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

项目负责人/主要研究者（最后，第一，中间）：Fishe，Jennifer，N K23摘要 项目摘要 哮喘是儿童最常见的慢性疾病，也是急诊医疗的主要原因。 治疗然而，缺乏证据和指导方针的紧急医疗服务（EMS）的治疗 在到达急诊室（艾德）之前，艾德指南建议早期系统性 在艾德到达后1小时内给予皮质类固醇（CS），因为研究表明 住院人数和艾德住院时间（LOS）减少。对于接受EMS治疗的患者， 为更早的CS管理提供了机会。本项目的目标是确定EMS是否 CS的施用改善了患者的结果。初步数据显示，目前 10%的EMS儿童哮喘患者在艾德到达之前接受CS。 考虑到CS对艾德患者预后影响的时间敏感性，我们的假设是EMS CS的施用将减少入院、艾德LOS和重症监护病房的入院。通过 进行试点集群随机对照试验，这项研究将填补一个显着的院前知识空白 紧急儿科哮喘护理的连续性。本研究分析了成本和运输时间两个因素 与环境管理系统的运作和未来的准则实施有关。通过我们与拿骚县的合作， Alachua县和Lake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运输时间而变化。 在为期五年的K23职业发展奖期间，Jennifer Fishe博士将从一名接受指导的 调查员到独立调查员定位，以实现R 01资金。这一转变将发生， 强有力的指导和结构化的培训计划，其中包括：1）知识和经验的发展 临床试验，包括保护人类受试者，2）获得生物统计学硕士学位，以及 3)成为一名独立调查员所需的高级管理人员和领导培训。费舍医生 导师和科学顾问团队包括临床试验和儿科哮喘的主题专家/ 紧急医疗服务，R 01赠款和临床试验的经验，以及职业发展。 PHS 398/2590（Rev. 06/09）第1页