Impact of COVID-19 on the Patient Enrollment for a Pragmatic, Cluster Randomized Clinical Trial for Fibromyalgia

The goal was to present our experience on adapting to the challenges of the COVID-19 pandemic during enrollment to a pragmatic clinical trial. Transcutaneous Electrical Nerve Stimulation (TENS) in Physical Therapy (PT) Study (FM-TIPS) is a pragmatic, cluster-randomized clinical trial examining if the addition of TENS to routine PT improves movement-evoked pain in patients with fibromyalgia(FM). FM patients (n=600) will be enrolled from 33 PT clinics (17 PT only, 16 PT with TENS) across six healthcare systems. During the planning year, COVID-19 impacted PT practice and in-person interactions requiring the study team to adapt clinician training and data capture procedures. We will discuss the pandemic's impact during the patient enrollment. We developed alternative strategies to protect study integrity and minimize missing data due to potential restrictions of in-person visits including procedures for electronic consent and training participants in TENS use virtually and/or in-person using personal protective equipment and social distancing. Assessment of the primary outcome variable and questionnaires were transitioned for the patient to perform at home virtually with embedded patient-specific instructional videos. To enhance clinic engagement, weekly enrollment updates, monthly meetings, newsletters, and action plans for underperforming clinics were developed. To increase patient communication, a “welcome” touchpoint by phone, reminder emails, and touchpoints ahead of primary and secondary data collection points were added. Several clinics were added to increase the heterogeneity of the sample, to replace clinics that are unable to participate due to site closures or understaffing, and to decrease the enrollment burden on participating sites. COVID-19 posed considerable challenges to the statistical design and analysis of this pragmatic trial. We developed a plan for uneven enrollment across clinics and a sub-analysis of data for patients enrolled during or after the pandemic. Conducting this trial during COVID-19 required greater flexibility for providers and patients to facilitate continued enrollment. FM-TIPS work is supported by the National Institutes of Health (NIH) through the NIH HEAL Initiative under award number UG3AR076387 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This work also received logistical and technical support from the PRISM Resource Coordinating Center under award number U24AT010961 from the NIH through the NIH HEAL Initiative. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative.