Treating seizures faster: The quality improvement in time to treat status epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol

Adam P. Ostendorf, Nationwide Children's Hospital and The Ohio State University, 700 Children's Drive, Columbus, OH 43230, USA. Electronic address: adam.ostendorf@nationwidechildrens.org.
Tobias Loddenkemper, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, USA.
Lindsey A. Morgan, Seattle Children's Hospital and University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, USA.
Brian Appavu, Division of Neurology Department of Neuroscience, Barrow Neurological Institute at Phoenix Children's Hospital, 1919 E Thomas Rd, Phoenix, AZ 85213, USA.
Raquel Farias-Moeller, Department of Neurology, Division of Pediatric Neurology, Children's Wisconsin and the Medical College of Wisconsin, 8915 W Connell Avenue, Milwaukee, WI 53226, USA.
Dana Harrar, Center for Neuroscience and Behavioral Health, Children's National Hospital, George Washington University, 111 Michigan Avenue NW, Washington, DC 20010, USA.
Craig Press, Departments of Neurology and Pediatrics, The Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Boulevard, Philadelphia, PA 19104, USA.
Nicholas S. Abend, Departments of Neurology and Pediatrics, The Children's Hospital of Philadelphia, University of Pennsylvania, 3401 Civic Center Boulevard, Philadelphia, PA 19104, USA.
William D. Gaillard, Center for Neuroscience and Behavioral Health, Children's National Hospital, George Washington University, 111 Michigan Avenue NW, Washington, DC 20010, USA.
Shasha Bai, Emory University School of Medicine, 2015 Uppergate Dr, Atlanta, GA 30307, USA.
Mariah Eisner, Biostatics Resource at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH 43230, USA.
Lauren McHenry, Nationwide Children's Hospital and The Ohio State University, 700 Children's Drive, Columbus, OH 43230, USA.
Emily Kroshus, Department of Pediatrics, University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, USA.
Kathryn Vannatta, Nationwide Children's Hospital and The Ohio State University, 700 Children's Drive, Columbus, OH 43230, USA.
Howard P. Goodkin, Department of Neurology, University of Virginia School of Medicine, 1215 Lee Street, Charlottesville, VA 22903, USA.

Document Type

Journal Article

Publication Date

2-8-2025

Journal

Contemporary clinical trials

Volume

151

DOI

10.1016/j.cct.2025.107831

Keywords

Benzodiazepine; Implementation science; Quality improvement; Seizure; Status epilepticus; Stepped wedge design

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).

Department

Neurology

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