Clinical trial NCT04854616: Cessation of Smoking Trial in the Emergency Department
Official title: Cessation of Smoking Trial in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Electronic Cigarette Use
E-Cig Use
Vaping
Keywords: intervention
emergency department
e-cigarette
electronic cigarette
A&E
Accident and Emergency
vaping
behavioural intervention
stop smoking services
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
First posted: 2021-04-22
Enrollment: 987
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous smoking abstinence
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: 6 months after randomisation
measure: Number of quit attempts
timeFrame: Baseline and 6 months after randomisation
measure: Time to relapse (if applicable)
timeFrame: 6 months after randomisation
measure: Number of cigarettes per day
timeFrame: Baseline and 6 months after randomisation
measure: Nicotine dependence
timeFrame: Baseline and 6 months after randomisation
measure: Number of times using an e-cigarette per day
timeFrame: Baseline and 6 months after randomisation
measure: Self-reported dry cough or mouth or throat irritation
timeFrame: Baseline and 6 months after randomisation
measure: Motivation to stop smoking
timeFrame: Baseline and 6 months after randomisation
measure: Self-reported use of healthcare services in the last 3 months
timeFrame: Baseline and 6 months after randomisation
measure: Self-reported use of smoking cessation services in the last 3 months
timeFrame: Baseline and 6 months after randomisation
measure: Quality of Life questionnaire
timeFrame: Baseline and 6 months after randomisation
measure: Adverse events
timeFrame: 1, 3, and 6 months after randomisation
measure: Smoking status
timeFrame: 1, 3 & 6 months after randomisation
measure: Frequency of e-cigarette use in the past 6 months
timeFrame: 6 months after randomisation
measure: Long term follow-up 7-day point prevalence abstinence
timeFrame: Measured between 12 and 18 months post randomisation
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Ian Pope, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.