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

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2022 · $741,419

## Abstract

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.

## Key facts

- **NIH application ID:** 10403955
- **Project number:** 5R01AT010462-03
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Ana-Maria Vranceanu
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $741,419
- **Award type:** 5
- **Project period:** 2020-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10403955

## Citation

> US National Institutes of Health, RePORTER application 10403955, Toolkit for Optimal Recovery after Orthopedic Injury; A multi-site feasibility study to prevent persistent pain and disability (5R01AT010462-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10403955. Licensed CC0.

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