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

骨科损伤后最佳恢复工具包；

• 批准号: 10622581
• 负责人: Ana-Maria Vranceanu
• 金额: $ 73.86万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10622581
• 关键词: Acute; Address; Adherence; Adoption; Adult; Agreement; Anxiety; Area; Benchmarking; Bone Tissue; Boston; Bypass; Caring; Clinic; Clinical; Clinical Trials; Collaborations; Data; Development; Education; Educational Materials; Effectiveness; Elements; Ensure; Ethnic Origin; Feasibility Studies; Feedback; Focus Groups; Future; General Hospitals; Geography; Goals; Health Care Costs; Home; Hospitalization; Hybrids; Individual; Infrastructure; Injury; Intervention; Interview; Kentucky; Massachusetts; Medical; Medical Staff; Medical center; Methodological Studies; Mind-Body Intervention; National Center for Complementary and Integrative Health; Nurses; Operative Surgical Procedures; Orthopedic Surgery; Orthopedics; Outcome; Pain; Pamphlets; Patients; Persistent pain; Phase; Physical Function; Play; Population; Positioning Attribute; Preparation; Procedures; Proctor framework; Protocols documentation; Provider; Psychologist; Psychosocial Assessment and Care; Psychosocial Factor; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Reporting; Research; Risk; Role; Sampling; Secure; Severities; Signal Transduction; Site; Surgeon; Testing; Thinking; Training; Trauma; Trauma patient; Traumatic injury; Work; arm; austin; biopsychosocial; chronic pain; depressive symptoms; design; disability; effectiveness trial; efficacy study; efficacy testing; efficacy trial; experience; feasibility testing; feasibility trial; implementation outcomes; implementation science; implementation strategy; improved; individual patient; information gathering; injury recovery; innovation; intervention delivery; medical appointment; medical schools; mind/body; multidisciplinary; musculoskeletal injury; opioid use; pain catastrophizing; post-traumatic symptoms; prevent; programs; psychologic; psychosocial; racial diversity; recruit; satisfaction; soft tissue; success; therapy development; trauma centers; trauma units; treatment as usual; virtual

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.

项目摘要 使用NCCIH U01机制，我们旨在建立基准，以成功实施未来 现场视频的科学严格的多站点混合有效性试验（UG3/UH3机制），个人 心理身体计划工具包，可在受伤后与最佳恢复（TOR）相对于最小增强的常规护理控制 （MEUC）送给急性骨科肌肉骨骼损伤的个别患者，有慢性疼痛和 残疾。我们在马萨诸塞州综合医院（MGH）1级创伤诊所的飞行员可行性试验 可行性，可接受性，参与后改善信号的证据，并允许我们确定 招聘和研究实施的限制和障碍，这为当前的提案提供了信息。多站点 可行性研究将在3个地理上不同的1级创伤中心进行：MGH（MA），戴尔医学院 （TX），列克星敦（KY）。首先，使用Proctors实施成果框架的要素，我们将进行重点 与骨科医生和每个站点的员工组成的小组，以了解心理护理的障碍和促进者 研究推荐/程序和开发培训材料以绕过这些障碍并确保研究的整合 每个站点内的程序（AIM 1）。接下来，我们将进行TOR的可行性多站点随机对照试验 针对UC（60名患者/部位； 30/ARM； 50个完成者），以先验设置的基准为目标。我们的团队独特地定位 对于这个U01，拥有心理学家（Vranceanu;总体PI）和骨科医生（RING; Dell Site PI），拥有超过12年的时间 合作。 PI和统计学家在干预开发，可行性测试，临床方面具有广泛的专业知识 试验和实时视频干预交付。我们招募了具有先前经验的实施科学专家 在骨科手术中。每个骨科创伤部门都有兴奋和支持，我们招募了 骨科医生热衷于心理心理护理在每个站点担任冠军。我们希望增强护理 通过低烧伤身体计划（TOR）的骨科创伤患者的重点是优化恢复和 防止慢性疼痛和残疾。对研究实施的早期关注将加强随后的严格 如果效率数据支持这一点，UG3/UH3试验以及将来的实施信息。