A National Trauma Care System Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury (2016) / Chapter Skim
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4 Generating and Applying Knowledge to Improve Trauma Outcomes
4 Generating and Applying Knowledge to Improve Trauma Outcomes
Pages 149-232
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From page 149... ...
Data from registries and performance improvement processes also can inform trauma research and drive the development of new best practices. At the start of the wars in Afghanistan and Iraq, the military adopted these civilian-sector trauma system practices in the development of its Central Command (CENTCOM)
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Using the learning trauma care system framework laid out in Chapter 3, this chapter presents an assessment of the cyclical process -- in both the military and civilian sectors -- by which data are captured, new knowledge is generated and transformed into evidence-based best trauma care practices, and those best practices are disseminated within and across systems. DIGITAL CAPTURE OF THE TRAUMA PATIENT CARE EXPERIENCE Trauma professionals have been leaders in the early use of data to improve care at the local, regional, state, and national levels.
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. These data direct military medical research to areas of greatest need and support continuous performance improvement processes (Bailey et al., 2013; Blackbourne et al., 2012)
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. Collection and integration of prehospital data The challenges of trauma data collection are especially marked in the military prehospital setting, where operational demands hinder documentation of injuries and care delivery by medics.
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MERcURY is a specialty registry integrated with the DoDTR. One notable constraint on the collection and sharing of prehospital trauma data is the serious security concern that arises from the potential to link prehospital casualty data with military tactics, techniques, and procedures.
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to the Prehospital Trauma Registry, documentation of prehospital care remains inconsistent as leadership mandates are not enforced (Kotwal et al., 2013b)
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AFMES data are entered into the DoD Mortality Trauma Registry, which enables analysis of service member deaths for trends and modifiable risk factors to inform improvements in equipment, tactics, and casualty care (DHB, 2015)
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The barrier is one of will. Digital Capture of Civilian Trauma Data Civilian-Sector Trauma Registries In the civilian sector, trauma data are captured in registries and other data repositories at multiple levels.
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. Collection and integration of prehospital data In the civilian sector, EMS captures patient data and transmits a record of care to hospital providers using paper or electronic patient care records (Landman et al., 2012)
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. However, the NEMSIS project's National EMS Database does not adequately capture interfacility transfers, critical care transfers, and air medical care.
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. Collection and integration of hospital-based data The collection and integration of civilian hospital-based trauma care data improved dramatically with the introduction of the National Trauma Data Standard by the American College of Surgeons Committee on Trauma in 2009.
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and predominant causes of preventable civilian trauma deaths. The civilian sector would benefit from additional studies of preventable trauma deaths, particularly in the prehospital setting.
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. Data sharing between DoD and the VA represents a special case of data sharing between the military and civilian sectors, with the challenge arising from the patient's movement from the military to a civilian system.
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Can data be Yes for some elements, Yes Yes, has this capability, collected no for others but is limited by TMDS electronically/ expeditionary framework imported from existing patient care records? How much Moderate (all ACS COT Near complete (includes 100 percent for those coverage by trauma centers)
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; no 2015: initiated acoustic prehospital deaths module NOTE: ACS COT = American College of Surgeons Committee on Trauma; CONUS = continental United States; DOA = dead on arrival; DoDTR = Department of Defense Trauma Registry; DOW = died of wounds; EMS = emergency medical services; ICD = International Classification of Diseases; JTS = Joint Trauma System; JTTS = Joint Theater Trauma System; MOTR = military orthopedic trauma registry; NEMSIS = National EMS Information System; NHTSA = National Highway Traffic Safety Administration; NTDB = National Trauma Data Bank; OCONUS = outside the continental United States; PHTR = Pre-Hospital Trauma Registry; TIDOS = Trauma Infectious Disease Outcome Study; TMDS = Theater Medical Data Store; VA = U.S. Department of Veterans Affairs.
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. It is clear that at present, significant confusion surrounding HIPAA limits the willingness of researchers and institutions to share data, both between and within the military and civilian sectors, and guidance on how to be HIPAA compliant when engaging in both research and performance improvement activities would be of great benefit.
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. Evidence and insights derived from the military's use of this approach have led to the generation and modification of clinical practice guidelines, the identification of questions requiring further research, and the transfer of innovative care practices to the civilian sector (an example is damage control resuscitation, described in Box 4-2)
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. The change was also supported by concomitant research in the civilian sector.
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A survey of trauma centers participating in the American College of Surgeons Trauma Quality Improvement Program found that mass transfusion protocols in the majority of centers (79 percent) follow DCR principles, including a high plasma:RBC ratio (Camazine et al., 2015)
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. In the context of trauma research, an exception from informed consent would be required in most instances which, while possible, would be difficult, time-consuming, and ethically challenging to achieve in a military trauma setting.
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Once generated, this evidence is integrated into JTS clinical practice guidelines and performance improvement processes at the local and system levels (Eastridge et al., 2010)
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However, the civilian sector is not driven by the same sense of urgency that motivates the military's flexibility in its reliance on experiential learning. Rather, the civilian sector's use of focused empiricism
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In accordance with National Trauma Data Bank and the Centers for Disease Control and Prevention definitions, the annual rate of VAP per 1,000 ventilator days was calculated for 2003-2011. However, given patient movement along the trauma care continuum, an incidence of VAP could not be assigned to a specific role and was underreported.
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, the civilian sector is much slower than the military sector to change guidelines and policies based on experiential learning (Haider et al., 2015) -- a reflection of the acknowledged risks of focused empiricism.
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. Pragmatic This type of trial measures treatment effectiveness or the benefit the intervention trial produces in routine clinical practice, and it accurately reflects variation in patient populations and care delivery (Patsopoulos, 2011)
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The patient survived his injuries and, despite some remaining difficulties with attention span and memory, was able to recover functional independence. Learning Context Although current Joint Trauma System clinical practice guidelines for severe traumatic brain injury (TBI)
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Further research on the interventions developed, refined, and incorporated into clinical practice guidelines during wartime is needed to confirm that the military's use of aggressive surgical interventions has contributed to improved mortality outcomes in military patients with severe TBI. Knowing that such types of injuries are inevitable in war, this research would ideally take the form of multiple clinical trials conducted in the civilian sector (with support from the U.S.
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DoD's Combat Casualty Care Research Program addresses clinical gaps as well as research questions emerging from clinician experience and performance improvement data in theater. The program thereby serves as a key intermediary in efforts to advance trauma care capabilities, responding to the identification of knowledge gaps and augmenting the evidence base that supports the generation and dissemination of clinical practice guidelines (Rasmussen et al., 2014)
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. DoD's Combat Casualty Care Research Program reacts directly to battlefield medical problems identified through the DoDTR.
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Civilian Sector In the civilian sector, a major difference from the military's approach to research is the absence of a centralized institute dedicated to trauma and emergency care research. A number of research agendas and gap analyses have emerged (EMSC National Resource Center, 2009; NHTSA, 2001; Sayre et al., 2005)
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. While the networks described above are positive examples of trauma and emergency care research under way in the civilian sector, it is important to note that critical systems research may require different kinds of infrastructure (e.g., linked prehospital and hospital databases as described earlier in this chapter)
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There are welldefined emergency and trauma care research questions that would benefit from a coordinated and well-funded research strategy." Examples of highpriority trauma research needs (clinical and systems research) compiled by the committee, applicable to both the military and civilian sectors, are presented in Table 4-6.
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•• Develop methodology, training, and equipment to improve the ability of far forward medical personnel to transfuse whole blood and blood products. •• Determine how various endpoints of resuscitation affect clinical outcomes in patients with traumatic brain injury, hemorrhagic shock, or both.
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•• Develop individualized strategies for treating the various manifestations of moderate and severe blunt and penetrating traumatic brain injury. •• Develop therapeutics to improve outcomes of mild, moderate, and severe traumatic brain injury.
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Systems •• Determine the optimal number of trauma centers per population unit. research •• Determine optimal methods for transitioning proven clinical modalities into routine clinical practice.
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. In addition to METRC, there are multiple examples of trauma research carried out through collaboration between the military and civilian sectors, funded in large part by DoD, including • two clinical trials comparing the military-developed blood transfu sion protocol -- damage control resuscitation (see Box 4-2)
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Success to date confirms the potential for civilian and military trauma centers to collaborate on critical research issues and leverage the strength that comes from engaging patients and providers from across multiple centers. METRC has initiated more than 18 prospec tive multicenter studies involving the participation of more than 5,000 active duty and civilian trauma patients.
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. The origin of funding directed at military trauma research threatens the sustainability and efficacy of DoD's Combat Casualty Care Research Program.
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. Importantly, in contrast with other military research portfolios, such as infectious disease, there is no equivalent to DoD research on combat casualty care in the civilian sector.
