Treating seizures faster: The quality improvement in time to treat status epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2025-04-01 Epub Date: 2025-02-08 DOI:10.1016/j.cct.2025.107831

Adam P. Ostendorf , Tobias Loddenkemper , Lindsey A. Morgan , Brian Appavu , Raquel Farias-Moeller , Dana Harrar , Craig Press , Nicholas S. Abend , William D. Gaillard , Shasha Bai , Mariah Eisner , Lauren McHenry , Emily Kroshus , Kathryn Vannatta , Howard P. Goodkin

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Abstract

Background

Acute seizures may evolve into status epilepticus (SE), prolonged and self-sustaining seizures that may result in brain injury or death. Rapid treatment with a benzodiazepine (BZD) is most effective. However, SE treatment remains delayed in many cases. We previously performed a single-center quality improvement study which resulted in more rapid treatment, decreased intensive care utilization, and decreased cost. Now, we are conducting a multicenter trial to test the hypothesis that pragmatic changes in treating acute inpatient seizures reduce time and are implementable across diverse hospital settings.

Methods/Design

We designed a multicenter stepped wedge cluster randomized trial with three unidirectional 12-month steps following one baseline step. After dissemination visits, sites will attempt to implement a standardized bundle consisting of: (1) standardize default BZD to non-IV; (2) target treatment time within 10 min; (3) relocate and bundle items for BZD administration to a single location; (4) prioritize basic seizure first aid as initial assessment; (5) implement SE-specific documentation templates; (6) implement multidisciplinary site QI teams. Our primary outcome is median time from seizure diagnosis to BZD administration. Secondary outcomes are median changes in Pediatric Cerebral Performance Category score, ICU transfer rate, and cost of hospitalization. We will study implementation outcomes using mixed methods based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.

Discussion

QuITT-SE is designed to test the effect and implementation of a pragmatic set of interventions on treatment times in SE. If successful, results will provide a generalizable roadmap for broad implementation through healthcare systems that should improve outcomes in SE.

Trial registration: Clinicaltrials.gov (NCT06194747). Funded by the National Institutes of Health (R01NS133037).

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更快地治疗癫痫发作：治疗癫痫持续状态（QuITT-SE）多中心随机阶梯楔形临床试验方案的质量改善

背景：急性发作可发展为癫痫持续状态（SE），长时间和自我持续发作，可导致脑损伤或死亡。用苯二氮卓类药物（BZD）快速治疗最有效。然而，在许多病例中，SE治疗仍然延迟。我们之前进行了一项单中心质量改进研究，结果是更快的治疗，减少了重症监护的使用，降低了成本。现在，我们正在进行一项多中心试验，以验证在治疗急性住院癫痫发作方面的务实变化可以缩短时间，并且可以在不同的医院环境中实施。方法/设计我们设计了一项多中心阶梯楔形群随机试验，在一个基线步骤之后进行三个单向12个月的步骤。在传播访问后，站点将尝试实现标准化的捆绑包，包括：(1)将默认BZD标准化为非iv；(2)目标治疗时间在10 min以内；（三）将开发区管理事项集中、集中；(4)将基础癫痫急救作为初步评估；(5)实现se特有的文档模板；(6)实施多学科现场QI团队。我们的主要结果是从癫痫发作诊断到BZD给药的中位时间。次要结局是儿童脑功能分类评分的中位变化、ICU转诊率和住院费用。我们将使用基于Reach、有效性、采用、实施、维护（RE-AIM）框架的混合方法研究实施结果。quitt -SE旨在测试一套实用的干预措施对SE治疗时间的影响和实施情况。如果成功，结果将为通过医疗保健系统广泛实施提供一个可推广的路线图，这将改善SE的结果。试验注册：Clinicaltrials.gov （NCT06194747）。由美国国立卫生研究院资助（R01NS133037）。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.