Enrollment, Randomization, and Follow-Up
RECRUITMENT
Once the patient was accepted to SUMMIT, research staff reviewed the medical record to confirm study eligibility and then contacted the patient to obtain written informed consent and conduct baseline surveys. Research staff then opened an opaque sealed envelope that contained the group assignment generated by a randomization process in R, version 3.3.1 (R Project for Statistical Computing), and they informed the participant. The SUMMIT and EUC teams were then notified of treatment assignment. Six months after randomization, research staff contacted participants, reconfirmed informed consent, and conducted follow-up surveys. At that point, those randomized to EUC were able to join SUMMIT. Patients received a $5 debit card for each survey completed. The first patient was enrolled in August 2016, and the last patient was enrolled in November 2019. During study planning, a power analysis determined that a sample of 200 participants would be able to detect a 30% reduction in hospitalization. Due to resource constraints and the COVID-19 pandemic, recruitment was halted after 159 participants were randomized.