search
Back to results

Cessation of Smoking Trial in the Emergency Department (CoSTED)

Primary Purpose

Smoking Cessation, Electronic Cigarette Use, E-Cig Use

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CoSTED Intervention
Sponsored by
Norfolk and Norwich University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring intervention, emergency department, e-cigarette, electronic cigarette, A&E, Accident and Emergency, vaping, behavioural intervention, stop smoking services

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CoSTED Intervention

Treatment as Usual

Arm Description

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

Signposting to NHS smoking cessation services through provision of written information about local services.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Number of quit attempts
Numerical value
Time to relapse (if applicable)
(if applicable)
Number of cigarettes per day
Numerical value
Nicotine dependence
At baseline & 6 month follow up, participants will be asked about their nicotine dependence using the Fagerstrom test for nicotine dependence
Number of times using an e-cigarette per day
Numerical value
Self-reported dry cough or mouth or throat irritation
This will be measures as a yes/no response for symptoms in the last week
Motivation to stop smoking
Motivation to Stop Smoking scale (MTSS)
Self-reported use of healthcare services in the last 3 months
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
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
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
Smoking status
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

Full Information

First Posted
March 26, 2021
Last Updated
November 4, 2022
Sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborators
University of East Anglia
search

1. Study Identification

Unique Protocol Identification Number
NCT04854616
Brief Title
Cessation of Smoking Trial in the Emergency Department
Acronym
CoSTED
Official Title
Cessation of Smoking Trial in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborators
University of East Anglia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
972 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CoSTED Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Signposting to NHS smoking cessation services through provision of written information about local services.
Intervention Type
Behavioral
Intervention Name(s)
CoSTED Intervention
Intervention Description
Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
Primary Outcome Measure Information:
Title
Continuous smoking abstinence
Description
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)
Time Frame
6 months after randomisation
Secondary Outcome Measure Information:
Title
7-day point prevalence abstinence
Description
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
Time Frame
6 months after randomisation
Title
Number of quit attempts
Description
Numerical value
Time Frame
Baseline and 6 months after randomisation
Title
Time to relapse (if applicable)
Description
(if applicable)
Time Frame
6 months after randomisation
Title
Number of cigarettes per day
Description
Numerical value
Time Frame
Baseline and 6 months after randomisation
Title
Nicotine dependence
Description
At baseline & 6 month follow up, participants will be asked about their nicotine dependence using the Fagerstrom test for nicotine dependence
Time Frame
Baseline and 6 months after randomisation
Title
Number of times using an e-cigarette per day
Description
Numerical value
Time Frame
Baseline and 6 months after randomisation
Title
Self-reported dry cough or mouth or throat irritation
Description
This will be measures as a yes/no response for symptoms in the last week
Time Frame
Baseline and 6 months after randomisation
Title
Motivation to stop smoking
Description
Motivation to Stop Smoking scale (MTSS)
Time Frame
Baseline and 6 months after randomisation
Title
Self-reported use of healthcare services in the last 3 months
Description
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
Time Frame
Baseline and 6 months after randomisation
Title
Self-reported use of smoking cessation services in the last 3 months
Description
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
Time Frame
Baseline and 6 months after randomisation
Title
Quality of Life questionnaire
Description
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)
Time Frame
Baseline and 6 months after randomisation
Title
Adverse events
Time Frame
1, 3, and 6 months after randomisation
Title
Smoking status
Description
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
Time Frame
1, 3 & 6 months after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Pope, MD
Organizational Affiliation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Cessation of Smoking Trial in the Emergency Department

We'll reach out to this number within 24 hrs