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Trials. 2019 Nov 28;20(1):659. doi: 10.1186/s13063-019-3850-1.

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.

Author information

1
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK. rachna.begh@phc.ox.ac.uk.
2
Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
3
Academic Unit of Psychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, SO17 1BJ, UK.
4
School of Experimental Psychology, University of Bristol, Bristol, BS8 1TU, UK.
5
Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
6
School of Health Sciences, University of East Anglia, Norwich, NR4 7UL, UK.
7
Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.
8
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.

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.

KEYWORDS:

Addiction; Cessation; Electronic cigarettes; Primary care; Quitting; Smoking; Tobacco; Treatment

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