A pragmatic randomized controlled trial of artificial intelligence (AI)-based predictive analytics monitoring for early detection of clinical deterioration

BackgroundThis pragmatic randomized controlled trial aimed to assess the effect of a passive display of artificial intelligence (AI)-based predictive analytics on hours free of clinical deterioration events among medical and surgical patients in an acute care cardiology medical-surgical ward. Methods10,422 inpatient visits were randomly assigned by cluster to the intervention group of a display of risk trajectories or to a control group of usual medical care. The trial was undertaken on an 85-bed inpatient cardiology and cardiac surgery ward of an academic hospital with a substantial implementation and education plan. This was a passive display with no specific response mandated. The primary analysis compared events of clinical deterioration (death, emergent ICU transfer, emergent endotracheal intubation, cardiac arrest, or emergent surgery) and compared mortality 21 days after admission. ResultsPatients with a large spike in risk score had, on average, twice the length of hospital stay (6.8 compared to 3.4 days). There was no change in the primary outcome between groups. Among those who had a clinical event, there were more event-free hours in the intervention/display-on group compared to the standard-of-care/display-off, but this did not approach statistical significance. 11% of patients were transferred into or out of display beds, a censoring event removing them from the analysis, thereby undermining aspects of the randomized nature of the study. ConclusionPredictive analytics monitoring incorporating continuous cardiorespiratory monitoring and displays of risk trajectories coupled with an education plan did not improve patient outcomes or reduce deaths. While necessary to conduct the study, the pragmatic design allowed for significant movement towards intervention/displayed beds for sicker patients. Design considerations in the future must focus on understanding clinicians interpretation, care processes, and communication practices. Trial registrationNCT04359641