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ToolsPope, Ian, Clark, Lucy, Clark, Allan, Ward, Emma, Belderson, Pippa, Stirling, Susan, Parrott, Steve, Li, Jinshuo, Coats, Timothy, Bauld, Linda, Holland, Richard, Gentry, Sarah, Agrawal, Sanjay, Bloom, Benjamin, Boyle, Adrian, Gray, Alastair M., Morris, Geraint and Notley, Caitlin (2024) Cessation of smoking in people attending UK Emergency departments: the COSTED RCT with economic and process evaluation. Health Technology Assessment. ISSN 1366-5278 (In Press)
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Microsoft Word (OpenXML) (COSTED synopsis 27.9.24 PURE)
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Abstract
Background: the Emergency Department (ED) represents a potentially valuable opportunity to support smoking cessation. Evidence is lacking around the use of e-cigarettes in opportunistic settings like the ED. Objective: to undertake a randomised controlled trial in people who smoke attending UK Emergency departments, testing a brief intervention which included provision of an e-cigarette vs. signposting to smoking cessation services; assessing smoking abstinence. Design: a two-arm pragmatic, multicentre, parallel-group, individually randomised, controlled superiority trial with an internal pilot, economic evaluation and mixed methods process evaluation Setting: six Emergency Departments across England and Scotland. Participants: adults who smoked daily, who were attending the ED for medical treatment or accompanying someone attending for medical treatment, were invited to participate. People were excluded if they had an expired carbon monoxide (CO) of less than 8 parts per million, required immediate medical treatment, were in police custody, had a known allergy to nicotine, were daily e-cigarette users, were considered not to have capacity to consent or had already taken part in the trial. Intervention: brief stop smoking advice, e-cigarette starter kit and referral to stop smoking services. Main outcome measures: the primary outcome was biochemically validated sustained abstinence at six months. Those lost to follow-up, or not providing biochemical verification were considered not to be abstinent. Secondary outcomes were: self-reported seven day smoking abstinence, number of quit attempts, number of cigarettes per day, nicotine dependence and incidence of self-reported dry cough or mouth or throat irritation. Results: at six months, of 972 participants randomised, biochemically verified smoking abstinence was 7.2% in the intervention group and 4.1% in the control group (percentage difference = 3.3% (95% CI 0.3 to 6.3; p= 0.032) (RR 1.76 [95% CI 1.03 to 3.01]). Self-reported 7-day abstinence at 6 months was 23.3% in the intervention group and 12.9% in the control group (percentage difference = 10.6% (95% CI 5.86 to 15.41; pLimitations: the inability to blind participants or researchers, the relatively low level of biochemical verification due to the nature of the population recruited and the fact those in the control group did not receive usual care. Conclusions: an opportunistic smoking cessation intervention comprising brief advice, an e-cigarette starter kit and referral to stop smoking services is effective for sustained smoking abstinence with few reported adverse events.. Future work: future work will include testing other behaviour change interventions in the Emergency Department and adapting the COSTED intervention for other settings. Study registration: ClinicalTrials.gov number, NCT04854616 Funding details: this project was funded by the National Institute for Health and Care Research (NIHR) HTA programme and will be published in XXX Journal; Vol. XX, No. XX. See the NIHR Journals Library website for further project information.
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