Exploring the uptake and use of electronic cigarettes provided to smokers accessing homeless centres: a four-centre cluster feasibility trial

Background Smoking prevalence is extremely high in adults experiencing homelessness, and there is little evidence regarding which cessation interventions work best. This study explored the feasibility of providing free electronic cigarette starter kits to smokers accessing homeless centres in the UK. Objectives Seven key objectives were examined to inform a future trial: (1) assess willingness of smokers to participate in the study to estimate recruitment rates; (2) assess participant retention in the intervention and control arms; (3) examine the perceived value of the intervention, facilitators of and barriers to engagement, and influence of local context; (4) assess service providers’ capacity to support the study and the type of information and training required; (5) assess the potential efficacy of supplying free electronic cigarette starter kits; (6) explore the feasibility of collecting data on contacts with health-care services as an input to a main economic evaluation; and (7) estimate the cost of providing the intervention and usual care. Design A prospective cohort four-centre pragmatic cluster feasibility study with embedded qualitative process evaluation. Setting Four homeless centres. Two residential units in London, England. One day centre in Northampton, England. One day centre in Edinburgh, Scotland. Intervention In the intervention arm, a single refillable electronic cigarette was provided together with e-liquid, which was provided once per week for 4 weeks (choice of three flavours: fruit, menthol or tobacco; two nicotine strengths: 12 or 18 mg/ml). There was written information on electronic cigarette use and support. In the usual-care arm, written information on quitting smoking (adapted from NHS Choices) and signposting to the local stop smoking service were provided. Results Fifty-two per cent of eligible participants invited to take part in the study were successfully recruited (56% in the electronic cigarette arm; 50.5% in the usual-care arm; total n = 80). Retention rates were 75%, 63% and 59% at 4, 12 and 24 weeks, respectively. The qualitative component found that perceived value of the intervention was high. Barriers were participants’ personal difficulties and cannabis use. Facilitators were participants’ desire to change, free electronic cigarettes and social dynamics. Staff capacity to support the study was generally good. Carbon monoxide-validated sustained abstinence rates at 24 weeks were 6.25% (3/48) in the electronic cigarette arm compared with 0% (0/32) in the usual-care arm (intention to treat). Almost all participants present at follow-up visits completed measures needed for input into an economic evaluation, although information about staff time to support usual care could not be gathered. The cost of providing the electronic cigarette intervention was estimated at £114.42 per person. An estimated cost could not be calculated for usual care. Limitations Clusters could not be fully randomised because of a lack of centre readiness. The originally specified recruitment target was not achieved and recruitment was particularly difficult in residential centres. Blinding was not possible for the measurement of outcomes. Staff time supporting usual care could not be collected. Conclusions The study was associated with reasonable recruitment and retention rates and promising acceptability in the electronic cigarette arm. Data required for full cost-effectiveness evaluation in the electronic cigarette arm could be collected, but some data were not available in the usual-care arm. Future work Future research should focus on several key issues to help design optimal studies and interventions with this population, including which types of centres the intervention works best in, how best to retain participants in the study, how to help staff to deliver the intervention, and how best to record staff treatment time given the demands on their time. Trial registration Current Controlled Trials ISRCTN14140672; the protocol was registered as researchregistry4346. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 7. See the NIHR Journals Library website for further project information.