Enhanced psychosocial assessment and rapid follow-up care for people presenting to emergency departments with self-harm and/or suicidal ideation: the Assured feasibility study and internal pilot trial.
Sally O'Keeffe, Mimi Suzuki, Mary Ryan, Stefan Priebe, Richard Byng, Alan Simpson, Vera Araújo-Soares, Rikke Albert, Renata Fialho, Neil Walker, Alexandra Elissavet Bakou, Rose McCabe
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Abstract
Background: Patients presenting to emergency departments (EDs) following an episode of self-harm are at risk of future suicide. There are few evidence-based interventions for self-harm in the ED context in England. This study sought to assess the feasibility of a trial of a newly developed brief psychological intervention, the Assured approach. This approach consisted of an enhanced psychosocial assessment, collaborative safety planning and three rapid solution-focussed follow-up sessions. Phase 1 was a feasibility study, and phase 2 was an internal pilot trial of a cluster randomised controlled trial to assess whether progression to a full-scale trial was warranted.
Methods: In phase 1, patients were recruited and allocated to a study arm, the Assured arm or treatment as usual, depending on the allocation of their assessing practitioner, in four EDs in England. They were invited to research assessments after consent and at 6 months. Phase 2 was the internal pilot of a cluster randomised controlled trial conducted in six EDs in England. Practitioners were randomised to deliver the Assured approach or treatment as usual. Patients were recruited and allocated to a study arm depending on the allocation of their assessing practitioner. They were invited to complete research assessments after consent and at 3, 9 and 18 months.
Results: Sixty-one patients were recruited into the Assured (n = 46) and treatment as usual (n = 15) arms in phase 1. Findings showed we could recruit and follow up patients over a 6-month period. The research procedures were acceptable to patients and practitioners, and the intervention was delivered with acceptable fidelity to the intervention manual. Forty-seven patients were recruited into the phase 2 internal pilot trial, falling substantially short of our target of 491 in the stop-go criteria, indicating that the trial was not feasible in its current design.
Conclusion: The feasibility study indicated that both the intervention and research processes were acceptable. However, the internal pilot trial revealed substantial challenges in recruiting patients and delivering the intervention in the ED context. Adaptations to the trial design and intervention are proposed to enable the Assured approach to be tested in a future trial, to improve care for this underserved population.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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