title: Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial.
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as new cholesterol-lowering drugs initiated during the year preceding the intervention, considered inadequate, and withdrawn during the study period; EVITA, defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate; COST, defined as the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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01997671. November 28, 2013.
authors.forename: Mireia
authors.initials: M
authors.lastname: Fàbregas
authors.forename: Irene
authors.initials: I
authors.lastname: Berges
authors.forename: Francesc
authors.initials: F
authors.lastname: Fina
authors.forename: Eduardo
authors.initials: E
authors.lastname: Hermosilla
authors.forename: Ermengol
authors.initials: E
authors.lastname: Coma
authors.forename: Leonardo
authors.initials: L
authors.lastname: Méndez
authors.forename: Manuel
authors.initials: M
authors.lastname: Medina
authors.forename: Sebastià
authors.initials: S
authors.lastname: Calero
authors.forename: Elena
authors.initials: E
authors.lastname: Serrano
authors.forename: Rosa
authors.initials: R
authors.lastname: Morros
authors.forename: Mònica
authors.initials: M
authors.lastname: Monteagudo
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain. bbolibar@idiapjgol.org.
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Bolíbar
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D057286:Electronic Health Records; D030141:Feedback, Psychological; D005260:Female; D058005:General Practitioners / Q000193:education*; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards*; D011322:Primary Prevention / Q000379:methods*; D058996:Quality Improvement
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors