5712S
INTRODUCTION/BACKGROUND: Dr. Dente PI, located at Emory University conducts research in the field of surgical critical care and is performing studies under prime award Emory Subaward/HU00012020018 â Surgical Critical Care Initiative (SC2I): Civilian application of military decision support tools for critically injured patientsâ . Dr. Dente PI will utilize the technical expertise of Dr. Buchman at Emory University to meet the objectives identified in the above mentioned study. Specifically, Dr. Buchman will continue to ensure the project milestones and deliverables are met throughout the period of performance. The specific goals are outlined in the technical requirements and deliverables section of this document. There have been unprecedented advances in combat casualty care and surgical research that have emanated from the recent military experiences in Afghanistan and Iraq involving critically injured service men and women. Emerging strategies are shifting away from reactive resuscitation to more organized approaches to patient management that pair biological data assimilation with protocolized decision support algorithms to provide the best treatment decisions for complex multisystem wounds. These approaches are being shown to improve the care of critically injured service personnel, and are highly likely to be useful in caring for critically injured civilians (e.g. victims of motor vehicle accidents and other traumatic injuries). Recognizing that the partnering of DoD and civilian trauma centers will speed the validation and implementation of evolving surgical practices within the military, while leveraging insights gained from military experiences to improve civilian surgical quality, the Surgical Critical Care Initiative (SC2i) has been formed. The SC2i partners DoD and civilian academic surgeons to allow for the evolution and refinement of the best practices for the care of critically injured patients and leverage current military experiences to the betterment of United States healthcare in general.
Emory University
Cooperative Agreement HU00012120029
$1.8m 4/7/21 5707S
1.0 SCOPE OF DOCUMENT This document provides information regarding work planned by DecisionQ Corporation to support the SC2i for Contract Year 2021. Staffing projections are complete with names for this 12-month period. The document is organized in three (3) parts: 1. Scope of Document 2. Scope of Work 3. Budgets and Justification for the 12-month Contract Year 2021 period beginning 1 April 2021 and ending 31 March 2022 2.0 SCOPE OF WORK 2.1 Program Development DecisionQ will: 2.1.1 Provide support to the SC2i program to simplify the technical creation and deployment of SC2i CDSTs in preparation for commercialization. This will enable early deployment of SC2i CDSTs within the consortium and selected partners to allow collection of the operational information required for commercialization by potential customers. 2.1.2 Attend SC2i programmatic planning meetings and teleconferences, prepare programmatic planning materials, and help identify new areas of research. 2.1.3 Help ensure IRB protocols are observed. DecisionQ staff will undergo the required ethical training for all company personnel who will be handling and/or processing SC2i data. 2.1.4 Work as a member of the Oversight Committee to support new projects for the SC2i Team with the potential to satisfy the objectives of the initiative, define these projects and develop procedures for these projects. 2.1.5 Provide support for activities and within the budgets allocated. 2.1.6 Work on developing FasterAnalytics-based CDSTs with APIs for quick, early stage CDST deployment in an effort to collect clinical and financial benefit data. Deployment will be within the SC2i consortium and to partner facilities as identified by SC2i leadership in accordance with DecisionQâ s FasterAnalytics license agreement. 2,1,7 Support Product Development Groups as necessary. 2.2 Program Support Mr. Todd Radano will lead the Commercialization Team that is part of the WounDx Working Group. A number of DecisionQ personnel will support him in that role. In that role, he will participate as part of the SC2i Executive Team that works with MSD to build a long-term working relationship that includes obtaining contractual assurances in the form of Manufacturing and Distribution Agreements, Non-Compete Agreements, and other agreements typical for relationships such as SC2i will have with MSD. Under his direction, DecisionQ staff will also develop and finalize the WounDx model for deployment. Mr. Radano will work with the selected legal staff to ensure that the proper agreements between MSD and USU are in place to meet the requirements of the SC2i consortium. DecisionQ will regularly work within the Bioinformatics Core Services (BiCS) organization to produce deployable clinical decision support models for the projects SC2iâ s PIs are pursuing as budget allows.
Decisionq Corporation
Cooperative Agreement HU00012120029
$1.1m 4/7/21 5727S
INTRODUCTION/BACKGROUND: Dr. Eric Elster, located at the Uniformed Services University of Health Sciences (USUHS), conducts research in the field of disciplines and is the Principal Investigator leading studies under the prime award, the SC2i. The goal of the SC2i is to specifically study injured civilian and military patients, curate and analyse data derived from their clinical courses, and use these data to develop clinical decision support tools (CDSTs) to improve the care of injured patients, particularly those injured in combat. The program also seeks to elucidate the basic biology of human injury and resilience and serve as a platform for training students and postdoctoral trainees in trauma-related research. Dr. Allan Kirk serves as the civilian lead of the SC2i, and directs the civilian enrolment at Duke University, as well as the civilian application of SC2i developed CDSTs and the curation and analysis of biological data relevant to the study of trauma and resilience. Dr. Eric Elster will utilize the technical expertise of Dr. Allan D. Kirk and Duke University to meet the objectives identified in the abovementioned study. Specifically, Dr. Allan D. Kirk will lead the following: â ¢ Continue an on-going Tissue Data Acquisition Protocol (TDAP) being conducted at Duke University Hospital (DUH) investigating the application of biomarker-based wound care decision support tools in civilian traumatic injuries â ¢ Expand the existing surgical biorepository at Duke University and coordinate this with similar expansions at participating SC2i sites, including USUHS, Walter Reed National Military Medical Center (WRNMMC), Emory University Hospital (EUH) and Grady Memorial Hospital (GMH); â ¢ Coordinate maintenance of a data repository for SC2i data that meets with applicable federal guidelines, and initiate the necessary technical build-outs required for robust and secure sharing of scientific and research study subject data among SC2i investigators; â ¢ Continue to provide mechanisms for conducting research involving pre-existing or newly developed bedside clinical decision support tools, specifically initiating formal evaluation of an existing â Massive Transfusion Protocolâ application at GMH and DUH, with capabilities of expanding to additional civilian and military sites; â ¢ Continue a training program within the SC2i to provide pre- and post-graduate program-applicable research training for medical students, graduate students and/ or surgical and intensive care residents; and, â ¢ Work collaboratively with and through the SC2i Executive and Oversight Boards to identify emerging technologies, treatment paradigms and insights relevant to surgical critical care, and craft clinical trials to evaluate these to develop improved decision support tools and therapies for service men and women. Under guidance of the applicable multiparty Cooperative Research and Development Agreement (CRADA), this project will facilitate the incorporation of civilian medical centers, specifically those with advanced surgical, critical care and trauma service capabilities, into the clinical investigative network of the SC2i. This will greatly increase the capacity for SC2i investigators to evaluate and test clinical decision support tools in real world settings of critical injury and illness and similarly provide civilian surrogates for military combat injured personnel.
Duke University
Cooperative Agreement HU00012120029
$1.9m 4/7/21