Cessation of Smoking Trial in the Emergency Department

Study Overview
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Brief Summary
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The Cessation of Smoking Trial in the Emergency Department (CoSTED) is an National Institute for Health Research (NIHR) Health Technology Assessment (HTA) funded randomised controlled trial (RCT). The research question is in people attending the Emergency Department who smoke, does a brief intervention (including the provision of an electronic cigarette (e-cigarette) and referral to stop smoking services) increase smoking cessation in comparison with usual care and is it cost effective? The trial includes an internal pilot, health economic evaluation and process evaluation. The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm. The sample size is 972 (486 in intervention and control) across 6 sites.

Detailed Description
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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? Background: Tobacco smoking is the leading cause of years of life lost in the United Kingdom (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. Patient and Public Involvement (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 National Health Service (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 Emergency Department (ED) setting in the UK, which potentially provides a highly motivating opportunistic route to intervention. Aims and objectives: To undertake an RCT, with internal pilot, comparing a brief intervention (including provision of an e-cigarette and referral to local smoking cessation services), assessing long term smoking abstinence, in people attending Emergency Departments. To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems 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 To undertake a cost effectiveness analysis of the intervention in comparison with usual care, from an NHS and personal social services (PSS) perspective To undertake an embedded mixed-methods process evaluation to assess delivery, implementation, fidelity and contamination Methods: Randomised Controlled Trial 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 validated by carbon monoxide monitoring with cut off of ≥8ppm. The sample size is 972 (with a power of 90% and a difference in quit rates between the groups of 6%). Anticipated impact and dissemination: The investigators 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.

Official Title
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Cessation of Smoking Trial in the Emergency Department

Conditions
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Smoking Cessation, Electronic Cigarette Use, E-Cig Use, Vaping

Intervention / Treatment
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* Behavioral: CoSTED Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years old who are current daily tobacco smokers Current daily tobacco smoker (self-reporting smoking of at least one cigarette per day) Attending the ED for medical treatment (or accompanying a patient attending for medical treatment) Submitting an expired carbon monoxide (CO) breath test reading of more than ≥8 parts per million (ppm). Exclusion Criteria: Requiring immediate medical treatment as defined by the treating clinician. In police custody. Known history of allergy to nicotine replacement products. Currently defined as dual users - already using an e-cigarette daily as well as smoking conventional cigarettes. Without the capacity to give informed consent for participation in the study Have taken part in the CoSTED trial already

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoSTED Intervention<br>CoSTED is an opportunistic smoking cessation intervention comprising three elements: brief smoking cessation advice the provision of an electronic cigarette (e-cigarette) and training in its use referral to stop-smoking services | Behavioral: CoSTED Intervention<br>* Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.<br>|
| No Intervention: Treatment as Usual<br>Signposting to NHS smoking cessation services through provision of written information about local services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous smoking abstinence | The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm.This is according to the Russell standard, stated as: continuous abstinence (Russell Standard) [ Time Frame: Six months post quit date ] Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide) | 6 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence | 7-day point prevalence abstinence, i.e. current smoking status, Self-report of having smoked no cigarettes (not even a puff) in the past seven days, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm | 6 months after randomisation | 
| Number of quit attempts | Numerical value | Baseline and 6 months after randomisation | 
| Time to relapse (if applicable) | (if applicable) | 6 months after randomisation | 
| Number of cigarettes per day | Numerical value | Baseline and 6 months after randomisation | 
| Nicotine dependence | At baseline & 6 month follow up, participants will be asked about their nicotine dependence using the Fagerstrom test for nicotine dependence | Baseline and 6 months after randomisation | 
| Number of times using an e-cigarette per day | Numerical value | Baseline and 6 months after randomisation | 
| Self-reported dry cough or mouth or throat irritation | This will be measures as a yes/no response for symptoms in the last week | Baseline and 6 months after randomisation | 
| Motivation to stop smoking | Motivation to Stop Smoking scale (MTSS) | Baseline and 6 months after randomisation | 
| Self-reported use of healthcare services in the last 3 months | At baseline & 6 month follow up, participants will be asked about their use of GP services in the past 3 months including number of times they have attended face-to-face and telephone appointments | Baseline and 6 months after randomisation | 
| Self-reported use of smoking cessation services in the last 3 months | At baseline & 6 month follow up, participants will be asked about their use of smoking cessation services in the past 3 months and number of times attended | Baseline and 6 months after randomisation | 
| Quality of Life questionnaire | At 6-month follow-up, quality of life will be assessed using EQ-5D-5L where a higher value equates to a lower quality of life (i,e. worse outcome) | Baseline and 6 months after randomisation | 
| Adverse events |  | 1, 3, and 6 months after randomisation | 
| Smoking status | This is the only outcome that will be asked at 1-month, 3-months and 6-months from randomisation. This will be a binary question of have you smoked even a single puff of a cigarette in the past 2 weeks- point prevalence abstinence | 1, 3 & 6 months after randomisation | 
| Frequency of e-cigarette use in the past 6 months | E-cigarette usage in the past 6 months | 6 months after randomisation | 
| Long term follow-up 7-day point prevalence abstinence | 7-day point prevalence abstinence, i.e. current smoking status, Self-report of having smoked no cigarettes in the past seven days | Measured between 12 and 18 months post randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A&E, intervention, emergency department, e-cigarette, electronic cigarette, Accident and Emergency, vaping, behavioural intervention, stop smoking services