Systems Engineering to Improve Traumatic Brain Injury Care in the Military Health System: Workshop Summary (2009)

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1 Introduction Engineers have long been closely involved in the development of medical technologies (devices, equipment, pharmaceuticals) and in sup- porting medical research (instrumentation, computational tools, etc.) (IOM, 1995; NAE, 2003). Revolutionary advances in bioengineering and genomics and the promise of quantum advances in diagnostic tools and therapies testify to the vitality of the partnership. Yet engineers and engineering techniques have remained on the periphery of efforts to understand, assess, and manage or redress the challenges involved in health care delivery. Even information and communications technologies, which have been widely applied to the administrative and financial aspects of the health care industry, have had relatively little impact on the core business of health care—clinical operations. Moreover, the principles, tools, and research of an entire “family” of engineering disciplines associated with the analysis, design, and control of complex systems (operational systems engineering [OSE], which includes aspects of industrial engineering, operations research, human factors engineering, and financial engineering/risk analysis) have largely been absent from the clinical operations of health care delivery. OSE combines science and mathematics to improve the operations of systems and enterprises that provide goods and services by describing, analyzing, planning, designing, and integrating systems with complex interactions among people, processes, materials, equipment, and facili- ties. Operational systems engineers use deterministic and probabilistic 11 

12 Systems Engineering to Improve Traumatic Brain Injury CARE mathematics (called stochastic processes) to describe how a system operates, change the design of a system based on those descriptions, and integrate all elements of operations, including people, processes, materials, and equipment, to improve the efficiency and effectiveness of the system at all levels. The multiple crises facing our health care system related to quality, cost, and access clearly reflect the complexity of the current system and the urgent need for information and OSE tools that can help unravel some of those complexities and ultimately improve the quality of care. The health care system must begin to analyze and resolve some of the difficult tensions and trade-offs among the six areas of urgent need iden- tified by the Institute of Medicine (IOM, 2001)—safety, effectiveness, efficiency, timeliness, patient-centeredness, and equity. In addition, the analysis must take into account the competing objectives, priorities, and quality perspectives of patients, physicians, nurses, administrators, insurers, regulators, and other “stakeholders.” These kinds of complex trade-offs are not unique to health care. Product manufacturers (e.g., automakers) also make trade-offs between product features, for example, that might reduce maintenance costs but increase manufacturing costs and, in turn, increase the retail cost of the product. Many engineering-intensive manufacturing and service industries have worked with operation systems engineers to analyze trade-offs and otherwise improve the efficiency of their operations. Over a period of decades, these experiences have demonstrated the value of OSE tools and methods in deepening the understanding of the function and dynamics of complex systems, providing insights into interactions between subsystems and processes, and, ultimately, enabling more effec- tive management and more efficient performance. In the 2005 National Academy of Engineering (NAE)/IOM report, Building a Better Delivery System: A New Engineering/Health Care Part- nership, these same engineering tools were shown to have the potential of doing the same for the delivery and management of health care. However, although OSE seems a natural partner for addressing some of the challenges facing the health care system, practitioners of the two dis- ciplines are still largely ignorant of each other’s methods, metrics, values, and mindsets. Most clinicians and health care administrators have had little exposure to the problem-solving methodologies and vocabulary of engineers, and few engineers are knowledgeable about the complex sociotechnical fabric of health care processes and systems. Thus neither 

Introduction 13 has been able to communicate with the other in terms that would lead to fruitful collaboration to address the growing crises of health care delivery (NAE/IOM, 2005). Health Care Quality and Cost Challenges Facing the Military Health System The U.S. Military Health System (MHS) is a $40 billion per year enterprise that provides operational medicine, training, research, and Force Health Protection support across the full range of military operations. MHS delivers health care services to 9.2 million eligible beneficiaries through TRICARE direct and managed care programs and directly controls an extensive integrated health care delivery system encompassing salaried health care personnel, facilities, infrastructure, research, education and training capabilities, and other assets. Roughly 70 percent of all care received by TRICARE beneficiaries is purchased by participating private-sector health care providers. Col- lectively, the TRICARE benefit includes a national network of more than 220,000 physicians, all U.S. hospitals, and approximately 55,000 retail pharmacies (TRICARE, 2006). It is estimated that about a third of TRICARE beneficiaries will be served by its care programs for 50 years or more. Like the rest of the nation’s health care delivery enterprise in which it is embedded, MHS faces a number of pressing challenges related to the quality and cost of health care. Although MHS is com- mitted to ­making evidence-based medicine the standard throughout the T ­ RICARE system, the diffusion and application of best-practice treat- ments for illnesses and recommended processes for care pose significant challenges to the system. Like health care costs in the overall U.S. economy, the costs of d ­ efense health programs are increasing much faster than inflation and the U.S. Department of Defense (DOD) budget overall. TRICARE costs more than doubled, from $19 billion to $38 billion, in the five- year period from FY2001 to FY2006, and they are projected to reach $64 billion by FY2015 (TRICARE, 2006). The sheer scope, diversity, and highly distributed nature of the MHS integrated care delivery system, which extends from battlefields and field hospitals overseas to U.S.-based military treatment facilities to a large, diverse assemblage of 

