A07_ATTACHMENT_5_to_SOL_-_PERFORMANCE_WORK_STATEMENT(TASK_ORDER_0001).docx

ATTACHMENT 5 - TASK ORDER 0001

PERFORMANCE WORK STATEMENT

Linking Investigations in Trauma and Emergency Services (LITES): A prospective, multicenter, observational study to characterize the presentation, management and outcomes of moderate and severe physical injury in the United States

Background

The purpose of LITES is to create a standing research network of US trauma systems and centers with the capability to conduct prospective, multicenter, injury care and outcomes research of relevance to the Department of Defense (DOD). With limited ability to conduct larger scale, high-impact, clinical research on US service personnel in active theaters of war, the DoD and its Combat Casualty Care Research Program (CCCRP) must turn to civilian trauma systems and centers to answer questions aimed at narrowing high-priority gaps in care of the severely injured. The imperative to continue to resolve high-priority gaps and provide solutions (knowledge and materiel) to the DoD requirements-driven CCCRP is integral to learning lessons from the recent wars and readying and innovating for future, more complex operational environments. To understand the full effectiveness of US trauma systems and centers to serve in this capacity, it is necessary to initiate a study which broadly characterizes the overall burden of moderate and severe physical injury in the US, its regional variation and methods of management and measures of survival and recovery.

LITES is a network with the standing capacity to perform injury care and outcomes research. The intent is to maintain a responsive, flexible and efficient network that is operationally oriented, clinically relevant, and provides timely evidence to guide the development and revisions to trauma care guidelines. The LITES network will also serve as a platform in which the initial feasibility and effectiveness of individual materiel solutions emerging from the CCCRP can be demonstrated in a realistic, clinical environment prior to their study in more formal clinical trials or their broader implementation in the operational environment. The LITES network will also serve as a platform in which comparative effectiveness studies can be performed on multiple materiel solutions, and the feasibility and success of such products validated in small and controlled populations prior to their wider study or operational exposure. The information resulting from the LITES network will be integral to informing new and emerging clinical practice guidelines (CPGs) and clinical recommendations (CR) as well as modifying or updating existing standards. The LITES network will also inform and make more efficient, future research and development initiated by the CCCRP.

Initial Clinical Study

The inaugural project for the LITES network will be to conduct an observational study with the primary aim to understand the epidemiology of traumatic injuries in the US; including regional variations in severity and types of injury, modes and methods of management, and survival and recovery rates (outcomes). This initial foundational study will also yield important guidance and create opportunities to improve efficiency for subsequent clinical research to be conducting using the LITES capability, including but not limited to directing certain lines of research to the most appropriate centers and systems within the network.

Methods

The initial study will be a prospective, multicenter, observational study which includes all trauma centers within the LITES network. The purpose of the study is to characterize traumatic injury, current treatment, and outcomes, particularly for the moderate and severely injured in the US. The study protocol will be designed by the LITES Network using the parameters provided in this request and contain all necessary elements to achieve Investigational Review Board (IRB) approval from all LITES Network sites. This study will not alter current practice but will be solely observational in nature.

The following data will be collected for two years. Following an interim analysis, the LITES Network will recommend modifications to these individual data points and data collection plan. Upon the approval of CCCRP, the revised data collection will be completed during the final two years of the award.

Key data to be collected Patient-Level Data for all trauma patients with an Injury Severity Score ≥ 9:

1) Patient Demographics, to include (but not limited to) age, gender, race/ethnicity, socioeconomic status, method of injury, Injury Severity Score (ISS), Abbreviated Injury Scale (AIS).

2) Pre-hospital data, to include (but not limited to) time of injury, scene time, initial vital signs, times and description of pre-hospital interventions, time and dose of any medications administered (especially for pain, infection, resuscitation) and medic qualifications.

3) Transport data, to include (but not limited to) transport time, transport method(s), vital signs during transport, times and description of interventions provided during transport, time, types of information provided to receiving facility prior to arrival, time and dose of any medications administered (especially for pain, infection, resuscitation) and medic/nurse qualifications.

4) Emergency room data, to include (but not limited to) arrival time, vital signs (initial, and every 15 minutes), physical exam, time and description of interventions and diagnostic tests, initial diagnosis, time and dose of any medications administered (especially for pain, infection, resuscitation) and disposition (eg. discharge, admitting service, death).

5) Operating room data, to include (but not limited to) types of operative and other interventions and type of anesthesia and complications if any, blood and blood products used, time and dose of any medications administered (especially for pain, infection, resuscitation and/or blood pressure maintenance).

6) Adjunctive treatment and imaging, including (but not limited to) time of arrival, interventions, and findings/diagnosis.

7) Inpatient data, to include (but not limited to) vital signs, interventions, time and dose of any medications administered (especially for pain, infection, resuscitation and/or blood pressure maintenance) and disposition.

