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.
The U01 proposal will set the stage for a scientifically rigorous multi-site hybrid efficacy-effectiveness trial via the UG3/UH3 NCCIH mechanism. The ultimate goal is to enhance the care of orthopedic patients with musculoskeletal injuries who are at risk for chronic pain and disability, through implementation of the mind body program Toolkit for Optimal Recovery after Injury (TOR) delivered via secure live video within all orthopedic trauma practices. There are ample opportunities to improve patient and provider satisfaction, decrease suffering and health care costs.