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Richards, Ph.D., M.P.H. nearly 10 percent of total DALYs in the United States each year9 but receives only about 1 percent of NIH's biomedical research budget, although the committee acknowledges that proportionality to disease burden is an overly 9 Injuries accounted for 7,945,100 out of 81,834,600 all-cause DALYs in the United States in 2010 (U.S.
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. Limited funding in the civilian sector results in few high-quality clinical research studies to further advances in trauma care.
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Like the Common Rule, the FDA regulations address IRB function, composition, and review. In contrast with the Com mon Rule, the FDA regulations require that informed consent be obtained from the subject or the subject's legally authorized representative for all FDA-regulated clinical investigations except as provided in 21 CFR § 50.23 (involving certain life-threatening emergencies, military operations, or public health emergencies)
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As discussed in the sections below, continued efforts to streamline regulatory processes would have a major impact on the ability to use limited trauma research funds efficiently and effectively. Unclear distinction between quality improvement and research At the core of a continuously learning health system as envisioned by the Institute of Medicine is the imperative to learn from the everyday practice of medicine (IOM, 2013)
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versus medical practice, • quality improvement research versus quality improvement, • pragmatic clinical trials (comparative effectiveness research in real life settings) versus medical practice, • comparative effectiveness research versus medical practice, and • research on medical practice versus medical practice.
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This challenge is particularly problematic given the limited research equity available in both the military and civilian sectors. SOURCE: This box draws on the dismounted complex blast injury case study in Appendix A, except where other citations are noted.
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The Common Rule requires prior review and approval of nonexempt human subjects research by an IRB.12 Approval by multiple IRBs is not required for multisite studies and may not be beneficial -- for example, in research on public health disasters and rare diseases and in most emergency care research (Goldkind et al., 2014)
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Privacy protections for data sharing As discussed earlier in this chapter, HIPAA regulations present barriers to using and sharing trauma patient data across systems for research purposes and care within and between the military and civilian sectors (Baily et al., 2006; Seymour et al., 2014)
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Covered entities may also use and disclose protected health information as a limited data set with a data use agreement without an authorization. A data use agreement -- entered with the intended recipient of the limited data set -- specifies the ways in which the data set may be used and how it will be protected.15 Informed consent challenges for trauma research Trauma research involving human subjects is highly heterogeneous, ranging from minimal-risk epidemiological studies to clinical trials of experimental interventions for life-threatening conditions that must be administered shortly after injury (Goldkind et al., 2014)
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For combat casualty care research that is sponsored, conducted, or supported by DoD, even greater challenges arise in attempting to enroll military personnel in studies. For example, there is ongoing debate regarding the validity of the
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Under the Common Rule, minimal-risk trauma research, such as retrospective studies using registry data, can qualify for a waiver of informed consent.16 No provision exists, however, for waiving or altering nformed consent processes for FDA-regulated minimal-risk research. i U nder these conditions, investigators cannot conduct an FDA-regulated clinical investigation, such as a study of a minimal-risk device, if the research ffers no direct benefit to participants and does not otherwise qualify o for the exception from informed consent under 21 CFR § 50.24 (see Box 4-9)
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the most difficult to approve. Although a number of changes to these federal regulations are currently under consideration, including revisions to the Common Rule and changes to FDA regulatory processes under the 21st Century Cures Act, it remains to be seen whether these proposed changes will go into effect and ease the regulatory barriers delaying and preventing needed trauma research.
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In a learning trauma care system, improvements in trauma care do not depend on the ability of individual providers to discover, assimilate, retain, and put into practice the ever-increasing supply of clinical evidence. Instead, trauma care providers have access to such resources as evidence-based clinical practice guidelines and clinical decision support tools that capture, organize, and disseminate the best available information to guide decision making and reduce variation in care and outcomes (IOM, 2013)
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The exchange of knowledge in real time enables providers to address challenges and questions at the point of care, offering immediate potential improvements to care delivery and patient outcomes. The following sections review four key mechanisms for timely dissemination of trauma knowledge: clinical guidelines, clinical decision support tools, telemedicine, and the Senior Visiting Surgeon Program.
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. Tactical combat casualty care (TCCC)
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. JTS clinical practice guidelines (CPGs)
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. Guidelines in the Civilian Sector In the civilian sector, evidence-based guidelines have proliferated in recent years, with the Agency for Healthcare Research and Quality's National Guidelines Clearinghouse listing more than 2,500 published guidelines.
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The civilian sector's adoption of tourniquet use is a case in point. Despite clear evidence of its benefit in preventing death from hemorrhage, uptake of this practice has been variable across the nation.
