Prioritizing Patient Safety While Maintaining Study Integrity During COVID-19: Lupus Intervention Fatigue Trial Modifications and Lessons Learned

Background/Purpose: The coronavirus disease 2019 (COVID-19) global pandemic has drastically impacted the health system and the research community Many research institutions and funding agencies recommended a moratorium on conducting in-person research and study enrollment until protocol changes to protect patient safety were implemented and approved We turned the guidance provided by the Institutional Review Board (IRB) into actionable items without compromising the integrity of the primary, secondary, and exploratory outcomes of the study The purpose of this project is to detail the modifications made to the Lupus Intervention Fatigue Trial (LIFT) and to summarize the lessons learned to meet the varied challenges created by the highly transmissible virus Methods: The research team evaluated current study protocols to determine which components required modification The research team determined that the following protocols required modifications: 1) the intervention that included four individual coaching sessions and 2) four, two-hour, in-person assessments, including a physician exam, blood draws, and urine samples along with online patient-reported outcomes (PROs) at a University Medical Center Research Unit The team made modifications that would allow for all interventions and assessments to be safely conducted remotely without compromising the integrity of the study aims Results: The intervention components were revised immediately to convert all individual coaching sessions to remote sessions Next, we reviewed all study assessments and modifications were made to electronically consent participants, provide links for completion of online PROs, and perform telemedicine visits for the physician assessment Collection of safety labs presented the biggest challenge since this required an in-person visit at a laboratory and we elected to delay this up to one month after the physician assessment, or used standard of care test results if they were done within a month of the physician assessment We also offered the option of not doing the lab tests With these modifications, we were able to complete all follow-up visits and no patients dropped out of the study We were not able to collect the protocol extra blood for future research testing and some patients could not measure their vital signs at home Conclusion: The LIFT study was severely impacted by COVID-19 We provide insight into how our study protocol was modified without compromising the integrity of the primary, secondary, and exploratory outcomes of the study The modifications utilized by the LIFT study and lessons learned while revising the LIFT protocols resulted in efficiencies that will be included in a revised protocol and will foster additional ideas to overcome the challenges in areas where we missed data collection and may serve as a useful example for other behavioral interventions to adapt their research studies given COVID-19 restrictions