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-Salvanés, Blanca Novella, María Jesús Fernández Luque, Luis María Sánchez-Gómez, Lourdes Ruiz-Díaz, Rosa Sánchez-Alcalde, Belén Sierra-García, Soledad Mayayo, Marta Ruiz-López, Pilar Loeches, Javier López-Gónzález, Amelia González-Gamarra, SIRVA2 group, A Albarran Pinar, E Bartolomé Benito, L Barutel Rubio, R Carraro Casieri, J M Castillo, M Cid Artigas, A Cubillo Senra, A Ferrández Infante, M J Fernández Luque, A Gallego Arenas, L Garcia Olmos, I Garcia Polo, G Gil Juberías, A Gonzalez Gamarra, P Loeches Belinchón, F López Corral, C López Gonzalez, J López González, M A Martinez Alvarez, H Martinez Sanz, M S Mayayo Vicente, F Mayordomo Sanchez de la Morena, B Novella Arribas, A Parejo Llenero, S Payan Agudo, P Pérez Cayuela, C Refolio Abella, F Rodríguez Salvanés, S Ruiz Alonso, L Ruiz Diaz, M Ruiz López, R M Sánchez Alcalde, L M Sánchez-Gómez, B Sierra García, C Suarez Fernández, Francisco Rodríguez-Salvanés, Blanca Novella, María Jesús Fernández Luque, Luis María Sánchez-Gómez, Lourdes Ruiz-Díaz, Rosa Sánchez-Alcalde, Belén Sierra-García, Soledad Mayayo, Marta Ruiz-López, Pilar Loeches, Javier López-Gónzález, Amelia González-Gamarra, SIRVA2 group, A Albarran Pinar, E Bartolomé Benito, L Barutel Rubio, R Carraro Casieri, J M Castillo, M Cid Artigas, A Cubillo Senra, A Ferrández Infante, M J Fernández Luque, A Gallego Arenas, L Garcia Olmos, I Garcia Polo, G Gil Juberías, A Gonzalez Gamarra, P Loeches Belinchón, F López Corral, C López Gonzalez, J López González, M A Martinez Alvarez, H Martinez Sanz, M S Mayayo Vicente, F Mayordomo Sanchez de la Morena, B Novella Arribas, A Parejo Llenero, S Payan Agudo, P Pérez Cayuela, C Refolio Abella, F Rodríguez Salvanés, S Ruiz Alonso, L Ruiz Diaz, M Ruiz López, R M Sánchez Alcalde, L M Sánchez-Gómez, B Sierra García, C Suarez Fernández

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.

Figures

Figure 1
Figure 1
Patients Flow chart: number of patients finally studied and their distribution.

References

    1. En Field MJ, Lohr KN, editor. Clinical Practice guidelines: directions for a new program. Washington, DC; National Academy Press; 1990. Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine.
    1. Chassin MR, Brook RH, Park RE, Keesey J, Fink A, Kosekoff J. et al.Variations in the use of medical and surgical services by the Medicare population. N Engl J Med. 1986;314:285–290. doi: 10.1056/NEJM198601303140505.
    1. Cook DJ, Greengold NL, Ellrodt AG, Weingarten SR. The Relation between Systematic Reviews and Practice Guidelines. Ann Intern Med. 1997;127:210–216.
    1. Battista R, Hodge M, Vineis P. Medicine, practice and guidelines: the uneasy juncture of science and art. J Clin Epidemiol. 1995;48:875–880. doi: 10.1016/0895-4356(94)00199-Z.
    1. Scannell KM, Miller N, Glock M. Practice Guidelines. Bethesda, Maryland: National Library of Medicine; 1992. Current Bibliographies in Medicine; pp. 92–14.
    1. Accessed January 2010.
    1. Subías PJ, Bouzá K, Casanovas E, García JA, Jiménez J. et al.Estudio de efectividad PAPPS (1998) y resultados preliminares de la evaluación PAPPS (1999) Aten Primaria. 1999;24(1 Suppl):11–17.
    1. Grimshaw JM, Russel IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet. 1993;342:1317–1322. doi: 10.1016/0140-6736(93)92244-N.
    1. Worral G, Chaulk P, Freaake D. The effects of clinical practice guidelines on patient outcomes in primary care: a systematic review. CMAJ. 1997;156(12):1705–1712.
    1. Davis DA, Taylor-Vaisey A. Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical guidelines. CMAJ. 1997;157(4):408–416.
    1. Langley C, Faulkner A, Watkins C, Gray S, Harvey I. Use of guidelines in primary care practitioners, perspectives. Fam Pract. 1998;15:105–111. doi: 10.1093/fampra/15.2.105.
    1. Grimshaw J, Russell IT. Achieving health gain though clinical guidelines: Developing scientifically valid guidelines. Qual Health Care. 1993;2:243–248. doi: 10.1136/qshc.2.4.243.
    1. Freemantle N, Harvey E, Wolf F, Oxman A, Grilli R, Bero L. In the Cochrane Database of Systematic Reviews. Oxford; 1997. The effectiveness of printed educational materials in changing the behavior of healthcare professionals.
    1. Freemantle N. Implementation strategies. Fam Pract. 2000;17:S7–S10. doi: 10.1093/fampra/17.suppl_1.S7.
    1. Cohen DL, Littenberg B, Wetzel C, Neuhauser DB. Improving physician compliance with preventive medicine guidelines. Med Care. 1992;20:1040–1045.
    1. Doroodchi H, Abdolrasulnia M, Foster JA, Foster E, Turakhia MP, Skelding KA, Sagar K, Casebeer LL. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events. BMC Fam Pract. 2008;9:42. doi: 10.1186/1471-2296-9-42.
    1. Galan Maiques A, Brotons Cuixart C, Villar Álvarez F, Lobos Bejaranos JM, Torçal Laguna J, Orozco Beltran D, Navarro Pérez J, Ortega Sánchez-Pinilla R, Gil Guillen V, Vilaseca Canals J. Recomendaciones Preventivas cardiovasculares PAPPS 2009. Actualización PaPPS.
    1. Armitage P, Berry G. Statistical Methods in Medical Research. Blackwell Scientific Publications; 1987. pp. 179–185.
    1. Cambpell MJ. Cluster randomized trials in general (family) practice research. Stat Methods in Med Res. 2000;9:81–94. doi: 10.1191/096228000676246354.
    1. Adams G, Gulliford M, Ukoumunne O, Eldridge S, Chinn S, Campbell M. Patterns in intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57:785–794. doi: 10.1016/j.jclinepi.2003.12.013.
    1. Okoumunne O, Thompson S. Analysis of cluster randomized trials with repeated cross-sectional binary measurements. Stat Med. 2001;20:417–433. doi: 10.1002/1097-0258(20010215)20:3<417::AID-SIM802>;2-G.
    1. Hayes R, Moulton L. Cluster Randomised Trials. Chapman & Hall Eds; 2009.
    1. Donner A, Klar N. Desing and Analysis of Cluster Randomized Trials. Arnold: London; 2000.
    1. Donner A, Donald A. Analysis of data arising from stratified design with the cluster as unit of randomization. Stat Med. 1987;6:43–52. doi: 10.1002/sim.4780060106.
    1. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8:6.
    1. Bland JM, Kerry SM. Trials randomized in clusters. BMJ. 1997;315:600.
    1. Campbell M, Mollison J, Grimshaw J. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001;20:391–399. doi: 10.1002/1097-0258(20010215)20:3<391::AID-SIM800>;2-Z.

Source: PubMed

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