Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center (Hub)

创新紧急护理临床试验网络 (SIREN) 的策略 - 网络临床中心（中心）

• 批准号: 9282911
• 负责人: MOHAMUD RAMZANALI DAYA
• 金额: $ 24.64万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9282911
• 关键词: Accident and Emergency department; Acute; Anesthesia procedures; Anesthesiology; Antihypertensive Agents; Cardiac; Cardiology; Caring; Centers for Disease Control and Prevention (U.S.); Childhood; Clinical; Clinical Trials Network; Collaborations; Contracts; Coronary; Creatine Kinase MB Isoenzyme; Critical Care; Data; Development; Disclosure; Electric Countershock; Emergency Care; Emergency Medicine; Emergency Situation; Emergency medical service; Emergency research; Enrollment; Ethnic Origin; Evaluation; Event; Faculty; Funding; Health Sciences; Health Services Research; Heart Arrest; Hematology; Hemorrhage; Hospitals; Informed Consent; Institutional Review Boards; Lead; Leadership; Methods; Monitor; Multi-Institutional Clinical Trial; Myocardial Ischemia; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Neurologic; Neurological emergencies; Neurology; Operative Surgical Procedures; Oregon; Outcome; Participant; Patient-Focused Outcomes; Patients; Performance; Persons; Physicians; Population; Positioning Attribute; Principal Investigator; Procedures; Publications; Race; Recording of previous events; Recruitment Activity; Reporting; Research; Research Personnel; Resuscitation; Risk stratification; Rural; Science; Scientist; Site; Syncope; Toxicology; Translational Research; Trauma; Tube; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Universities; Work; Writing; clinical infrastructure; community consultation; cost; endotracheal; experience; improved outcome; innovation; member; neurosurgery; payment; remediation; respiratory; tertiary care; treatment trial

Oregon Health & Science University (OHSU) has the institutional experience, study team leadership, and pre- existing research networks to lead a successful enrollment hub for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). OHSU has specific experience managing multisite ED and EMS research as one of ten regional enrolling hubs for the NIH/ NHLBI Resuscitation Outcomes Consortium (ROC) and one of 22 enrolling hubs for the NIH/ NINDS Neurological Emergency Treatment Trials (NETT) consortium. The OHSU SIREN study team includes principal investigators, co-investigators, and study/ data managers for the OHSU ROC and NETT hubs. Our faculty team members are all federally funded clinical scientists and include two of the top 10 NIH funded DEM investigators in 2015. We have over 100 person- years of combined experience conducting multi-site research in EMS and ED settings. We leverage our extensive experience with multisite ED/ EMS research and our study team leadership to: Aim 1. Create a SIREN enrollment network to achieve an annual enrollment of at least 100 participants. 1a. Construct an ED Spoke Network. We propose eight spokes that have the following qualifications: 1. Tertiary-care clinical infrastructure to support all SIREN trials; 2. Strong history of ED research enrollment; 3. Pre-existing research collaborations with the OHSU SIREN team. Our network serves a high volume and diverse (by race, ethnicity, payer) population, and has enrolled >14,000 patients in the past two years. 1b. Construct an EMS Network. For out-of-hospital SIREN studies, we will continue to use our extensive regional EMS research network created through our ROC and NETT experiences. This includes 18 EMS agencies and 14 receiving hospitals that have enrolled ~2,000 patients through ROC and NETT. 1c. Construct a Subspecialty Expert Panel. We build on ROC, NETT and multiple other collaborative emergency care research to include experts in anesthesiology, cardiology, cardiothoracic surgery, critical care, emergency medicine, hematology, neurology, neurosurgery, and trauma surgery. Aim 2. Contribute to governance and scientific efforts of the national SIREN network. 2a. Participate in SIREN governance efforts. Our SIREN study team members have held leadership positions on ROC/NETT committees, including Executive, Trauma, Cardiac, Regulatory, EMS, and Publications. We will continue similar governance committee participation for the SIREN network. 2b. Lead SIREN scientific efforts. We have led ROC writing groups, served as facilitators for ROC trials, and co-authored >40 ROC reports. We anticipate making similar contributions to SIREN. We propose two SIREN trials (Hypotensive Trauma Resuscitation, Modified Endotracheal Tubes). In summary, OHSU has the institutional experience, study team leadership, and pre-existing ED and EMS research networks to lead a successful SIREN hub.

俄勒冈健康与科学大学 (OHSU) 拥有机构经验、研究团队领导力和预 现有的研究网络将领导一个成功的招生中心，以实现紧急创新战略 护理临床试验网络 (SIREN)。 OHSU 拥有管理多站点 ED 和 EMS 的具体经验 作为 NIH/NHLBI 复苏结果联盟 (ROC) 十个区域招募中心之一的研究 以及 NIH/NINDS 神经紧急治疗试验 (NETT) 22 个招募中心之一 财团。 OHSU SIREN 研究团队包括主要研究人员、共同研究人员和研究/数据 OHSU ROC 和 NTT 中心的经理。我们的教职团队成员都是联邦政府资助的临床 科学家，其中包括 2015 年 NIH 资助的前 10 名 DEM 研究人员中的两名。我们有超过 100 名人员 拥有多年在 EMS 和 ED 环境中进行多地点研究的综合经验。我们利用我们的 在多站点 ED/EMS 研究方面拥有丰富的经验，我们的研究团队领导力能够： 目标 1. 创建 SIREN 注册网络，实现每年至少 100 名参与者的注册。 1a.构建 ED 辐条网络。我们建议具有以下资格的八个辐条： 1. 支持所有 SIREN 试验的三级护理临床基础设施； 2. ED 研究招生的悠久历史； 3. 与 OHSU SIREN 团队已有的研究合作。我们的网络服务量大且 多样化（按种族、民族、付款人）人群，在过去两年已招募了超过 14,000 名患者。 1b.构建EMS网络。对于院外 SIREN 研究，我们将继续使用我们广泛的 通过我们的 ROC 和 NTT 经验创建的区域 EMS 研究网络。其中包括 18 个 EMS 机构和 14 家接收医院已通过 ROC 和 NTT 招募了约 2,000 名患者。 1c.组建专科专家组。我们以 ROC、NETT 和多个其他协作为基础 紧急护理研究包括麻醉学、心脏病学、心胸外科、危重病学等方面的专家 护理、急诊医学、血液学、神经病学、神经外科和创伤外科。 目标 2. 为国家 SIREN 网络的治理和科学工作做出贡献。 2a.参与 SIREN 治理工作。我们的 SIREN 研究团队成员担任领导职务 ROC/NETT 委员会的职位，包括执行、创伤、心脏、监管、EMS 和 出版物。我们将继续参与 SIREN 网络的类似治理委员会。 2b.领导 SIRN 的科学工作。我们领导了 ROC 写作小组，担任 ROC 试验的协调员， 并与人合着了超过 40 份 ROC 报告。我们预计会对 SIRN 做出类似的贡献。我们建议两个 SIREN 试验（低血压创伤复苏、改良气管插管）。 总之，OHSU 拥有机构经验、研究团队领导力以及已有的 ED 和 EMS 研究网络引领成功的 SIREN 中心。