Toolkit for Optimal Recovery after Orthopedic Injury; A multi-site feasibility study to prevent persistent pain and disability

项目总结 利用NCCIH U01机制，我们的目标是建立基准，以便能够成功实施未来 科学严谨的个人直播多点混合效能试验(UG3/UH3机制) 用于最佳受伤后恢复(TOR)的心身计划工具包与最低限度增强的日常护理控制 (MEUC)提供给有慢性疼痛和骨科急性肌肉骨骼损伤风险的个别患者 残疾。我们在马萨诸塞州综合医院(MGH)一级创伤诊所进行的试点可行性试验 参与TOR后的可行性、可接受性、改善的信号的证据，并使我们能够确定 招聘和研究实施方面的限制和障碍是目前提议的依据。多站点 可行性研究将在3个地理位置不同的一级创伤中心进行：MGH(MA)、戴尔医学院 德克萨斯州，肯塔基州列克星敦。首先，利用检察官执行成果框架的要素，我们将进行重点 在每个部位都有骨科医生和工作人员的小组，以了解心理护理的障碍和促进者 研究转介/程序并开发培训材料以绕过这些障碍并确保研究的一体化 每个站点内的程序(目标1)。接下来，我们将进行TOR的可行性多点随机对照试验 针对UC(60名患者/站点；30名/ARM；50名完成者)以先验设定的基准为目标。我们的团队定位独特 对于这款U01，有一位心理学家(Vranceanu；整体PI)和整形外科医生(Ring；Dell Site PI)，有超过12年的经验 协作。PI和统计学家在干预措施开发、可行性测试、临床 试验和现场视频干预交付。我们招募了一位有工作经验的实施科学专家 在骨科手术中。每个骨科创伤单位都有令人兴奋的支持，我们招募了 整形外科医生热衷于心理社会护理，在每个部位都是冠军。我们希望加强对患者的关怀 骨科创伤患者通过低负担心身计划(TOR)专注于优化康复和 预防慢性疼痛和残疾。这种对研究实施的早期关注将支持随后的 UG3/UH3试验以及通知未来的TOR实施，如果这得到疗效数据的支持。

PROJECT SUMMARY Using the NCCIH U01 mechanism, we aim to establish benchmarks to allow for successful implementation of a future scientifically rigorous multi-site hybrid efficacy-effectiveness trial (UG3/UH3 mechanism) of the live video, individual mind body program Toolkit for Optimal Recovery after Injury (TOR) versus a minimally enhanced usual care control (MEUC) delivered to individual patients with acute orthopedic musculoskeletal injuries at risk for chronic pain and disability. Our pilot feasibility trial at the Massachusetts General Hospital (MGH) Level 1 Trauma Clinic provided evidence for feasibility, acceptability, signal of improvement after TOR participation, and allowed us to identify limitations and barriers to recruitment and study implementations, which informed the current proposal. The multi-site feasibility study will be conducted at 3 geographically diverse Level 1 trauma centers: MGH (MA), Dell Medical School (TX), Lexington (KY). First, using elements of Proctors’ Implementation Outcomes Framework we will conduct focus groups with orthopedic surgeons and staff at each site to understand barriers and facilitators to psychological care and study referrals/procedures and develop training materials to bypass these barriers and ensure integration of study procedures within each site (aim 1). Next, we will conduct a feasibility multi-site randomized controlled trial of the TOR against UC (60 patients/site; 30/arm; 50 completers) targeting a priori set benchmarks. Our team is uniquely positioned for this U01, with a psychologist (Vranceanu; overall PI) and orthopedic surgeon (Ring; Dell site PI) with over 12 years’ collaboration. The PI and statistician have extensive expertise in intervention development, feasibility testing, clinical trials, and live video intervention delivery. We recruited an implementation science expert with prior experience working in orthopedic surgery. There is excitement and support from each of the Orthopedic Trauma Units, and we recruited orthopedic surgeons passionate about psychosocial care to serve as champions at each site. We hope to enhance the care of orthopedic trauma patients through a low burden mind body program (TOR) focused on optimizing recovery and preventing chronic pain and disability. This early focus on study implementation will bolster the rigor of the subsequent UG3/UH3 trial as well as inform future TOR implementation, should this be supported by efficacy data.