E-Cig Use, Electronic Cigarette Use, Smoking Cessation, Vaping
Conditions
Keywords
intervention, emergency department, e-cigarette, electronic cigarette, A&E, Accident and Emergency, vaping, behavioural intervention, stop smoking services
Brief 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.
Interventions
Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adults ≥18 years old who are current daily tobacco smokers 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
1. Requiring immediate medical treatment as defined by the treating clinician. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Smoking Abstinence | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Abstinence | 6 months after randomisation | 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 |
| Number of Quit Attempts | 6 months after randomisation | Numerical value |
| Number of Cigarettes Per Day | 6 months after randomisation | Numerical value |
| Nicotine Dependence | 6 months after randomisation | Measured by using the Fagerstrom test for nicotine dependence. 1-2= low dependence, 3-4 low to moderate dependence, 5-7= moderate dependence, 8-10= high dependence. Minimum score is 1 and maximum score is 10. |
| Number of Times Using an E-cigarette Per Day | 6 months after randomisation | Numerical value |
| Self-reported Dry Cough or Mouth or Throat Irritation | 6 months after randomisation | This will be measures on symptoms in the last week on a scale of 1-5, 1= not at all (best score) to 5= extremely (worst score) |
| Motivation to Stop Smoking | 6 months after randomisation | Motivation to Stop Smoking scale 1-7. 1= no motivation to stop smoking (worst score) 7= motivate to stop in the next month (best score) |
| Adverse Events | 6 months after randomisation | The number of participants reporting serious adverse events. |
| Smoking Status | 1 month after 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 |
| Smoking Status at 3 Months | 3 months after randomisation | 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 |
| Smoking Status at 6 Months | 6 months after randomisation | 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 |
Countries
United Kingdom
Contacts
Norfolk and Norwich University Hospitals NHS Foundation Trust
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.50 years STANDARD_DEVIATION 13.65 |
| Carbon monoxide concentration | 488 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 64 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Race (NIH/OMB) White | 825 Participants |
| Sex: Female, Male Female | 187 Participants |
| Sex: Female, Male Male | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 310 | 0 / 292 |
| other Total, other adverse events | 23 / 310 | 20 / 292 |
| serious Total, serious adverse events | 25 / 310 | 25 / 292 |