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