Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jan 31;7(1):e014420.
doi: 10.1136/bmjopen-2016-014420.

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  1 , Vilma Irazola  1 , Alfredo Lozada  2 , Martin Chaparro  1 , Marilina Santero  1 , Laura Gutierrez  1 , Rosana Poggio  1 , Andrea Beratarrechea  1 , Adolfo Rubinstein  1
Affiliations
Randomized Controlled Trial

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 et al. BMJ Open. .

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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

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.
See this image and copyright information in PMC

References

    1. Global health risks. Mortality and burden of disease attributable to selected major risks. Geneva: World Health Organization, 2009.
    1. Farzadfar F, Finucane MM, Danaei G et al. . National, regional, and global trends in serum total cholesterol since 1980: systematic analysis of health examination surveys and epidemiological studies with 321 country-years and 3.0 million participants. Lancet 2011;377:578–86. 10.1016/S0140-6736(10)62038-7 - DOI - PubMed
    1. Prospective Studies C, Lewington S, Whitlock G et al. . Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet 2007;370:1829–39. 10.1016/S0140-6736(07)61778-4 - DOI - PubMed
    1. Baigent C, Keech A, Kearney PM et al. . Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366:1267–78. 10.1016/S0140-6736(05)67394-1 - DOI - PubMed
    1. Stone NJ, Robinson JG, Lichtenstein AH et al. . 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2889–934. 10.1016/j.jacc.2013.11.002 - DOI - PubMed

Publication types

MeSH terms

Substances

Associated data