Title: Cessation of Smoking Trial in the Emergency Department (CoSTED)
Funder: Department of Health and Social Care

Abstract: Smoking is the main cause of death and illness in the UK. When patients come into contact with the NHS there is a valuable opportunity to help them to stop smoking. Doctors in the United States have tested delivering stop smoking advice to patients in the Emergency Department and have found it sometimes improves the number of people who quit, but no studies have tried this approach in the UK. Along with providing brief stop smoking advice, offering patients a ‘starter pack’ e-cigarette, could be introduced to patients attending the Emergency Department to support a quit attempt. Evidence suggest these are likely to be more effective and popular than other stop smoking aids. _x000D_ _x000D_ The study will be run in two parts. First we will do a smaller study to understand whether it is practical to carry out a larger study. We will ask adult smokers who attend the Emergency Department whether they would agree to take part. Those who say yes, will then be assigned to one of two groups: stop smoking advice with the offer of a ‘starter pack’ e-cigarette OR given information about locally available stop smoking services. Each participant will have an equal chance of being in either group, this will be decided randomly (as if by the throw of a dice). Both sets of patients will be asked if they are still smoking at 1, 3 and 6 months after they attended the Emergency Department. At 6 months if patients in either group say they have quit smoking this will be confirmed by checking the amount of carbon monoxide (a gas you inhale from cigarettes) they breathe out using a breath test monitor. Patients will be given a voucher as a thank you for taking part in the trial. We will establish clear criteria to judge whether we should go ahead with the larger study. If we do, we will continue recruitment across five hospital Emergency Departments and follow the same approach._x000D_ _x000D_ Overall, we will aim to recruit approximately 1,000 patients who are current smokers. Once the trial has finished the number of people who quit smoking in each group will be compared. We will also work out how much it costs to advise people to quit smoking in the Emergency Department, and the cost of the e-cigarettes given out. We will ask some of the people who took part how they felt about taking part and why they quit smoking if they did, or why they did not quit if they did not. _x000D_ _x000D_ Involving patients and members of the public has been key to the design of this study and advising on practical aspects. Working with the UEA Addiction Research group Public Involvement Panel, we will establish a patient representative group to help oversee delivery. Two named members of the public will work closely with us to oversee management of the trial. We will share our findings with academics, medical professionals and members of the public.

Lay abstract: Research question: In people attending the Emergency Department who smoke does a brief intervention (including the provision of an e-cigarette and referral to stop smoking services) increase smoking cessation in comparison with usual care and is it cost effective? _x000D_ _x000D_ Background: Tobacco smoking is the leading cause of years of life lost in the UK, and negatively impacts significantly on physical health conditions and recovery outcomes from injury or surgery. Currently, smoking prevalence is recorded at approximately 15% of the population, but this masks substantial variation between different population groups. PPI development work demonstrates that prevalence of smoking for people attending the emergency department is approximately 24%. Most current smokers will, if asked, state that they want to quit, but need support. The NHS long term plan and the Tobacco control plan for England recommend smokers are supported to quit at every contact with the health service by 2023/4. To date there have been no RCTs of smoking cessation support in the ED setting in the UK, which potentially provides a highly motivating opportunistic route to intervention._x000D_ _x000D_ Aims and objectives: To undertake a randomised controlled trial (RCT), with internal pilot, comparing a brief intervention (including provision of an e-cigarette and referral to smoking cessation services), assessing long term smoking abstinence, in people attending Emergency Departments. _x000D_ 1. To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems. _x000D_ 2. To definitively test real-world effectiveness of an ED based smoking cessation intervention in comparison with usual care, by comparing smoking abstinence at 6 month follow-up between trial groups. _x000D_ 3. To undertake a cost effectiveness analysis of the intervention in comparison with usual care, from an NHS and personal social services (PSS) perspective._x000D_ 4.To undertake an embedded mixed-methods process evaluation to assess delivery, implementation, fidelity and contamination._x000D_ _x000D_ Methods: RCT of people who smoke attending an Emergency Department, with an internal pilot, health economic evaluation and process evaluation. The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically confirmed at 6 months. The sample size is 972 (with a power of 90% and a difference in quit rates between the groups of 6%)._x000D_ _x000D_ Start date 01/04/2021. Total duration 30 months: 31/09/2023_x000D_ Trial set up- 01/04/2021 – 30/09/2021 (6 months)_x000D_ Recruitment- 01/10/2021 – 30/09/2022 (12 months)_x000D_ Follow up- 01/11/2021 – 31/03/2023 (6 months from last month of recruitment)_x000D_ Analysis- 01/04/2023 – 31/07/2023 (4 months)_x000D_ Dissemination- 01/08/2023 – 30/09/2023 (2 months)_x000D_ _x000D_ Anticipated impact and dissemination: We will definitively test an ED based smoking cessation intervention and make recommendations for future implementation if effective. The intervention has the potential to reduce smoking prevalence by at least 6% based on existing evidence, impacting on improved long term health outcomes for approximately 334,000 members of the UK population if adopted across the NHS. Results will be disseminated at international conferences and published in leading journals to reach academic experts, through NHS networks and the Royal College of Emergency Medicine to reach commissioners, managers and members of the public.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE