title: 'Seizure First Aid Training' for people with epilepsy who attend emergency departments, and their family and friends: study protocol for intervention development and a pilot randomised controlled trial.
abstract: BACKGROUND
  People with chronic epilepsy (PWE) often make costly but clinically unnecessary emergency department (ED) visits. Offering them and their carers a self-management intervention that improves confidence and ability to manage seizures may lead to fewer visits. As no such intervention currently exists, we describe a project to develop and pilot one.
  
  
  METHODS
  To develop the intervention, an existing group-based seizure management course that has been offered by the Epilepsy Society within the voluntary sector to a broader audience will be adapted. Feedback from PWE, carers and representatives from the main groups caring for PWE will help refine the course so that it addresses the needs of ED attendees. Its behaviour change potential will also be optimised. A pilot randomised controlled trial will then be completed. 80 PWE aged ≥16 who have visited the ED in the prior 12 months on ≥2 occasions, along with one of their family members or friends, will be recruited from three NHS EDs. Dyads will be randomised to receive the intervention or treatment as usual alone. The proposed primary outcome is ED use in the 12 months following randomisation. For the pilot, this will be measured using routine hospital data. Secondary outcomes will be measured by patients and carers completing questionnaires 3, 6 and 12 months postrandomisation. Rates of recruitment, retention and unblinding will be calculated, along with the ED event rate in the control group and an estimate of the intervention's effect on the outcome measures.
  
  
  BACKGROUND
  Ethical approval: NRES Committee North West-Liverpool East (Reference number 15/NW/0225). The project's findings will provide robust evidence on the acceptability of seizure management training and on the optimal design of a future definitive trial. The findings will be published in peer-reviewed journals and presented at conferences.
  
  
  BACKGROUND
  ISRCTN13 871 327.
authors.affiliation: Department of Psychological Sciences, University of Liverpool, Liverpool, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Noble
authors.affiliation: Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
authors.forename: A G
authors.initials: AG
authors.lastname: Marson
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: C
authors.initials: C
authors.lastname: Tudur-Smith
authors.affiliation: Institute of Pharmaceutical Science, King's College London, Liverpool, UK.
authors.forename: M
authors.initials: M
authors.lastname: Morgan
authors.affiliation: Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK.
authors.forename: D A
authors.initials: DA
authors.lastname: Hughes
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: S
authors.initials: S
authors.lastname: Goodacre
authors.affiliation: Department of Basic and Clinical Neuroscience, King's College London, London, UK.
authors.forename: L
authors.initials: L
authors.lastname: Ridsdale
mesh_terms: D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D004827:Epilepsy / Q000150:complications; D005392:First Aid; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010353:Patient Education as Topic; D010865:Pilot Projects; D012107:Research Design; D012640:Seizures / Q000209:etiology / Q000628:therapy*; D012648:Self Care; D020377:Self Efficacy; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
keywords: ACCIDENT & EMERGENCY MEDICINE; EDUCATION & TRAINING (see Medical Education & Training); QUALITATIVE RESEARCH; REHABILITATION MEDICINE; THERAPEUTICS