Cessation of Smoking Trial in the Emergency Department (CoSTED)

• ClinicalTrials.gov Identifier: NCT04854616
• Recruitment Status: Recruiting
• First Posted: April 22, 2021
• Last Update Posted: March 2, 2022
• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Collaborator: University of East Anglia
• Information provided by (Responsible Party): Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation; Electronic Cigarette Use; E-Cig Use; Vaping	Behavioral: CoSTED Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 972 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cessation of Smoking Trial in the Emergency Department
• Actual Study Start Date: January 4, 2022
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Continuous smoking abstinence [ Time Frame: 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 Outcome Measures :

1. Time to relapse [ Time Frame: 6 months after randomisation ]
   (if applicable)
2. Number of cigarettes per day [ Time Frame: 6 months after randomisation ]
3. Number of times using an e-cigarette per day [ Time Frame: 6 months after randomisation ]
4. Self-reported dry cough [ Time Frame: Baseline and 6 months after randomisation ]
   This will be measures as a yes/no response for symptoms of dry cough in the last week
5. Incidence of mouth or throat irritation [ Time Frame: 6 months after randomisation ]
6. Self-reported use of General Practitioner (GP) services in the last 3 months [ Time Frame: Baseline & 6 months after randomisation ]
   At baseline & 6 month follow up, participants will be asked about their use of GP services in the past 3 months including number of times they have attended face-to-face and telephone appointments
7. Self-reported use of smoking cessation services in the last 3 months [ Time Frame: Baseline & 6 months after randomisation ]
   At baseline & 6 month follow up, participants will be asked about their use of smoking cessation services in the past 3 months and number of times attended
8. Quality of Life questionnaire [ Time Frame: 6 months after randomisation ]
   At 6-month follow-up, quality of life will be assessed using EQ-5D-5L where a higher value equates to a lower quality of life (i,e. worse outcome)
9. Adverse events [ Time Frame: 6 months after randomisation ]
10. Smoking status [ Time Frame: 1, 3 & 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

Other Outcome Measures:

1. Abstinence prevalence [ Time Frame: 1, 3 & 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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Ian Pope, MD; 01603 597191; i.pope@uea.ac.uk

Contact: Caitlin Notley, PhD; 01603 591275; c.notley@uea.ac.uk

Locations

United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust; Recruiting

Norwich, Norfolk, United Kingdom, NR4 7UY

Contact: Ian Pope, MD 01603 597191 i.pope@uea.ac.uk

Principal Investigator: Ian Pope, MD

Sponsors and Collaborators

Norfolk and Norwich University Hospitals NHS Foundation Trust

University of East Anglia

Investigators

• Principal Investigator: Ian Pope, MD; Norfolk and Norwich University Hospitals NHS Foundation Trust

More Information

• Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04854616
• Other Study ID Numbers: R208399; NIHR129438 ( Other Grant/Funding Number: NIHR HTA (UK) )
• First Posted: April 22, 2021
• Last Update Posted: March 2, 2022
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:

intervention; emergency department; e-cigarette; electronic cigarette; A&E; Accident and Emergency; vaping; behavioural intervention; stop smoking services

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes