1/2 Toolkit for Optimal Recovery after Orthopedic Injury; A multi-site trial

About This Grant

ABSTRACT: Using the NCCIH UG3/UH3 mechanism we aim to conduct a fully powered, single blind, multi-site efficacy trial at 5 geographically diverse Level 1 Trauma Centers (Duke Medical Center, Dell Medical School, Vanderbilt University Medical Center, University of Kentucky Medical Center and Massachusetts General Hospital). We build on a successful NCCIH funded multisite feasibility trial (R01AT010462) which optimized our protocol for study implementation (aim 1), met 29 feasibility benchmarks, and explored clinical benefit in improvement in outcomes and putative mechanistic targets (aim 2). In the UG3, in partnership with the Data Coordinating Center (DCC) at John Hopkins’s METRC (Castillo, PI) we aim to finalize the study protocols, operating procedures and data collections systems to be used in the RCT, fulfill regulatory requirements and obtain DSMB (aim 1), and train and certify study clinicians, conduct start-up activities at all sites, and conduct a run-in period at our new site Duke Medical Center and mock participants at the 4 sites that recruited as part of the prior R01 and are familiar with study procedures. In the UH3, in partnership with the DCC we aim to establish the efficacy (aim 1) of our mind body intervention Toolkit for Optimal Recovery after Injury (TOR) versus our Minimally Enhanced Usual Care control (MEUC) on physical function (primary outcome), and secondary outcomes of pain intensity, depression, post-traumatic stress and putative mechanistic targets (pain catastrophizing, pain anxiety, coping and mindfulness). We hypothesize that TOR will be more efficacious in reducing primary and secondary outcomes compared to MEUC. We also aim to establish whether TOR dependent improvements in the primary and secondary outcomes maintain through 3 months follow up (aim 2) and the degree to which TOR-dependent improvements in physical function, pain, depression and posttraumatic stress symptoms are mediated my improvements in putative mechanistic targets and modified by clinical and demographic variables (aim 3). We bring together an interdisciplinary team who worked together to develop the infrastructure for the current project, and strong multi-site feasibility of TOR and study procedures supporting the efficacy RCT. Findings from this first test of efficacy of TOR will inform a future large hybrid effectiveness-implementation trial to support our larger goal of implementing TOR as standard of care in orthopedic trauma centers across the USA.