Cessation of Smoking Trial in the Emergency Department (CoSTED): protocol for a multicentre randomised controlled trial

Introduction: Attendees of Emergency departments (ED) have a higher than expected prevalence of smoking. ED attendance may be a good opportunity to prompt positive behaviour change, even for smokers not currently motivated to quit. This study aims to determine whether an opportunist smoking cessation intervention delivered in the ED can help daily smokers attending the ED quit smoking and is cost-effective. Methods and analysis: A two-arm pragmatic, multicentred, parallel-group, individually randomised, controlled superiority trial with an internal pilot, economic evaluation and mixed methods process evaluation. The trial will compare ED-based brief smoking cessation advice, including provision of an e-cigarette and referral to local stop-smoking services (intervention) with the provision of contact details for local stop-smoking services (control). Target sample size is 972, recruiting across six National Health Service (NHS) EDs in England and Scotland. Outcomes will be collected at one, three and six months. The primary outcome at 6 months is Carbon Monoxide (CO) verified continuous smoking abstinence. Ethics and dissemination: The trial was approved by the South Central – Oxford B Research Committee (21/SC/0288). Dissemination will include the publication of outcomes, and the process and economic evaluations in peer reviewed journals. The findings will also be appropriately disseminated to relevant practice, policy and patient representative groups. Trial registration number: NCT04854616; protocol version 4.