Multisite, stepped-wedge, cluster, effectiveness-implementation clinical trial in 12 adult medical-surgical ICUs with ≥10 beds, using Epic as electronic health record (EHR) and pre-existing AS programs. Sites received facilitated implementation support over the 15-month trial period, succeeded by 9 months of follow-up. Outcomes include ICU-onset CDI rates, FQ days of therapy (DOT), alternative antibiotic DOT, average length of stay and hospital mortality. The study team collected implementation data to assess implementation effectiveness using the Systems Engineering Initiative for Patient Safety model.
Study details: https://clinicaltrials.gov/study/NCT03848689#publications
Safdar N, Parmasad V, Brown R, et al. Decreasing ICU-associated Clostridioides difficile infection through fluoroquinolone restriction, the FIRST trial: a study protocol. BMJ Open 2021. 11:e046480. doi: 10.1136/bmjopen-2020-046480.