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Computerized Guideline in Heart Failure: Implementation Process and Impact Evaluation

This study has been completed.
Sponsor:
Collaborator:
Barcelona and Girona primary care research centre. Catalan Health Institute.
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00792402
First received: November 17, 2008
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

Objective: To assess the effectiveness of implementation process of an electronic Heart Failure guideline in primary care in the city of Barcelona.


Condition
Chronic Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Implementation Process and Impact of the Heart Failure Electronic Clinical Guideline in the Catalan Health Institute Primary Care Health Board

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • ACE/ARBs, ACE/ARBs+BB, hospitalisation rates, survival rate, reliability/ usability/applicability of computerised guideline, economic measurements [ Time Frame: 2005 to 2007 ] [ Designated as safety issue: No ]

Enrollment: 13008
Study Start Date: November 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 control group
Computerized data collection of outcome measures in usual care
2 intervention group
Computerized data collection of outcome measures and interviews to clinicians which are using a computerized Heart Failure guideline in their daily practice.

Detailed Description:

Design: Two types of design will be applied, according to the specific aims. On the one hand it is a cross-sectional and a qualitative study, on the other hand it is quasi-experimental study. Pre-post intervention with a control group, as well as, of repeated measures in the intervention group

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Setting: 20 general practices in Barcelona (intervention group),with an assigned population of 558515 inhabitants and Girona (control Group) with 23 general practices, and an assigned population of 480827.In 2007, the intervention region had a rate of 1499 patients per GP and from 16 to 52 thousand listed patients per practice with and average of attending rate of 68%, and the control region had a rate of 1558 patients per GP and from 4 to 47 thousand listed patients per practice with and average of attending rate of 76%.

Subjects: Managers and general and nurse practitioners from Barcelona and Girona primary care practices included in the study. Patients with diagnoses related to Heart Failure.

Criteria

Inclusion Criteria:

  • general and nurse primary care practitioners working in Barcelona and Girona for the Health Catalan Institute.
  • Managers involved in implementation process for the computerised clinical guideline in Barcelona from the Health Catalan Institute.
  • patients with diagnoses of Heart Failure according to ICD-10 according to general practice clinical records.

Exclusion Criteria:

  • Managers and general and nurse primary care practitioners working in Barcelona health Centres where there were any other quality improvement project related to Heart failure at the time of the intervention which we are evaluating. Managers from the control group (Girona).
  • patients with a mental health disorder or terminal illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792402

Locations
Spain
Unitat de Suport a la Recerca
Barcelona, Spain, 08006
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Barcelona and Girona primary care research centre. Catalan Health Institute.
Investigators
Principal Investigator: Josep M Davins, MD, PhD Unitat de Suport a la Recerca, Barcelona, Spain
Study Director: Eva Frigola, Masters Unitat de Suport a la Recerca, Barcelona, Spain
  More Information

No publications provided

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT00792402     History of Changes
Other Study ID Numbers: PI07/91020
Study First Received: November 17, 2008
Last Updated: November 22, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
chronic heart failure
Computerized clinical guidelines
Primary care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013