Development of a Traumatic Brain Injury Model System Within the Department of Veterans Affairs Polytrauma System of Care

Abstract

Background: 

In 2008, the Department of Veterans Affairs Polytrauma Rehabilitation Centers partnered with the National Institute on Disability and Rehabilitation Research to establish a Model Systems program of research that would closely emulate the civilian Traumatic Brain Injury (TBI) Model Systems Centers Program established in 1987.

Objective: 

To describe the development of a TBI Model Systems program within the Department of Veterans Affairs Polytrauma System of Care.

Methods: 

Enrollment criteria and data collection/data quality efforts for the newly established Department of Veterans Affairs sites are reviewed.

Results: 

Significant progress has been made in the establishment of a Model Systems program for the Polytrauma System of Care. Data collection has moved forward and program-specific modifications have been implemented.

Conclusion: 

The Veterans Affairs TBI Model System program is established and growing, with many projects underway and a strong working relationship with the civilian TBI Model System programs.

TRAUMATIC BRAIN INJURY (TBI) has long been a major health concern for US Veterans and service members, but attention to TBI has been particularly focused since the beginning of combat operations in Afghanistan (Operation Enduring Freedom [OEF]) and Iraq (Operation Iraqi Freedom [OIF]) in 2003.^1,2 Of note, as early as 1991, the Department of Veterans Affairs (VA) and the Department of Defense (DoD) identified 6 Lead TBI centers—2 in DoD medical treatment facilities (Walter Reed Army Medical Center, Wilford Hall Medical Center) and 4 in VA medical centers (Minneapolis, Minnesota; Palo Alto, California; Richmond, Virginia; and Tampa, Florida)—to develop and maintain clinical expertise and to provide ongoing education and advance research in TBI. This collaborative effort was congressionally mandated and initially called the Defense and Veterans Head Injury Program. In the decade between the Persian Gulf War and the beginning of OEF, the Defense and Veterans Head Injury Program established and promoted clinical, educational, and research programs in these VA and military settings. In 2001, the Defense and Veterans Head Injury Program was renamed the Defense and Veterans Brain Injury Center. Congress passed laws in 2004-2005 establishing the Polytrauma System of Care and redesignating the 4 VA Lead TBI centers as Polytrauma Rehabilitation Center (PRC) sites. The PRCs served as flagship inpatient rehabilitation centers for OEF/OIF service members and Veterans with complex polytraumatic injuries as well as with noncombat TBIs. A fifth PRC site (San Antonio, Texas) was added in 2010.

The National Defense Authorization Act of Fiscal Year 2008 (Pub L No. 110-181, §1704) ordered the establishment of a TBI Veterans Health Registry that would include information about all OEF/OIF service members who exhibit symptoms associated with TBI, as well as all OEF/OIF Veterans who filed a claim for disability compensation related to TBI. Section 1704 also directed the Secretary of the VA to collaborate with government agencies involved in TBI rehabilitation and research, including the Defense and Veterans Brain Injury Center and the US Department of Education's National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, the NIDRR would assist the VA in establishing a TBI Model Systems (TBIMS) program of research for the VA, modeled on the civilian TBIMS Centers Program that NIDRR has funded since 1987.^3–8

CIVILIAN NIDRR TBIMS CENTERS PROGRAM

The TBIMS program includes the United States' largest longitudinal TBI database, with more than 11500 participants, and has been instrumental in developing and researching novel diagnostic tools and interventions. Investigators from TBIMS Centers have produced more than 500 peer-reviewed publications. The TBIMS database is managed by the NIDRR-funded TBIMS National Data and Statistical Center (NDSC) at Craig Hospital in Denver, Colorado. Since the establishment of the TBIMS Centers Program, 23 different TBIMS Centers have contributed data on participants sustaining TBI (predominantly moderate and severe initial severity) and receiving inpatient rehabilitation, with 16 actively funded sites currently throughout the country. An additional 3 previously funded sites continue to follow the participants they enrolled in the database. Participants enrolled in the TBIMS database are followed up at 1, 2, and 5 years postinjury and then every 5 years thereafter. There is presently a cohort of participants who have been evaluated at 20 years postinjury. In addition to studies specifically related to the TBIMS database, the TBIMS Centers Program requires that centers conduct specific research, participate in multicenter research, and collaborate with the Model Systems Knowledge Translation Center. TBIMS Centers also have the option to participate in ongoing Special Interest Groups covering topics of general interest and relevance to TBI researchers and clinicians (eg, disorders of consciousness, aging with TBI and TBI in the elderly, sleep). This mechanism allows for further collaboration between sites and investigators. The development, growth, and accomplishments of the TBIMS Centers Program are extensively documented.^3–8 A key factor in the decision for the VA to collaborate with NIDRR was the 20-year history of longitudinal outcome tracking that could be adapted for the military and Veteran TBI population being served in the VA. The close relationship between the 2 entities would facilitate comparison of VA outcomes with those of major academic TBI rehabilitation centers across the country.

VA POLYTRAUMA REHABILITATION CENTERS

The 5 VA PRC sites^* provide the most comprehensive inpatient, residential, and outpatient TBI care in the VA system. The PRCs are regional hubs in the Polytrauma System of Care's nationwide model of care (www.polytrauma.va.gov) and provide all levels of care from acute rehabilitation to residential and outpatient programming, which are all Commission on the Accreditation of Rehabilitation Facilities accredited. All PRCs have specialized Emerging Consciousness Programs for patients with disorders of consciousness and intensive inpatient rehabilitation care for patients with complex polytraumatic injuries. The PRC sites also have Polytrauma Transitional Rehabilitation Programs for individuals who have progressed through acute inpatient rehabilitation and can benefit from a less restrictive environment as they transition to a more typical independent living environment. Finally, all of the PRC sites have outpatient TBI programs to serve Veterans with a wider range of concerns related to TBI and for injuries that did not require inpatient hospitalization or acute rehabilitation stays.

The PRC inpatient units have at least 12 dedicated comprehensive rehabilitation beds, with 2 to 4 beds designated for use by the Emerging Consciousness Programs. All PRC sites are staffed by highly trained, interdisciplinary teams that include physical medicine and rehabilitation physicians, nurses, social workers, psychologists, neuropsychologists, physical therapists, occupational therapists, speech-language pathologists, recreation therapists, and extensive additional ancillary and support staff. The PRC programs were developed to provide clinical leadership, collaborative research, educational programming for providers and families, and collaboration with academic institutions to facilitate best practices in TBI rehabilitation.

VA/NIDRR INTERAGENCY AGREEMENT

An Interagency Agreement between NIDRR and the VA was signed in 2008 with the goals of determining the unique content of the VA PRC database and progressing to the establishment of the VA PRC TBIMS. Owing to the unique data security needs of the VA, a parallel VA PRC TBIMS database, separate from the existing NIDRR TBIMS database and managed by NDSC staff, was established. In 2009, NDSC staff involved in the project completed the required VA data security trainings to meet VA data security needs. The VA TBIMS data management system was reviewed and the required data security agreements were executed. In parallel, a VA PRC TBIMS database with 352 VA PRC-specific variables was developed along with standard operating procedures (SOPs), inclusion criteria, and data elements. This VA PRC TBIMS database was designed to capture longitudinal data and track outcomes of individuals with TBI treated in the PRCs to promote research and system of care innovations, and for comparative research across the civilian and Veteran populations.

INITIAL STEPS IN ADAPTING NIDRR TBIMS PROGRAM OF RESEARCH FOR IMPLEMENTATION AT THE VA PRC SITES

Beginning in 2009, the PRC staff was oriented to the NIDRR TBIMS through regular conference calls, attendance at twice-yearly TBIMS Project Directors Meetings, and participation in quarterly data collectors teleconferences. By mid-July 2010, each of the 4 PRC sites secured local institutional review board approval and was subsequently visited by NDSC staff both to implement the VA PRC TBIMS database and to optimize data quality. At each site, staff from a geographically proximate “sister” NIDRR TBIMS Center participated in the on-site training for the VA PRC TBIMS database to foster further collaboration between the VA and NIDRR sites. Among the VA TBIMS Centers, plans for research projects are ongoing and initial manuscripts are in preparation.

THE VA PRC TBIMS PROGRAM OF RESEARCH

Inclusion criteria

It was anticipated that the nature of combat-related TBI might be different from injuries seen in civilian settings. Thus, while exact matching of variables and content with the civilian TBIMS database would have obvious utility, it was also clear that the VA sample would likely differ from the civilian TBI samples in important ways. Combat-injured individuals represent a unique and important segment of Veterans with brain injury, although most do not sustain moderate to severe injuries, which has been the focus of the civilian TBIMS data collection effort. Therefore, it was thought that narrowing the focus of the VA TBIMS database to include only moderate to severe injuries would exclude too large a proportion of Veterans with brain injury serviced by the VA Polytrauma System of Care. Thus, the VA TBIMS includes the traditional moderate to severe initial TBI cohort that is comparable with the NIDRR TBIMS cohort, plus 2 additional cohorts with either a mild initial TBI severity or a cohort with disorder of consciousness with very severe TBI. Table 1 compares inclusion and exclusion criteria for the civilian NIDRR TBIMS database and the VA TBIMS database. The most notable differences between the cohorts are with respect to characterization and documentation of acute injury characteristics and specific inclusion/exclusion criteria that allow for a wider range of injury severity (ie, mild TBI [mTBI]) in the VA TBIMS database (see Table 1). Additional VA variables contain military relevant characteristics including years of service, deployment to combat, and posttraumatic stress disorder symptom assessment.

TABLE 1: Participant selection criteria for civilian versus VA TBIMS databases

Consistent with most admissions to civilian NIDRR TBIMS programs, individuals hospitalized for intensive inpatient rehabilitation secondary to moderate to severe TBI are most similar to the large sample collected through the civilian TBIMS programs over the years. The expectation is that the majority of PRC inpatients admitted will fit into this category and will provide for important comparisons with the civilian TBIMS sample and identify unique characteristics of the Veteran and military sample.⁹ In civilian samples, individuals with mTBI represent the largest proportion of all brain injuries sustained.¹⁰ While this is also true for active duty soldiers, those who sustain mTBI, in the context of polytraumatic injuries, may warrant admission to PRC programs to receive comprehensive rehabilitation so that this relatively large cohort could be characterized and its outcomes assessed. The VA TBIMS data collection efforts were expanded to include these individuals. An additional patient group of interest within the PRC sites comprises individuals with a disorder of consciousness (coma, vegetative state, minimally conscious state) who are admitted to specialized inpatient rehabilitation programs called Emerging Consciousness Programs at the VA PRC sites.¹¹ Although patients with disorder of consciousness do not represent the typical inpatient rehabilitation cohort in civilian centers, they are included in the NIDRR TBIMS database at some sites.¹² Data from the civilian TBIMS studies of this cohort indicate positive outcomes in the initial 5 years postinjury, thus highlighting their importance for inclusion in a VA rehabilitation outcomes study. Furthermore, they represent a group with high clinical service utilization.¹³

Data and data collection points

The VA PRC TBIMS program was designed to produce a comparison database to the civilian NIDRR TBIMS; however, the data also include additional elements to allow for enhanced monitoring of both the acute and chronic effects of TBI. When possible, elements included in the National Institutes of Health NINDS (National Institute of Neurological Disorders and Stroke) Common Data Elements, Version 2 (CDE-2), initiative were included in the database.¹⁴ Data collected are standardized across form I and form II categories. Form I refers to data collected around the time of enrollment (acute stage) and at regular postinjury follow-ups (form II).

Form I data collection involves coding date and mechanism of injury, neuroimaging findings, and severity indices. Severity indices include emergency department Glasgow Coma Scale score (or earliest documented Glasgow Coma Scale score, if treated in theater of combat), duration of loss of consciousness, and duration of posttraumatic amnesia. The NIDRR TBIMS approach to characterizing information has been adopted across all indices and extended, as needed, to reflect medical record documentation for military missions around the globe. Participant demographic, premorbid psychosocial, and vocational histories are also collected upon enrollment. Patients or collaterals/family members (depending upon cognitive status of the participant) are interviewed to obtain information. Medical records are reviewed from all postinjury hospitalizations and throughout rehabilitation to document medical course and rehabilitation outcomes.

Form II includes data collected during follow-up evaluations done on a fixed-interval schedule (1, 2, 5 years postinjury and every 5 years thereafter). Data collected include rehabilitation, vocational, economic, and psychosocial outcomes (see Table 2). The follow-up schedule is based on time postinjury, rather than enrollment, and as such, all outcomes are anchored at a similar time postinjury across participants. Table 2 is an abbreviated summary of outcome data elements, data collection schedule, and National Institutes of Health NINDS CDE-2 status.

TABLE 2: Injury characterization and outcome measures collected in the VA TBIMS program of research

DATA QUALITY AND OPERATIONS

Each PRC site has a project director and/or a database manager who are responsible for site operations and who report to the VA Lead TBIMS project director. Some sites also have data collectors who support site database managers. The NDSC conducts data and operations support services, as previously described. The VA Lead TBIMS project director and site project directors meet twice annually with NDSC and project directors from civilian TBIMS to discuss enrollment, data quality, and operations. Database managers meet approximately every 18 months to discuss and receive training in operations. The VA TBIMS implemented data collection procedures that have been audited and demonstrated to be both feasible and reliable by the NIDRR TBIMS NDSC.

To ensure data completeness and quality, the specific data collection procedures are outlined in a dynamic, Web-based syllabus and SOPs available online at www.tbindscva.org. The NDSC maintains these tools and updates them, as needed, on the basis of consensus decisions made by VA TBIMS project directors. A Web-based VA TBIMS data entry, management, and reporting system modeled after the system used by the NIDRR TBIMS Centers is managed by the NDSC. Each PRC enters enrollment and data collection forms I and II on a quarterly basis. Rigorous procedures are in place to ensure validity of data collected, coding accuracy, and reliability of data entry. Table 1 is a summary comparing the TBIMS SOPs used to ensure data quality for the VA PRC TBIMS and NIDRR TBIMS databases. For example, each site has an independent reabstraction and review of a form I case per quarter to ensure reliability of coding. In addition to procedures described in Table 1, the NIDRR NDSC conducts on-site Quality Support Visits to each PRC to verify implementation of data quality procedures and provide ongoing training. The NDSC creates and disseminates reports on a quarterly basis, summarizing participant enrollment, completeness of form I and II data, data entry error counts, and data quality target analysis based on established thresholds described later.

