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

中重度创伤性脑损伤（TBI）导致身体，行为和认知障碍，可能对社区功能产生破坏性影响。综合性跨学科住院康复可以最大限度地发挥功能，减少并发症。然而，临床医生和研究人员无法回答这个问题，“广泛的康复实践中，哪一种可以最有效地促进康复和改善结果？”由于康复过程的复杂性和TBI患者人群的异质性，比较有效性研究的标准方法（随机对照试验）是不够的。然而，随着医疗资源的日益有限和住院时间的缩短，确定可以优化TBI患者结局的特定康复方法是迫切和关键的。 一个务实的，前瞻性的观察性研究，以缩小这一证据差距的建议。通过利用国家残疾研究所的基础设施，独立生活和康复研究的TBI模型系统，世界上最大的中重度TBI纵向研究，比较不同康复方法有效性所需的数据将迅速积累。通过电子病历（EMR）和先进的统计方法，数据采集的最新进展提供了科学研究康复复杂性的途径。目标1：本研究旨在利用EMR技术，确保在患者住院的自然过程中，通过标准化文档捕获对康复治疗至关重要的数据。目标二：本研究总结了关于治疗方法的比较有效性的初步研究结果，旨在评估不同治疗方法对患者结局的影响。据推测，直接针对现实生活中的活动（ContextTx）和更高层次的功能（AdvTx）的性能的康复干预措施将单独和组合提高社区参与在受伤后1年，以及在出院和受伤后1年的功能独立性。目标3：识别随时间变化的患者和设置因素，这些因素可以在康复过程中发生变化，并改变治疗效果。 先进的统计分析加上数据采集，通过来自一线提供者的有效设计的EMR文档变得可行，将提供必要的数据，以确定哪些治疗方法与更好的患者结局相关。这反过来将为临床提供者提供有价值的知识，为患者设计最有效的治疗计划。这项研究的结果将进一步赋予临床操作人员必要的信息，以倡导和促进以证据为基础的治疗TBI恢复财政管理人员，认证机构和监管机构。

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.