People with severe mental illness are three times more likely to die from smoking-related diseases than the general population, yet they have no tailored support to stay smoke-free after leaving hospital. Mental health wards across England are now entirely smoke-free, and many patients stop or reduce smoking during their stay. But within days of discharge, nearly all relapse. Existing stop-smoking services are not designed for this group, who face high stress, social isolation, and limited access to support. This programme aims to close that gap. The researchers will co-design a smoking cessation and relapse prevention intervention with patients, carers, and clinicians, then test it in a randomised controlled trial. They will also assess cost-effectiveness and develop an implementation framework so the approach can be rolled out across the NHS. If successful, the intervention could save lives, reduce health inequalities, and save NHS resources by preventing the long-term costs of smoking-related illness. It would also provide a practical, evidence-based tool for a patient group that has been systematically overlooked in tobacco control efforts.
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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.
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