Design and analysis of stepped wedge cluster randomized trials.
Michael A Hussey, James P Hughes
https://pubmed.ncbi.nlm.nih.gov/16829207Actively Recruiting
Phase Not Applicable
Age: 30Days - 18Years
All Genders
ID06194747
Quality Improvement in Time to Treatment of Status Epilepticus A Stepped-Wedge Cluster Randomized Trial in Hospitalized Children
Led by Nationwide Children's Hospital · Updated on 2026-04-01
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
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Research Team
A
Adam Ostendorf, MD
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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Kathryn A O'Hara
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https://pubmed.ncbi.nlm.nih.gov/39929261