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: 10132389
• 负责人: Jennifer Noel Fishe
• 金额: $ 16.29万
• 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/10132389
• 关键词: Accident and Emergency department; Admission activity; Adopted; Adoption; Adrenal Cortex Hormones; Adult; Affect; Age; Ambulances; Antiinflammatory Effect; Asthma; Biometry; Budgets; Caring; Charge; Child; Childhood; Childhood Asthma; Chronic Disease; Clinical; Clinical Trials; Cost Analysis; 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; Hospital Departments; Hospitalization; Hour; Intensive Care Units; Intravenous; K-Series Research Career Programs; Knowledge; Lead; 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; Research; Research Personnel; Rural; Steroids; Structure; Tablets; Testing; Time; Training; Translating; Treatment Failure; Up-Regulation; Update; asthma exacerbation; asthmatic patient; base; 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 项目概要 哮喘是儿童最常见的慢性疾病，也是紧急医疗的主要原因 治疗。然而，缺乏紧急医疗服务 (EMS) 治疗的证据和指南 在急诊科 (ED) 到达之前了解小儿哮喘的情况。急诊科指南建议早期系统治疗 到达急诊室后一小时内给予皮质类固醇 (CS)，因为研究表明相关 住院人数和急诊住院时间 (LOS) 减少。对于接受 EMS 治疗的患者，存在 甚至有机会更早地进行 CS 管理。该项目的目标是确定 EMS 是否 CS 的管理可改善患者的治疗效果。我们的初步数据表明，目前不到 10% 的 EMS 儿童哮喘患者在 ED 到达之前接受了 CS 治疗。 考虑到 CS 对 ED 患者预后影响的时间敏感性，我们的假设是 EMS CS 的管理将减少入院率、急诊室住院率和重症监护病房入院率。经过 进行试点集群随机对照试验，这项研究将填补院前知识的重大空白 在小儿哮喘紧急护理的连续过程中。本研究分析了成本和运输时间这两个因素 与 EMS 操作和未来指南实施相关。通过我们与拿骚县的合作， 阿拉楚阿县和莱克县 EMS 机构，我们计划在三年内招募 330 名患者， 分析 EMS CS 管理的临床结果和成本，以及两者如何随 EMS 运输时间变化。 在五年 K23 职业发展奖期间，Jennifer Fishe 博士将从受指导的 调查员转为独立调查员，旨在获得 R01 资助。这种转变的发生是由于 强有力的指导和结构化培训计划，其中包括： 1) 知识和经验的发展 进行临床试验，包括保护人类受试者，2) 获得生物统计学理学硕士学位，以及 3) 成为独立调查员所需的资助和领导力培训。菲什博士的 导师和科学顾问团队包含临床试验和小儿哮喘方面的主题专家/ 紧急医疗服务、R01 拨款和临床试验经验以及职业发展。 PHS 398/2590 (Rev. 06/09) 第 1 页 继续格式页