Cessation of Smoking Trial in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 972
- 试验地点
- 1
- 主要终点
- Continuous smoking abstinence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
CoSTED Intervention
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
干预措施: CoSTED Intervention (Behavioral)
Treatment as Usual
Signposting to NHS smoking cessation services through provision of written information about local services.
结局指标
主要结局
Continuous smoking abstinence
时间窗: 6 months after randomisation
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)
Continuous Smoking Abstinence
时间窗: 6 months after randomisation
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)
次要结局
- Time to relapse (if applicable)(6 months after randomisation)
- Number of times using an e-cigarette per day(Baseline and 6 months after randomisation)
- Motivation to stop smoking(Baseline and 6 months after randomisation)
- Frequency of e-cigarette use in the past 6 months(6 months after randomisation)
- Number of quit attempts(Baseline and 6 months after randomisation)
- 7-day point prevalence abstinence(6 months after randomisation)
- Number of cigarettes per day(Baseline and 6 months after randomisation)
- Nicotine dependence(Baseline and 6 months after randomisation)
- Self-reported use of healthcare services in the last 3 months(Baseline and 6 months after randomisation)
- Adverse events(1, 3, and 6 months after randomisation)
- Smoking status(1, 3 & 6 months after randomisation)
- Self-reported dry cough or mouth or throat irritation(Baseline and 6 months after randomisation)
- Self-reported use of smoking cessation services in the last 3 months(Baseline and 6 months after randomisation)
- Quality of Life questionnaire(Baseline and 6 months after randomisation)
- Long term follow-up 7-day point prevalence abstinence(Measured between 12 and 18 months post randomisation)
- 7-day Point Prevalence Abstinence(6 months after randomisation)
- Number of Quit Attempts(6 months after randomisation)
- Number of Cigarettes Per Day(6 months after randomisation)
- Nicotine Dependence(6 months after randomisation)
- Number of Times Using an E-cigarette Per Day(6 months after randomisation)
- Self-reported Dry Cough or Mouth or Throat Irritation(6 months after randomisation)
- Motivation to Stop Smoking(6 months after randomisation)
- Adverse Events(6 months after randomisation)
- Smoking Status(1 month after randomisation)
- Smoking Status at 3 Months(3 months after randomisation)
- Smoking Status at 6 Months(6 months after randomisation)