Brown, Katherine E.

Coleman, Tim

Fulton, Emily A.

Gokal, Kajal

Jackson, Louise

Kwah, Kayleigh

Naughton, Felix

Newby, Katie

Owen, Alun

Schumacher, Lauren

Background: Smoking remains a leading cause of illness and preventable death. UK NHS Stop Smoking Services (SSS) significantly increase the likelihood of a smoker quitting; however, access is in decline. Cost-effective interventions to promote SSS are needed. StopAppTM is a brief, digital behaviour change intervention (web-app) designed to increase booking and attendance at SSS, enabling instant booking at a convenient time and location. Trial Design: A two-arm parallel group individual participant feasibility RCT of StopAppTM (intervention) compared with standard promotion of and referral to SSS (control) was conducted in order to assess recruitment, attrition and health equity of the trial design. The study included a health economic evaluation and nested qualitative process evaluation. Methods: Smokers aged 16 years+ were recruited in one local authority via GP practices, community settings (CS) and social media (SM); completing baseline measures and follow-up (FU) two months post-randomisation, entirely online. Participants had to live or work within the selected local authority. A target of 120 participants was set. Objective data on SSS use were collected from participating SSS. To assess health equity, the representation of age groups, gender, ethnicity and socioeconomic status in baseline recruits and follow-up completers/non-completers was considered. Results: Eligible participants (N=123) were recruited over 116 days (1.06 participants per day), with good representation from lower SES groups, BAME groups and all age groups. Demographic profiles of FU completers and non-completers were broadly similar, suggesting health equity of study methods. The overall rate of attrition was 51.2%. Loss to FU by setting was lowest in the SM setting (n=24/61; 39.3%); and highest in the GP setting (n=21/26; 80.8%). Most measures had less than 5% missing data with only a few exceptions. Social media represented the most effective and cost-efficient recruitment method. In a future, definitive, multi-site trial with recruitment driven by SM, the data suggest it would be possible to recruit more than 1 500 smokers over 12 months. Objective service data revealed five SSS bookings using StopAppTM (two did-not-attends), though some challenges with access to data were identified. A further five participants in the intervention arm self-reported sing SSS outside of StopAppTM compared to two control arm participants. Event rate calculations for the intervention were 8% (objective data), 17% (including self-reports) and 3.5% from control arm self-reports. Taking account of the calculated margin of error, a conservative effect size of 6% has been estimated for a definitive full trial. A sample size of 840 participants would be required to detect an effect for the primary outcome measure of booking a SSS appointment in a full RCT. The process evaluation findings from participants demonstrated satisfaction with the participation process, contact from the research team, and acceptability of study methods and provision of e-vouchers. Staff interviews revealed how they found out about the study, motivations to be involved, positive and negative experiences of the trial, and included suggestions for improvements, and thoughts about encouraging smokers to take part. Discussion: This feasibility RCT found that with recruitment driven either wholly or mainly by SM it is possible to recruit and retain sufficient smokers to assess the effectiveness and cost-effectiveness of StopAppTM. The study methods and measures were found to be acceptable and equitable but accessing the objective SSS data about booking, attendance and quit dates was a challenge. This process will require close liaison with Pinnacle Health, relevant LAs and local service providers to form a clear strategy to permit data access, informed by the learning from this feasibility trial. Conclusion: Given the limited methodological issues identified, a full trial appears to be feasible if the objective service data is accessible. This will require careful planning and will also demand a targeted social media campaign for recruitment. Changes to some study measures are needed to address missing data for some items and a more intensive FU data collection process is also recommended. Future work: We plan to conduct a full, definitive RCT if the concerns around data access from the service providers can be sufficiently resolved. This trial will likely encompass a primary recruitment strategy of social media to reflect how StopAppTM might eventually be used in practice, with participation incentivised by e-vouchers. Limitations: Our trial experienced some high attrition, used non-targeted online recruitment and found collecting SSS data difficult resulting in a reliance on self report data.  Study Registration: Research Registry: 3995. Trial Registered 18th April 2018. Funding details: This research was funded by the National Institute for Health Research Public Health Research grant number 15/183/26

University of Birmingham Research Portal

A Web-Based Behaviour Change Intervention with E-Referral System to Increase Attendance at NHS Stop Smoking Services (The MyWay Project): A Randomised Controlled Feasibility Trial of StopApp

A Web-Based Behaviour Change Intervention with E-Referral System to Increase Attendance at NHS Stop Smoking Services (The MyWay Project): A Randomised Controlled Feasibility Trial of StopApp

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