Clostridioides difficile Near-Patient Testing Versus Centralized Testing: A Pragmatic Cluster Randomized Crossover Trial

Abstract

Background Management of suspected C. difficile infections (CDI) in the hospital setting typically results in patient isolation, laboratory testing, infection control, and presumptive treatment. We investigated whether implementation of rapid near patient testing (NPT) reduced patient isolation time, hospital length of stay, antibiotic usage, and cost. Methods A two-period pragmatic cluster randomized crossover trial was conducted. 39 wards were randomized into two study arms. The primary outcome measure was effect of NPT on patient isolation time using a mixed effect generalized linear regression model. Secondary outcomes examined included hospital length of stay and antibiotic therapy based on a negative binomial regression model. Natural experiment (NE), intention-to-treat (ITT), and per protocol (PP) analyses was conducted. Results During the entire study period, a total of 656 patients received NPT for CDI and 1667 received SOC testing. For the primary outcome, a significant decrease of patient isolation time with NPT was observed (NE 9.4 hours [p<0.01], ITT 2.3 [p<0.05], PP 6.7[p<0.1]). A significant reduction in hospital length of stay was observed with NPT for short stay (NE 47.4% [p<0.01], ITT 18.4% [p<0.01] and ITT 34.2% [p<0.01]). Each additional hour delay for a negative result increased metronidazole use (24 DDD per 1000 patients, p<0.05) and non-CDI treating antibiotics by 70.13 mg (p<0.01). NPT testing was found to save USD25.48 per patient when including test cost and patient isolation. Conclusions The cluster randomized cross-over trial demonstrated that implementation of CDI NPT can contribute to significant reductions in isolation time, hospital length of stay, antibiotic usage, and health care cost.