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Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial

Begh, Rachna; Coleman, Tim; Yardley, Lucy; Barnes, Rebecca; Naughton, Felix; Gilbert, Hazel; Ferrey, Anne; Madigan, Claire; Williams, Nicola; Hamilton, Louisa; Warren, Yolanda; Grabey, Jenna; Clark, Miranda; Dickinson, Anne; Aveyard, Paul

Authors

Rachna Begh

Tim Coleman

Lucy Yardley

Rebecca Barnes

Felix Naughton

Hazel Gilbert

Anne Ferrey

Claire Madigan

Nicola Williams

Louisa Hamilton

Yolanda Warren

Jenna Grabey

Miranda Clark

Anne Dickinson

Paul Aveyard



Abstract

Background: Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking.

Methods/design: This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme.

Discussion: This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI.

Trial registration: ISRCTN registry, ISRCTN59404712. Registered 28/11/17.

Journal Article Type Article
Publication Date 2019-12
Journal Trials
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 20
Issue 1
Article Number 659
APA6 Citation Begh, R., Coleman, T., Yardley, L., Barnes, R., Naughton, F., Gilbert, H., …Aveyard, P. (2019). Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial. Trials, 20(1), https://doi.org/10.1186/s13063-019-3850-1
DOI https://doi.org/10.1186/s13063-019-3850-1
Keywords Medicine (miscellaneous); Pharmacology (medical)
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3850-1#citeas
Additional Information Received: 30 April 2019; Accepted: 25 October 2019; First Online: 28 November 2019; : The study gained approval from the National Research Ethics Committee Wales REC 4 (REC reference: CitationRef removed/WA/0352) and Health Research Authority (HRA). The CI will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. The CI will ensure that this study is conducted in accordance with relevant regulations and with Good Clinical Practice.Written versions of the participant information and informed consent forms will be re-presented to participants at the baseline visit by the study researcher, detailing no less than: the nature of the study; what it will involve for the participant; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, without affecting their legal rights, and with no obligation to give the reason for withdrawal.The participant will be allowed as much time as wished to consider the information, and the opportunity to question the Investigator, their GP or other independent parties to decide whether they will participate in the study. Written informed consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the informed consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorised to do so by the chief investigator. A copy of the signed informed consent will be given to the participant, a copy will be retained at the study site and the original signed form will be stored securely at the University of Oxford.Verbal consent will be obtained for interviews conducted over the telephone with practitioners and members of the vape team and recorded on an audio consent script. The PIS will be sent to participants in advance of the interview when they are invited to take part. A copy of the audio consent form will be sent to participants.As the true nature of the study is disguised from participants, the study team will post a letter to or email participants to explain the true nature and scope of the study after they have completed their 8-month follow up. Participants will be given the option to withdraw their data by notifying the study team within 7 days of receiving the letter/email.; : Not applicable.; : The authors declare that they have no competing interests.

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Copyright Statement
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/)





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