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Open Access Study protocol

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

Francisco Rodríguez-Salvanés1, Blanca Novella2*, María Jesús Fernández Luque3, Luis María Sánchez-Gómez4, Lourdes Ruiz-Díaz5, Rosa Sánchez-Alcalde6, Belén Sierra-García7, Soledad Mayayo8, Marta Ruiz-López9, Pilar Loeches10, Javier López-Gónzález11, Amelia González-Gamarra12 and on behalf of the SIRVA2 group

Author Affiliations

1 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

2 Centro de Salud Potosí, Atención Primaria de Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). Red Temática de Investigación en Enfermedades Cardiovasculares (RECAVA). (C/Potosí 7), Madrid, (28016), España

3 Agencia Laín Entralgo, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (C/Gran Vía 27), Madrid, (28013), España

4 Agencia de Evaluación de Tecnología Sanitarias (AETS), ISCIII. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (C/Monforte de Lemos 5), Madrid, (28029), España

5 Centro de Salud Valleaguado, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (Avda Príncipes de España 30), Coslada, (28820), España

6 Centro de Salud Valdebernardo, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (Bulevar Indalecio Prieto, 26), Madrid, (28032), España

7 Centro de Salud Nuñez Morgado, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP).(C/Núñez Morgado s/n), Madrid, (28036), España

8 Centro de Salud Londres, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (C/Londres 55), Madrid, (28006), España

9 Centro de Salud San Andrés, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (C/Alberto Palacios 22), Madrid, (28021), España

10 Centro de Salud Dr Tamames, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (Pza del Dr Tamales s/n), Coslada, 28820, España

11 FREMAP. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (Avenida Pablo Iglesias 36-40), Madrid, (28039), España

12 Centro de Salud Goya, Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). (C/O´Donnell 55), Madrid, (28009), España

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BMC Family Practice 2011, 12:21  doi:10.1186/1471-2296-12-21

Published: 19 April 2011

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.

Aim

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.

Trial Registration

ClinicalTrials.gov: NCT01270022

Keywords:
Primary healthcare; Randomised clinical trial; Cluster analysis; Clinical practice guidelines; Cardiovascular disease