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

Tracking Information

First Received Date ^ICMJE

November 17, 2008

Last Updated Date

November 22, 2011

Start Date ^ICMJE

November 2007

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00792402 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Computerized Guideline in Heart Failure: Implementation Process and Impact Evaluation

Official Title ^ICMJE

Implementation Process and Impact of the Heart Failure Electronic Clinical Guideline in the Catalan Health Institute Primary Care Health Board

Brief Summary

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Chronic Heart Failure

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

13008

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00792402

Other Study ID Numbers ^ICMJE

PI07/91020

Has Data Monitoring Committee

Yes

Responsible Party

Jordi Gol i Gurina Foundation

Study Sponsor ^ICMJE

Jordi Gol i Gurina Foundation

Collaborators ^ICMJE

Barcelona and Girona primary care research centre. Catalan Health Institute.

Investigators ^ICMJE

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

Information Provided By

Jordi Gol i Gurina Foundation

Verification Date

November 2011

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

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