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

项目摘要 使用NCCIH U 01机制，我们的目标是建立基准，以便成功实施未来的 现场视频的科学严谨的多中心混合疗效-效果试验（UG 3/UH 3机制），个体 身心计划创伤后最佳恢复工具包（TOR）与最低限度增强的常规护理控制 （MEUC）提供给有慢性疼痛风险的急性骨科肌肉骨骼损伤个体患者， 残疾。我们在马萨诸塞州总医院（MGH）1级创伤诊所进行的试点可行性试验提供了 可行性、可接受性的证据，TOR参与后的改善信号，并使我们能够识别 招募和研究实施方面的限制和障碍，这为目前的提案提供了信息。多地 可行性研究将在3个地理位置不同的1级创伤中心进行：MGH（MA），戴尔医学院 (TX)，列克星敦（KY）。首先，我们将利用监督者实施成果框架的要素， 与每个研究中心的整形外科医生和工作人员组成小组，了解心理护理的障碍和促进因素， 研究转介/程序，并制定培训材料，以绕过这些障碍，并确保学习的整合 每个地点的程序（目标1）。接下来，我们将对TOR进行可行性多中心随机对照试验 针对UC（60例患者/研究中心; 30例/组; 50例完成者），目标是先验设定的基准。我们的团队是独一无二的 对于此U 01，与心理学家（Vranceanu;总体PI）和整形外科医生（Ring;戴尔工厂PI）合作，拥有超过12年的经验 协作PI和统计学家在干预开发、可行性试验、临床 审判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 在整形外科。有兴奋和支持，从每个骨科创伤单位，我们招募了 整形外科医生热衷于心理社会护理，在每个站点担任冠军。我们希望加强对 骨科创伤患者通过一个低负担的身心计划（TOR），重点是优化恢复， 预防慢性疼痛和残疾。这种对研究实施的早期关注将加强后续研究的严谨性。 UG 3/UH 3试验以及告知未来的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.