The VA TBIMS maintains the same rigorous data quality guidelines and targets used by the NIDRR TBIMS Centers Program. Each center seeks to (1) enroll 80% of eligible participants each quarter and year; (2) successfully follow 90% of participants for the form II year 1 and year 2 follow-up (successful follow-up = those followed, expired or incarcerated); (3) successfully follow 80% of participants for form II year 5, 10, 15, etc, follow-up; and (4) maintain less than 10% missing data on all form I and II variables each year. The VA TBIMS teams discuss quarterly data quality reports during monthly VA TBIMS project directors' conference calls to improve enrollment, data completeness, and accuracy.

The VA TBIMS has leveraged the experience of the civilian NIDRR TBIMS Centers Program to develop a comparable data set and feasible data collection procedures for TBI injuries sustained around the globe. As such, acute care medical records from combat theater or geographically remote civilian settings (ie, other countries or states) may be difficult to access. To address this challenge, VA TBIMS sites are expanding their outreach to community facilities to ensure that complete medical records are obtained and continue to engage in discussions with DoD partners to optimize the availability of acute care medical records from combat theatre. The VA TBIMS is using firsthand experiences of data collectors to identify opportunities for revisions of the syllabus and SOPs to ensure valid and reliable data collection procedures across the centers. These opportunities for process improvement are routinely discussed by teams of the VA TBIMS Centers during monthly conference calls and semiannual face-to-face meetings.

THE IMPACT OF THE TBIMS

It is anticipated that the VA TBIMS infrastructure will facilitate development and expansion of investigator-initiated research across the VA PRCs in both the acute and chronic stages of recovery after TBI. With the unique opportunity to study the full range of TBI injury severity over the lifetime of the Veteran, the VA TBIMS infrastructure may serve as a resource for multicenter, investigator-initiated projects. Already in the past year, 2 multicenter projects have been developed and are under review examining personalized medicine approaches to enhancing TBI outcome and the study of community reintegration facilitators and barriers for persons with moderate and severe TBI. As the VA TBIMS database evolves, adoption of NINDS CDE-2 initiative has influenced sample characterization and outcomes collected. TBI Core and Supplemental Measures are currently part of routine data collection (see Table 2). To our knowledge, this will serve as the first prospective, longitudinal study of TBI outcomes using CDE-2 with Veterans. In addition to formal outcome measures, CDE-2 recommendations for demographics, injury characterization, neuroimaging, and vocational outcomes have also been adopted. In addition, VA TBIMS data will allow for prospective research of critical VA and DoD issues, including the following:

• Longitudinal neurobehavioral course and outcomes after mild, moderate, and severe TBI from multiple causes, including blast exposure.
• Characterization of suicide attempts and hospitalizations before and after TBI.
• Longitudinal tracking of posttraumatic stress disorder and depressive symptoms after TBI.
• Community reintegration, including independent living, participation, and employment outcomes after TBI.
• Prospective tracking of illicit drug and alcohol use after TBI.
• Enhancing injury severity characterization using single and combined indices of neurobehavioral measures, imaging, and functioning.

NEW AND CHRONIC TBI REMAINS A VA PROBLEM

Despite the resolution of hostilities in the Middle East, the ongoing care of TBI remains a prominent priority for the VA. Recent DoD estimates indicate that newly diagnosed TBIs remain 3-fold higher than those diagnosed prior to OEF/OIF/OND (Operation New Dawn, Iraq), with 84% of injuries occurring in nondeployed settings.¹⁵ With the large numbers of persons with TBI being managed in the VA, research remains an important issue, particularly as the VA transitions to become providers for TBI as a chronic health condition. The ability to compare the VA and civilian TBI experiences across multiple levels of injury severity will allow opportunities for clinical benchmarking as well as research cross-fertilization. While the scientific literature based on non-Veteran populations indicates that the vast majority of symptoms associated with mTBI will resolve relatively rapidly, the limited Veteran-based research appears to support a greater proportion of individuals with persistent symptoms at 6 to 12 months after injury.^16,17 Other differences in TBIs of varying severity will be explored with the ongoing utility of the TBIMS database. And, finally, the development of TBIMS quality infrastructure to facilitate empirical understanding of the chronic condition of TBI in Veterans across the injury severity spectrum will provide improved readiness for future military conflicts.