title: Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters.
abstract: This work describes the methodology used to assess a strategy for implementing clinical practice guidelines (CPG) for cardiovascular risk control in a health area of Madrid.
  
  
  BACKGROUND
  The results on clinical practice of introducing CPGs have been little studied in Spain. The strategy used to implement a CPG is known to influence its final use. Strategies based on the involvement of opinion leaders and that are easily executed appear to be among the most successful.
  
  
  OBJECTIVE
  The main aim of the present work was to compare the effectiveness of two strategies for implementing a CPG designed to reduce cardiovascular risk in the primary healthcare setting, measured in terms of improvements in the recording of calculated cardiovascular risk or specific risk factors in patients' medical records, the control of cardiovascular risk factors, and the incidence of cardiovascular events.
  
  
  METHODS
  This study involved a controlled, blinded community intervention in which the 21 health centres of the Number 2 Health Area of Madrid were randomly assigned by clusters to be involved in either a proposed CPG implementation strategy to reduce cardiovascular risk, or the normal dissemination strategy. The study subjects were patients ≥ 45 years of age whose health cards showed them to belong to the studied health area. The main variable examined was the proportion of patients whose medical histories included the calculation of their cardiovascular risk or that explicitly mentioned the presence of variables necessary for its calculation. The sample size was calculated for a comparison of proportions with alpha = 0.05 and beta = 0.20, and assuming that the intervention would lead to a 15% increase in the measured variables. Corrections were made for the design effect, assigning a sample size to each cluster proportional to the size of the population served by the corresponding health centre, and assuming losses of 20%. This demanded a final sample size of 620 patients. Data were analysed using summary measures for each cluster, both in making estimates and for hypothesis testing. Analysis of the variables was made on an intention-to-treat basis.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01270022.
authors.affiliation: Unidad de Información Clínico Asistencial, Servicio de Admisión y Documentación Clínica, Hospital Universitario de la Princesa (HUP), Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP), Red Temática de Investigación en Enfermedades Cardiovasculares (RECAVA), (C/Diego de León 62), Madrid, (28006), España.
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodríguez-Salvanés
authors.forename: Blanca
authors.initials: B
authors.lastname: Novella
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Fernández Luque
authors.forename: Luis María
authors.initials: LM
authors.lastname: Sánchez-Gómez
authors.forename: Lourdes
authors.initials: L
authors.lastname: Ruiz-Díaz
authors.forename: Rosa
authors.initials: R
authors.lastname: Sánchez-Alcalde
authors.forename: Belén
authors.initials: B
authors.lastname: Sierra-García
authors.forename: Soledad
authors.initials: S
authors.lastname: Mayayo
authors.forename: Marta
authors.initials: M
authors.lastname: Ruiz-López
authors.forename: Pilar
authors.initials: P
authors.lastname: Loeches
authors.forename: Javier
authors.initials: J
authors.lastname: López-Gónzález
authors.forename: Amelia
authors.initials: A
authors.lastname: González-Gamarra
mesh_terms: D002318:Cardiovascular Diseases / Q000517:prevention & control*; D016000:Cluster Analysis; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D004502:Education, Medical, Continuing; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D013030:Spain