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Open Access Highly Accessed Study protocol

Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial

Mireia Fàbregas12, Irene Berges3, Francesc Fina4, Eduardo Hermosilla2, Ermengol Coma4, Leonardo Méndez4, Manuel Medina4, Sebastià Calero5, Elena Serrano6, Rosa Morros27, Mònica Monteagudo27 and Bonaventura Bolíbar27*

Author Affiliations

1 ABS La Marina, SAP Esquerra, Institut Català de la Salut, Barcelona, Spain

2 Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain

3 Hospital Parc Taulí, Sabadell, Spain

4 Sistemes d’Informació d’Atenció Primària (SISAP) – Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP), Institut Català de la Salut, Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain

5 Àrea de Desenvolupament Clínic, Direcció Adjunta d’Afers Assistencials, Institut Català de la Salut, Institut Universitari d'investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain

6 Centre d’Atenció Primària Baix a Mar, Consell comarcal del Garraf, Vilanova i la Geltrú, Barcelona, Spain

7 Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain

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BMC Family Practice 2014, 15:135  doi:10.1186/1471-2296-15-135

Published: 15 July 2014

Abstract

Background

Although hypercholesterolemia is considered a cardiovascular risk factor, in isolation it is not necessarily sufficient cause for a cardiovascular event. To improve event prediction, cardiovascular risk calculators have been developed; the REGICOR calculator has been validated for use in our population. The objective of this project is to develop an intervention with general practitioners (GPs) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease.

Methods

This nonblinded, cluster-randomized clinical trial analyzes data from primary care electronic medical records (ECAP) and other databases. Inclusion criteria are patients aged 35 to 74 years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period. Dependent variables include the following: RETIRA, defined as new cholesterol-lowering drugs initiated during the year preceding the intervention, considered inadequate, and withdrawn during the study period; EVITA, defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate; COST, defined as the total cost of inadequate new treatments prescribed; and REGISTER, defined as the recording of cardiovascular risk factors. Independent variables include the GP’s quality-of-care indicators and randomly assigned study group (intervention vs control), patient demographics, and clinical variables. Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect, adjusted for individual and GP variables.

Discussion

The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care. The goal is to improve the prescription adequacy of lipid-lowering therapies for primary prevention.

Trial registration

ClinicalTrials.gov Identifier: NCT01997671. November 28, 2013.

Keywords:
Primary health care; Lipid-lowering therapy; Prescriptions; Prescription adequacy; Primary prevention; Electronic health records; Clinical practice guidelines; Clinical trial; Cardiovascular disease