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Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk

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ClinicalTrials.gov Identifier: NCT01270022
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 5, 2011
Information provided by:

January 4, 2011
January 5, 2011
January 5, 2011
January 2004
April 2006   (Final data collection date for primary outcome measure)
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No Changes Posted
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Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk
Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk.
The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular risk, with a local adaptation model of the existing guidelines in clinical practise at present, of each of the different cardiovascular risk factors, and the implementation strategy.

With this objective this study will be developed in three diferent phases. The guideline in clinical practice elaboration. It will be based in evidence medicine and it will be adapted based in the cardiovascular risk factors guidelines published at the present.

The spreding and implementation of the guideline between the sanitarians, as much in primary medicine as in specialised area, involved in the care of the patient in cardiovascular risk, in the Area 2 in Madrid.

And the evaluation of the implementation strategy, used between the primary care physicians.

For the local adaptation, will be used a systematic review of the different guidelines in the Spanish and international literature, published in the last years about this topic.

The ones with better quality criteria will be selected and doctors and nurses related from different specialities, involved in the cardiovascular illness, as much as members of the staff of the medical management an nursery, will be invited to participate in the selection of the recommendations of the guides and in the search of the consensus. After that, this guide will be given to a group of patients, who will be asked for a critical approach and their suggestions will be applied.

The evaluation will be done with a clinical trial designe , testing the use of the guide and its results on health intermediary variables. With this objective the results with an implementation technique based on opinion leaders plus computer reminder, will be evaluated, instead of using the standard implementation.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
  • Cardiovascular Risk Factors
  • Clinical Practice Guideline
  • Implementation Strategies
  • Primary Care
  • Other: Implementation
  • Other: dissemination
  • Experimental: Implementation
    Intervention: Other: Implementation
  • Active Comparator: dissemination
    Intervention: Other: dissemination
Rodríguez-Salvanés F, Novella B, Fernández Luque MJ, Sánchez-Gómez LM, Ruiz-Díaz L, Sánchez-Alcalde R, Sierra-García B, Mayayo S, Ruiz-López M, Loeches P, López-Gónzález J, González-Gamarra A; SIRVA2 group. 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. BMC Fam Pract. 2011 Apr 19;12:21. doi: 10.1186/1471-2296-12-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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July 2010
April 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients whose health cards showed them to belong to the studied health area

Exclusion Criteria:

  • Clinical history have not opened in the health center or this one is empty
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Blanca Novella Arribas, Gerencia de Atención Primaria Area 2 Madrid
Gerencia De Atencion Primaria Area 2 De Madrid
Health Research Fund of ISCIII Spain
Principal Investigator: Blanca Novella, MD. pHD Gerencia de Atención Primaria del área 2
Gerencia De Atencion Primaria Area 2 De Madrid
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP