Study Results
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Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2024-02-01
2027-03-31
Brief Summary
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Detailed Description
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This study is an effectiveness-implementation hybrid study. The effectiveness-implementation hybrid design is ideal for assessing both clinical interventions and implementation.17 Importantly, our interventions have strong face-validity, are evidence-based, low-risk and low-cost. For instance, the price to change BZD formulations is nominal (\~$1 per dose), and other QI bundle interventions are primarily focused on frontline staff process changes. While testing the effect of the QI bundle on time to BZD treatment, we will utilize this framework and mixed methods analysis to measure implementation and identify barriers and facilitators. Thus, this proposal is of high-value, as it will provide randomized multicenter efficacy data while providing understanding for broad implementation following study end.
For the effectiveness component, we will utilize a stepped-wedge cluster randomized design. Based on our preliminary data, the intraclass correlation coefficient is estimated around 0.5, an overall sample size of 60 episodes will be adequate to achieve powers greater than 90%. A potential pitfall of the stepped wedge design is the potential confounding effects of temporal trends. We will mitigate this by tracking data at the primary site, which will be in the sustain phase throughout the study entirety. We reduce temporal effects of site enrollment (e.g., staffing changes, temporal trends in hospital admissions) by enrolling sites at different times throughout the calendar year.
The implementation component was designed utilizing the Practical, Robust Implementation and Sustainability Model (PRISM).\[2\] PRISM provides a scientifically rigorous and structured approach to implementation strategy development through domains focusing on (1) program, (2) external environment, (3) implementation and sustainability infrastructure and (4) recipients.\[2\] These elements are addressed as follows:
Program. Organizational readiness across the study sites will be critical for success. Our proposal is based on evidence derived from a successful single-center study. The QI bundle is low-cost and all interventions are currently FDA-approved. Our innovative de-implementation of time-consuming, low-value workflows (e.g. IV medication administration) will decrease care complexity in the initial stages of SE treatment. The QI bundle components are trialable, adaptable and reversible. Treatment results are immediately observable by stakeholders through individual outcomes (SE cessation) and shared measure and feedback data reports. We highlight improved outcomes and safety as organizational, caregiver, and patient priorities to achieve broad buy-in.
External Environment. Regulatory and professional organization priorities support our area of study and primary efficacy outcomes. Rapid treatment of SE has been identified as a quality measure by the AAN11, and guidelines for such care have been published by the AES.\[3\] Additionally, our study proposal further aligns with NAEC, which mandates a focus on rapid treatment of SE through pathway requirements across 260 hospitals. Data from our proposal will serve as a framework for accomplishing the goal of rapid SE treatment, which is inconsistently met at present.\[4\]
Implementation and sustainability infrastructure. Our infrastructure will utilize proven features associated with successful implementation projects.\[5,6\] Co-investigators experienced in working within pSERG will provide a bridge to the local QI and clinical teams, engaging stakeholders at all 3 organizational levels (frontline staff, mid-level management and senior administration). Measure and feedback will be emphasized through control chart data and implementation reports. Furthermore, the adaptable protocol allows for site-specific implementation strategies for the QI bundle as well as iterative PDSA development in the Sustain and Independent phases in order to address local drivers.
Recipients. Positive organizational characteristics are supported by LOS from senior hospital administrators and nurse managers. Furthermore, the co-investigators have previously collaborated with pSERG from their respective centers. Each site has access to data through Export, Transform, Load (ETL) data queries and EHR. The diverse demographics of patients is aided through intentional site selection and inclusion of nearly all ages of children. Importantly, our proposed interventions of performing basic seizure first aid and using non-IV forms of BZD aligns with those of patients and families in the ambulatory setting.\[7\]
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Baseline phase
During this arm, sites will provide routine care.
No interventions assigned to this group
Adoption phase
Following the dissemination visit, sites will actively work to implement the bundle of interventions.
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
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.
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.
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.
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.
Interventions
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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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Seizures meeting AT LEAST ONE of the following criteria:
1. continuous clinically apparent seizure lasting greater than 5 minutes
2. continuous clinically apparent seizure of any duration receiving BZD
3. repeated seizures without return to neurological baseline within 5 minutes
Exclusion Criteria
* SE episode occurs in a child with electrographic-only seizures without clinical signs other than encephalopathy
30 Days
18 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Boston Children's Hospital
OTHER
Children's National Research Institute
OTHER
Children's Hospital and Health System Foundation, Wisconsin
OTHER
UVA Children's Hospital
OTHER
Seattle Children's Hospital
OTHER
Phoenix Children's Hospital
OTHER
Emory University
OTHER
Nationwide Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Adam Ostendorf, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital and The Ohio State University
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00003386
Identifier Type: -
Identifier Source: org_study_id
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