Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Fàbregas, Mireia, Berges, Irene, Fina, Francesc, Hermosilla, Eduardo, Coma, Ermengol, Méndez, Leonardo, Medina, Manuel, Calero, Sebastià, Serrano, Elena, Morros, Rosa, Monteagudo, Mònica, Bolíbar, Bonaventura
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4112648/
https://www.ncbi.nlm.nih.gov/pubmed/25027229
http://dx.doi.org/10.1186/1471-2296-15-135
_version_ 1782328199383875584
author Fàbregas, Mireia
Berges, Irene
Fina, Francesc
Hermosilla, Eduardo
Coma, Ermengol
Méndez, Leonardo
Medina, Manuel
Calero, Sebastià
Serrano, Elena
Morros, Rosa
Monteagudo, Mònica
Bolíbar, Bonaventura
author_facet Fàbregas, Mireia
Berges, Irene
Fina, Francesc
Hermosilla, Eduardo
Coma, Ermengol
Méndez, Leonardo
Medina, Manuel
Calero, Sebastià
Serrano, Elena
Morros, Rosa
Monteagudo, Mònica
Bolíbar, Bonaventura
author_sort Fàbregas, Mireia
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4112648
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-41126482014-07-29 Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial Fàbregas, Mireia Berges, Irene Fina, Francesc Hermosilla, Eduardo Coma, Ermengol Méndez, Leonardo Medina, Manuel Calero, Sebastià Serrano, Elena Morros, Rosa Monteagudo, Mònica Bolíbar, Bonaventura BMC Fam Pract Study Protocol 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. BioMed Central 2014-07-15 /pmc/articles/PMC4112648/ /pubmed/25027229 http://dx.doi.org/10.1186/1471-2296-15-135 Text en Copyright © 2014 Fàbregas et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Fàbregas, Mireia
Berges, Irene
Fina, Francesc
Hermosilla, Eduardo
Coma, Ermengol
Méndez, Leonardo
Medina, Manuel
Calero, Sebastià
Serrano, Elena
Morros, Rosa
Monteagudo, Mònica
Bolíbar, Bonaventura
Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
title Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
title_full Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
title_fullStr Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
title_full_unstemmed Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
title_short Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
title_sort effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4112648/
https://www.ncbi.nlm.nih.gov/pubmed/25027229
http://dx.doi.org/10.1186/1471-2296-15-135
work_keys_str_mv AT fabregasmireia effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT bergesirene effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT finafrancesc effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT hermosillaeduardo effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT comaermengol effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT mendezleonardo effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT medinamanuel effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT calerosebastia effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT serranoelena effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT morrosrosa effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT monteagudomonica effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial
AT bolibarbonaventura effectivenessofaninterventiondesignedtooptimizestatinsuseaprimarypreventionrandomizedclinicaltrial