Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial

Pablo Gulayin, Vilma Irazola, Alfredo Lozada, Martin Chaparro, Marilina Santero, Laura Gutierrez, Rosana Poggio, Andrea Beratarrechea, Adolfo Rubinstein, Pablo Gulayin, Vilma Irazola, Alfredo Lozada, Martin Chaparro, Marilina Santero, Laura Gutierrez, Rosana Poggio, Andrea Beratarrechea, Adolfo Rubinstein

Abstract

Introduction: Hypercholesterolaemia is estimated to cause 2.6 million deaths annually and one-third of the cases of ischaemic heart disease. In Argentina, the prevalence of hypercholesterolaemia increased between 2005 and 2013 from 27.9% to 29.8%. Only one out of four subjects with a self-reported diagnosis of coronary heart disease is taking statins. Since 2014, statins (simvastatin 20 mg) are part of the package of drugs provided free-of-charge for patients according to cardiovascular disease (CVD) risk stratification. The goal of this study is to test whether a complex intervention targeting physicians and pharmacist assistants improves treatment and control of hypercholesterolaemia among patients with moderate-to-high cardiovascular risk in Argentina.

Methods and analysis: This is a cluster trial of 350 patients from 10 public primary care centres in Argentina to be randomised to either the intervention or usual care. The study is designed to have 90% statistical power to detect a 0.7 mmol/L reduction in low-density lipoproteins cholesterol from baseline to 12 months. The physician education programme consists of a 2-day initial intensive training and certification workshop followed by educational outreach visits (EOVs) conducted at 3, 6 and 9 months from the outset of the study. An on-site training to pharmacist assistants during the first EOV is performed at each intervention clinic. In addition, two intervention support tools are used: an app installed in physician's smartphones to serve as a decision aid to improve prescription of statins according to patient's CVD risk and a web-based platform tailored to send individualised SMS messages to patients.

Ethics and dissemination: Ethical approval was obtained from an independent ethics committee. Results of this study will be presented to the Ministry of Health of Argentina for potential dissemination and scale-up of the intervention programme to the entire national public primary care network in Argentina.

Trial registration number: NCT02380911.

Keywords: Cardiovascular Risk; Good Clinical Practice Guidelines; MEDICAL EDUCATION & TRAINING; Statins.

Conflict of interest statement

Competing interests: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Conceptual framework for implementation fidelity. Adapted from Carrol C. Implementation Science, 2007.
Figure 2
Figure 2
Study design.
Figure 3
Figure 3
Intervention components.
Figure 4
Figure 4
Treatment algorithm.

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