CoSTED: Cessation of Smoking Trial in the Emergency Department

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04854616

Collaborator

University of East Anglia (Other)

972

Enrollment

Location

Arms

14.8

Anticipated Duration (Months)

65.6

Patients Per Site Per Month

Study Details

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	N/A

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.

To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems
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
To undertake a cost effectiveness analysis of the intervention in comparison with usual care, from an NHS and personal social services (PSS) perspective
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

Anticipated 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 :

Jan 4, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 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.

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

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 Outcome Measures

Time to relapse [6 months after randomisation]
(if applicable)
Number of cigarettes per day [6 months after randomisation]
Number of times using an e-cigarette per day [6 months after randomisation]
Self-reported dry cough [Baseline and 6 months after randomisation]
This will be measures as a yes/no response for symptoms of dry cough in the last week
Incidence of mouth or throat irritation [6 months after randomisation]
Self-reported use of General Practitioner (GP) services in the last 3 months [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
Self-reported use of smoking cessation services in the last 3 months [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
Quality of Life questionnaire [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)
Adverse events [6 months after randomisation]
Smoking status [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

Abstinence prevalence [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

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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).

Exclusion Criteria:

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