14 Systems Engineering to Improve Traumatic Brain Injury CARE partnering (contracting) U.S.-based private-sector health care providers, make the tasks of improving quality and efficiency of care delivery that much more difficult. Additional burdens have been placed on the system by the needs of members of the armed forces and National Guard/Army Reserve who have sustained injuries in Iraq and Afghanistan. The Operational Systems Engineering Imperative for the Military health system In many respects, MHS is well positioned to meet the challenges described above. An extensive “in-house” integrated delivery system, in which physicians and other health professionals are salaried employ- ees organized into multispecialty group practices governed by strong managerial hierarchies, has demonstrated a capacity for introducing and carrying through system-wide changes in the organization and the delivery of care. Over the past decade, DOD has invested heavily in health infor- mation infrastructure to support its operations. The backbone of this infrastructure is the Armed Forces Health Longitudinal Technology Ap- plication (AHLTA), an extensive electronic health record that combines clinical and other health-related information from patient encounters worldwide. AHLTA currently supports the delivery of medical care to more than 7 million of its 9.2 million beneficiaries. AHLTA captures more than 55,000 patient encounters every workday and contains data on more than 9.5 million outpatient encounters. DOD is working closely with the Department of Veterans Affairs (VA) to bring about full interoperability of AHLTA with the Veterans Health Information Systems and Technology Architecture (VISTA), the VA’s highly acclaimed electronic health record. Integration of the two systems will provide a seamless exchange of medical information while continuing to serve the distinct core missions of each (Versel, 2006). Although not yet fully realized, AHLTA and its underlying information systems have the potential for supporting both evidence-based medicine and evidence-based management throughout MHS—a transition that will be critical to improving the quality and reducing the costs of mili- tary health care. MHS has also been more aggressive than most other health care providers in adopting proven business planning and quality 

Introduction 15 i ­ mprovement methods from the private sector (e.g., Six-Sigma method, Toyota Production System, Continuous Process Improve- ment concepts and tools) to improve its performance (DOD, 2006). In the ­Quadrennial Defense Review: Roadmap for Medical Transforma- tion, MHS laid out an expansive agenda for transforming its health professional workforce, infrastructure, clinical and business opera- tions, financing, and the participation of TRICARE beneficiaries in their own health care (MHS, 2006). MHS also has an extensive in-house education, training, research, and testing infrastructure, including its own medical school (Uniformed Services University of the Health Sciences), and numerous research c ­ enters (e.g., National Capital Area Simulation Center, Center for Edu- cation and Research in Patient Safety, and others) that have been enlisted fully in the Medical Transformation agenda. Even though MHS has laid a foundation for addressing the massive health care quality and cost challenges ahead, there has been a grow- ing awareness in DOD that building on this foundation and bringing about a sustainable transformation in the quality and productivity of its operations will require that MHS draw on a wide array of tools, techniques, technology, and knowledge developed in the disciplines of systems engineering, industrial engineering, operations research, human factors, computer science and engineering, and the social and behavioral sciences for the design, analysis, and control of complex processes and systems. These tools and techniques have also been improved through experience in their applications to many engineering-intensive manu- facturing and service industries. These same engineering tools and technologies could help MHS optimize system performance with respect to specific goals, such as safety, patient-centeredness, and timeliness, and improve its anticipation, mea- surement, and management of the effects of these interventions on other performance goals, such as cost, access, and productivity. Nevertheless, the health care sector as a whole, including MHS, has been relatively slow to embrace OSE tools and techniques (NAE/IOM, 2005). There have been some interactions and successes, however. Small numbers of clinicians, care teams, and administrators, most of them based in large, integrated, salaried, multispecialty group practices, have adapted some OSE tools, such as statistical process control, queuing theory, and human factors engineering, to health care on a tactical level to improve the performance of discrete care processes, units, and 

