Title: Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR): a definitive randomised evaluation of a bespoke smoking cessation service
Funder: Department of Health and Social Care

Abstract: We have already conducted a successful external pilot of the SCIMITAR trial and we propose a fully-powered trial in this challenging but important area. DESIGN: RCT, with concurrent economic evaluation. SETTING: mental services & primary care; with sites in York, Leeds &Bradford, North Yorkshire and the North East, South Yorkshire, Manchester and the North West, and North London. TARGET POPULATION: Adults with severe and enduring mental illness (SMI) who currently smoke, and are interested in cutting down/quitting. HEALTH TECHNOLOGY: In response to an NIHR commissioning brief we have already developed a manualised 'bespoke smoking cessation service' for people with SMI; delivered by a mental health professional. The Bespoke Smoking Cessation (BSC) service combines evidence-supported interventions (largely NRT & behavioural support), adapted to a patient population with SMI. The intervention has been developed in conjunction with the National Centre for Smoking Cessation Training (NCSCT). There is a strong emphasis on nicotine-supported smoking reduction and eventual quitting. The manualised bespoke service is offered on a 1:1 basis over four months for people with SMI in primary and secondary care settings. Pharmacotherapy is provided by the patients’ usual GP. This package of care has been shown to be acceptable, with good participant engagement in our developmental phase and pilot trial. A key feature is the delivery of manualised smoking cessation delivered by a mental health professional. The comparator technology is usual care (signposting to existing smoking cessation service provided by the patients' own GP practice or local NHS quit smoking services). PRIMARY OUTCOME: smoking cessation measured at 12 months post-randomisation (exhaled carbon monoxideand sustained self reported quitting ‘Russell standard’) – outcome specified by HTA at the commissioning phase of the pilot trial. SECONDARY OUTCOMES: carbon monoxide-verified smoking cessation at 3 and 6 months; Health Related Quality of Life (SF-12); Nicotine dependence, mood (PHQ9); patient satisfaction health, utility (EQ5D) at 3, 6 & 12 months ECONOMIC EVALUATION: the incremental cost per QALY of bespoke smoking cessation programme compared to usual care will be calculated from both the NHS and societal perspective. PROCESS EVALUATION: In our external pilot phase we have already examined acceptability (to patients with SMI and healthcare staff) and barriers and facilitators to the delivery and uptake of bespoke smoking cessations services using qualitative methods. We do not propose any further process evaluation in the definitive trial. SAMPLE SIZE: powered to detect a risk ratio of 1.8 or equivalently a 16% absolute difference in quit rates. To give 90% power (5% two sided sig.) to show a difference we require a sample size of 160 per group or 200 participants per group after allowing for 20% attrition (i.e. 400 in total). PROJECT TIMETABLES INCL. RECRUITMENT RATE: We will obtain ethical approval to continue the SCIMITAR trial following our successful pilot. We will extend recruitment to include five new centres. Months 0-6 site set up and R&D approvals. Months 6-24 recruitment. Month 36 last follow-up. Month 42 final report. There is agreement for excess treatment costs.

Lay abstract: The proportion of people with severe mental illness (such as schizophrenia and bipolar illness) who smoke is three to four times higher than people without such disorders. This contributes to poor health, poverty and early death in this vulnerable population. People with severe mental illness die on average 20 to 25 years earlier than those without, and smoking makes a significant contribution to this health inequality. Unfortunately people with SMI do not seek help for their general health problems as readily as people with no mental ill health. Whilst smoking rates are falling in the general population, they have remained unchanged amongst people who use mental health services. For these reasons, it is clear that conventional approaches to smoking cessation might need to be tailored to people with SMI, to address lower motivation to quit, and to ensure that help is delivered in a way that anticipates the specific difficulties of those with mental illness. Conventional NHS approaches also place a strong emphasis on being able to set a quit date from the outset. In work conducted prior to this trial, we have found that people with SMI might be put off by such an approach, but would be more inclined to try to cut down in the first instance with the support of treatments such as nicotine patches and gum (‘cut down to quit’). This approach is not widely offered in routine NHS services. A suitable package of care to help people with SMI cut down or quit has already been developed by the present team in research commissioned by NIHR. In order to judge whether this tailored approach is worthwhile we now need to know whether it works better than care that is offered by usual NHS quit smoking services. We also do not know whether such an approach is good value for money in relation other things that might be done for this population. We have designed a programme of research to address this question, and we are now midway through this. We have developed a package of care which could potentially work, and we call this a 'bespoke smoking cessation service'. We have brought together all existing research in the area and have consulted with those who are affected by problems of mental ill health and smoking (service users, carers and professionals). On a smaller-scale we have begun to conduct a 'fair test' of a smoking interventions service (the SCIMITAR pilot clinical trial). The SCIMITAR pilot has been successful in that we have been able to recruit, randomly allocate and follow up 97 participants in this trial. We have made some changes to the design of the SCIMITAR trial in response to what we have learned. We now wish to conduct an appropriately sized clinical study in order to answer the NIHR-prioritised question with certainty. In the definitive SCIMITAR trial people with severe mental illness will be offered either the new treatment for smoking or offered access to existing services according to the play of chance. We think it important to judge the lasting benefits of the treatment, and will test this over a period of one year using a 'gold standard outcome' which analyses the breath of ex-smokers and is the best indicator of smoking status. Trails in this area have previously relied upon self report and have examined much shorter term impacts. The SCIMITAR trial will be the largest trial in this important area and will ensure that NHS patients will benefit from the results of publicly funded research.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;MENTAL HEALTH;RESPIRATORY;STROKE