Abstract
BACKGROUND: Cardiovascular disease (CVD) imposes a significant burden on the Argentinian population. Management of its leading risk factors can significantly reduce the CVD burden in high-resource settings, but there is insufficient evidence for effective implementation of evidence-based interventions in lower-resource settings like Argentina. METHODS: In this two-arm cluster-randomized trial we seek to compare the effective implementation, of a multicomponent intervention, versus usual care, to improve the management of high CVD risk across the care continuum in three provinces of Argentina. The multicomponent intervention strategy links five primary components of the CVD care continuum to improve its management: (1) a data management system linking a digital mHealth (mobile health) screening tool used by community health workers (CHWs), (2) an electronic appointment scheduler that is integrated with the primary care center electronic appointment system, (3) point of care testing for lipid profiles, (4) a clinical decision support (CDS) system for medication initiation, and (5) a text message (SMS) reminder system to improve treatment adherence and life-style changes. The primary outcome is the mean change in Framingham laboratory-based, 10-year absolute CVD risk score between the study arms from baseline to twelve months after enrollment. CONCLUSIONS: This protocol describes the development of a multicomponent intervention to implement effective management of CVD, developed with partners at the National and provincial Departments of Health in Argentina, with the goal of understanding its effective implementation in a primary health care system strengthened by universal health coverage, provision of free health care services, and provision of free medication.