Quality Improvement in Time to Treatment of Status Epilepticus

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Adam Ostendorf, MD
adam.ostendorf@nationwidechildrens.org
614-722-5145
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 450
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, Children's National Research Institute, Phoenix Children's Hospital, Seattle Children's Hospital, Boston Children's Hospital, Children's Hospital of Philadelphia, Children's Hospital and Health System Foundation, Wisconsin, UVA Children's Hospital
Leads: Nationwide Children's Hospital

This content was sourced from clinicaltrials.gov