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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

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
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
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
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 throughprimary 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 two months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at eight 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.
Smoking, Tobacco, Electronic Cigarettes, Cessation, Quitting, Addiction, Treatment, Primary Care
1745-6215
Begh, Rachna
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Coleman, Tim
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Yardley, Lucy
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Barnes, Rebecca
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Naughton, Felix
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Gilbert, Hazel
ac6d2ea2-4360-46f4-80b9-d1c5061dbbce
Ferrey, Anne
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Madigan, Claire
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Williams, Nicola
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Hamilton, Louisa
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Warren, Yolanda
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Grabey, Jenna
ae75693d-6da5-4834-bdcb-771ec029c256
Clark, Miranda
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Dickinson, Anne
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Aveyard, Paul
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Begh, Rachna
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Coleman, Tim
f35d7107-efec-4c58-a9f5-bbb9cd3ff35c
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Barnes, Rebecca
ff01993c-6ae3-4d1e-9ee0-30d0bc9d0720
Naughton, Felix
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Gilbert, Hazel
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Ferrey, Anne
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Madigan, Claire
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Williams, Nicola
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Hamilton, Louisa
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Warren, Yolanda
8c357c6a-e2a7-4461-8b7f-087b319896e5
Grabey, Jenna
ae75693d-6da5-4834-bdcb-771ec029c256
Clark, Miranda
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Dickinson, Anne
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Aveyard, Paul
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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 and Aveyard, Paul (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, [659]. (doi:10.1186/s13063-019-3850-1).

Record type: Article

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
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 throughprimary 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 two months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at eight 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.

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Accepted/In Press date: 25 October 2019
e-pub ahead of print date: 28 November 2019
Published date: 28 November 2019
Keywords: Smoking, Tobacco, Electronic Cigarettes, Cessation, Quitting, Addiction, Treatment, Primary Care

Identifiers

Local EPrints ID: 436889
URI: http://eprints.soton.ac.uk/id/eprint/436889
ISSN: 1745-6215
PURE UUID: 1f044fde-cf04-47b6-8cb0-b54ee7fb39e3
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

Catalogue record

Date deposited: 13 Jan 2020 17:32
Last modified: 17 Mar 2024 02:47

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Contributors

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

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