Cluster randomized controlled trial of TIA electronic decision support in primary care

Abstract

Objective: To test if TIA/stroke electronic decision support in primary care improves management.

Methods: Multicenter, single-blind, parallel-group, cluster randomized, controlled trial comparing TIA/stroke electronic decision support guided management with usual care. Main outcomes were guideline adherence and 90-day stroke risk. Secondary outcomes were cerebrovascular/vascular/death/adverse events, cost, and user feedback. Main analysis was logistic regression with a normal random effect for clusters using a generalized linear mixed model.

Results: Twenty-nine clinics were randomized to intervention, 27 to control, recruiting 172 and 119 eligible patients. More intervention patients received guideline-adherent care (131/172; 76.2%) than control patients (49/119; 41.2%) (adjusted odds ratio [OR] 4.57; 95% confidence interval [CI] 2.39-8.71; p < 0.001). Ninety-day stroke occurred in 2/172 (1.2%) intervention and 5/119 (4.2%) control patients (OR 0.27; 95% CI 0.05-1.41; p = 0.098). Ninety-day TIA or stroke occurrence was lower in the intervention group, 4/172 (2.3%) compared to 10/119 (8.5%) control (adjusted OR 0.26; 95% CI 0.70-0.97; p = 0.045). Fewer vascular events/deaths occurred in intervention, 6/172 (3.5%), than in control patients, 14/119 (11.9%) (adjusted OR 0.27; 95% CI 0.09-0.78; p = 0.016). Treatment cost ratio of 0.65 (95% CI 0.47-0.91; p = 0.013) favored the intervention without increased adverse events. Clinician feedback was positive.

Conclusion: Primary care use of the TIA/stroke electronic decision support tool improves guideline adherence, safely reduces treatment cost, achieves positive user feedback, and may reduce cerebrovascular and vascular event risk following TIA/stroke.

Classification of evidence: This study provides Class II evidence that a primary care electronic decision support tool improves guideline adherence and might reduce 90-day stroke risk.