Transcription

A NATIONALTRAUMA CARE SYSTEMIntegrating Military and CivilianTrauma Care Systems to AchieveZero Preventable Deaths After Injury

Committee on Military Trauma Care’s Learning HealthSystem and Its Translation to the Civilian SectorDonald Berwick (Chair), Institute for Healthcare ImprovementEllen Embrey, Stratitia, Inc., and 2c4 Technologies, Inc.Sara F. Goldkind, Goldkind Consulting, LLCAdil Haider, Brigham and Women’s Hospital, and HarvardUniversityCOL (Ret) John Bradley Holcomb, University of Texas HealthScience CenterBrent C. James, Intermountain HealthcareJorie Klein, Parkland Health & Hospital SystemDouglas F. Kupas, Geisinger Health SystemCato Laurencin, University of ConnecticutEllen MacKenzie, Johns Hopkins University School of Hygieneand Public HealthDavid Marcozzi, University of Maryland School of MedicineC. Joseph McCannon, The Billions InstituteNorman McSwain, JR., (until July 2015), Tulane Department ofSurgeryJohn Parrish, Consortia for Improving Medicine with Innovationand Technology (CIMIT); Harvard Medical SchoolRita Redberg, University of California, San FranciscoUwe E. Reinhardt, (until August 2015), Princeton UniversityJames Robinson, Denver Health EMS-Paramedic DivisionThomas Scalea, R. Adams Cowley Shock Trauma Center,University of MarylandC. William Schwab, University of PennsylvaniaPhilip C. Spinella, Washington University in St. Louis School ofMedicine2

Study Sponsors American College of Emergency PhysiciansAmerican College of SurgeonsNational Association of Emergency Medical TechniciansNational Association of EMS PhysiciansTrauma Center Association of AmericaU.S. Department of Defense’s U.S. Army Medical Research and MaterielCommand U.S. Department of Homeland Security’s Office of Health Affairs U.S. Department of Transportation’s National Highway Traffic SafetyAdministration3

Charge to the Committee Identify and describe the key components of a learning healthsystem necessary to optimize care of individuals who havesustained traumatic injuries in military and civilian settings. Characterize the military’s Joint Trauma System (JTS) andDefense Health Program research investment and theirintegrated role as a continuous learning and evidence-basedprocess improvement model. Examine opportunities to ensure that advances in trauma careare sustained and built on for future combat operations. Consider strategies necessary to more effectively translate,sustain, and build upon elements of knowledge and practice fromthe military’s learning health system into the civilian health sectorand lessons learned from the civilian sector into the militarysector.4

Case StudiesTo address its charge, the committee drewupon 5 case studies centered aroundcommon combat-related injuries that werealso relevant to civilian sector trauma cases:–––––Extremity hemorrhageBlunt trauma with vascular injuryDismounted complex blast injuryPediatric burnSevere traumatic brain injuryCase studies were used throughout the report tohighlight military learning processes, gaps, andopportunities for improved translation of bestpractices to and from the civilian sector.5

Timeline May 2015July 2015September 2015November 2015January 2016June 2016Ongoing1st committee meeting2nd committee meeting and public workshop3rd committee meeting and public workshop4th committee meeting5th committee meetingReport releaseReport disseminationIn addition to in-person committee meetings, the committee gatheredinformation through Web-based meetings held in October 2015,December 2015, January 2016, and February 2016.6

Definitions Preventable deaths after injury: Those casualties whose lives could have beensaved by appropriate and timely medical care, irrespective of tactical, logistical, orenvironmental issues. Focused empiricism: An approach to process improvement under circumstancesin which: (1) high-quality data are not available to inform clinical practice changes,(2) there is extreme urgency to improve outcomes because of high morbidity andmortality rates, and (3) data collection is possible.A key principle of focused empiricism is using the best data available incombination with experience to develop clinical practice guidelines that, through aniterative process, continue to be refined until high-quality data can be generated tofurther inform clinical practice and standards of care. Expert trauma care workforce: Each interdisciplinary trauma team at all Roles ofcare includes an expert for every discipline represented. These expert-levelproviders oversee the care provided by their team members, all of whom must beminimally proficient in trauma care (i.e., appropriately credentialed with currentexperience caring for trauma patients).7

