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



Noble, Adam ORCID: 0000-0002-8070-4352, Snape, D, Nevitt, Sarah ORCID: 0000-0001-9988-2709, Holmes, EAF, Morgan, M, Tudur Smith, C ORCID: 0000-0003-3051-1445, Hughes, DA ORCID: 0000-0001-8247-7459, Buchanan, M, McVicar, J, MacCallum, E
et al (show 3 more authors) (2020) 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. BMJ Open, 10 (4).

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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 ‘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.

Item Type: Article
Depositing User: Symplectic Admin
Date Deposited: 24 Apr 2020 14:03
Last Modified: 24 Jul 2021 05:10
DOI: 10.1136/bmjopen-2019-035516
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3083622

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