Digital QI Intervention Modestly Improves LDL-C Control in Patients With ASCVD

A pragmatic, cluster-randomized clinical trial found that a digitally enabled, multifaceted quality improvement (QI) intervention modestly reduced low-density lipoprotein cholesterol (LDL-C) levels and increased use of intensive lipid-lowering therapy among patients with established atherosclerotic cardiovascular disease (ASCVD), though a substantial share of patients remained above recommended targets.¹

The study is published in JAMA Cardiology.

“In this cluster randomized clinical trial, a digitally enabled, multifaceted QI intervention embedded within routine clinical care modestly improved LDL-C control and increased use of intensive and combination [lipid-lowering therapy] among patients with established ASCVD,” wrote the researchers of the study.

Closing the LDL-C Treatment Gap in Brazilian Outpatient Clinics

Elevated LDL-C is a well-established causal risk factor for ASCVD, and statin-based reduction has repeatedly been shown to lower cardiovascular risk. Despite this evidence, registries have long documented a persistent gap between guideline recommendations and real-world lipid management, particularly in resource-limited settings such as Brazil.

To address this gap, investigators conducted a 2-arm cluster-randomized trial across 28 public and private outpatient clinics in Brazil. Clinics were randomized to a digitally enabled QI intervention or routine care. Adult patients with established ASCVD were enrolled between November 2023 and December 2024 and followed for 6 months. The intervention combined previsit screening, electronic clinical decision support algorithms, audit and feedback mechanisms, and clinician and patient engagement tools integrated into routine workflows to support lipid monitoring, treatment intensification, and adherence.

Intervention Group Achieved Greater LDL-C Reduction

Among 1465 enrolled patients (mean [SD] age, 62.3 [10.1] years; 61.0% male), 714 were randomized to the intervention arm and 751 to control. At 6 months, mean LDL-C concentration was 76.3 (37.5) mg/dL in the intervention group vs 85.6 (37.1) mg/dL in the control group, an adjusted mean difference of −6.62 mg/dL (95% CI, −11.11 to −2.13; P = .004).

Patients receiving the intervention were more likely to reach an LDL-C concentration below 50 mg/dL (23.5% vs 13.4%; OR, 1.86; 95% CI, 1.30-2.65) and to achieve a 50% or greater reduction in LDL-C (18.6% vs 13.4%; OR, 1.76; 95% CI, 1.27-2.43). Prescription of intensive and combination lipid-lowering therapy was also significantly higher in the intervention group. No significant between-group differences in major cardiovascular events were observed over the follow-up period.

For comparison, a European observational study found that statin monotherapy remained the dominant lipid-lowering approach in Europe, with only about 1 in 10 patients receiving combination therapy, underscoring that even higher-resourced health systems face similar treatment-intensity gaps.²

However, this trial has several limitations, including a predominantly specialized-clinic setting that may limit generalizability to primary care, a 6-month follow-up too short to assess long-term LDL-C sustainability or cardiovascular outcomes, and a prespecified cost-effectiveness analysis was not conducted.¹ Point-of-care LDL-C testing underestimated laboratory values, and slightly higher nonenrollment in the intervention arm may reflect selection toward digitally receptive patients, though sensitivity analyses showed consistent effect estimates and robust between-group comparisons. The open-label design may also have influenced clinician behavior beyond the specific intervention components tested.

Managed Care Implications

For managed care organizations, the findings suggest that digitally enabled QI programs embedded in clinical workflows can measurably improve LDL-C control and appropriate therapy intensification without requiring new pharmacologic options. However, the persistence of residual undertreatment—even within a structured intervention—signals that health plans and provider networks may need to pair digital decision support with additional levers, such as formulary access to combination therapies, pharmacist-led titration protocols, or value-based incentives tied to lipid target attainment, to fully close the ASCVD care gap.

“These findings add incremental evidence that a digitally enabled QI strategy can contribute to bridging evidence-practice gaps in secondary cardiovascular prevention and complement pharmacological advances in real-world settings, although the partial effectiveness of the present strategy indicates that further refinement of implementation strategies and digitally enabled delivery methods is needed to fully close the residual care gap,” wrote the researchers.

References

1. Machline-Carrion MJ, Santo K, Girotto AN, et al. Digitally enabled quality improvement intervention and LDL-C control in atherosclerotic cardiovascular disease. JAMA Cardiol. doi:10.1001/jamacardio.2026.2510
2. Ray KK, Molemans B, Schoonen WM, et al. EU-wide cross-sectional observational study of lipid-modifying therapy use in secondary and primary care: the DA VINCI study. Eur J Prev Cardiol. 2021;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047