Comparing Treatment Approaches to Promote Inpatient Rehabilitation Effectiveness for Traumatic Brain Injury (CARE 4 TBI)

Moderate-severe traumatic brain injury (TBI) results in physical, behavioral, and cognitive impairments that can have a devastating impact on functioning in the community. Comprehensive interdisciplinary inpatient rehabilitation can maximize function and reduce complications. However, clinicians and researchers are unable to answer the question, “Which of the wide range of rehabilitation practices can most effectively advance recovery and improve outcomes?” Due to the complexity of the rehabilitation process and the heterogeneity of the TBI patient population, the standard approach to comparative effectiveness research, the randomized controlled trial, is inadequate. Nevertheless, with growing limitations on healthcare resources and shorter lengths of stay, it is urgent and critical to identify the specific rehabilitation approaches that can optimize outcomes for persons with TBI. A pragmatic, prospective observational study to close this evidence gap is proposed. By leveraging the infrastructure of the National Institute on Disability, Independent Living and Rehabilitation Research’s TBI Model Systems, the largest longitudinal study of moderate-severe TBI in the world, the data needed to compare the effectiveness of different rehabilitation approaches will quickly accumulate. Recent advances in data capture, through electronic medical records (EMR), and in advanced statistical methods provide the avenue by which the complexity of rehabilitation can be scientifically studied. Aim 1: This study aims to leverage EMR technology to ensure data identified as critical to rehabilitation treatment are captured through standardized documentation during the natural course of a patient’s hospitalization. Aim 2: Incorporating the findings of preliminary studies on comparative effectiveness of treatment approaches, this study will aim to evaluate the impact of different approaches to treatment on patient outcomes. It is hypothesized that rehabilitation interventions directly targeting performance of real-life activities (ContextTx) and higher-level functions (AdvTx) will individually and in combination improve community participation at 1-year post-injury, as well as on functional independence at discharge and at 1-year post-injury. Aim 3: Identify time-varying patient and setting factors that can change over the course of rehabilitation and that modify the effects of treatment. Advanced statistical analyses coupled with data capture made feasible by effectively designed EMR documentation from frontline providers will provide the data necessary to identify which treatment approaches are associated with better patient outcomes. This in turn will arm clinical providers with valuable knowledge to design the most effective treatment plans for patients. The findings of this study will further empower clinical operators with the necessary information to advocate and promote evidence-based treatments for TBI recovery to fiscal stewards, credentialing bodies, and regulatory agencies.