Clinical trial NCT01270022: Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk
Official title: Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Clinical Practice Guideline
Implementation Strategies
Primary Care
Lead sponsor: Gerencia De Atencion Primaria Area 2 De Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Health Research Fund of ISCIII Spain
First posted: 2011-01-05
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria del área 2
Study officials:
affiliation: Gerencia de Atención Primaria del área 2
name: Blanca Novella, MD. pHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Salvanes F, Novella B, Fernandez Luque MJ, Sanchez-Gomez LM, Ruiz-Diaz L, Sanchez-Alcalde R, Sierra-Garcia B, Mayayo S, Ruiz-Lopez M, Loeches P, Lopez-Gonzalez J, Gonzalez-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.