JMIR Publications

ABSTRACT

Background:

Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery after orthopedic injury; TOR). In a pilot single-site randomized controlled trial (RCT), TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial.

Objective:

The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. Here we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation.

Methods:

This study will be conducted at 3 geographically diverse Level 1 trauma centers, anonymized as Site A, Site B, and Site C. We will conduct a multisite feasibility RCT of TOR versus a minimally enhanced usual care control (MEUC) (60 patients/site; 30/arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury/surgery (baseline). Participants randomized to TOR will receive a 4-session mind-body treatment delivered via secure live video by trained clinical psychologists. Participants randomized to MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes are assessed at baseline, posttreatment, and 3-month follow-up.

Results:

Enrollment is estimated to begin in April 2021. The target date of completion for the feasibility RCT is April 2024.

Conclusions:

This investigation examines the multisite feasibility of TOR administered via live videoconferencing to adult patients with acute orthopedic injuries. If feasible, the next step is a multisite hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a novel avenue to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries at risk for chronic pain and disability.