Background: Orthopedic injuries are the leading cause of hospital admissions in the USA, and many of these patients transition into chronic pain. Currently, there are no evidence-based interventions targeting prevention of chronic pain in patients with orthopedic injuries. We iteratively developed a four-session intervention “The Toolkit for Optimal Recovery” (TOR) which we plan to subsequently test for efficacy in a phase III hybrid efficacy-effectiveness multi-site clinical trial. In order to prevent methodological weaknesses in the subsequent trial, we conducted a feasibility pilot to evaluate the TOR delivered via secure live video versus usual care (UC) in patients with orthopedic injuries from an urban, level I trauma clinic, who screen in as at risk for chronic pain and disability. We tested the feasibility of recruitment, acceptability of screening, and randomization methods; acceptability of the intervention, treatment adherence, and treatment fidelity; satisfaction with the intervention; feasibility of the assessment process at all time points; acceptability of outcome measures for the definitive trial; and within-treatment effect sizes.
Methods: We aimed to recruit 50–60 participants, randomize, and retain them for ~ 4 months. Assessments were done electronically via REDCap at baseline, post-intervention (approximately 5 weeks after baseline), and 3 months later. We followed procedures we intend to implement in the full-scale hybrid efficacy-effectiveness trial.
Results: We recruited 54 participants and found that randomization and data collection procedures were generally acceptable. The majority of participants were white, educated, and employed. Warm hand-off referrals were more effective than research assistants directly approaching patients for participation without their providers’ engagement. Feasibility of recruitment, acceptability of screening, and randomization were good. Satisfaction with the program, adherence to treatment sessions, and treatment fidelity were all high. There were no technical issues associated with the live video delivery of the TOR. There was minimal missing data and outcome measures were deemed appropriate. Effect sizes for improvement after participation in TOR were moderate to large. There were many lessons learned for future trials.
Conclusions: This study provided evidence of the feasibility of the planned hybrid efficacy-effectiveness trial design when implemented at our home institution. Establishing feasibility of the intervention and study procedures at other trauma centers with more diverse patient populations and different clinical practices is required before a multi-site phase III efficacy-effectiveness trial.
Trial registration: ClinicalTrials.gov ID: NCT03405610. Registered on January 28, 2018—retrospectively registered.
Digital Object Identifier (DOI)
This work was supported by an Orthopedic Research and Education Foundation (OREF) grant awarded to Ana-Maria Vranceanu, PhD.
Original data is stored in a secure database within the Partners’ REDCap system. Scored and cleaned data, as well as output for analyses are available upon request from the study PI, Ana-Maria Vranceanu.
Vranceanu, Ana-Maria; Jacobs, Cale A.; Lin, Ann; Greenberg, Jonathan; Funes, Christopher J.; Harris, Mitchel B.; Heng, Marilyn M.; Macklin, Eric A.; and Ring, David, "Results of a Feasibility Randomized Controlled Trial (RCT) of the Toolkit for Optimal Recovery (TOR): A Live Video Program to Prevent Chronic Pain in At-Risk Adults with Orthopedic Injuries" (2019). Orthopaedic Surgery and Sports Medicine Faculty Publications. 18.