16 Systems Engineering to Improve Traumatic Brain Injury CARE d ­ epartments. Unfortunately, to date little strategic use has been made of more information- and information technology (IT)-intensive OSE tools and techniques for analyzing and optimizing performance at higher levels of the health care system, such as for individual health care organizations, regional care systems, and the public health system (NAE/IOM, 2005). Moreover, information about the successes, failures, and lessons learned by these early adopters of systems tools and techniques has not been systematically gathered or widely shared. In addition, although economic, organizational, managerial, educational, policy-related, and other barriers to the use of systems tools and complementary knowledge have been characterized and some strategies for overcoming them have been developed, this information has not been widely disseminated. Goals of the Workshop In 2007, the U.S. Army Medical Research and Materiel Command (USAMRMC) asked NAE and IOM to conduct a series of workshops to gather information and provide guidance to MHS on using ­systems tools and technologies to improve the quality and productivity of health care delivery to the nation’s armed forces and other eligible beneficiaries of TRICARE. As the initial activity, USAMRMC asked the National Academies to undertake a workshop using a case-study approach to identify promising areas for the near-, medium-, and long-term appli­ cation of OSE tools and IT to the modeling, analysis, design, and improvement of the care of patients with traumatic brain injury (TBI) across the military health care continuum—from battlefield to field hospital and U.S.-based military health care facilities to TRICARE networks (defense/civilian health care interfaces) and VA health care facilities. The ultimate objective is to improve the delivery of TBI care at both the tactical and strategic levels. During the planning phase of the workshop, a steering committee of experts in TBI, military and veterans health care delivery, and OSE (see Appendix A), supported by NAE and IOM professional staff, compiled a list of issues raised by the MHS community related to the care of mild, moderate, and severe TBI cases (see Appendix B). This extended list of stakeholder issues was drawn from recent studies and reports on MHS care of TBI cases and a preliminary meeting of steering ­ committee  See references to Chapters 2 and 3. 

Introduction 17 members and NAE and IOM staff with representatives of MHS on D ­ ecember 20, 2007 (see Appendix C). At the workshop planning meet- ing in February 2008, the committee identified a subset of issues from this list that could potentially benefit from OSE (see Appendix D). Chapter 6 details how these issues were translated into focus areas and discussion topics for the workshop (see Appendix E). The Challenge of Traumatic Brain Injury Care TBI—often called the signature injury of the Iraq and Afghani- stan conflicts—is caused by a blow, jolt, or penetrating wound to the head that disrupts the normal functioning of the brain. In fact, TBIs account for nearly one-third of the injuries incurred by soldiers evacu- ated to Walter Reed Army Medical Center from the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) theater. Between January 2003 and March 2008, more than 6,600 patients with TBIs were seen at MHS, VA, and civilian hospitals responsible for providing care under the aegis of the Defense and Veterans Brain Injury Center (DVBIC, 2008). TBI is not only a wartime injury, however. The Centers for Disease Control and Prevention estimate that at least 1.4 million people in the United States incur TBIs each year, primarily as a result of falls, ­motor vehicle accidents, assaults, or being struck by or against an object (CDC, 2006). Of these, about 235,000 are hospitalized, and about 50,000 die. However, even these numbers, troubling as they are, prob- ably underestimate the problem. Mild TBI (mTBI), which accounts for the vast majority of cases, is poorly documented and sometimes goes unrecognized in the pres- ence of other injuries or does not become apparent for a period of time after the incident. Nonetheless, the neurologic and cognitive impacts of mTBI—which can include impaired memory and attention/concen- tration, headaches, slowed thinking, irritability, depression, and sleep disturbances (DVBIC, 2008)—can profoundly affect the lives of the injured and their families. According to a 2008 report by the Government Accountability O ­ ffice, caregivers in the MHS treating patients with TBI, especially  TBIs resulting from sports injuries often fall into this category.  The MHS is a DOD enterprise comprising “the Office of the Assistant Secretary of 

