Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)

紧急护理临床试验网络：紧急护理临床试验网络 (SIREN) 创新策略

• 批准号: 10552366
• 负责人: GABOR D KELEN
• 金额: $ 46.03万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10552366
• 关键词: Accident and Emergency department; Cardiac; Censuses; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Data; Development; Economically Deprived Population; Educational workshop; Emergency Care; Emergency Medicine; Emergency medical service; Emergency research; Enrollment; Ensure; Environment; Equity; Ethnic Origin; Faculty; Funding; Future; Grant; Health; Health system; Heart failure; Hematology; Individual; Institution; Lead; Leadership; Maryland; Medicine; Mentors; Mentorship; Minority; Mission; Multicenter Trials; Neurologic; Nurses; Outcome; Patient Recruitments; Patient-Focused Outcomes; Patients; Population; Positioning Attribute; Principal Investigator; Productivity; Protocols documentation; Publications; Race; Records; Research; Research Personnel; Rural Population; Sepsis; Sexual and Gender Minorities; Site; Structure; System; Testing; Training; Underrepresented Minority; Underrepresented Populations; United States National Institutes of Health; Urban Population; Visit; Washington; Woman; clinical center; clinical research site; design; diversity and inclusion; ethnic minority; experience; flexibility; gender minority; improved; improved outcome; inner city; innovation; lung failure; novel therapeutics; organizational structure; programs; prospective; quality assurance; racial minority; recruit; respiratory; response; service providers; sexual minority; socioeconomic disadvantage; success; tool; underserved community; working group

The objective of this proposal is to create a new Clinical Center (Hub) organized by the Johns Hopkins Medicine Department of Emergency Medicine (JHM DEM) for the SIREN research program. The JHM Hub- and-Spoke network is comprised of nine fully committed Spoke institutions with the capacity to recruit from more than 25 unique clinical sites across five states and Washington, DC. Annual ED census of the network exceeds 1.6 million visits with strong representation of minority, socioeconomically disadvantaged and rural populations. Emergency medical services (EMS) systems associated with Hub and spokes have committed to the SIREN program through direct participation in research conducted with the JHM Hub-and-Spoke network. The JHM DEM will leverage extensive clinical research experience a robust institutional research environment to make immediate and meaningful contributions to the national SIREN program and to improve outcomes for patients with neurologic, cardiac, respiratory, hematologic, and traumatic conditions. The JHM DEM has been continuously engaged in clinical research since 1985 and is a consistent national leader in annual publications and grants, total research funding, NIH funding, and total faculty with funded research. To date, the JHM DEM has enrolled tens of thousands of patients in prospective emergency care research. The JHM Hub-and-Spoke network will achieve success for SIREN through the following Specific Aims: Aim 1: Create a Hub network administrative structure that guarantees efficient and effective recruitment for and execution of SIREN clinical trials. An innovative Hub-of-Hubs network design will allow for rapid scalability to meet individual SIREN trial needs. Tools to facilitate effective and efficient recruitment, protocol execution, data entry, and quality assurance will be disseminated across the JHM SIREN network. Aim 2. Promote diversity of inclusion in SIREN clinical trials and clinical research leadership. Improving health outcomes for underserved communities is a core clinical and research mission of JHM; promoting representation of these groups in SIREN studies will be a major focus of the JHM SIREN Hub. A second major focus will be inclusion and multi-site mentorship of women and underrepresented racial, ethnic, sexual, and gender minorities within our Hub-and-Spoke research team. Aim 3. Train future leaders in emergency care clinical trials research. Our Hub network will serve as a training environment for junior emergency care investigators (residents, fellows, junior faculty, nurses, EMS providers). Junior investigators will gain mentored experience in clinical trials research through workshops and didactics developed by the Hub, execution of SIREN trials, and participation in technical working groups including those focused on optimizing trial implementation and development of new trial proposals. These aims will be executed through a tripartite Hub organizational structure that includes (1) an Administrative Core, (2) a Governance Core, and (3) Technical Working Groups.

该提案的目的是创建由约翰·霍普金斯医学急诊医学部（JHM DEM）组织的新临床中心（HUB）为警报研究计划。 JHM枢纽和辐条网络由九个完全承诺的讲话机构组成，其能力从五个州和华盛顿特区的25多个独特的临床场所招募。该网络的年度ED人口普查超过160万次访问，对少数族裔，社会经济处于弱势群体和农村人口的代表性很高。与枢纽和辐条相关的紧急医疗服务（EMS）系统通过直接参与JHM Hub and Skoke网络进行的研究致力于警笛计划。 JHM DEM将利用广泛的临床研究体验强大的机构研究环境，为国家警笛计划做出立即有意义的贡献，并改善神经，心脏，呼吸道，血液学和创伤状况的患者的结果。自1985年以来，JHM DEM一直从事临床研究，并且是年度出版物和赠款，全面研究资金，NIH资助以及资助研究的全部教师的一致国家领导者。迄今为止，JHM DEM已将成千上万的患者纳入前瞻性急诊研究。 JHM Hub and Skoke网络将通过以下特定目的通过以下特定目的获得Siren的成功：AIM 1：创建一个集线器网络管理结构，以保证警笛临床试验的高效招募和执行。创新的枢纽网络设计将允许快速可扩展性满足单个警报试验需求。促进有效，有效招聘，协议执行，数据输入和质量保证的工具将在JHM Siren网络中传播。目标2。促进警笛临床试验和临床研究领导力中的包容性多样性。改善服务不足社区的健康结果是JHM的核心临床和研究任务。在警笛研究中促进这些群体的代表将是JHM警笛枢纽的主要重点。第二个主要重点将是我们的枢纽研究团队中的妇女以及代表性不足的种族，种族，性和性别少数群体的多站点指导。目标3。培训未来的急诊临床试验研究领导者。我们的枢纽网络将作为初级急诊研究人员（居民，研究员，初级教师，护士，EMS提供者）的培训环境。初级调查人员将通过枢纽开发的研讨会和教学术在临床试验研究中获得指导的经验，并参与技术工作组，包括专注于优化试验实施和开发新试验建议的工作组。这些目标将通过三方枢纽组织结构执行，该结构包括（1）行政核心，（2）治理核心和（3）技术工作组。