Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 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

Rachna Begh  1 , Tim Coleman  2 , Lucy Yardley  3   4 , Rebecca Barnes  5 , Felix Naughton  6 , Hazel Gilbert  7 , Anne Ferrey  8 , Claire Madigan  8 , Nicola Williams  8 , Louisa Hamilton  8 , Yolanda Warren  8 , Jenna Grabey  8 , Miranda Clark  2 , Anne Dickinson  2 , Paul Aveyard  8
Affiliations
Comparative Study

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

Rachna Begh et al. Trials. .

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.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Planned participant flow through the trial
Fig. 2
Fig. 2
Schedule of study visits, procedures and assessments
See this image and copyright information in PMC

References

    1. Office for National Statistics: Adult smoking habits in the UK: 2018. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/....
    1. Action on Smoking and Health: The local costs of tobacco – ASH “Ready Reckoner”: 2018 Edition. 2018. Available from: http://ash.lelan.co.uk/.
    1. Godtfredsen NS, Vestbo J, Osler M, Prescott E. Risk of hospital admission for COPD following smoking cessation and reduction: a Danish population study. Thorax. 2002;57(11):967–972. doi: 10.1136/thorax.57.11.967. - DOI - PMC - PubMed
    1. Kanner RE, Anthonisen NR, Connett JE. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med. 2001;164(3):358–364. doi: 10.1164/ajrccm.164.3.2010017. - DOI - PubMed
    1. Jiang F, Chen M, Hu C, Bao Y, Jia W. Effects of active and passive smoking on chronic kidney disease in patients with type 2 diabetes mellitus. Zhonghua nei ke za zhi. 2014;53(11):858–864. - PubMed

Publication types