Trial intervention
Participants in the intervention group were allocated to receive a BSC intervention designed specifically to help people with SMI stop smoking. This intervention was delivered by a mental health professional (care co-ordinator, support worker, mental health nurse) trained in smoking cessation interventions. The training took place over 2 days and was provided by trained smoking cessation advisors. The BSC intervention consisted of up to 12 one-to-one face-to-face meetings between the participant and the MH-SCP, who worked in conjunction with the participant and their GP or mental health specialist to ensure that the participant received smoking cessation medication and medication monitoring. The initial meeting generally took 1 hour, with subsequent meetings lasting 30 minutes. Meetings were initially weekly; however, towards the end of the programme the participant had the choice of meeting fortnightly if preferred. Pharmacotherapies were provided for as long as was deemed necessary, in line with NICE guidance,17and were determined by the GP without the influence of the SCIMITAR+ trial team. In line
with NICE recommendations, MH-SCPs offered advice on the range of treatment options available to people in the NHS (including medication, behavioural support and follow-up).31It was not the remit
of the trial to assess specific smoking cessation pharmacotherapies or treatments per se, although data on frequency of their use were collected. The intervention was based on that used by the National Centre for Smoking Cessation and Training (NCSCT), but the following specific modifications were applied to tailor the intervention to people with SMI: (1) recognising the need for several assessment sessions prior to setting a ‘quit date’; (2) recognising the purpose of smoking in the context of their mental illness, such as the use of smoking to relieve side effects from antipsychotic medication (and how this will be managed during a cessation attempt); (3) recognising the need to involve other members of the multidisciplinary team in planning a successful quit attempt for those with complex care needs and multiagency programmes of care; (4) arranging meetings so that they take place in a mutually agreeable location, often in the participant’s home rather than in the GP surgery or on NHS trust premises; (5) providing additional face-to-face support following an unsuccessful quit attempt or relapse; and (6) informing the GP and psychiatrist of a successful quit attempt so that they can review antipsychotic medication doses in line with changes in metabolism. Participants were encouraged to (1) reduce smoking to quit, (2) set their own quit dates and (3) make several attempts to quit if their initial attempt failed. All participants remained under the care of their GP and continued to receive their usual NHS treatment.
A detailed description of the development and content of the smoking cessation intervention is given in the report of the SCIMITAR pilot trial.1
Control intervention
This was a ‘usual-care’ control group, whereby participants were encouraged to consult with their GP or local NHS quit smoking services. GPs were given advice to follow current NICE guidelines for smoking cessation, without the additional support of a bespoke MH-SCP. Usual care could include pharmacotherapies to aid smoking cessation (NRTs, bupropion or varenicline either separately or in combination), access to self-help materials and referral to local NHS stop smoking clinics (which would not be specifically tailored to the needs of those with SMI). Participants were encouraged to reduce smoking to quit and set their own quit dates; however, they were managed solely by their own GP or mental health specialist and, crucially, did not receive regular visits from a MH-SCP. Details of NRT that control participants received were gathered by accessing participants’ GP notes, and details of any smoking cessation management were requested from participants in the follow-up questionnaires.
Smoking cessation medication provision
Clear guidance on the prescription of anti-smoking medications in the presence of SMI (including safety considerations) has been published and was made available to all GPs to help inform their prescribing decisions (for both control and intervention participants).48A key feature of the SCIMITAR+ trial was to
ensure that GPs manage anti-smoking medications within this framework and in accordance with their prior knowledge of the patient and their concomitant use of medication. This was carried out with the aim of replicating ‘real-life practice’ of the use of anti-smoking medications in primary care. The medication profile of the individual participants was reviewed by their GP or mental health specialist to assess any potential safety issues (in line with the latest practice guidance on the provision of smoking cessation interventions in the NHS2). An important aspect of the design of this study was that the SCIMITAR+ team
had no direct influence over prescribing decisions by GPs, as this was not a drug trial or an investigation of a medicinal product(s).
Follow-up
Participants were followed up 6 months and 12 months after randomisation.
All assessments were carried out face to face where possible and, where not possible, a systematic approach was used to explore other avenues to collect self-report data; the participant was offered the option of completing the questionnaires over the telephone or having the questionnaires sent by post for them to complete and return. If it was not possible to make contact with the participant, a family member or friend, designated by the participant at their baseline interview, was contacted to verify the participant’s current smoking status.
Outcomes
Primary outcomes
The primary outcome was self-reported abstinence from smoking at 12 months post randomisation, defined as answering ‘not even a puff’ to the question ‘have you smoked in the last week?’, validated by CO breath measure, with abstinence defined as a CO measurement of < 10 parts per million (p.p.m.).
Secondary outcomes
l Self-reported smoking cessation.
l Number of cigarettes smoked per day (self-report).
l Motivation to Quit questionnaire (MTQ).50 l Patient Health Questionnaire-9 items (PHQ-9).51 l Generalised Anxiety Disorder-7 items (GAD-7).52
l Health-related quality of life [Short Form questionnaire-12 items (SF-12) version 1 was used, as this was used in the pilot trial].53
l EuroQol-5 Dimensions, five-level version (EQ-5D-5L).54 l BMI.
l Health service use collected via a bespoke questionnaire.
Table 1 gives details of the measures collected and the time points at which they were collected.
Withdrawal
A study participant could be withdrawn from the trial by their GP, mental health specialist or smoking cessation practitioner, or may choose to do so themselves, at any time. If the withdrawal was due to an adverse event, procedures followed a trial-specific standard operating procedure (SOP) for adverse events (see Appendix 3).
Where possible, data were collected on the nature of the withdrawal. Reasons for a practitioner to withdraw a participant included pregnancy, admission to hospital for reasons unrelated to the trial and, inability to attend treatment or assessment sessions. Relapse to resuming smoking was not a reason to withdraw a participant, as they could resume treatment and make several attempts to quit smoking.
Participants were given a choice of (1) withdrawal from treatment only (participants were still followed up at 6 and 12 months), (2) withdrawal from follow-up or (3) complete withdrawal from the study, including follow-up and medication data collection. Withdrawal from the study did not affect the participants’ treatment or access to NHS services.
Any data collected from the participant prior to withdrawal were still included in the final analysis of the data.