Cessation of Smoking Trial in the Emergency Department
Condition: Smoking Cessation; Electronic Cigarette Use; E-Cig Use; Vaping
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      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: 
      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.

        1. To run an internal pilot study, with clear stop/go criteria, primarily to test
           recruitment systems

        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

        3. To undertake a cost effectiveness analysis of the intervention in comparison with usual
           care, from an NHS and personal social services (PSS) perspective

        4. 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.
    

Intervention name(s): CoSTED Intervention
Intervention type(s): Behavioral
Intervention description(s): Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intervention; emergency department; e-cigarette; electronic cigarette; A&E; Accident and Emergency; vaping; behavioural intervention; stop smoking services