Improving Status Epilepticus Treatment Times

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.

Conditions

• Status Epilepticus

Interventions

OTHER

Quality 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

OTHER

Quality 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.

OTHER

Quality 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• UVA Children's Hospital

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• Emory University

  collaborator OTHER

• Nationwide Children's Hospital

  lead OTHER

Principal Investigators

• Adam Ostendorf, MD · Nationwide Children's Hospital and The Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

30 Days

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United States

Study Locations