Trial Design
We conducted a cluster randomized stepped-wedge clinical trial across 4 CSCs in the greater Houston-area from January 1, 2021, to February 27, 2022. This study design was chosen as it was not feasible to randomize at the individual patient level to AI software analysis. Because of the large number of health care professionals and the extreme acuity of decision-making involved in the care of patients with AIS, there was concern that any uncertainty on whether the communication platform could be used or whether alerts would be sent could negatively impact patient care. In addition, literature had previously been published demonstrating improvements in clinical care using this platform and the software had achieved US Food and Drug Administration clearance for this purpose.Each CSC site corresponded to a single cluster and allocation to trial intervention was determined by the cluster. All patients treated with EVT during the trial period were included unless excluded for the reasons listed below in the Participants section. There was no blinding to allocation, as clinical care teams began to receive AI-enabled alerts once each cluster was activated and were aware of the activation time frames. Four steps were used, corresponding to the activation of 1 CSC per cluster at a time to the AI software. The duration of time between each step was determined a priori based on the volume of EVT procedures, as described in the sample size calculation section below. Periods were divided into pre-AI (unexposed), transition, and post-AI (exposed). The transition period lasted 2 weeks and corresponded to the period during which each CSC adjusted to the activation of the AI software (as described in the Intervention section below). In the final analysis, patients treated with EVT during the transition period were included in the pre-AI cohort, as described in the Statistical analysis section below. The order in which the clusters were activated was determined in a random fashion with 1 exception: the academic CSC was decided to be the final activation, as it was felt that additional time would be needed to prepare for this activation given the large number of residents and fellows involved in patient care at this CSC.