Context The Imperative– The U.S. service members the nation sends into harm’sway and every American should have the best possiblechance for survival and functional recovery after injury. The Urgency– Military burden: 6,850 service member deaths in Iraq andAfghanistan. Nearly 1,000 from potentially survivableinjuries.– Civilian burden: 147,790 U.S. trauma deaths in 2014 - asmany as 30,000 may have been preventable with optimaltrauma care.– Threats from active shooter and other mass casualtyincidents.– As wars end and service members leave the military, theknowledge, experience and advances in trauma caregained over past decade are being lost. The OpportunityTraumatic injury accounts fornearly half of all deaths forAmericans under 46 years ofage and cost the nation 670Bin 2013.– Existence of a military trauma system built on a learning system framework that hasachieved unprecedented survival rates for casualties.– Organized civilian trauma system that is well positioned to assimilate recent wartimetrauma lessons learned and serve as a repository and incubator for innovation during theinterwar period.8

Framework for a Learning Trauma Care SystemCommittee built upon the components of a continuously learning healthsystem articulated by IOM (2013) report Best Care at Lower Cost.Components of a continuously learningtrauma care system: Digital capture of the patient care experience Coordinated performance improvement andresearch to generate evidence-based besttrauma care practices Processes and tools for timely dissemination oftrauma knowledge Systems for ensuring an expert trauma careworkforce Patient-centered trauma care Leadership-instilled culture of learning Transparency and incentives aligned for qualitytrauma care Aligned authority and accountability for traumasystem leadershipPatient centeredness is the coreof a learning trauma care system.9

The Vision: A National Trauma Care SystemA national strategy and jointmilitary–civilian approach forimproving trauma care is lacking.A unified effort is needed toensure the delivery of optimaltrauma care to save the lives ofAmericans injured within theUnited States and on thebattlefield.A national learning trauma caresystem would ensurecontinuous improvement oftrauma care best practices inmilitary and civilian sectors.“Military and civilian trauma care will be optimized together, or not at all.”10

Findings and RecommendationsThe Aim (Rec 1)The Role of Leadership– National-Level Leadership (Rec 2)– Military Leadership (Rec 3)– Civilian Sector Leadership (Rec 4)An Integrated Military–Civilian Framework for Learning toAdvance Trauma Care– Improving the Collection and Use of Data (Recs 5 and 9)– A Collaborative Research Infrastructure in a Supportive RegulatoryEnvironment (Recs 7 and 8)– Systems and Incentives for Improving Prehospital Trauma CareQuality (Rec 10)– Developing Expertise (Recs 6 and 11)11

The AimWithout an aim, there is no system (Deming).Recommendation 1: The White House should set anational aim of achieving zero preventable deaths afterinjury and minimizing trauma-related disability. The 75th Ranger Regiment demonstrated that achieving zeropreventable deaths is an achievable goal when leadership takesownership of trauma care and data is used for continuous reflectionand improvement.12

The Role of Leadership13

National-Level LeadershipFindings:– The absence of any higher authority to encouragecoordination, collaboration, standardization, and alignment intrauma care across and within the military and civilian sectorshas resulted in variations in practice, suboptimaloutcomes for injured patients, and a lack of nationalattention and funding directed at trauma care.– Previous White House-led national initiatives have helpedunify and ensure collaboration among existing efforts andpoints of authority spread across military and civilian federalagencies, state and local governments, and professionalorganizations.14

National-Level LeadershipRecommendation 2: The White House should lead theintegration of military and civilian trauma care toestablish a national trauma care system. This initiativewould include assigning a locus of accountability andresponsibility that would ensure the development ofcommon best practices, data standards, research, andworkflow across the continuum of trauma care.The White House should:– Convene federal agencies and other governmental, academic, and privatesector stakeholders to agree on the aims, design, and governance of anational trauma care system.– Ensure appropriate funding and the reduction of regulatory barriers– Strategically communicate the value of a national trauma care system thatcan respond domestically to mass casualty incidents.Full list of actions detailed in bulletsthat follow the recommendation15

Military LeadershipFindings:– Within the military leadership structure, there isno overarching authority responsible for ensuring medicalreadiness to deliver combat casualty care.– Responsibility, authority, and accountability for battlefieldcare are diffused across central and service-specific medicalleadership, as well as line leadership.– An inconsistent level of understanding by senior medicaland line leadership of the value of a learning trauma caresystem impedes continuous learning and improvement.16

