Title: Promoting Smoking CEssation and PrevenTing RElapse to tobacco use following a smokefree mental health inpatient stay: the SCEPTRE programme
Funder: Department of Health and Social Care

Abstract: 1. Aims and Objectives The aim is to develop and test the feasibility, effectiveness and cost-effectiveness of a co-produced intervention to sustain or enhance smoking behaviour change and prevent smoking relapse for hospital inpatients with severe mental illness after discharge. Key research questions are: Based on behaviour change theory, how can existing smoking treatment strategies be tailored and further developed into an intervention to support mental health inpatients in maintaining or achieving smoking abstinence/cessation after discharge? Is it feasible and acceptable to deliver the intervention and manage the research process in our study context and study population? Is the intervention effective and cost-effective? How can opportunities for implementation at scale and with reach be maximised? 2. Background and Rationale Tobacco smoking is the largest contributor to health inequalities among people with mental illness. Smoking until recently was the norm in inpatient settings. Mental health Trusts across England are currently implementing recent NICE guidance to become entirely smokefree with no exemptions, and there is evidence that inpatients smoking behaviour and attitudes towards smoking change during their stay. However, almost all patients return to previous smoking patterns soon after discharge. There are currently no tailored strategies to support patients in sustaining or enhancing smoking behaviour change that occurred during an inpatient stay. 3. Research Plan Development and design of the intervention Relevant evidence-based intervention components will be identified from the literature, contextualised and mapped onto a theoretical behaviour change framework. Opportunities for further development will be identified, and a new theory- and evidence-based intervention will be co-produced with patients, carers, staff and other stakeholders. Delivery and data collection pathways will be designed, and an intervention manual and a draft logic model developed. Feasibility study The intervention and materials will be piloted and refined to maximise acceptability and likely effect. A randomised controlled feasibility trial will be conducted to address uncertainties relating to recruitment, retention, outcome measurement, randomisation, and resource use. A protocol for a full RCT and a refined intervention manual will be produced. Randomised controlled trial The clinical effectiveness and cost-effectiveness of the intervention will be assessed relative to usual care. Economic evaluation The short-term and long-term cost-effectiveness of the intervention will be determined. Implementation framework development A process evaluation guided by core constructs of the Theoretical Domains Framework will be carried out to identify barriers and facilitators to implementation of the intervention beyond the trial setting. 4. Projected Outputs & Dissemination Plan A new manualised smoking cessation and relapse prevention intervention for discharged mental health patients; a logic model detailing the resources and outputs associated with model delivery; a long-term economic model; and recommendations for implementation will be produced. Apart from scientific dissemination, findings will be disseminated through the CLAHRC, ARC, CRNs, ASH and The Mental Health Foundation, and incorporated in policy development. 5. Benefits to Patients and the NHS The intervention will directly benefit patients (and their families). It has potential to save lives and NHS resources, and to decrease health inequalities.

Lay abstract: The proportion of people with mental illness who smoke tobacco is very high compared to the general population. It can reach figures over 70% among those with schizophrenia and in hospitalised patients with severe mental illness &ndash; compared to only 15% in the general population. As people with mental illness are usually heavily addicted to tobacco, smoking causes large amounts of disease and deaths in this group, often from cardiovascular, respiratory illness and cancer. Smoking has been recognised as the single largest cause of health inequalities for people with mental illness. People with mental illness lose up to 20 years of life mainly to the consequences of smoking. Although mental health patients often want to quit and can do so successfully, smoking is rarely addressed in mental health care. In many mental health settings in England, a historic smoking culture can still be found. Guidance from the National Institute of Health and Care Excellence (NICE) recommends that mental health settings become entirely smokefree, and that mental health patients should have access to evidence-based stop smoking treatment. Mental health Trusts across England are in the process of implementing this guidance. For many patients, receiving treatment in a smokefree inpatient environment will be a rare experience of abstaining from tobacco in their adult lives. At the moment, no strategies to help maintain or achieve a smokefree lifestyle and avoid relapse after discharge exist. This means that most patients will return to old smoking behaviours within days of discharge. Important opportunities to promote health and save lives are being missed. We propose to develop and test ways to support mental health inpatients after discharge in maintaining or achieving abstinence from tobacco smoking, building on existing evidence and behaviour change theory. We will identify relevant studies from the literature and list strategies used to support service users who smoke, mapping them to behaviour change theory. Closely involving service user/carer representatives and staff, we will develop a new comprehensive intervention with components that are most likely to support behaviour change and tailor them to our study context, focused on the time around and after discharge. We will develop an intervention manual, test the intervention package and refine it where necessary. We will conduct a randomised controlled trial, to see whether our intervention is more effective than current practice in helping people quit or stay quit, and analyse whether it represents value for money in the long term. We will share results widely through local, national and international academic, clinical and PPI networks. If our findings are positive, we will develop a strategy for implementing the intervention in the NHS. An effective and cost-effective support model could help to save lives in a disadvantaged group.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;RESPIRATORY;MENTAL HEALTH;CARDIOVASCULAR;STROKE