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.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
Really impressive implementation trial with strong results. Highlights a gap that probably exists in most hospitals caring for stroke patients. Unclear how transferable this work is to other settings, however.
Physician rater
Results seem slightly anomalous in that non-stroke related outcomes were improved but stroke outcomes, such as disability, remained unaffected.
Physician rater
Fascinating application of artificial intelligence in stroke care. I am uncertain how much of the clinical decision support system (CDSS) information was provided to the emergency department (ED) team versus the inpatient stroke care team. As written, this seems mostly applicable to inpatient stroke teams, which reduced my rating of relevance to 5 of 7. Nonetheless, if this CDSS was pushed upstream to the ED (particularly in remote settings without ready access to Neurology or Neuro-radiology), this approach could likely demonstrate similar benefits in the ED setting.
, McMaster University