Treating seizures faster: The Quality Improvement in Time to Treat Status Epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol.
Publication/Presentation Date
4-1-2025
Abstract
BACKGROUND: Acute seizures may evolve into status epilepticus (SE), prolonged and self-sustaining seizures that may result in brain injury or death. Rapid treatment with a benzodiazepine (BZD) is most effective. However, SE treatment remains delayed in many cases. We previously performed a single-center quality improvement study which resulted in more rapid treatment, decreased intensive care utilization, and decreased cost. Now, we are conducting a multicenter trial to test the hypothesis that pragmatic changes in treating acute inpatient seizures reduce time and are implementable across diverse hospital settings.
METHODS/DESIGN: We designed a multicenter stepped wedge cluster randomized trial with three unidirectional 12-month steps following one baseline step. After dissemination visits, sites will attempt to implement a standardized bundle consisting of: (1) standardize default BZD to non-IV; (2) target treatment time within 10 min; (3) relocate and bundle items for BZD administration to a single location; (4) prioritize basic seizure first aid as initial assessment; (5) implement SE-specific documentation templates; (6) implement multidisciplinary site QI teams. Our primary outcome is median time from seizure diagnosis to BZD administration. Secondary outcomes are median changes in Pediatric Cerebral Performance Category score, ICU transfer rate, and cost of hospitalization. We will study implementation outcomes using mixed methods based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
DISCUSSION: QuITT-SE is designed to test the effect and implementation of a pragmatic set of interventions on treatment times in SE. If successful, results will provide a generalizable roadmap for broad implementation through healthcare systems that should improve outcomes in SE.
TRIAL REGISTRATION: Clinicaltrials.gov (NCT06194747). Funded by the National Institutes of Health (R01NS133037).
Volume
151
First Page
107831
Last Page
107831
ISSN
1559-2030
Published In/Presented At
Ostendorf, A. P., Loddenkemper, T., Morgan, L. A., Appavu, B., Farias-Moeller, R., Harrar, D., Press, C., Abend, N. S., Gaillard, W. D., Bai, S., Eisner, M., McHenry, L., Kroshus, E., Vannatta, K., & Goodkin, H. P. (2025). Treating seizures faster: The Quality Improvement in Time to Treat Status Epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol. Contemporary clinical trials, 151, 107831. https://doi.org/10.1016/j.cct.2025.107831
Disciplines
Medicine and Health Sciences | Pediatrics
PubMedID
39929261
Department(s)
Department of Pediatrics
Document Type
Article