Seizure First Aid Training for people with Epilepsy (SAFE) frequently attending emergency departments and their significant others: Results of a UK multi-centre randomised controlled pilot trial

Adam J. Noble*, Dee Snape, Sarah Nevitt, Emily A. Holmes, Myfanwy Morgan, Catrin Tudur-Smith, Dyfrig A. Hughes, Mark Buchanan, Jane McVicar, Elizabeth MacCallum, Steve Goodacre, Leone Ridsdale, Anthony G. Marson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Objective To determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE). Design Pilot RCT with embedded microcosting. Setting Three English hospital emergency departments (EDs). Participants Patients aged ≥16 with established epilepsy reporting ≥2 ED visits in the prior 12 months and their significant others (SOs). Interventions Patients (and their SOs) were randomly allocated (1:1) to SAFE plus treatment-as-usual (TAU) or TAU alone. SAFE is a 4-hour group course. Main outcome measures Two criteria evaluated a definitive RCT's feasibility: (1) ≥20% of eligible patients needed to be consented into the pilot trial; (2) routine data on use of ED over the 12 months postrandomisation needed securing for ≥75%. Other measures included eligibility, ease of obtaining routine data, availability of self-report ED data and comparability, SAFE's effect and intervention cost. Results Of ED attendees with a suspected seizure, 424 (10.6%) patients were eligible; 53 (12.5%) patients and 38 SOs consented. Fifty-one patients (and 37 SOs) were randomised. Routine data on ED use at 12 months were secured for 94.1% patients. Self-report ED data were available for 66.7% patients. Patients reported more visits compared with routine data. Most (76.9%) patients randomised to SAFE received it and no related serious adverse events occurred. ED use at 12 months was lower in the SAFE+TAU arm compared with TAU alone, but not significantly (rate ratio=0.62, 95% CI 0.33 to 1.17). A definitive trial would need ∼674 patient participants and ∼39 recruitment sites. Obtaining routine data was challenging, taking ∼8.5 months. Conclusions In satisfying only one predetermined a stop/go' criterion, a definitive RCT is not feasible. The low consent rate in the pilot trial raises concerns about a definitive trial's finding's external validity and means it would be expensive to conduct. Research is required into how to optimise recruitment from the target population. Trial registration number ISRCTN13871327.

Original languageEnglish
Article numbere035516
JournalBMJ Open
Volume10
Issue number4
DOIs
Publication statusPublished - 16 Apr 2020

Keywords

  • accident & emergency medicine
  • clinical trials
  • epilepsy
  • health economics
  • organisation of health services

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