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

中度至重度创伤性脑损伤 (TBI) 会导致身体、行为和认知障碍，可能对社区功能产生毁灭性影响。综合性跨学科住院康复可以最大限度地提高功能并减少并发症。然而，临床医生和研究人员无法回答这样的问题：“各种康复实践中，哪一种能够最有效地促进康复并改善结果？”由于康复过程的复杂性和 TBI 患者群体的异质性，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限制和住院时间的缩短，确定可以优化 TBI 患者预后的具体康复方法至关重要。 提出了一项务实的前瞻性观察研究来缩小这一证据差距。通过利用国家残疾、独立生活和康复研究所的 TBI 模型系统（世界上最大的中重度 TBI 纵向研究）的基础设施，比较不同康复方法有效性所需的数据将快速积累。通过电子病历 (EMR) 进行数据采集和先进统计方法的最新进展为科学研究康复的复杂性提供了途径。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被确定为对康复治疗至关重要的数据。目标 2：结合治疗方法比较有效性的初步研究结果，本研究旨在评估不同治疗方法对患者结果的影响。据假设，直接针对现实生活活动表现 (ContextTx) 和高级功能 (AdvTx) 的康复干预将单独或组合改善受伤后 1 年的社区参与，以及出院时和受伤后 1 年的功能独立性。目标 3：确定随时间变化的患者和设置因素，这些因素可能会在康复过程中发生变化并改变治疗效果。 先进的统计分析与前线提供者有效设计的电子病历文档相结合的数据采集将提供必要的数据，以确定哪些治疗方法与更好的患者结果相关。这反过来又将为临床提供者提供宝贵的知识，为患者设计最有效的治疗计划。这项研究的结果将进一步为临床操作人员提供必要的信息，以向财政管理者、认证机构和监管机构倡导和推广 TBI 恢复的循证治疗方法。

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.