Trial status and protocol version
RECRUITMENT
The study protocol was developed prior to the COVID-19 pandemic and received IRB approval in January 2020. The pilot study, scheduled to run at one site in spring 2020 and the main study, scheduled to start in September 2020, were greatly impacted by the COVID 19 pandemic, pushing all timelines back and requiring major adjustments to many aspects of the study protocol, especially the recruitment methods. Study recruitment of PCPs began in January 2021. Patient recruitment began in March 2021. Patient recruitment will be completed April 30, 2023. This manuscript was based upon Protocol Version 7.0.