Improving Treatment Speed for Status Epilepticus in Children Using a Quality Improvement Program
Led by Nationwide Children's Hospital · Updated on 2026-04-01
450
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a stepped-wedge cluster randomized effectiveness-implementation hybrid study to improve the treatment time for Status Epilepticus SE in hospitalized, non-critically ill children. The study aims to reduce the time between SE diagnosis and the first dose of a benzodiazepine BZD, potentially lowering risks of complications and death. This design allows assessment of both the clinical impact and how well the intervention can be applied across multiple hospitals.
Seven hospital centers will take part, each starting the quality improvement QI bundle intervention at different times in a staggered manner. The QI bundle includes standardizing the use of intranasal or buccal midazolam, targeting BZD treatment within 10 minutes of seizure onset, reorganizing medication supplies, using basic seizure first aid, creating SE-specific electronic health record documentation, and forming multidisciplinary QI teams. The study involves phases of routine care, adoption of the bundle, and sustained implementation with or without central support.
Participants will be monitored during hospitalization to measure the time to first BZD dose as the primary outcome. Secondary outcomes include rates of ICU transfer, hospitalization costs, and changes in neurological function scores over 30 days. Data collection will include focus groups, process mapping, and simulations, alongside continuous feedback and support for sustaining the interventions. The study expects to provide valuable insights into both clinical effectiveness and practical implementation over its duration.
CONDITIONS
Brief Title
Improving Status Epilepticus Treatment Times
Research Team
A
Adam Ostendorf, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Quality Improvement Bundle
Usual Care (Pre-Intervention)
Description
A set of coordinated interventions designed to standardize and speed up benzodiazepine (BZD) administration for children in status epilepticus, such as route standardization (intranasal or buccal midazolam), rapid medication delivery targeting under 10 minutes, supply relocation, improved seizure first aid, and integrated EHR steps. At some sites, supported by additional local PDSA cycles and external guidance.
The standard approach to treating pediatric status epilepticus before implementing the study's structured quality improvement (QI) bundle. Local protocols and workflow, without changes to medication access or enhanced team procedures.
Role in Study
Evaluated as the intervention period, where QI bundle components are actively used and outcomes (such as time to BZD delivery) are measured for effect compared to baseline.
Serves as the internal control phase, reflecting treatment timing and processes before QI interventions. Outcomes are compared to those seen during and after QI bundle adoption.
Primary Use in Care
Intended to improve the speed and consistency of administering benzodiazepines and related care processes for children experiencing status epilepticus.
Reflects typical pediatric status epilepticus care absent targeted workflow or early medication delivery interventions.
How It Is Delivered
QI bundle includes actions such as setting a default midazolam route, aiming for BZD delivery within 10 minutes, relocating medications and supplies for access, staff seizure first aid refreshers, and EHR updates. Some sites also used continuous feedback and coaching via local PDSA cycles.
Treatment and workflow followed local hospital protocols, with no structured QI elements or standardized medication-time targets.
Evidence Status
Trial is ongoing; outcome evidence for whether the QI bundle reduces treatment times and improves clinical endpoints such as ICU transfers remains under clinical investigation.
Represents the actual pre-intervention outcomes in participating sites, prior to QI intervention. No specific published benchmark for SE treatment time or outcomes; reflects local routine care.
Important Limitations
As a bundled QI process, effect may depend on staff engagement, local resource availability, and implementation fidelity. Not all elements may be equally adopted or sustainable over time; the impact on clinical endpoints cannot be fully predicted before results are posted.
Pre-intervention care may suffer from delays in medication administration, varied supply access, or non-standard clinical workflows. Quality of care and speed may differ widely across sites and circumstances.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 30Days - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
SE episode occurs in a male or female child aged between over 30 days to under 19 years
Seizures meeting at least one of the following: continuous seizure lasting more than 5 minutes, continuous seizure of any duration receiving benzodiazepine, or repeated seizures without return to neurological baseline within 5 minutes
You will not qualify if you...
SE episode occurs in a child with infantile spasms
SE episode occurs in a child with electrographic-only seizures without clinical signs other than encephalopathy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline phase
Duration - Varies by site enrollment period
Participants receive routine care without the quality improvement interventions.
Care occurs as part of routine hospital visits
Adoption phase
Duration - 1 month or as sites begin implementation after dissemination visit
Participants experience active implementation of the quality improvement bundle to improve treatment times for status epilepticus.
Care occurs as part of routine hospital visits with additional monitoring
Sustain phase
Duration - Ongoing after adoption phase
Participants experience continued use of the quality improvement bundle with site-specific plan-do-study-act cycles supported centrally.
Care occurs as part of routine hospital visits with ongoing quality improvement activities
Independent phase
Duration - Ongoing after sustain phase until study completion
Participants experience sustained use of the quality improvement bundle with site-specific plan-do-study-act cycles without central support.
Care occurs as part of routine hospital visits with continued local quality improvement efforts
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Treating seizures faster: The Quality Improvement in Time to Treat Status Epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol.
Adam P Ostendorf, Tobias Loddenkemper, Lindsey A Morgan...