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.

急性癫痫发作可能会演变成癫痫持续状态（SE），即长时间或反复癫痫发作，但无症状。 恢复意识，导致不可逆转的脑损伤或死亡，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) 快速治疗癫痫发作，SE 及其 相关的发病率和死亡率是可以避免的。例如，儿童癫痫发作 10 分钟后接受治疗 发病期间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估 SE 护理的质量指标。尽管 这些基于证据的建议表明，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质量改进 (QuITT-SE) 研究将检查 各儿科医院标准化 QI 干预措施的实施和效果 地理、患者人口统计和资源。拟议的干预措施是在 单中心研究将指导时间内治疗的 SE 发作次数增加了一倍，降低了发病率， 并在接下来的 17 个月内减少了超过 200 万美元的费用。我们的首要目标是研究 跨多个中心实施这些 QI 干预措施及其对 SE 治疗时间的影响 有效性与实施混合设计。 QuITT-SE 试验将是阶梯式楔形集群随机试验 儿科癫痫持续状态研究小组（一个由以下组织组成的联盟）在多个地点进行了试验 拥有研究和治疗儿童 SE 专业知识的医院。在这个项目期间，混合了质量和 将使用定量方法来确定与干预措施相关的实施因素。此外， 在实用、稳健的实施和可持续性模型 (PRISM) 中使用标准化 QI 流程 将有助于识别与延迟 SE 治疗相关的特定地点驱动因素和主题，改善 研究结果的普遍性。 具体目标是： 1) 主要：确定实施 QI 捆绑包如何影响治疗时间 住院非危重儿童中的 SE。 2a) 次要：确定对儿童脑部的影响 实施 QI 捆绑后住院非危重儿童的表现类别评分。 2b) 第二：确定 QI 捆绑传播对 SE 住院费用的影响 住院的非重症儿童 3) 探索性：探索实施 QI 捆绑包所涉及的因素 在住院儿童中治疗 SE 的时间。 公共健康影响：每年，SE 导致美国儿童死亡约 15,000-45,000 人 费用约为 40 亿美元，并且随着癫痫发作时间的延长而显着增加。成功完成QuITT-SE 将制定一套基于证据的干预措施以及实施框架，以改善结果 以及 SE 治疗在不同医院环境中的价值。