TRIDENT

Title – Tobacco risk reDuctions with E-Cigarette Nicotine Therapy among adults with serious MI (TRIDENT). Being led from Oxford University by Professor Paul Aveyard.

Aims To develop a brief offer of an e-cigarette, and a continued support programme given by mental health professionals (MHPs) that meets the needs of people with serious mental illness (SMI) who smoke and have declined help to quit. To assess if this offer can promote e-cigarette use, cigarette reduction, and quitting. Background People with SMI (schizophrenia or bipolar disorder) are more likely to smoke, consequently developing heart disease and cancers 10-20 year earlier than people without. People who decline help to stop smoking can be helped to reduce, with 90% accepting an e-cigarette, 68% regularly using it, and 20% halving cigarette consumption. However, in our previous study, early success did not lead to quitting completely. People who cannot contemplate stopping smoking need more support to achieve this. Continued skilled support has been shown to improve sustained quitting in people with SMI. Methods Working with MHPs and people with SMI who smoke, we aim to understand their thoughts on being offered e-cigarettes when seeing an MHP and their needs for continued support for smoking reduction and eventually quitting. We will ask people with SMI to think aloud about their responses and thoughts listening to anonymous clips from consultations of GPs offering e-cigarettes to patients who smoke to reduce (not stop) smoking. We will do the same with MHPs. Additionally, we will identify the most appropriate ways to support smoking reduction and quit attempts, adapting these by consulting with people with SMI and MHPs. Once we have a brief offer and a support programme, we will assess whether we can recruit people with SMI and whether MHPs deliver the intervention as intended. We will assess whether people with SMI accept the e-cigarette, use it, and engage with the support programme. Using pre-set criteria, we will assess whether to proceed to a large-scale study. This study will be large enough to reliably assess whether the offer of the e-cigarette and ongoing support means people with SMI are more likely to stop smoking. We will assess whether the costs of this intervention are worth the benefits to health from stopping smoking. Patient and Public Involvement (PPI) Our SMI PPI panel were enthusiastic about this research. The panel supported gradual smoking reduction rather than quitting abruptly, and strongly advocated continued support. We will recruit people with experience of SMI and smoking to help determine whether we have adapted our programmes sufficiently to move to the next stage in this programme of research. Sharing findings Working through the NHS planning group on smoking, we will assess how this programme can be integrated into NHS care. If the intervention proves effective, we will work with our PPI group to explain and gather support for this approach.

Abstract:

Research question Can people with serious mental illness (SMI) who smoke and who do not want to stop smoking be engaged to reduce harm from and eventually stop smoking with a brief opportunistic intervention and a behavioural support programme? Background Smoking is common in people with SMI and leads to early onset of non-communicable disease. We can engage 90% of people declining help to stop smoking to switch partially to e-cigarettes with a brief opportunistic intervention. There is trial evidence that ongoing support for harm reduction increases cessation despite participants initial intentions. Objectives To develop an intervention to promote, and support persisting use of, an e-cigarette, increasingly switching from smoking to achieve eventual smoking abstinence. Test the brief offer and continued support package in routine mental healthcare to assess feasibility and fidelity. Assess the effectiveness of the intervention in promoting smoking cessation in routine mental healthcare. Assess the cost-effectiveness of the intervention. Create a package to support implementation in the National Health Service (NHS). Methods Intervention development will follow the person-based approach and comprise a review of qualitative literature on vaping and discuss the relative importance of these beliefs with our patient panel of people with experience of SMI. We will adapt a successful brief opportunistic intervention by playing snippets of past consultations to participants with SMI to gauge participants reactions to the intervention and adapt the intervention. We will do likewise with mental health professionals (MHPs) to tailor the intervention to their concerns. We will use these findings to adapt the cessation-focused SCIMITAR smoking cessation intervention for people with SMI to reduction and, if appropriate, cessation. Feasibility and fidelity of intervention will be tested in a 3:1 8-week randomised trial with red-amber-green criteria for recruitment, fidelity of brief intervention, follow-up, acceptance of the e-cigarette, and attendance at behavioural support. Participants waiting to see an MHP will be recruited and randomised to receive a brief opportunistic intervention or no further support. The brief intervention aims to promote switching to vaping if participants decline help to stop smoking. This will comprise an e-cigarette and enrolment on a support programme to promote partial then total switching. Effectiveness will be tested in a 1:1 randomised trial comprising 958 participants recruited and randomised as in the feasibility trial. The primary outcome is abstinence at three months but prolonged abstinence at 9 months, reduction in smoking to <50% of baseline, and mood changes will be secondary outcomes. Incremental cost-effectiveness ratios will be assessed using the EQUIPT model to account for the long-term effects of cessation on health and health and social care costs. Implementation will be supported by an embedded qualitative process assessment to assess conditions needed for implementation and effectiveness. Timelines for delivery Intervention development 12 months, feasibility 9 months, main trial and process assessment 3 years. Anticipated Impact and Dissemination Brief opportunistic interventions have high cumulative reach and have been cost saving to the NHS Despite modest effects on cessation could be important for public health.