Abstract
BACKGROUND: Clinical decision support systems hold promise for improving adherence to guidelines and reducing decision-making time in acute ischemic stroke management. We developed a stroke-specific clinical decision support system smartphone app termed cerebri and assessed its efficacy in reducing imaging-to-decision time and enhancing guideline adherence in a real-world clinical setting. METHODS: We conducted a prospective, single-center, calendar-day-randomized pilot study at the Emergency Department of Campus Bio-Medico University Hospital in Rome, Italy, from December 1, 2024, to March 30, 2025 (80 effective study days). Eligible participants were adult patients (≥18 years) with suspected ischemic stroke presenting within 24 hours of symptom onset. Randomization occurred by day, assigning patients to either the cerebri group (app providing clinical decision support plus a timer function) or the control group (timer function only, without decision support). The app was used by the neurologist on-call that workday. Primary outcomes were imaging-to-decision time (imaging to decision time: the time from imaging completion to therapeutic decision, in minutes) and adherence to European Stroke Organization guidelines. Guideline adherence was expressed as the percentage of cases compliant, and assessed separately for diagnostic decisions (appropriate imaging modality), therapeutic decisions (appropriate treatment choice), and overall adherence (compliance with both diagnostic and therapeutic domains). Multivariable linear and logistic regression analyses adjusted for age, National Institutes of Health Stroke Scale, and revascularization therapies were performed. RESULTS: Fifty patients (mean age, 73.1±13.3 years; 64% female) were enrolled (25 cerebri, 25 control). Patients in the cerebri group had significantly reduced median imaging to decision time (6 versus 22 minutes; adjusted difference: -18.8 minutes [95% CI, -37.4 to -3.5]; P=0.009). Overall guideline adherence was significantly higher in the cerebri group (96% versus 73.9%; adjusted odds ratio, 11.6 [95% CI, 1.12-121.16]; P=0.040). Therapeutic guideline adherence was 100% in the cerebri group versus 86.9% in the control (P=0.062). CONCLUSIONS: Cerebri significantly improved decision-making speed and adherence to stroke guidelines in the hyperacute management of ischemic stroke. The app demonstrated feasibility and efficacy even in nontertiary stroke centers, suggesting its potential for broader implementation to enhance stroke care quality and equity.