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: 10918399
• 负责人: Ana-Maria Vranceanu
• 金额: $ 2.99万
• 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/10918399
• 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.

项目总结