Title: Examining the effectiveness of GP and nurse promotion of e-cigarettes in supporting reduced smoking and abstinence in hardcore smokers with smoking-related chronic disease (ERASE)
Funder: Department of Health and Social Care

Abstract: Background Many clinicians recognise the frustration of offering the same help repeatedly to people who continue smoking despite smoking-related chronic illnesses only to elicit the same refusal. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet GPs are repeatedly mandated to offer these by the Quality and Outcomes Framework in annual reviews. Electronic cigarettes (e-cigarettes) are now the most commonly used cessation aid but their use is contested. Although there is unanimity that e-cigarettes are less harmful than tobacco cigarettes, scare stories' put off hardened smokers trying e-cigarettes. Clinicians have no clear guidance on what advice to give to their patients about e-cigarettes. Aims I propose to examine the feasibility and early evidence of effectiveness of primary care clinicians offering an e-cigarette starter pack and encouragement to smokers to switch from tobacco to partial use of e-cigarettes if the patient again declines help to stop smoking. The eventual product of this research would be an application for a full-scale trial to examine the effectiveness of clinicians encouraging use of e-cigarettes in promoting cessation. However, the intervention needs to be developed and tested in a feasibility trial and show proof of concept first. Plan of investigation This fellowship is formed of three research streams. The first stream involves developing the intervention. I will review the literature to assess how practitioners and smokers view e-cigarettes and conduct qualitative interviews with GPs and nurses to understand their knowledge, perceptions and attitudes towards e-cigarettes and provision to hardcore smokers. The findings will inform the development of an online training programme for practitioners on offering brief advice and encouragement to use e-cigarettes for hardcore smokers with no intention of stopping smoking. Practitioners and smokers will provide feedback on the training during development. New and experienced e-cigarette users will assist in developing written materials, a peer-led online forum, and provide a telephone support line to offer technical support and general encouragement in the use of e-cigarettes. The second stream will involve feasibility testing of the intervention, as well as gaining a preliminary evidence of effectiveness in a randomised controlled trial. I will recruit 160 smokers with specified smoking-related illness immediately prior to the start of a new round of the GP pay-for-performance scheme. GPs and nurses will be trained using the online training programme to offer e-cigarettes to people who decline help to stop smoking. I will follow-up participants two months after their consultation. Feasibility outcomes are whether smokers who have no desire to stop can be recruited to a smoking study' and whether they can be followed-up. I will assess whether patients will take-up and use e-cigarettes in sufficient numbers to give a realistic prospect of detecting differences in cessation in the definitive trial, but the trial is powered to give preliminary evidence of short-term effectiveness for proof of concept. The third research stream involves a process evaluation of whether clinicians can be trained to offer appropriately-balanced advice about e-cigarettes and whether they implement this in a randomised trial in routine practice. Benefits to patients and NHS If practitioners can be trained in this way to offer advice about e-cigarettes and patients take up this offer, patients at high risk of increased morbidity and mortality from smoking could be helped to reduce their smoke intake and increase their chances of quitting. For almost all these specified smoking-related conditions, stopping smoking would be the single most effective way to improve health for patients and is likely to reduce health service costs.

Lay abstract: Many people with illness caused by smoking continue smoking despite being regularly offered help to quit by their GPs. They have tried and exhausted regular medications to stop and so their health deteriorates because of smoking. Electronic cigarettes, known as e-cigarettes', are increasingly used by smokers not seeking treatment, many of whom reduce smoking and stop without initially intending to do so. Research tells us that people smoke for nicotine but it is the tar in cigarette smoke not the nicotine that damages health. Providing nicotine by e-cigarettes, which feel like smoking, probably reduces harm and the evidence suggests it helps people reduce the number of cigarettes they smoke and stop smoking. GPs and nurses do not currently offer e-cigarettes as a treatment option for people who have tried or refused other treatments for stopping smoking. They have no clear guidance on what advice to give patients about e-cigarettes, despite being frequently asked about them. Little is known about the type of information being communicated by GPs and nurses to patients about e-cigarettes and the impact this has on patients' use of them. If GPs and nurses are trained to give appropriate advice and offer e-cigarettes to people who are reluctant to quit, this might encourage smokers to try e-cigarettes, reduce their smoking and eventually stop smoking altogether. The aim of this research is to develop and test a new approach to help people who have smoking-related illnesses and cannot stop smoking switch to e-cigarettes. The first step in this research is to develop a training programme that will give GPs and nurses up-to-date information about e-cigarettes and teach them how to offer and encourage their use in patients who do not want to stop smoking. To do this, I will search the literature on e-cigarettes and put together the evidence on what is known about them. I will interview GPs and nurses about how they feel about e-cigarettes and identify any concerns they have in offering them to patients so that these issues are addressed in the training. These findings will be used to build a website to deliver the training programme to GPs and nurses online. I will work with GPs and nurses, e-cigarette users and smokers to develop, test and make changes to the website based on their feedback. People who use e-cigarettes often require practical support in how to use them. I will work with experienced e-cigarette users to develop leaflets, a website with an online help forum and a telephone call-back service for smokers who require help on how to use e-cigarettes. I will test these resources in smokers who have never used e-cigarettes and make changes based on their feedback. The training programme will then be used in a study to investigate whether GPs and nurses can be trained to give advice and offer e-cigarettes to smokers who do not want to stop but have illnesses caused by smoking. The study will look at whether smokers who have refused other treatments for stopping smoking would be happy to take part in the study and use e-cigarettes if they are recommended to do so by their GP or nurse. The study will also look at whether more people stop or halve their smoking in the short-term. Consultations will be recorded to see how well the GPs and nurses followed the training and to understand which communication strategies worked well in motivating patients to try and use an e-cigarette. I will interview patients after they have taken part in the study to see how they felt about being offered an e-cigarette by their GP or nurse. Members of the public have given advice on the design of the study. They suggested the best way to approach people to participate in the study and emphasised the importance of expert help on how to use e-cigarettes. Experienced e-cigarette users and former smokers will work with us in delivering the technical support to people who try using e-cigarettes for the first time. If I find that it is possible to recruit people and follow them up, that doctors and nurses give good advice and people use e-cigarettes to reduce or stop, I will plan a larger study to investigate whether GPs promoting e-cigarettes to smokers with smoking-related diseases helps people stop smoking in the long-term. This research will produce guidance and resources for GPs and nurses on how to treat smokers who do not want help to stop smoking and are at high risk of harm from continued smoking.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE