COVID Impacts on Pragmatic Trials of Nonpharmacological Approaches to Pain Management: A Mixed Methods Evaluation

ABSTRACT

Methods: This 2-phase study used a sequential, mixed methods design to explore changes made to study protocols, particularly clinical interventions, in response to the evolving pandemic. A structured REDCap questionnaire queried about emerging adaptations using the periodic reflections method across 3 timepoints. Following Phase 1 analysis, brief checklists and 3 setting-specific focus groups were completed with principal investigators and key staff via video-conference to elicit information about study adaptations. Focus group interview schedules and directed content analyses were guided by the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) taxonomy. Results: Eleven PCTs completed questionnaires and 16 representatives from 10 PCTs joined focus groups. In periodic reflections, teams reported between 2 to 6 adaptations in the first 5 months of the pandemic. PCTs in the implementation stage reported delays in site/clinic onboarding, staff training, and/or patient recruitment, with 3 trials pausing intervention delivery. Intervention protocols were adapted with 6 PCTs adding/expanding virtual care. Trials testing manual therapies reported clinic closures and care restrictions. FRAME analyses of focus groups identified adaptation goals to increase trial feasibility, decrease patient/provider COVID exposures, and increasing patient engagement/retention. Context adaptations focused on virtual delivery while content adaptations included adding elements to enhance safety, tailoring/refining protocols for virtual delivery, and removing/skipping hands-on pain management interventions. Background: The COVID-19 pandemic changed the delivery of healthcare services and disrupted clinical research programs. This study evaluated adaptations made to 11 in-progress, pragmatic clinical trials (PCTs) of non-pharmacological pain management interventions in Department of Veterans Affairs and Department of Defense healthcare facilities. Conclusion: While core elements of trial interventions were retained, investigators were required to adapt study protocols for non-pharmacological pain management PCTs to address COVID-related disruptions and restrictions.