Military LeadershipRecommendation 3: The Secretary of Defense should ensurecombatant commanders and the Defense Health Agency (DHA)Director are responsible and held accountable for the integrity andquality of the execution of the trauma care system in support of theaim of zero preventable deaths after injury and minimizing disability. The Secretary of Defense also should ensure the DHA Director has theresponsibility and authority and is held accountable for defining thecapabilities necessary to meet the requirements specified by the combatantcommanders with regard to expert combat casualty care personnel andsystem support infrastructure. The Secretary of Defense should hold the Secretaries of the militarydepartments accountable for fully supporting DHA in that mission. The Secretary of Defense should direct the DHA Director to expand andstabilize long-term support for the Joint Trauma System so its functionalitycan be improved and utilized across all combatant commands, giving actorsin the system access to timely evidence, data, educational opportunities,research, and performance improvement activities.Full list of actions detailed in bulletsthat follow the recommendation17

Civilian Sector LeadershipFindings:– Authority and accountability for civilian trauma carecapabilities are fragmented and vary from location to location,resulting in a patchwork of systems for trauma care in whichmortality varies twofold between the best and worsttrauma centers in the nation.– There is no federal civilian health lead for trauma care(including prehospital, in-hospital, and post-acute care) tosupport a learning health system for trauma care, despite pastrecommendations that such a lead agency be established.18

Civilian Sector LeadershipRecommendation 4: The Secretary of HHS should designate and fullysupport a locus of responsibility and authority within HHS for leading asustained effort to achieve the national aim of zero preventable deathsafter injury and minimizing disability. This leadership role shouldinclude coordination with governmental (federal, state, and local),academic, and private-sector partners and should address care fromthe point of injury to rehabilitation and post-acute care.The designated locus of responsibility should: Convene a consortium of federal and other governmental, academic, andprivate-sector stakeholders, including trauma patient representatives, tojointly define a framework for the recommended national trauma care system,including the designation of stakeholder roles and responsibilities, authorities,and accountabilities. Develop and implement guidelines for establishment of the appropriatenumber, level, and location of trauma centers within a region based on theneeds of the population.Full list of actions detailed in bulletsthat follow the recommendation19

Organizing and Demonstrating EffectivenessTiered roles andresponsibilities for military andcivilian stakeholders in anational trauma care system.Bidirectional exchange occursat all levels.Both sectors need to demonstrate the effectiveness of the learning trauma caresystem by each year diffusing across the entire system one or two deeplyevidence-based interventions (such as tourniquets) known to improve thequality of trauma care.20

An Integrated Military – Civilian Frameworkfor Learning to Advance Trauma Care21

Improving the Collection and Use of DataFindings:– The collection and integration of trauma data across the care continuumis incomplete in both the military and civilian sectors.– Military and civilian trauma management information systems rely oninefficient and error-prone manual data abstraction to populate registries.– Data are fragmented across existing trauma registries and other datasystems, and data sharing within and across the military and civilian sectorsis impeded by political, operational, technical, regulatory, and securityrelated barriers.– In both the military and civilian sectors, performance transparency at theprovider and system levels is lacking.– Providers lack real-time access to their performance data.– No process exists for benchmarking trauma system performance across theentire continuum of care within and between the military and civilian sectors.– Military participation in national trauma quality improvement collaborativesis minimal; only a single military hospital participates in an ACS TQIP.22

Improving the Collection and Use of DataRecommendation 5: The Secretary of HHS and the Secretary of Defense,together with their governmental, private, and academic partners, should workjointly to ensure that military and civilian trauma systems collect and sharecommon data spanning the entire continuum of care. Measures related toprevention, mortality, disability, mental health, patient experience, and otherintermediate and final clinical and cost outcomes should be made readilyaccessible and useful to all relevant providers and agencies.– Congress and the White House should hold DoD and the VA accountable for enabling the linkingof patient data stored in their respective systems.– ACS, NHTSA, and NASEMSO should work jointly to enable patient-level linkages across theNEMSIS National EMS Database and the National Trauma Data Bank.– HHS, DoD, and their professional society partners should jointly engage the National QualityForum in the development of measures of the overall quality of trauma care. These measuresshould be used in trauma quality improvement programs, including ACS TQIP.Recommendation 9: All military and civilian trauma systems should participatein a structured trauma quality improvement process.– ACS should expand TQIP to encompass measures from point-of-injury/prehospital care throughlong-term outcomes, for its adult as well as pediatric programs.– CMMI should pilot, fund, and evaluate regional, system-level models of trauma care delivery.Full list of actions detailed in bulletsthat follow the recommendation23

