Cessation of Smoking Trial in the Emergency Department (COSTED)

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Electronic Cigarette Use; Vaping; E-Cig Use
• Intervention / Treatment: Behavioral: CoSTED Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 972
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospitals Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
No Intervention: Treatment as Usual; Signposting to NHS smoking cessation services through provision of written information about local services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Smoking Abstinence	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)	6 months after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day Point Prevalence Abstinence	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	6 months after randomisation
Number of Quit Attempts	Numerical value	6 months after randomisation
Number of Cigarettes Per Day	Numerical value	6 months after randomisation
Nicotine Dependence	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.	6 months after randomisation
Number of Times Using an E-cigarette Per Day	Numerical value	6 months after randomisation
Self-reported Dry Cough or Mouth or Throat Irritation	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)	6 months after randomisation
Motivation to Stop Smoking	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)	6 months after randomisation
Adverse Events	The number of participants reporting serious adverse events.	6 months after randomisation
Smoking Status	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	1 month after randomisation
Smoking Status at 3 Months	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	3 months after randomisation
Smoking Status at 6 Months	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	6 months after randomisation

Collaborators and Investigators

• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Collaborators: University of East Anglia
• Investigators: Principal Investigator: Ian Pope, MD, Norfolk and Norwich University Hospitals Nhs Foundation Trust

Publications and helpful links

General Publications

• 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.
• Ward E, Belderson P, Clark A, Stirling S, Clark L, Pope I, Notley C. How do people quit smoking using e-cigarettes? A mixed-methods exploration of participant smoking pathways following receiving an opportunistic e-cigarette-based smoking cessation intervention. Addiction. 2024 Dec;119(12):2185-2196. doi: 10.1111/add.16633. Epub 2024 Sep 10.
• 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.

Helpful Links

• CoSTED trial web page
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Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: intervention; electronic cigarette; emergency department; e-cigarette; vaping; behavioural intervention; A&E; Accident and Emergency; stop smoking services
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Smoking; Health Behavior; Emergencies; Vaping; Smoking Cessation
• Other Study ID Numbers: R208399; NIHR129438 (Other Grant/Funding Number: NIHR HTA (UK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data underlying the main trial results will be available in a public, open access repository immediately following publication of the major findings of the study. Details of the repository and a persistent URL will be provided on publication of the main results. Study protocol, statistical analysis plan, informed consent form, and other documents will also be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No