Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial

在救护车环境中早期使用类固醇：观察性设计试验

• 批准号: 10596088
• 负责人: Jennifer Noel Fishe
• 金额: $ 13.74万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10596088
• 关键词: Accident and Emergency department; Admission activity; Adopted; Adoption; Adrenal Cortex Hormones; Adult; Affect; Age; Agreement; Ambulances; Antiinflammatory Effect; Asthma; Biometry; Budgets; Caring; Charge; Child; Childhood; Childhood Asthma; Chronic Disease; Clinical; Clinical Trials; County; Critical Illness; Data; Development; Economics; Emergency department visit; Emergency medical service; Enrollment; Environment; Florida; Foundations; Funding; Future; Geographic Information Systems; Goals; Grant; Guidelines; Health Care Costs; Hospitalization; Hospitals; Hour; Intensive Care Units; Intravenous; K-Series Research Career Programs; Knowledge; Leadership; Length of Stay; Master of Science; Medical emergency; Mentors; Mentorship; Methylprednisolone; Modeling; Multicenter Trials; Oral; Oral Administration; Outcome; Patient-Focused Outcomes; Patients; Physicians; Pilot Projects; Positioning Attribute; Principal Investigator; Protocols documentation; Randomized; Randomized, Controlled Trials; Recommendation; Research; Research Personnel; Rural; Steroids; Structure; Tablets; Testing; Time; Training; Translating; Treatment Failure; Up-Regulation; Update; asthma exacerbation; asthmatic patient; career development; common treatment; cost; design; evidence base; experience; hospital admission rate; human subject protection; improved; improved outcome; information system analysis; innovation; multidisciplinary; novel; operation; pediatric emergency; prednisolone; primary outcome; programs; prospective; receptor; rural area; secondary outcome; service providers; suburb; time use; treatment services; trial design; underserved rural area

Program Director/Principal Investigator (Last, First, Middle): Fishe, Jennifer, N K23 Abstract Project Summary Asthma is the most common chronic disease of childhood and a leading cause of emergency medical treatment. Yet there is a paucity of evidence and guidelines for emergency medical services (EMS) treatment of pediatric asthma prior to emergency department (ED) arrival. ED guidelines recommend early systemic corticosteroid (CS) administration within one hour of ED arrival, since studies have shown associated decreases in hospital admissions and ED length-of-stay (LOS). For patients treated by EMS, there exists an opportunity for even earlier administration of CS. The goal of this project is to determine whether EMS administration of CS improves patient outcomes. Our preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival. Given the time-sensitivity of CS' effects on patient outcomes in the ED, our hypothesis is that EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions. By performing a pilot cluster randomized controlled trial, this study will fill a significant prehospital knowledge gap in the continuum of emergent pediatric asthma care. This study analyzes cost and transport times, two factors relevant to EMS operations and future guideline implementation. Through our partnership with Nassau County, Alachua County and Lake County EMS agencies, we plan to enroll 330 patients over a three-year period to analyze clinical outcomes and costs of EMS CS administration, and how both vary with EMS transport time. During the five-year K23 career development award period, Dr. Jennifer Fishe will progress from a mentored investigator to an independent investigator positioned to achieve R01 funding. That transition will occur due to strong mentorship and a structured training plan which includes: 1) Development of knowledge and experience with clinical trials, including protection of human subjects, 2) Attaining a Master of Science in Biostatistics, and 3) Grantsmanship and Leadership training necessary to become an independent investigator. Dr. Fishe's mentor and scientific advisor team contains subject matter experts on clinical trials and pediatric asthma / emergency medical services, experience with R01 grants and clinical trials, as well as career development. PHS 398/2590 (Rev. 06/09) Page 1 Continuation Format Page

项目总监/首席研究员（最后，第一，中间）：Fishe，Jennifer，N K23摘要 项目摘要 哮喘是最常见的儿童慢性疾病，也是紧急医疗的主要原因 治疗。然而，紧急医疗服务（EMS）治疗的证据和准则很少 急诊科（ED）到达之前的小儿哮喘。 ED指南建议早期系统性 皮质类固醇（CS）在ED到达后一小时内给药，因为研究表明 医院入院和急诊室（LOS）的减少。对于由EMS治疗的患者，存在 甚至更早地管理CS的机会。该项目的目的是确定EMS是否 CS的给药可改善患者的预后。我们的初步数据表明，目前少于 10％的EMS小儿哮喘患者在ED到达之前接受CS。 鉴于CS对ED中患者预后的影响的时间敏感性，我们的假设是EMS CS的管理将减少医院入院，ED LOS和重症监护病房的入院。经过 进行飞行员群集随机对照试验，本研究将填补院前知识差距 在新兴的小儿哮喘护理中。这项研究分析了成本和运输时间，两个因素 与EMS操作和未来指南实施有关。通过与拿骚县的合作关系 Alachua县和Lake County EMS机构，我们计划在三年内注册330名患者 分析EMS CS给药的临床结果和成本，以及与EMS运输时间的变化。 在五年的K23职业发展奖期间，詹妮弗·菲什（Jennifer Fishe）博士将从一个指导中进步 对独立调查员的调查员，该研究人员的定位旨在获得R01资金。由于 强大的指导和结构化培训计划，其中包括：1）知识和经验的发展 通过临床试验，包括对人类受试者的保护，2）获得生物统计学科学硕士和 3）成为独立调查员必要的授予技巧和领导培训。 Fishe博士 导师和科学顾问团队包含有关临床试验和小儿哮喘 /的主题专家 紧急医疗服务，R01赠款和临床试验的经验以及职业发展。 PHS 398/2590（修订06/09）第1页延续格式页面