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Published in: Trials 1/2019

Open Access 01-12-2019 | Care | Study protocol

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

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

Published in: Trials | Issue 1/2019

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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.
Appendix
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Metadata
Title
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
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
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3850-1

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