Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 17, 2008
November 22, 2011
November 2007
November 2011   (final data collection date for primary outcome measure)
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 ]
hospitalisation rates, patients´lifestyle advice compliance, professionals´ performance [ Time Frame: at 3, 6 and 12 months after initiation of the intervention trial (2006) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00792402 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Computerized Guideline in Heart Failure: Implementation Process and Impact Evaluation
Implementation Process and Impact of the Heart Failure Electronic Clinical Guideline in the Catalan Health Institute Primary Care Health Board

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

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Chronic Heart Failure
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13008
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00792402
PI07/91020
Yes
Jordi Gol i Gurina Foundation
Jordi Gol i Gurina Foundation
Barcelona and Girona primary care research centre. Catalan Health Institute.
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
Jordi Gol i Gurina Foundation
November 2011

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