Promoting Smoking Cessation and Preventing Relapse to Tobacco Use following a smokefree mental health in-patient stay (SCEPTRE feasibility study): a multi-centre randomised controlled feasibility study protocol

Introduction

Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health trusts presently invest substantial effort and resources to implement smokefree policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help smokers remain abstinent or quit smoking during their smokefree inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smokefree mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and Analysis

This feasibility study will be an individually randomised, controlled trial in eight National Health Service (NHS) mental health trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who are tobacco smokers on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3-months and a second timepoint between 4-6 months post-randomisation. With 64 participants (32 in each group) the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% confidence interval of ±3% and ±10% respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and Dissemination

Ethics approval was obtained from the North West – Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and Patient and Public Involvement (PPI) networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/ .

Trial registration number: ISRCTN77855199

Strengths and limitations of this study

• The use of a theory and evidence-based intervention to support smoking cessation and prevent relapse to tobacco following a smokefree mental health inpatient stay, can be effective for impacting long term smoking behaviour.

• The objective of the SCEPTRE feasibility trial is to test recruitment and radomisation of participants and collection of proposed outcome data in planning for a large randomised controlled trial.

• Quantitative and qualitative methods will be used to determine if research and intervention processes are acceptable and feasible and inform the decision of progression to full trial.

• The outcomes to be assessed will be relevant to patients, carers, mental health professionals, and policymakers.

• The present study is limited to English speaking adults admitted to acute mental health inpatient wards.

• Usual care varies greatly within and between Trusts nationally, making comparisons between intervention and standard care heterogenous.