Effect of a clinical decision support system on stroke care quality and outcomes in patients with acute ischaemic stroke (GOLDEN BRIDGE II): cluster randomised clinical trial

Abstract Objective To evaluate the efficacy of a clinical decision support system (CDSS) on stroke care quality and clinical outcomes among patients with acute ischaemic stroke. Design Multicentre, cluster randomised clinical trial. Setting 77 hospitals across China. Participants 77 hospitals (38 randomised to intervention group, 39 to control group) enrolled 21 603 patients with acute ischaemic stroke admitted to hospital within seven days after symptom onset. Interventions Hospitals in the intervention group received stroke CDSS support including artificial intelligence assisted imaging analysis, classification of stroke causes, and evidence based treatment recommendations. Hospitals in the control group provided usual care. Main outcomes measures The primary outcome was a new vascular event (composite of ischaemic stroke, haemorrhagic stroke, myocardial infarction, and vascular death) within three months after initial symptom onset. Secondary outcomes included the composite measure and all-or-none measure of evidence based performance measures for acute ischaemic stroke care quality, a new vascular event at six and 12 months, and disability (modified Rankin Scale score 3-6) and all cause mortality at three, six, and 12 months. Safety outcomes were moderate or severe bleeding events and all bleeding events at three, six, and 12 months. Results 11 054 patients in the intervention group and 10 549 patients in the control group were enrolled from January 2021 to June 2023. New vascular events at three months occurred in 2.9% (320/11 054) in the intervention group compared with 3.9% (416/10 549) in the control group (adjusted hazard ratio 0.74, 95% confidence interval (CI) 0.58 to 0.93, P=0.01). The CDSS intervention effect remained significant in the cluster level analysis (−0.01, −0.02 to −0.004, P=0.003). Patients in the intervention group were more likely to have a higher composite measure (91.4% (77 049/84 276) v 89.8% (70 794/78 834), adjusted odds ratio 1.21, 95% CI 1.17 to 1.26, P<0.001). New vascular events were significantly lower in the intervention group at 12 months (4.0% (440/11 054) v 5.5% (576/10 549), adjusted hazard ratio 0.73, 95% CI 0.56 to 0.95, P=0.02). No significant differences were found in disability and all cause mortality. Moderate or severe bleeding, and all bleeding did not differ significantly between the two groups. Conclusions Use of the stroke CDSS in patients with acute ischaemic stroke in China led to a significant decrease in new vascular events at three months. The stroke CDSS intervention was also effective in improving stroke care quality and decreasing long term vascular events. Trial registration ClinicalTrials.gov NCT04524624