Original research
from tobacco smoking, tailored to the participants’ presenting condition (eg, discussing improved wound healing for patients attending with a laceration). This part of the intervention was a single session undertaken within the ED while patients were waiting to be seen or after discharge. The e-cigarette starter kit (DotPro, manufactured by Liberty Flights, an independent e-cigarette manufacturer not funded by the tobacco industry) is a ‘pod’ device. The kit included 11 pods (3 tobacco flavoured, 4 berry flavoured and 4 menthol flavoured) of 20 mg/mL nicotine strength. This device was chosen based on in-depth patient and public consultation, considering ease of use, nicotine delivery, satisfaction, price and availability. Participants were electronically referred to the local stop smoking service which provided routinely available follow-up support. This typically consisted of a telephone call offering support and, if taken up, advice on how to quit and free provi- sion of NRT. The intervention was delivered by smoking cessation advi- sors trained specifically for the role. The advisors were either research nurses, research practitioners, ED nurses or healthcare assistants seconded to the trial and received 2.5 days of training. A TIDieR checklist, 12 logic model and intervention manual are available on the Open Science Framework. 10 Participants allocated to the control group were given details of local NHS stop smoking services via written material but were not referred directly. Procedures Research assessments were undertaken at baseline and then 1, 3 and 6 months after randomisation. Local site research teams undertook the baseline assessments face-to-face in the ED. Follow-up questionnaires were sent as a link in a text message or email, or by mail with freepost envelopes for return. We attempted to contact all participants who did not respond to the initial request at least twice. Those who reported smoking abstinence at 6 months were invited to undertake a CO reading either at the ED, at a convenient location or remotely by being sent a CO monitor and having a video call with a researcher. Participants were not given details about CO test cut-offs or that it was being used to verify abstinence. All measures except for the CO verification at baseline and 6 months were self-reported. It was not possible to blind outcome assessors to study group. On completion of the 6-month follow-up questionnaires, participants received a £30 shopping voucher for taking part. A further £30 voucher was offered to participants who reported being smoke-free for providing a CO reading. Participants were, however, unaware they would be offered the additional £30 when completing follow-up questionnaires to avoid it acting as an incentive. Outcomes The primary effectiveness outcome was self-reported contin- uous smoking abstinence, biochemically validated by CO moni- toring at 6 months with a cut-off of <8 ppm (according to the Russell standard). 13 If smoking status or CO readings could not be obtained, the participant was assumed to be smoking as is agreed practice in smoking cessation trials. 13 14 Bedfont Micro Smokerlyzers (Bedfont Scientific, Maidstone, UK) were used at baseline and follow-up to measure CO levels. Participants were classified as having been biochemically-verified continuously abstinent if they reported having fewer than six lapses in the last 6 months and gave a CO reading of <8 ppm. Self-reported 7-day
alone, or behavioural support combined with an offer of nico- tine replacement therapy (NRT). 7 Evidence shows that e-ciga- rettes are more effective than NRT in supporting people to quit smoking, but the majority of trial evidence comes from people who are motivated to stop smoking rather than people who potentially have no prior intention to quit. 8 An intervention to treat tobacco dependency in an ED setting using e-cigarettes has not previously been tested. In this trial we aimed to test the real-world effectiveness of an ED-based brief tailored smoking cessation intervention in comparison with usual care, by comparing continuous smoking abstinence at 6-month follow-up between trial groups. The Cessation of Smoking Trial in the Emergency Department (COSTED) is a two-arm pragmatic, multicentre, parallel-group, individually randomised controlled trial carried out at six UK NHS EDs. 9 The study protocol has been published 9 and is avail- able in online supplemental file 1 and the statistical analysis plan is available online. 10 A full economic evaluation and process evaluation were embedded and will be published separately. Participants We recruited adults (aged 18 years or older) who reported smoking tobacco daily, attending the ED for medical treatment or accompanying someone attending for medical treatment. Participants were screened while they were in the ED. People were excluded if they had an expired carbon monoxide (CO) of <8 parts per million (ppm), required immediate medical treat- ment, were in police custody, had a known allergy to nicotine, were current dual users (defined as daily e-cigarette use), were considered not to have capacity to consent or had already taken part in the trial. METHODS Trial design Where the person accompanying an included patient met the inclusion criteria and wished to participate, they were enrolled in a similar way to the patients and assigned to the same treatment group as the patient they accompanied. They were followed up but are not included in the analysis reported in this paper as they were not randomised individually (as per the protocol). Randomisation People who met the inclusion criteria and gave consent were individually randomised (1:1) to the intervention or control groups through a web-based service provided by the Norwich Clinical Trials Unit. This computer-generated randomisation employed varying block sizes and was stratified by the recruit- ment sites which allowed for concealment of allocation. Due to the participatory nature of the intervention, it was not feasible to blind participants or those delivering the intervention to group allocation. Interventions Participants allocated to the intervention group received an opportunistic smoking cessation intervention undertaken face- to-face in the ED, comprising three elements: (1) brief smoking cessation advice (up to 15 min), (2) the provision of an e-cig- arette starter kit plus advice on its use (up to 15 min) and (3) referral to local stop smoking services. The advice was delivered individually (or with an accompa- nying person) by a dedicated smoking cessation advisor based in the ED. Protocol-driven 10 theory-based 11 smoking cessation advice addressed key aspects of the importance of switching away
Pope I, et al . Emerg Med J 2024; 41 :276–282. doi:10.1136/emermed-2023-213824
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