Improving Status Epilepticus Treatment Times

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT06194747
Status
Recruiting
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Conditions

  • Status Epilepticus

Eligibility Criteria

Sex
ALL
Age
30 Days - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Quality improvement bundle — OTHER
    (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
    Sites 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
    Sites will implement both the standard QI bundle as well as site-specific PDSA cycles without central data or methods support.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Baseline phase
    During this arm, sites will provide routine care.
  • Experimental: Adoption phase
    Following the dissemination visit, sites will actively work to implement the bundle of interventions.
  • Experimental: Sustain phase
    During this arm, sites will actively work to sustain the implemented interventions and will be allowed to develop site-specific plan-do-study-act cycles in order to address site-specific key drivers with central data and methodological support.
  • Experimental: Independent phase
    During this arm, sites will continue to sustain the implemented interventions and develop site-specific plan-do-study-act cycles in order to address site-specific key drivers without central data and methodological support.

Primary Outcome Measure

Time from the SE diagnosis to first dose of BZD [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Adam P Ostendorf, MD
[email protected]
614-722-5145

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By research site
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