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01.12.2014 | Study protocol | Ausgabe 1/2014 Open Access

BMC Family Practice 1/2014

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

Zeitschrift:
BMC Family Practice > Ausgabe 1/2014
Autoren:
Mireia Fàbregas, Irene Berges, Francesc Fina, Eduardo Hermosilla, Ermengol Coma, Leonardo Méndez, Manuel Medina, Sebastià Calero, Elena Serrano, Rosa Morros, Mònica Monteagudo, Bonaventura Bolíbar
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1471-2296-15-135) contains supplementary material, which is available to authorized users.

Competing interest

This manuscript contains no information on medical devices. The authors neither received, nor will receive, individual financing of their work. The authors declare that there are no competing interests.

Authors’ contributions

BB is the principal investigator and coordinator of the project. The study was designed by BB, MF, IN, and FF. These authors, with the help of EH, MM, SC, RM and ES, designed the intervention. EH, FF, RM were responsible for database creation and management. The intervention was implemented by FF, EH, EC, LM, SC and MM. EH performed the statistical analyses. All the authors have read and revised the various versions of the manuscript and have approved this final version.

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.
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