NCT00792402

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

4 years

First QC Date

November 17, 2008

Last Update Submit

November 22, 2011

Conditions

Keywords

chronic heart failureComputerized clinical guidelinesPrimary care

Outcome Measures

Primary Outcomes (1)

  • ACE/ARBs, ACE/ARBs+BB, hospitalisation rates, survival rate, reliability/ usability/applicability of computerised guideline, economic measurements

    2005 to 2007

Study Arms (2)

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.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unitat de Suport a la Recerca

Barcelona, 08006, Spain

Location

Study Officials

  • Josep M Davins, MD, PhD

    Unitat de Suport a la Recerca, Barcelona, Spain

    PRINCIPAL INVESTIGATOR
  • Eva Frigola, Masters

    Unitat de Suport a la Recerca, Barcelona, Spain

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

November 1, 2007

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations