Improving Status Epilepticus Treatment Times
ConditionStatus Epilepticus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-18
SponsorNationwide Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
SE episode occurs in a male or female child aged between > 30 days to < 19 years
continuous clinically apparent seizure lasting greater than 5 minutes
continuous clinically apparent seizure of any duration receiving BZD
repeated seizures without return to neurological baseline within 5 minutes
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Quality improvement bundle
Other intervention(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
Quality improvement bundle and local PDSA cycles with central support
Other interventionSites will implement both the standard QI bundle as well as site-specific PDSA cycles with central data and methods support.
Quality improvement bundle and local PDSA cycles without central support
Other interventionSites will implement both the standard QI bundle as well as site-specific PDSA cycles without central data or methods support.
Treatment groups
450 Participants
are divided into 4 treatment groupsGroup A: Baseline phaseNo intervention 0 interventions
Group B: Adoption phaseExperimental treatment 1 intervention
Group C: Sustain phaseExperimental treatment 1 intervention
Group D: Independent phaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time from the SE diagnosis to first dose of BZD
Time in minutes from SE diagnosis to treatment with the first dose of a benzodiazepine (BZD) as measured during hospitalization, which will decrease chances of morbidity and mortality
Time frame
30 daysSecondary outcomes
1
ICU transfer rate
Percent of SE episodes resulting in transfer to the ICU within 6 hours of the episode as well as at any point during the admission.
Time frame
30 days2
Cost of hospitalization
Cost of hospitalization will be calculated as follows: cost per SE type x LOS
Time frame
30 days3
Change in PCPC score
Change in PCPC score from admission to discharge
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nationwide Children's Hospital
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Boston Children's Hospital
Collaborator
Children's National Research Institute
Collaborator
Children's Hospital and Health System Foundation, Wisconsin
Collaborator
UVA Children's Hospital
Collaborator
Seattle Children's Hospital
Collaborator
Phoenix Children's Hospital
Collaborator
Emory University
Collaborator
Source ClinicalTrials.gov