomes (length of stay, institutionalisation, and mortality) and resource utilisation will be collected by a questionnaire, and via the electronic patient record.

Ethics and dissemination: Ethical approval was granted in Scotland (Scotland A NHS Research Ethics Committee) and England (Yorkshire and the Humber NHS Research Ethics Committee). The study involves administering tests commonly used in clinical practice. The main ethical issues are the essential recruitment of people without capacity. Dissemination is planned via publication in high impact journals, presentation at conferences, social media and the website www.the4AT.com.

Registration details: International standard randomised controlled trial number (ISRCTN) 53388093. UK Clinical Research Network ID: 19502