Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
987 participants
INTERVENTIONAL
2022-01-04
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CoSTED Intervention
CoSTED is an opportunistic smoking cessation intervention comprising three elements:
1. brief smoking cessation advice
2. the provision of an electronic cigarette (e-cigarette) and training in its use
3. referral to stop-smoking services
CoSTED Intervention
Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
Treatment as Usual
Signposting to NHS smoking cessation services through provision of written information about local services.
No interventions assigned to this group
Interventions
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CoSTED Intervention
Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
Eligibility Criteria
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Inclusion Criteria
2. Current daily tobacco smoker (self-reporting smoking of at least one cigarette per day)
3. Attending the ED for medical treatment (or accompanying a patient attending for medical treatment)
4. Submitting an expired carbon monoxide (CO) breath test reading of more than ≥8 parts per million (ppm).
Exclusion Criteria
2. In police custody.
3. Known history of allergy to nicotine replacement products.
4. Currently defined as dual users - already using an e-cigarette daily as well as smoking conventional cigarettes.
5. Without the capacity to give informed consent for participation in the study
6. Have taken part in the CoSTED trial already
18 Years
100 Years
ALL
Yes
Sponsors
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University of East Anglia
OTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Ian Pope, MD
Role: PRINCIPAL_INVESTIGATOR
Norfolk and Norwich University Hospitals NHS Foundation Trust
Locations
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Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Countries
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References
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Notley C, Clark L, Belderson P, Ward E, Clark AB, Parrott S, Agrawal S, Bloom BM, Boyle AA, Morris G, Gray A, Coats T, Man MS, Bauld L, Holland R, Pope I. Cessation of smoking trial in the emergency department (CoSTED): protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Jan 18;13(1):e064585. doi: 10.1136/bmjopen-2022-064585.
Pope I, Clark LV, Clark A, Ward E, Belderson P, Stirling S, Parrott S, Li J, Coats T, Bauld L, Holland R, Gentry S, Agrawal S, Bloom BM, Boyle AA, Gray AJ, Morris MG, Livingstone-Banks J, Notley C. Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial. Emerg Med J. 2024 Apr 22;41(5):276-282. doi: 10.1136/emermed-2023-213824.
Belderson P, Ward E, Pope I, Notley C. Selecting an e-cigarette for use in smoking cessation interventions and healthcare services: findings from patient and public consultation for the COSTED trial. BMJ Open. 2024 Mar 4;14(3):e078677. doi: 10.1136/bmjopen-2023-078677.
Related Links
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CoSTED trial web page
Other Identifiers
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NIHR129438
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R208399
Identifier Type: -
Identifier Source: org_study_id