Improving Status Epilepticus Treatment Times

Status Epilepticus Clinical Trial

— QuITT-SE  

Official title:

Quality Improvement in Time to Treatment of Status Epilepticus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194747
• Other study ID #: STUDY00003386
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Nationwide Children's Hospital
• Contact: Adam Ostendorf, MD
• Phone: 614-722-5145
• Email: adam.ostendorf[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The overall study design is a stepped-wedge cluster randomized trial. A stepped-wedge 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.[1] Seven centers will be randomly assigned to implement the QI bundle at staggered 1-month intervals after a baseline period. Only the timing of the dissemination visit will be randomized; all sites will receive the same materials and perform the same activities (e.g. focus group, process map development, simulations).

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]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 18 Years

Eligibility

Inclusion Criteria:

• 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:

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 infantile spasms

• SE episode occurs in a child with electrographic-only seizures without clinical signs other than encephalopathy

Related Conditions & MeSH terms

• Status Epilepticus

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (9)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Boston Children's Hospital, Children's Hospital and Health System Foundation, Wisconsin, Children's Hospital of Philadelphia, Children's National Research Institute, Emory University, Phoenix Children's Hospital, Seattle Children's Hospital, UVA Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

Glauser T, Shinnar S, Gloss D, Alldredge B, Arya R, Bainbridge J, Bare M, Bleck T, Dodson WE, Garrity L, Jagoda A, Lowenstein D, Pellock J, Riviello J, Sloan E, Treiman DM. Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society. Epilepsy Curr. 2016 Jan-Feb;16(1):48-61. doi: 10.5698/1535-7597-16.1.48. — View Citation

Hill CE, Parikh AO, Ellis C, Myers JS, Litt B. Timing is everything: Where status epilepticus treatment fails. Ann Neurol. 2017 Aug;82(2):155-165. doi: 10.1002/ana.24986. Epub 2017 Jul 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cost of hospitalization	Cost of hospitalization will be calculated as follows: cost per SE type x LOS	30 days