Improving Status Epilepticus Treatment Times

NCT06194747 | Recruiting

• 1 other identifier: STUDY00003386
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Status Epilepticus; Quality Improvement; Interventions

Outcome Measures

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

  30 days

Secondary Outcomes (3)

• ICU transfer rate

  30 days

• Cost of hospitalization

  30 days

• Change in PCPC score

  30 days

Study Arms (4)

Baseline phase

NO INTERVENTION

During this arm, sites will provide routine care.

Adoption phase

EXPERIMENTAL

Following the dissemination visit, sites will actively work to implement the bundle of interventions.

Other: Quality improvement bundle

Sustain phase

EXPERIMENTAL

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.

Other: Quality improvement bundle and local PDSA cycles with central support

Independent phase

EXPERIMENTAL

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.

Other: Quality improvement bundle and local PDSA cycles without central support

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

Adoption phase

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.

Sustain phase

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.

Independent phase

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• 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

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (6)

• Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

  PMID: 16829207 BACKGROUND

• Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.

  PMID: 18468362 BACKGROUND

• Solberg LI, Brekke ML, Fazio CJ, Fowles J, Jacobsen DN, Kottke TE, Mosser G, O'Connor PJ, Ohnsorg KA, Rolnick SJ. Lessons from experienced guideline implementers: attend to many factors and use multiple strategies. Jt Comm J Qual Improv. 2000 Apr;26(4):171-88. doi: 10.1016/s1070-3241(00)26013-6.

  PMID: 10749003 BACKGROUND

• Bradley EH, Holmboe ES, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. A qualitative study of increasing beta-blocker use after myocardial infarction: Why do some hospitals succeed? JAMA. 2001 May 23-30;285(20):2604-11. doi: 10.1001/jama.285.20.2604.

  PMID: 11368734 BACKGROUND

• O'Hara KA. First aid for seizures: the importance of education and appropriate response. J Child Neurol. 2007 May;22(5 Suppl):30S-7S. doi: 10.1177/0883073807303066.

  PMID: 17690085 BACKGROUND

• Ostendorf AP, Loddenkemper T, Morgan LA, Appavu B, Farias-Moeller R, Harrar D, Press C, Abend NS, Gaillard WD, Bai S, Eisner M, McHenry L, Kroshus E, Vannatta K, Goodkin HP. Treating seizures faster: The Quality Improvement in Time to Treat Status Epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol. Contemp Clin Trials. 2025 Apr;151:107831. doi: 10.1016/j.cct.2025.107831. Epub 2025 Feb 8.

  PMID: 39929261 DERIVED

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Ostendorf, MD

  Nationwide Children's Hospital and The Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Ostendorf, MD

CONTACT

614-722-5145; adam.ostendorf@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked as to whether the implementation bundle has been dissemination or implemented within the site they receive treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A stepped-wedge cluster randomized trial. This is a unidirectional crossover design in which clusters switch treatments at different time points, enabling statistically rigorous assessment of interventions while reducing ethical and resource limitations for quality improvement studies.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)