18 Systems Engineering to Improve Traumatic Brain Injury CARE mTBI, face substantial challenges: (1) no objective diagnostic tests for TBI are available; (2) the symptoms of mTBI overlap with those of other disorders and with health complaints common in the general popula- tion; and (3) OIF/OEF veterans with mTBI may not realize that their health problems are associated with TBI and thus may not seek care (GAO, 2008). The report also suggests that military personnel may be reluctant to acknowledge the condition, because it might be perceived (wrongly) as a mental illness or might affect their military careers. In a 2006 memo to the Assistant Secretary of Defense for Health Affairs, the Armed Forces Epidemiological Board identified several gaps in knowledge related to TBI and recommended measures to address those gaps (AFEB, 2006). Among the latter were getting a better under- standing of blast-associated TBI; developing a “DoD-wide consensus of care,” including standardized methods of battlefield assessment of TBI and follow-up clinical evaluations; developing requirements for more efficient and effective documentation of injuries and their disposition; and educating service members, their families, and “any individual in a position to encounter and care for soldiers at risk for a TBI during or after military service.” As the number of OIF/OEF veterans with brain injuries increases and as screening and evaluation programs expand, the demands on the TBI care delivery system will almost certainly increase. Organization of the Workshop Summary The remainder of this workshop summary provides a discussion of the problems and challenges of TBI for MHS, the promise of OSE analysis as a tool for improving the understanding of TBI and the de- livery of care, and the results of the NAE/IOM workshop. Chapters 2 through 5 summarize the presentations and discussion during the opening plenary session, which provided background on the medical aspects of TBI and major clinical and logistical challenges to TBI care and included illustrative examples of applications of OSE tools and Defense for Health Affairs; the medical departments of the Army, Navy, Marine Corps, Air Force, Coast Guard, and Joint Chiefs of Staff; the Combatant Command surgeons; and T ­ RICARE providers (including private sector health care providers, hospitals, and pharma- cies)” (MHS, 2008). TRICARE defines itself as “the Department of Defense’s worldwide health care program for uniformed service members and their families” (TRICARE, 2008). 

Introduction 19 techniques relevant to TBI care management, including a case study of a unit in a major academic health system that shifted from expert-based medical practice to expert-managed system-supported practice. Chapter 6 presents the charges to the working groups and the results of their deliberations, specifically 10 suggestions for illustrative “analysis plans” (i.e., designs for potential OSE studies/analyses/applications that could answer important questions raised by TBI stakeholders and ultimately improve the performance of the TBI care delivery system). References AFEB (Armed Forces Epidemiological Board). 2006. Traumatic Brain Injury in Military Service Members, 2006-02. Memorandum for the Honorable William Winkenwerder, Jr., M.D., Assistant Secretary of Defense for Health Affairs. Dated August 11, 2006. Available online at http://www.ha.osd.mil/afeb/2006/2006-02.pdf (accessed August 20, 2008). CDC (Centers for Disease Control and Prevention). 2006. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Prepared by Division of Injury Response, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. January 2006. Available online at http://www.cdc.gov/ncipc/pub-res/TBI_in_ US_04/TBI%20in%20the%20US_Jan_2006.pdf (accessed August 18, 2008). DVBIC (Defense and Veterans Brain Injury Center). 2008. Blast Injury FAQs. Available online at http://www.dvbic.org/cms.php?p=Blast_injury (accessed August 19, 2008). DOD (U.S. Department of Defense). 2006. Continuous Process Improvement Transforma- tion Guidebook, DTD May 06. Washington, D.C.: Department of Defense. Available online at https://acc.dau.mil/CommunityBrowser.aspx?id=32364 (accessed September 10, 2008). GAO (Government Accountability Office). 2008. VA Health Care: Mild Traumatic Brain Injury Screening and Evaluation Implemented for OEF/OIF Veterans, but Challenges Remain. GAO-08-276. Available online at http://www.gao.gov/new.items/d08276.pdf (accessed 19 August 2008). IOM (Institute of Medicine). 1995. Sources of Medical Technology: Universities and In- dustry, edited by N. Rosenberg, A.C. Gelijns, and H. Dawkins. Washington, D.C.: National Academy Press. IOM. 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Wash- ington, D.C.: National Academy Press. MHS (Military Health System). 2006. Quadrennial Defense Review: Roadmap for Medical Transformation. Military Health System Office of Transformation PowerPoint Presen- tation, July 13, 2006. Available online at http://www.tricare.osd.mil/ocfo/_docs/071306_ qdr_trans_infra.ppt#0 (accessed September 10, 2008). MHS. 2008. What is the MHS? Available online at http://www.health.mil/aboutMHS.aspx (accessed August 20, 2008). 

20 Systems Engineering to Improve Traumatic Brain Injury CARE NAE (National Academy of Engineering). 2003. The Impact of Academic Research on In- dustrial Performance. Washington, D.C.: The National Academies Press. NAE/IOM (Institute of Medicine). 2005. Building a Better Delivery System: A New Engi- neering/Health Care Partnership, edited by P.P. Reid, W.D. Compton, J.H. Grossman, and G. Fanjiang. Washington, D.C.: The National Academies Press. TRICARE. 2006. Sustaining Your Military Health Care Home Page. Available online at http://www.tricare.osd.mil/STB/index.cfm (accessed February 13, 2006). TRICARE. 2008. What is TRICARE? Available online at http://www.tricare.mil/mybenefit/ home/overview/WhatIsTRICARE? (accessed August 20, 2008). Versel, N. 2006. EHR offensive. For the Record 18(4): 26. Available online at http://www. fortherecordmag.com/archives/ftr_02202006p26.shtml.