2/2TOOLKIT for optimal recovery after orthopedic injury: a multi-site trial

The National Center for Complementary and Integrative Health awarded The Johns Hopkins University a cooperative agreement totaling $431,977 on August 5, 2026, under the Research and Training in Complementary and Integrative Health program (CFDA 93.213).

Johns Hopkins serves as the data coordinating center for a multisite randomized controlled trial testing the efficacy of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body intervention, against minimally enhanced usual care at five Level 1 trauma centers: Duke Medical Center, Dell Medical School, Vanderbilt University Medical Center, University of Kentucky Medical Center, and Massachusetts General Hospital. The trial builds on a prior NCCIH-funded feasibility study (R01AT010462) that optimized study protocols and established proof-of-concept for clinical benefit.

In the first year, Johns Hopkins will finalize study protocols, operating procedures, and data collection systems; fulfill regulatory requirements and establish a Data and Safety Monitoring Board; train and certify study clinicians across all sites; conduct site start-up activities; and execute a run-in period at Duke Medical Center and mock participant sessions at the four sites that participated in the prior feasibility trial. In years 2–5, the data coordinating center will conduct the efficacy trial and track maintenance of improvements through 3-month follow-up on primary outcomes of physical function and secondary outcomes including pain intensity, depression, post-traumatic stress, pain catastrophizing, pain anxiety, coping, and mindfulness.

Massachusetts General Hospital serves as the companion clinical coordinating center under a separate UG3/UH3 mechanism. Work is performed at Johns Hopkins in Baltimore, Maryland, with performance running through July 31, 2031.

Abstract

Using the nccih U24 mechanism we aim to serve as the data coordinating center for 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 initial project year, in partnership with the clinical coordinating center (CCC, companion UG3/UH3)) at massachusetts general hospital (PIS vranceanu and jochimsen) we aim to finalize the study protocols, operating procedures and data collection 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 years 2-5, in partnership with the CCC 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.