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

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

Objectives

To test the feasibility of future trial work, seven objectives were set. Table 1 presents the study objectives and associated outcome measures and whether the objective is specific to the cluster level or across levels.

TABLE 1 Feasibility study objectives and outcome measures

Objective	Outcome measure	Measured at
1. Assess willingness of smokers to participate in the feasibility study to estimate recruitment rates and inform a future trial	In both arms, we will record the number of smokers asked to take part and the number of smokers who consent	Across arms
2. Assess participant retention in the intervention and control arms	Record (1) how many participants complete assessment measures in each arm at each time point, and (2) how many participants still have, and are still using, ECs in the intervention arms	Across arms
3. Examine the perceived value of the intervention, facilitators of and barriers to engagement, and influence of local context	Qualitative interviews with 4-week completers and non-completers, quitters and smokers (n = 24, approximately six per site) between weeks 4 and 8 across both arms	Across arms
4. Assess service providers’ capacity to support the study and the type of information and training required	Qualitative interviews with keyworkers and front-line staff (n = 12, approximately three per site) across both arms	Across arms
5. Assess the potential efficacy of supplying free EC starter kits	Measure breath CO levels, self-reported quit rates/cigarette consumption at each follow-up time point	Across arms
6. Explore the feasibility of collecting data on contacts with health-care services among this population as an input to an economic evaluation in a full cRCT	Record participant utilisation of primary and secondary health-care services using a self-report service-use questionnaire at each time point and HRQoL using the EQ-5D-3L	Across arms
7. Estimate the cost of providing the intervention and UC	Record all resources used in the delivery, including staff costs, ECs and other costs incurred. Staff will complete a pro forma to record contact time, non-contact time and other resources used in delivery	Across arms

Attribution. Sharon Cox; Allison Ford; Jinshuo Li; Catherine Best; Allan Tyler; Deborah J Robson et al. (2021). Exploring the uptake and use of electronic cigarettes provided to smokers accessing homeless centres: a four-centre cluster feasibility trial. NIHR Journals Library. Copyright © Queen’s Printer and Controller of HMSO 2021. This work was produced by Cox et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Licensed under CC BY 4.0. NCBI Bookshelf NBK570404. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.