Improving outcomes in adult patients who self-harm-evaluating a brief psychological intervention in emergency departments (ASSURED): protocol of a randomised controlled clinical trial.
McCabe R., Suzuki M., O'Keeffe S., Walker N., Hooper R., Priebe S., Mihaylova B., Feng Y., Dickens C., Aitken P., Soares VA., Byng R., Giacco D., Kapur N., Lee W., Riou P., Ryan M., Simpson A., Smith H., Goldsmith LP., Bakou AE.
BACKGROUND: Patients with self-harm and suicidal ideation are increasingly presenting in emergency departments (ED) in the UK. Self-harm is the strongest risk factor for suicide. Currently, there are no evidence-based interventions for self-harm offered in the context of general hospitals in the UK. This trial, funded by the National Institute for Health and Care Excellence (NIHR), aims to assess the clinical and cost-effectiveness of the ASSURED intervention. The ASSURED intervention includes up to five rapid follow-up contacts, comprising a narrative interview and enhanced safety planning session and three solution-focused sessions. The trial is sponsored by Devon Partnership NHS Trust and City St George's, University of London. METHODS: ASSURED is a multicentre, two-arm, parallel-group, individually randomised, controlled trial comparing the ASSURED intervention with usual care. The primary outcome is whether study participants re-attend ED and are referred to liaison psychiatry within 18 months from the date of randomisation. Secondary outcomes include suicidality, self-reported self-harm, psychological wellbeing, social outcomes, experiences of attending the ED, and suicide. The study will also evaluate the cost-effectiveness of the intervention. The aim of this study was to recruit and randomise 620 patients across 14 acute hospital sites in London, Devon, Somerset, and the Midlands. Participants are invited to complete research assessments at baseline and 3, 9, and 18 months. The first participant was enrolled in the study in August 2022, and the recruitment target was met in December 2024. DISCUSSION: This will be the first UK trial to test the effectiveness and cost-effectiveness of a rapid intervention for patients presenting to EDs with self-harm and suicidal ideation and has the potential to improve outcomes for these patients. TRIAL REGISTRATION: ISRCTN 13472559. Registered on 18 of November 2021.