Quality Improvement in Time to Treatment of Status Epilepticus
Nationwide Children's Hospital
Summary
This is a stepped-wedge cluster randomized effectiveness-implementation hybrid study aimed at determining the effect of dissemination of a QI bundle on the time to treatment of SE among hospitalized, non-critically ill children. The primary study endpoint is to decrease the time from the SE diagnosis to treatment with the first dose of a benzodiazepine (BZD) as measured during hospitalization, which will decrease chances of morbidity and mortality.
Description
The overall study design is a stepped-wedge cluster randomized trial. A stepped-wedge is a unidirectional crossover design in which clusters switch treatments at different time points, enabling statistically rigorous assessment of interventions while reducing ethical and resource limitations for quality improvement studies.\[1\] Seven centers will be randomly assigned to implement the QI bundle at staggered 1-month intervals after a baseline period. Only the timing of the dissemination visit will be randomized; all sites will receive the same materials and perform the same activities (e.g. foc…
Eligibility
- Age range
- 0–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * SE episode occurs in a male or female child aged between \> 30 days to \< 19 years * Seizures meeting AT LEAST ONE of the following criteria: 1. continuous clinically apparent seizure lasting greater than 5 minutes 2. continuous clinically apparent seizure of any duration receiving BZD 3. repeated seizures without return to neurological baseline within 5 minutes Exclusion Criteria: * 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
Interventions
- OtherQuality improvement bundle
(1) standardizing BZD default to intranasal or buccal midazolam; (2) targeting initial BZD treatment within 10 minutes of seizure onset; (3) relocating and bundling all administration items needed to the hospital unit medication room; (4) utilizing basic seizure first aid in the initial patient assessment; (5) developing and implementing SE-specific EHR documentation; (6) multidisciplinary QI teams
- OtherQuality improvement bundle and local PDSA cycles with central support
Sites will implement both the standard QI bundle as well as site-specific PDSA cycles with central data and methods support.
- OtherQuality improvement bundle and local PDSA cycles without central support
Sites will implement both the standard QI bundle as well as site-specific PDSA cycles without central data or methods support.
Location
- Nationwide Children's HospitalColumbus, Ohio