Tailored interventions to assist smokers to stop smoking using e-cigarettes (TASSE)

Although smoking in the UK is declining in prevalence, it remains one of the largest avoidable causes of death and disease (96,000 deaths per year). A reduction in this figure is a key government aim. E-cigarettes (EC) are now the most popular method for quitting smoking. However, about half of smokers who try EC (also known as 'vaping') don't continue to use them because they are not satisfying enough. Vapers often say that finding the right device, nicotine strength and flavour are essential for stopping smoking and many vape shops offer some support to help smokers stop smoking by switching to vaping. However, not all smokers want to buy an e-cigarette from a vape shop and sometimes the type of advice can be confusing or overwhelming. Online stores offer even less help for smokers trying to switch. This study will test the effectiveness of a novel, scalable digital intervention that could increase the number of smokers who purchase an EC online to switch to vaping in order to stop smoking completely. The intervention would be compared to what smokers usually do - i.e. making their own choice about what to purchase.

Our previous work has helped us to identify promising approaches that might help smokers to switch to vaping. These could all be easily used in an online environment so that they could help more smokers. These are individual (tailored) advice on choice of: (1) device; (2) nicotine strength; and (3) flavour. We would also look at the effect of (4) written information around the reduced harm of vaping compared to smoking and (5) technical and behavioural support for stopping smoking which would be sent by mobile phone text messages. The EC text messages will developed as part of this project, and written information will be adapted from material we are already using in other studies. Both will be developed with smokers and vapers known to us. Using a method known as the multiphase optimisation strategy (which allows us to test the effects of a large number of treatments separately) we will provide proof of principle for the intervention package, and also identify which parts of it work best, and in which combinations.

We will recruit 1184 smokers who are interested in stopping smoking. Participants will follow a link to the study website and will answer a set of initial questions about themselves and their smoking. They will then be randomised to receive any combination of the five treatments, each linked to advice (depending on how they answered the initial questions). This advice will be presented to them via the study webpage and email. For example, if a participant was allocated to a combination that included both 'Tailored advice on device choice' and 'Tailored advice on nicotine strength', they would receive a recommendation about which device and nicotine strength to order. They would not receive information on flavour, written information or text messages. The recommendation would include direct links to the online store where products would appear in their shopping basket. All participants would be given a voucher with a unique number that would give them a free first purchase. This code would also allow us to see what purchase they made. After 3-months we will re-contact all participants and ask them about their smoking and vaping and how helpful the recommendation was.

As well as providing important evidence in its own right, we will use the information from this study to decide whether a larger and more focussed trial is worthwhile and, if so, which treatment elements to include. If we do run the larger trial, we will look at whether a refined package is a useful way of helping smokers to stop smoking completely by switching to vaping and how expensive it is. If the larger trial finds the approaches are effective, they could easily be included on websites and online vape stores globally.

The primary objective of this early phase study is to determine which of five, or a combination of, interventions is associated with the greatest proportion of smokers who are abstinent from smoking at 12-weeks post-randomisation. The final optimised intervention can then be examined in a future main study RCT with long-term outcomes. We will use the multiphase optimisation strategy (MOST) to gather evidence regarding a number of promising components (tailored advice on choice of: 1. device, 2. nicotine concentration, 3. flavour, 4. written information on EC around reduced harm; 5. technical and smoking cessation behavioural support delivered via text messages) to facilitate smoking cessation using EC that could be easily implemented in a digital environment. These will be compared to what smokers usually do - i.e. make their own choice about what to purchase. The study utilises a 2x2x2x2x2 factorial design resulting in 32 experimental conditions. Each intervention would be provided or not (on or off) to each of N=1184 smokers. Participants will complete a baseline online survey about their smoking habits before being randomised to one of the conditions. Each condition would be linked to tailored advice presented to participants on the study webpage and via email. For example, if a participant was allocated to the condition that included 'Tailored advice on device' and 'Tailored advice on nicotine' both ON, they would receive a personalised recommendation on device and nicotine strength, based on baseline questions responses. This recommendation would include direct links to the online store where the products would appear in their shopping basket. After 4 weeks and again at 3-months, we will re-contact all participants and ask them about their smoking and vaping. We will use multivariable logistic regression to model the primary outcome, (abstinence at 12-weeks). The model will include the main effects for each of the five interventions and their interactions.

Understanding, evaluating and implementing components that can increase the effectiveness of EC for smoking cession is important as it helps to address a key public health objective of reducing death and disease caused by smoking. Ultimately the work could have a positive impact on health and wealth by significantly reducing smoking rates, negative health outcomes and associated costs to the NHS. Healthier staff also help businesses to operate efficiently, enhancing customer satisfaction and increasing revenue.

Should an optimised intervention with proven efficacy emerge from the work, a key benefit would be its scalable nature (given the low cost and delivery medium). Any organisation that provides advice on stopping smoking (e.g. health and lifestyle services, NGOs, health-care related charities, commercial organisations including e-cigarette retailers) will be beneficiaries as they could implement the intervention within their online services. The intervention has the potential to be implemented anywhere in the world with little alteration. The research could also feed into global policy making if the full RCT demonstrates effectiveness - as many countries currently adopt restrictive EC policies and others are considering flavour bans. To maximise the reach of the impact via both such stakeholders and also other research groups, we will preserve the full intervention package and all data resulting from the study (with the exception of personal data) and make both publically available via the LSBU open repository. Stored along with the data will be metadata describing it to future users. This will include a summary for the data and a description of the collection method. These will be indexed by Google and other search engines, which will increase the exposure. Any publications arising from this project, including a full description of the final intervention package, will include the data Digital Object Identifier (DOI) which will link to the data. We will include a link to the data summary page and our approach to data sharing on our webpages at LSBU as well as on the co-investigators' webpages at UCL and UEA.

Our team is in a strong position to realise these impacts. Dawkins has an excellent track record of parliamentary and public engagement work which led to a very successful (100% 4* rating) REF2014 impact case. Dawkins is a member of the UK All Party Parliamentarian Group on E-Cigarettes and has links with Olivia Maynard, (Parliamentary Academic Fellow in the Parliamentary Office of Science and Technology POST). Dawkins, Cox and Kimber have also acted as advisors to delegations of government health ministers of Brazil and the Philippines and Dawkins and Brown have provided oral evidence at the Science and Technology Committee's enquiry into e-cigarette regulation (Jan & Feb. 2018). We will use these channels to promote our work and monitor its effects. We will also self-publicise our data, disseminating our findings via open access peer-review publication, conference presentations, blogs and press releases. We will share them with a wide range of key stakeholders with whom we already have close working relationships, including the Science and Media Centre, Cancer Research UK, The National Centre for Smoking Cessation and Training, Action on Smoking and Health, the National Institute for Health and Care Excellence and Public Health England via presentations, briefing papers and web-based material. We will also draw on our existing contacts, social media networks and mailing lists to disseminate findings to other beneficiaries (Stop Smoking Services, e-cigarette retailers and online e-cigarette forums). In all instances, we will also include the DOI for the data to encourage new users and researchers to utilise it. If the data is not yet available, the DOI will still resolve to the summary page, where the user can view the metadata and find out when the data will be available.