Remote and semi-automated methods to conduct a randomized clinical trial

Abstract

ABSTRACTBackgroundDesigning and conducting randomized controlled trials is not possible for some institutions and researchers due to their associated costs and personnel requirements. Advances in telehealth for patient care and clinical trial methods adaptations were hastened due to the coronavirus 2019 pandemic. We conducted subject recruitment, screening, informed consent, study product distribution, and data collection remotely using Research Electronic Data Capture (REDCap) and other readily available applications for a prospective randomized clinical trial on vitamin D3 supplementation to prevent influenza-like illness in healthcare workers.ObjectivesTo describe how to efficiently and cost-effectively conduct a randomized clinical trial using remote and semi-automated methods.MethodsA previously described prospective, controlled, trial in healthcare workers at a tertiary university hospital that used Zelen’s design to facilitate enrollment is used as a model. A random group of healthcare workers were invited to participate in the study through email. Following an automated process, interested individuals could schedule a HIPAA compliant, video-facilitated consent interview. Following e-consenting, participants received vitamin D3 supplementation bottles by mail and electronic surveys via email. Adherence to the study intervention was monitored through survey data review and vitamin D3 safety was monitored via real-time automated warnings to study staff if any symptoms, health changes, hospitalizations, or pregnancies were reported on monthly surveys.ResultsA small study staff of 10 team members were able to screen 406 subjects and enroll 299 subjects over a 3-month period using completely remote methods. Adherence to vitamin D3 supplementation was high (87%) over 9 months. Survey data completeness was 98.5% over 9 months. Participants and study staff scored the system usability 93.8% and 90%, respectively. The automated and remote methods allowed the study maintenance period to be managed by a small study team staff of 2 members while safety monitoring was conducted by 3-4 team members.ConclusionsThe remote and automated methods developed to conduct a randomized controlled trial produced efficient subject recruitment with excellent study product adherence and data completeness. These methods can significantly minimize costs and time without sacrificing safety or quality, thereby offering greater equity in scientific research. We share our XML file for researchers to use as a template for learning purposes or designing their own clinical trials.Trial RegistrationNCT04596657