A Collaborative Military–Civilian ResearchInfrastructureFindings:– Despite its significant societal burden, civilian investment in traumaresearch is not commensurate with the importance of injury.– Sustainment of DoD’s trauma research program is threatened thoughgaps identified in DoD’s Guidance on Development of the Forceremain less than 50 percent resolved.– Trauma care practices developed through a focused empiricismapproach need to be validated by higher quality collaborativeresearch studies.– In the civilian sector, no mechanism exists for directing researchinvestments toward identified gaps, a problem exacerbated by theabsence of a centralized institute dedicated to trauma andemergency care research.24

A Collaborative Military–Civilian ResearchInfrastructureRecommendation 7: To strengthen trauma research and ensure that theresources available for this research are commensurate with theimportance of injury and the potential for improvement in patientoutcomes, the White House should issue an executive order mandatingthe establishment of a National Trauma Research Action Plan requiring aresourced, coordinated, joint approach to trauma care research acrossDoD, HHS (NIH, AHRQ, CDC, FDA, PCORI), DOT, the VA, and others(academic institutions, professional societies, foundations).The National Trauma Research Action Plan should:– Direct the performance of a gap analysis to identify clinical and system researchgaps, considering needs specific to mass casualty incidents and special patientpopulations.– Develop the appropriate requirements-driven and patient-centered research strategyand priorities for addressing the gaps with patient input.– Specify an integrated military–civilian strategy with short, intermediate and long-termsteps for ensuring appropriate resources are directed toward the identified gaps.– Promote military–civilian research partnerships.Full list of actions detailed in bulletsthat follow the recommendation25

A Supportive Regulatory EnvironmentFindings:– The ambiguity between quality improvement and research slowsand even impedes quality improvement and research activities.– FDA and DoD requirements for informed consent impede neededtrauma research; ironically, these regulations make minimal riskresearch the most difficult to perform.– Common misperceptions about HIPAA regulations presentbarriers to using and sharing data across systems for both directpatient care and research purposes.– Greater flexibility in evidentiary standards (within legal constraints)could enable better leveraging of large bodies of clinical data forcritically needed life-saving products.– More systematic interface between FDA and DoD is needed tofacilitate more timely fielding of diagnostic and therapeutic products.26

A Supportive Regulatory EnvironmentRecommendation 8: To accelerate progress toward the aim of zero preventabledeaths after injury and minimizing disability, regulatory agencies should reviseresearch regulations and reduce misinterpretation of the regulations throughpolicy statements (i.e., guidance documents).Points of consideration:– Allow the FDA to develop criteria for waiver or modification of the requirement ofinformed consent for minimal-risk research.– For nonexempt human subjects research that falls under HHS or FDA human subjectsprotections, DoD should consider eliminating the need to also apply 10 U.S.C. 980,“Limitation on Use of Humans As Experimental Subjects” to the research.– HHS’s Office for Civil Rights should consider providing guidance on the scope andapplicability of HIPAA with respect to trauma care and trauma research.– The FDA should consider establishing an internal Military Use Panel that can serve asan interagency communication and collaboration mechanism to facilitate more timelyfielding of urgently needed medical therapeutic and diagnostic products for trauma.– HHS, when considering revisions to the Common Rule, should consider whether thedistinction between QI and research permits active use of pragmatic learning methods.Whatever distinction is ultimately made, the committee believes that it needs to supporta learning health system.Full list of actions detailed in bulletsthat follow the recommendation27

Systems and Incentives for ImprovingPrehospital Trauma Care QualityFindings: The greatest opportunity to save lives afterinjury is in the prehospital setting. Prehospital care is not currently linked tohealth care delivery reform efforts. Variable standards of care, a paucity ofuniversal protocols and currentreimbursement practices for civilian EMS(i.e., pay-for-transport) are majorimpediments to the seamless integrationof prehospital care into the trauma carecontinuum.Prehospital care needs to be aseamless component of thetrauma care chain of survival.28

