Chronic Heart FailureNCT00792402
Computerized Guideline in Heart Failure: Implementation Process and Impact Evaluation
An observational study of Chronic Heart Failure, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Objective: To assess the effectiveness of implementation process of an electronic Heart Failure guideline in primary care in the city of Barcelona. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 13,008 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2007to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, Computerized clinical guidelines, Primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACE/ARBs, ACE/ARBs+BB, hospitalisation rates, survival rate, reliability/ usability/applicability of computerised guideline, economic measurements
Measured: 2005 to 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Institute of Health
- Responsible party
- Sponsor
- Investigators
- Josep M Davins, MD, PhD, Principal investigator, Unitat de Suport a la Recerca, Barcelona, SpainEva Frigola, Masters, Study director, Unitat de Suport a la Recerca, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792402
- Sponsor's protocol ID
- PI07/91020
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2008
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Process and Impact of the Heart Failure Electronic Clinical Guideline in the Catalan Health Institute Primary Care Health Board
- ClinicalTrials.gov ID
- NCT00792402
- Acronym / sponsor ID
- PI07/91020
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, Computerized clinical guidelines, Primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,008 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Catalan Institute of Health
- Study start
- Nov 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ACE/ARBs, ACE/ARBs+BB, hospitalisation rates, survival rate, reliability/ usability/applicability of computerised guideline, economic measurements
Time frame: 2005 to 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep M Davins, MD, PhD principal investigator
Unitat de Suport a la Recerca, Barcelona, Spain
Eva Frigola, Masters study director
Unitat de Suport a la Recerca, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.