Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control

Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in atherosclerotic established cardiovascular disease (ASCVD) patients.

Patient Eligibility Criteria:Inclusion Criteria:Capable of using a smartphone with iOS or Android System ANDEstablished ASCVD, including:Coronary Artery Disease (CAD):Prior myocardial infarctionPrior coronary revascularization - percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)Angiographic or computerized tomography (CT)-imaging evidence of coronary atherosclerosis (≥ 50% stenosis in at least one major epicardial coronary artery)Stroke:• Prior ischemic stroke thought not to be caused by an embolic cause (e.g., atrial fibrillation, valvular heart disease or mural thrombus)Peripheral Artery Disease (PAD):Prior documentation of a resting ankle-brachial index ≤ 0.9History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal arteryPrior non-traumatic amputation of a lower extremity due to peripheral artery diseaseHistory of prior percutaneous or surgical carotid artery revascularizationCarotid Stenosis > 50% on prior angiography or ultrasound ANDProvision of informed consentExclusion Criteria:Patients with a recent cardiovascular event, less than 3 months prior to study inclusionPatients with LDL-C ≤ 70 mg/dLCurrent participation in other clinical trials involving lipid lowering treatmentsPatients that do not consent to trial participationCluster Eligibility Criteria:Inclusion Criteria:Outpatient Clinics from public or private hospitals OR, Private Practices, which assist patients with previous ASCVD on secondary prevention that provide a unit/institution authorization form for participation in the trial ANDMinimum monthly volume of 20 ASCVD patientsExclusion Criteria:Clusters that do not provide the unit/institution authorization form.