Systems and Incentives for ImprovingPrehospital Trauma Care QualityRecommendation 10: Congress, in consultation with HHS, shouldidentify, evaluate, and implement mechanisms that ensure theinclusion of prehospital care (e.g., emergency medical services) as aseamless component of health care delivery rather than merely atransport mechanism.Possible mechanisms that might be considered include:- Amendment of the Social Security Act such that EMS is identified as aprovider type.- Modification of CMS’s ambulance fee schedule to better link the quality ofprehospital care to reimbursement and health care delivery reform efforts.- Establishing responsibility, authority, and resources within HHS to ensurethat prehospital care is an integral component of health care delivery- Supporting and appropriately resourcing an EMS needs assessment todetermine the necessary EMS workforce size, location, competencies,training, and equipping needed for optimal prehospital medical care.29

Developing Expertise:Timely Dissemination of KnowledgeFindings:– The military’s teleconsultation programs in theater arejeopardized by a lack of funding and institutionalization.– While best practices in telemedicine exist within the United States(e.g., Project ECHO), this tool is not used to its full potential inmilitary or civilian trauma care.– Expansion of the scope of the Senior Visiting Surgeons programto providers other than surgeons could broaden its impact andimprove the exchange of tacit knowledge between military andcivilian providers.– More formal methods for military-civilian collaboration could bettertranslate military best practices and its agile approach into civilianguideline development processes.30

Developing Expertise:Timely Dissemination of KnowledgeRecommendation 6: To support the development, continuous refinement,and dissemination of best practices, the designated leaders of therecommended national trauma care system should establish processes forreal-time access to patient-level data from across the continuum of care andjust-in-time access to high-quality knowledge for trauma care teams andthose who support them.– Military and civilian trauma management information systems should be designed forthe purpose of improving the real-time front-line delivery of care. The greater trauma community as well as EMR and trauma registry vendorsshould lead the development of a bottom-up data system design around focusedprocesses for trauma care.– Military and civilian trauma system leaders should employ a multipronged approach toensure the adoption of guidelines and best practices by trauma care providers. This should encompass clinical decision support tools, PI programs, mandatorypre-deployment training, and continuing education. DoD and civilian partners should collaboratively develop guidelines and guidelineinformation should be included in national certification testing at all levels.Full list of actions detailed in bulletsthat follow the recommendation31

Developing Expertise:Ensuring an Expert WorkforceFindings:– Policy and operational barriers—variable trauma workload, beneficiary careresponsibilities, and the lack of defined trauma care career paths—impede themilitary’s ability to recruit, train and retain an expert trauma care workforce.– DoD lacks validated, standardized trauma training and skill sustainmentprograms.– The military’s reliance on just-in-time (e.g., trauma courses, short-durationpredeployment training programs) and on-the-job training does not provide theexperience necessary to ensure an expert trauma care workforce. Providersneed to regularly care for trauma patients.– Officer and enlisted leadership courses attended by senior line and medicalleaders do not provide education and training on trauma system concepts,resulting in a lack of understanding of such concepts by those whoare responsible for the execution of the theater trauma system.– Promotion incentives for military medical personnel are misaligned; currentpromotion structures do not encourage or reward the growth of clinical traumafocused expertise.32

Developing Expertise:Ensuring an Expert WorkforceRecommendation 11: To ensure readiness and to save lives through thedelivery of optimal combat casualty care, the Secretary of Defenseshould direct the development of career paths for trauma care.Furthermore, the Secretary of Defense should direct the Military HealthSystem to pursue the development of integrated, permanent jointcivilian and military trauma system training platforms to create andsustain an expert trauma workforce.– Ensure the verification of a subset of MTFs by ACS as Level I, II, or III traumacenters that will participate in civilian regional trauma systems.– Assign military trauma teams representing the full spectrum of providers ofprehospital, hospital, and rehabilitation-based care to civilian trauma centers.– Develop and sustain a research portfolio focused on optimizing mechanisms bywhich all (active duty, Reserve, and National Guard) military medical personnelacquire and sustain expert-level performance in combat casualty care.– Hold the DHA accountable for standardizing the curricula, skill sets, andcompetencies for all physicians, nurses, and allied health professionals (e.g.,medics, technicians, administrators).Full list of actions detailed in bulletsthat follow the recommendation33

Thank you!Free PDF of the report available at:nationalacademies.org/TraumaCareAdditional materials available onthe Academies website––––4-page report in briefRecommendation listInfographicSlide set34

Rita Redberg, University of California, San Francisco Uwe E. Reinhardt, (until August 2015), Princeton University James Robinson, Denver Health EMS-Paramedic Division Thomas Scalea, R. Adams Cowley Shock Trauma Center,