A pragmatic 2-arm cluster randomized trial (28 outpatient clinics in Brazil, n=1,465 adults with established ASCVD) evaluated a digitally enabled, multifaceted quality improvement (QI) strategy—including previsit screening, electronic clinical decision support, audit/feedback, and clinician/patient engagement tools—versus routine care over 6 months.
Mean LDL-C at 6 months was 76.3 mg/dL (intervention) vs. 85.6 mg/dL (control); adjusted mean difference −6.62 mg/dL (95% CI, −11.11 to −2.13; P=.004). More intervention patients hit LDL-C <50 mg/dL (23.5% vs. 13.4%; OR 1.86) or achieved ≥50% LDL-C reduction (18.6% vs. 13.4%; OR 1.76). No significant difference in major cardiovascular events was observed.
- Short 6-month follow-up limits assessment of hard cardiovascular outcomes. - Single-country setting (Brazil) may limit generalizability to other health systems. - Most patients still did not reach the LDL-C <50 mg/dL target, indicating only partial effectiveness; residual confounding from cluster-level differences is possible.
A digitally enabled QI bundle (decision support, audit/feedback, patient engagement) can modestly lower LDL-C and nearly double the rate of target attainment in ASCVD patients, but most patients will still not reach guideline targets—additional strategies are needed to close the gap.
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