Rosemary Higgins, senior associate dean for Research in the College of Health and Human Services, provided commentary for The Lancet on the first stepped-wedge trial conducted for safety education in the neonatal intensive care (NICU) setting.
“Safer care for critically ill neonates: A stepped-wedge cluster randomized controlled trial by Caeymaexis” is the first stepped-wedge trial for education and patient safety conducted in the newborn intensive care setting. The study showed that formally including both specialists and physicians (a “bundled” approach) throughout care yielded better care results than physicians seeking additional support as needed (a traditional approach).
Higgins’ commentary discusses the benefits and limitations of a stepped-wedge trial compared to a parallel cluster trial. “Education emphasizes safety which is essential for the vulnerable infants in the neonatal intensive care unit,” says Higgins about the impact of the trial. The results of the trial suggested a benefit from educational intervention and a meaningful reduction in negative events in participants.
In a step-wedged trial, all participants start in the control group and are moved into the intervention group at regular intervals (steps) throughout the trial, so that everyone is in the intervention group at the end of the trial. In a parallel-cluster trial, participants stay in either a “control” or “intervention” group throughout the entire trial. Higgins provided the commentary with Abhik Das from the Biostatistics and Epidemiology Division of RTI International.