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.

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