RecruitingNot ApplicableNCT06194747

Improving Status Epilepticus Treatment Times

Quality Improvement in Time to Treatment of Status Epilepticus


Sponsor

Nationwide Children's Hospital

Enrollment

450 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 DaysMax Age: 18 Years

Inclusion Criteria5

  • 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:
  • 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

Exclusion Criteria2

  • 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

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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.


Locations(1)

Nationwide Children's Hospital

Columbus, Ohio, United States

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NCT06194747


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