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, indicating a 6-year lag between the time tourniquet use stabilized in the military and civilian sectors. In some places in the United States, however, adoption occurred earlier.
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In states that use statewide protocols, by contrast, the protocols and training can be altered across the entire state with a single protocol change. Clinical Decision Support Tools Clinical decision support tools make knowledge of best trauma care practices, including clinical practice guidelines, available in real time at the point of care.
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Additionally, MTFs may not stock supplies or equipment for long-term care of burn patients, including dressings, medications, dvanced modes a of ventilation, or renal replacement devices. Since this case ccurred, analysis of o clinical data from the Department of Defense Trauma Registry has informed modifica tion of the JTS Burn Care Clinical Practice Guideline (JTS, 2013a)
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. The acquisition of an electronic health record optimized for protocol-based clinical decision support with integrated data capture to feed condition-specific clinical registries may hasten the evolution of the DoD trauma system toward this key feature of a learning system for trauma care.
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. Importantly, the forum facilitates performance improvement through both vertical connections (from the individual facility level to the joint theater trauma system level to the DoD trauma system level)
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In the context of civilian trauma care, telemedicine has great potential to transform care, costs, and patient visit cycle times.29 For example, tele medicine offers a possible solution to improve communication and the sharing of patient data along the trauma continuum of care, particularly between the prehospital and hospital settings. Technology that enables two-way video and voice communication and data transmission between ambulances and hospitals facilitates collaboration between emergency m edical technicians and receiving facility physicians on prehospital care of the patient and also helps the receiving trauma team to better prepare for the patient's arrival (Latifi et al., 2007)
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. Since its induction, the program has contributed to the initiation of research in theater, as well as independent documentation and validation of advances made in combat casualty care achieved under the JTS (Knudson et al., 2014; Moore et al., 2007)
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Related findings: • The collection and integration of trauma data across the care con tinuum is incomplete in both the military and civilian sectors. • Military and civilian trauma management information systems rely on inefficient and error-prone manual data abstraction to populate registries.
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• the civilian sector, no mechanism exists for directing research invest In ments toward identified gaps, a problem exacerbated by the absence of a centralized institute dedicated to trauma and emergency care research. CONCLUSION: A learning trauma care system cannot function optimally in the current federal regulatory landscape.
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, its use related to civilian trauma care is limited.
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, and initiate a request for urgent transport and links this information stream to the patient's existing medical database identifiers in the MCC computer. 30 This annex was adapted from a paper commissioned by the Committee on Military Trauma Care's Learning Health System and Its Translation to the Civilian Sector, written by lliott R
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A cricothyroidotomy is performed, and the casualty is placed on a mini-ventilator. The casualty is wrapped in a hypothermia prevention management kit, and an electronic tactical combat casualty care (TCCC)
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99.8°F, and GCS 3T. A cervical spine collar placed on the patient prior to arrival is rapidly removed in accordance with an evidencebased clinical practice guideline that summarizes the medical literature on the topic.
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All patient care data collected during the flight are automatically uploaded to the MCC computer. Ventilation is provided via closed-loop ventilation that automatically adjusts the inspired oxygen content and RR in response to changes in oxygenation and end-tidal carbon dioxide monitoring.
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He is able to use his right upper extremity and has modest antigravity strength in his right lower extremity. He has little use of his left upper or lower extremities as a result of the site of brain injury.
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Paper pre sented to the Committee on Military Trauma Care's Learning Health System and Its Translation to the Civilian Sector, Meeting One, May 18-19, Washington, DC. Bailey, J
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:189-199. CCCRP (Combat Casualty Care Research Program)
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Paper presented to the Committee on Military Trauma Care's Learning Health System and Its Translation to the Civilian Sector, Meeting Three, September 16-17, Washington, DC. Dixon, N
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: Implications for the future of combat casualty care. Journal of Trauma and Acute Care Surgery 73(6 Suppl.
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2013. Defense health: Actions needed to help ensure combat casualty care research achieves goals.
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2011. Clinical practice guidelines we can trust.
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2013b. The Tactical Combat Casualty Care Casualty Card TCCC guidelines -- proposed change 1301.
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2016. Building a clinical research network in trauma orthopaedics: The Major Extremity Trauma Research Consortium (METRC)
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2015. DoD Combat Casualty Care Research Program: Policy review.
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2014. US Combat Casualty Care Research Program: Answering the call.
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Paper presented to the Committee on Military Trauma Care's Learning Health System and Its Translation to the Civilian Sector, Meeting One, May 18-19, Washington, DC.
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