When modifications were made
Modifications were made during the implementation of the OPTIMIZE trial. The OPTIMIZE trial initiated enrollment in March 2019. In March 2020, with the onset of the COVID-19 pandemic, the trial suspended new enrollments across all sites due to health system restrictions on in-person care and non-essential clinical research activities. A total of 181 participants had enrolled across sites at the time of suspension. Just prior to the onset of COVID, in February 2020, the trial’s Data and Safety Monitoring Board met. Assessment of the overall treatment initiation rate was part of the open report for the board meeting. Initiation rates by treatment group were part of the closed report from which the investigators remained blinded. At that time, the treatment initiation rate for phase I was 65%, and 43% for phase II. These findings prompted the study team to develop a modification strategy to increase treatment initiation across phases. Before the modifications could be implemented, the COVID pandemic suspended enrollment in the trial.