TY - JOUR

T1 - 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

AU - Noble, A.J.

AU - Snape, D.

AU - Nevitt, S.

AU - Holmes, Emily

AU - Morgan, M.

AU - Smith, Catrin Tudur

AU - Hughes, Dyfrig

AU - Buchanan, M.

AU - McVicar, J.

AU - MacCallum, E.

AU - Goodacre, Steve

AU - Rinsdale, L.

AU - Marson, A.G.

N1 - This project was funded by the National Institute for Health Research’s Health Services and Delivery Research Programme (HS&DR Programme) (project number 14/19/09)

PY - 2020/4/16

Y1 - 2020/4/16

N2 - 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.TRIAL REGISTRATION NUMBER: ISRCTN13871327.

AB - 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.TRIAL REGISTRATION NUMBER: ISRCTN13871327.

KW - Epilepsy

KW - Accident & Emergency Medicine

KW - Organisation of health services

KW - Health economics

KW - Clinical Trials

U2 - 10.1136/bmjopen-2019-035516

DO - 10.1136/bmjopen-2019-035516

M3 - Article

C2 - 32303515

VL - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 4

M1 - e035516

ER -