8) Use of blood, blood products, and adjunctive blood and coagulation therapies with time and location of administration.

9) Outcome data, to include (but not limited to) rehabilitation plan, fever, types of infection, sepsis, unplanned surgical procedures, inpatient fall, length of stay, length of stay in ICU, death, and re-admission within 30 days.

Facility-Level Data (measured at baseline, as well as with any changes occurring during the period of performance):

1) Staffing models, to include (but not limited to) required training/certification, and amount of experience for all care locations and all clinical team members.

2) Facility capability, to include (but not limited to) number of operating rooms, number of trauma beds, number of ER and inpatient beds, radiological facilities.

3) Available physician specialties and designated response times.

4) Established clinical practice guidelines used to guide trauma care at each facility.

Data reporting Patient-level data will be reported for each network facility using the LITES Network processes developed specifically for this study. Each trauma center participating within the LITES Network will have the capacity to collect all necessary data and to transfer this data within a reasonable timeframe. Collection of complete data elements, and the facilities and capabilities to enable this collection, will be mandatory for involvement in the LITES network.

A final de-identified data set of patient-level data will be provided to the government after the interim analysis and at the conclusion of the study.

Time frame Data will be collected for this initial study for a period of 5 years or 60 months, and will include data from each medical facility within the LITES Network. Included patients will be followed for duration of hospital stay.

Sample collection and management Standard operating procedure manuals will be centrally developed and site coordinators will be trained in data and sample collection methods and continue through clinical death or discharge. No changes to existing protocols will be directed, though any changes to said protocols will be provided to the LITES CRO upon implementation to adjust data analysis as appropriate.

Data Collection and Management and Harmonization Data collected at all sites will where applicable be harmonized to the standard used for the NTRR and/or NTDB. In instances where this is not applicable, all data collection sites will coordinate with the LITES Network to ensure harmonization of data where possible and standardized data reporting during all phases of the trial across all data collection sites.

DELIVERABLES

1) Quarterly reports on the status of the study, to include an interim summary of study findings, as appropriate. These reports will also include a one-page ‘Quad Chart’, which will summarize the background/military relevance, project summary, a picture/graphic, and updated timeline and cost for each year of the study.

2) A written report following the interim analysis and at the conclusion of the study to characterize the overall LITES Network by injury mechanisms, body regions, blood and blood products used, morbidity and mortality outcomes, and recommendations for how to modify current standards of trauma care based on the study findings. Contract Data Requirements Lists (CDRL) – Reference Exhibit A001

3) A written report following the interim analysis and at the conclusion of the study to characterize each facility in the LITES Network by injury mechanisms, body regions, blood and blood products used, pre-hospital treatments, type of transport, staffing models for each role of care (ie. pre-hospital, transport, emergency room, operating room, intensive care unit, inpatient ward, etc.), practice patterns, morbidity and mortality outcomes. CDRL – Reference Exhibit A002

4) Annual presentation to the CCCRP addressing the following topics:

a. Description of the LITES Network and individual facilities.

b. Limitations of LITES Network identified during inaugural study with proposed solutions.

c. Report of quality and completeness of data collected with proposed solutions.

d. Up to five recommended topics that could be studied in the LITES Network to improve outcomes for moderately and severely injured trauma patients applicable to combat casualty care.

5) Presentation of key findings at subsequent Military Health System Research Symposium or other national medical conference as directed by CCCRP following the interim analysis, and each year following throughout the remainder of the study.

6) Two publishable manuscripts summarizing the current status of trauma care of the severely injured in the LITES Network following the interim analysis, and at the conclusion of the study to be submitted to a CCCRP sponsored medical journal supplement or other medical journal approved by CCCRP. CDRL – Reference Exhibit A003

7) Complete de-identified data set of patient-level data following the interim analysis and at the conclusion of the study. CDRL – Reference Exhibit A004

OWNERSHIP OF DATA AND ANALYSIS

Data will be maintained by the LITES Network, and the primary statistical analysis for this project will be conducted by the LITES Network. Individual sites may conduct sub-analyses with data collected from their facility, and further analysis and dissemination of the data may be completed at the discretion of the LITES Network members, with all resulting abstracts and publications requiring clearance from the CCCRP prior to submission. At the conclusion of the study, an electronic copy of the de-identified data set of patient-level data will be provided to the government.

EXHIBITS/ATTACHMENT(S):

EXHIBIT A001 – CONTRACT DATA REQUIREMENTS LIST (CDRL): PATIENT-LEVEL DATA

EXHIBIT A002 – CONTRACT DATA REQUIREMENTS LIST (CDRL): FACILITY-LEVEL DATA

EXHIBIT A003 – CONTRACT DATA REQUIREMENTS LIST (CDRL): PUBLISHABLE PAPERS

EXHIBIT A004 – CONTRACT DATA REQUIREMENTS LIST (CDRL): COMPLETE DATASET