Quality Improvement in time to Treatment of Status Epilepticus (QuITT-SE)

癫痫持续状态治疗的及时质量改进 (QuITT-SE)

• 批准号: 10720249
• 负责人: ADAM P. OSTENDORF
• 金额: $ 76.52万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10720249
• 关键词: Academy; Acute; Address; Admission activity; Adoption; American; Anticonvulsants; Benzodiazepines; Brain Death; Brain Injuries; Caring; Categories; Cerebrum; Cessation of life; Charge; Child; Childhood; Cluster randomized trial; Conscious; Diagnosis; Dose; Evidence based intervention; Geography; Goals; Guidelines; Healthcare Systems; Hospital Costs; Hospitalization; Hospitalized Child; Hospitals; Individual; Intensive Care; Intervention; Measures; Mechanical ventilation; Methodology; Methods; Morbidity - disease rate; Neurology; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Performance; Phase; Practical Robust Implementation and Sustainability Model; Process; Public Health; Qualitative Methods; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Refractory; Research; Resources; Safety; Seizures; Site; Societies; Standardization; Statistical Computing; Status Epilepticus; Testing; Time; United States; cost; demographics; design; effectiveness/implementation design; effectiveness/implementation trial; efficacy outcomes; evidence based guidelines; implementation determinants; implementation framework; improved; improved outcome; intervention effect; mortality; post implementation; process improvement

Acute seizures may evolve into status epilepticus (SE), i.e., prolonged or repeated seizures without regaining consciousness, resulting in irreversible brain injury or death costing ~$4 billion annually to the US healthcare system. If seizures are treated rapidly with a correctly-dosed benzodiazepine (BZD), SE and its associated morbidity and mortality may be averted. For instance, children treated after 10 minutes of seizure onset are 11 times more likely to die during their hospitalization than patients treated earlier. Therefore, the American Academy of Neurology identified time to treatment as a quality metric to evaluate SE care. Despite these evidence-based recommendations, delayed seizure treatment remains the status quo in many centers. The Quality Improvement in Time to Treatment of Status Epilepticus (QuITT-SE) study will examine the implementation and effects of a standardized set of QI interventions across pediatric hospitals with diversity in geography, patient demographics and resources. The proposed interventions were developed and tested in a single-center study that doubled the number of SE episodes treated within guideline timing, decreased morbidity, and mitigated over $2 million of charges in the following 17-month period. Our overarching goal is to study the implementation of these QI interventions and their effect on time to SE treatment across multiple centers utilizing an effectiveness-implementation hybrid design. The QuITT-SE trial will be a stepped-wedge cluster randomized trial across multiple sites within the Pediatric Status Epilepticus Research Group, an established consortium of hospitals with expertise in studying and treating SE in children. During this project, mixed qualitative and quantitative methods will be used to identify implementation factors related to the interventions. In addition, the use of standardized QI processes within the Practical, Robust Implementation and Sustainability Model (PRISM) will facilitate the identification of site-specific drivers and themes pertaining to delayed SE treatment, improving the generalizability of findings. The specific aims are: 1) Primary: Determine how implementing a QI bundle impacts the time to treat SE among hospitalized, non-critically ill children. 2a) Secondary: Determine the effect on Pediatric Cerebral Performance Category score among hospitalized, non-critically ill children after implementing a QI bundle. 2b) Secondary: Determine the effect of dissemination of a QI bundle on cost of hospitalization for SE among hospitalized, non-critically ill children 3) Exploratory: Explore the factors implicated in implementing a QI bundle on the time to treat SE among hospitalized children. Public Health Impact: Each year, SE results in an estimated 15,000-45,000 deaths in children in the US and costs ~$4 billion, increasing markedly with more prolonged seizures. Successful completion of QuITT-SE will produce a set of evidence-based interventions alongside an implementation framework to improve outcomes and value of SE treatment across diverse hospital settings.

急性癫痫发作可能演变为癫痫持续状态（SE），即，长期或反复发作， 恢复意识，导致不可逆的脑损伤或死亡，每年给美国造成约40亿美元的损失 医疗保健系统。如果使用正确剂量的苯二氮卓类药物（BZD）迅速治疗癫痫发作， 可以避免相关的发病率和死亡率。例如，在癫痫发作10分钟后接受治疗的儿童 在住院期间死亡的可能性是早期接受治疗的患者的11倍。因此 美国神经病学学会将治疗时间确定为评价SE护理的质量指标。尽管 这些基于证据的建议，延迟癫痫治疗仍然是许多中心的现状。 癫痫持续状态治疗时间的质量改善（Quitt-SE）研究将检查 在儿科医院实施一套标准化的QI干预措施， 地理、患者人口统计和资源。拟议的干预措施是在一个 一项单中心研究，在指南时间内治疗的SE发作次数增加了一倍，发病率降低， 并在随后的17个月内减轻了200多万美元的费用。我们的首要目标是研究 这些QI干预措施的实施及其对多个中心采用SE治疗时间的影响 一种有效性-实现混合设计。QuITT-SE试验将是一项阶梯楔形分组随机化试验， 在儿科癫痫持续状态研究组（Pediatric Status Epilepticus Research Group）的多个研究中心进行的一项试验， 拥有研究和治疗儿童SE专业知识的医院。在这个项目中，混合质量和 将使用定量方法来确定与干预措施有关的执行因素。此外该 在实用、稳健实施和可持续性模型（PRISM）中使用标准化QI流程 将有助于确定与延迟SE治疗有关的特定场地驱动因素和主题， 调查结果的普遍性。 具体目标是：1）主要：确定实施QI捆绑包如何影响治疗时间 在住院的非危重病儿童中的SE。2a）次要：确定对小儿脑 实施QI捆绑包后住院非危重病儿童的性能类别评分。（b） 次要目的：确定QI束传播对SE住院费用的影响， 住院的非危重患儿3）探索性：探索实施气束的相关因素 在住院儿童中治疗SE的时间。 公共卫生影响：每年，SE导致美国约15，000 - 45，000名儿童死亡 成本约为40亿美元，随着缉获时间的延长而显著增加。成功完成Quitt-SE 将制定一套基于证据的干预措施，同时制定一个实施框架，以改善成果 和不同医院环境中SE治疗的价值。