Title: A randomised controlled feasibility trial of a tailored digital behaviour change intervention with e-referral system to increase attendance at NHS Stop Smoking Services: The MyWay Project
Funder: Department of Health and Social Care

Abstract: Smokers are four times more likely to stop smoking with help from a NHS Stop Smoking Service (SSS). Service uptake has been in decline in recent years (especially in lower socio-economic status (SES) groups). This may be explained, in part, by the rising popularity of e-cigarettes. Other barriers include negative assumptions about what is offered. Given the proven effectiveness and cost-effectiveness of SSS, and the continuing pressure on public health budgets, the importance of ensuring that SSS are fully utilised, especially by low SES communities, remains. Recent research suggests that smokers who report higher motivation to quit, and who self referred to SSS had the highest quit rates. StopApp is a brief, tailored, evidence and theory-driven digital behaviour change intervention with the potential to reach greater proportions of the smokers making quit attempts each year and support self-referral to SSS. It is designed to increase motivation to attend SSS and includes the facility to instantly book an appointment at a location and time of choice, with reminders to attend. Although a number of digital interventions support smoking cessation, none have explored them as a method of increasing uptake at SSS. Therefore this intervention is, to the authors knowledge, the first to target booking and first attendance at SSS. With its built in capacity for scalability via the system it connects to, it could have significant benefits for improved smoking outcomes and cost savings to services in reduced administrative burden and wasted appointments. StopApp can be delivered to users via personal mobile phone or desktop computer, or via tablets in NHS and community settings, as part of 'Making Every Contact Count' (MECC). Because of the novelty of this intervention and general concerns around the potential for digital interventions to contribute to health inequalities a feasibility trial is required to assess whether it is possible to recruit the numbers required for a future potential RCT from a sufficiently representative sample of the smoking population. Objectives: To conduct a feasibility randomised controlled trial (RCT) to i) assess recruitment and attrition rates in primary care, community and online settings; ii) assess any differential recruitment and attrition by SES, age and gender; iii) assess acceptability of proposed outcome and health economic analysis measures; and iv) assess SSS attendance rates in control vs. intervention groups to support future trial effect size and sample size calculations. Methods: We will conduct a two-armed parallel group feasibility RCT. All smokers over the age of 16 years, identified from practice records in 4 GP practices, will be invited to participate. Smokers in community and online settings can opt to participate by following web links. Baseline data will include demographic information, current smoking status, use of SSS and motivation to stop. Participants will be randomised into one of two groups. Both groups will be sent an email or text with near identical content. The control group will be asked to link to an online leaflet about SSS. The intervention group will follow a web-link to the StopApp. At 2 month follow-up questionnaires will be sent to assess smoking status, booking and attendance at SSS, quit dates set and 4-week abstinence. Objective data will be accessed from services.

Lay abstract: Smoking is a leading cause of death and disease and costs the NHS billions each year. Most smokers want to quit and getting support from publicly funded stop smoking services (SSSs) means they are four times more likely to do so than when they attempt to stop alone. Although around one in every five people is a smoker, SSSs only ever reach around 5-10% of them and numbers have been in decline in the last few years. We know that smokers experience lots of barriers to service access that are never addressed (e.g. feeling that they shouldn’t need help to stop smoking). With continued pressure on public health funding, it is important to reach and support those most motivated to stop smoking to access available support, so services can maximise success. It is also important to reach those most likely to experience poor health because of smoking. The StopApp was designed to do this with help from a group of smokers and ex-smokers. It is a brief, web-based support tool designed to be easily accessible and usable by smokers. It deals with people’s barriers to SSS access and allows people to instantly book a SSS appointment, at a time and location to suit them, with text message and email confirmation and reminders. A future trial of this intervention could seek to find out if StopApp is successful at improving SSS bookings and attendance, but there is uncertainty about how easy it will be to recruit people and collect information from them, who will be willing to take part and the best locations to find people. A feasibility (small-scale test) trial is therefore proposed. All smokers aged over 16 years will be identified from 4 GP practices, and invited to take part. A range of community settings (e.g pharmacies, children’s centres, libraries) and online recruitment methods will also invite people to access the study website. Participants will complete questions about things including age, gender, current smoking status, previous use of SSS, use of e-cigarettes, pregnancy status if female and motivation to stop. Smokers will be randomly put into one of two groups. The usual care (control) group will be asked to read an online leaflet about SSS. The intervention group will be asked to use the StopApp. Participants will be told they can book an appointment at a SSS, but are under no obligation to do so. At follow-up (2 months from the first invitation) questionnaires will be emailed to all participants to confirm smoking status, whether they booked and attended an appointment, set a quit date and reached a 4-week period of not smoking, confirmed by the individual SSSs. Other information collected includes health and financial costs and benefits of the intervention; ethnicity, socio-economic status, number of cigarettes smoked, in each group. StopApp has been developed with input from smokers and ex-smokers, some of whom have used SSS, to ensure it is engaging, using the right language. They have tested the app, input to study design and recruitment; and will develop research materials, and reports of findings for organisations such as Public Health England, Action on Smoking and Health (ASH) and local authorities. We will also publish the study design and findings in an academic journal and present this at conferences.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE