Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials.

Objectives: COVID-19 abruptly halted in-person clinical care and research requiring a shift to virtual assessment and treatment. This unexpected transition of a 2-arm randomized controlled trial (RCT) examining interdisciplinary graded exposure treatment (GET Living) compared with multidisciplinary pain management for youth with chronic pain provided an opportunity to implement the first remotely delivered exposure treatment and remotely delivered biomechanical assessment for pediatric chronic pain. Here we describe these new approaches and provide lessons learned to inform future efforts in digital health care.
Methods: A total of 68 youth (M=14.2 y; 80.9% female) were enrolled in the RCT (n=31 in-person, n=5 hybrid, n=32 virtual, n=9 withdrew). Of those withdrawn, n=3 withdrew due to COVID-19 related reasons. Some RCT elements required slight modification (eg, e-consent, actigraphy deployment, recruitment, and screening), while others were significantly altered (eg, session format and lab-based biomechanical assessment). Data from exit interviews were also examined to assess perspectives on the virtual format transition.
Results: Results showed an increased enrollment rate when virtual care was an option (70.7%) compared with in-person (44.3%). Equivalent rates of completion for daily assessment (in-person, 72.8%; virtual, 73.3) were also observed, and participants described enhanced experience when able to complete exercises and exposures in their home environment during session (vs. a rehabilitation gym) allowing for genuine in vivo exposures (eg, household chores, riding bicycles).
Discussion: Overall, our data demonstrate acceptability, feasibility, and equivalent patient engagement to virtual treatment. Novel methods implemented in this RCT can inform trial design and measures of clinical endpoints for future digital health interventions.
Competing Interests: This investigation was supported by NIAMS/R21 AR072921 awarded to L.E.S. This clinical trial is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD. The authors declare no conflict of interest.
(Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)