Heart Failure, CongestiveNCT00414401
Clinical Reminders in Test Reports to Improve Guideline Compliance
A study testing Clinical Reminder in people with Heart Failure, Congestive, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Clinical Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Jun 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those undergoing echocardiography at one of the participating laboratories with an ejection fraction < 45%.
Who cannot join
- aortic stenosis, mitral stenosis
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.
Read the detailed description
Background:
Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.
Objectives:
To determine if a reminder attached to the echocardiography report would increase the use of beta-blockers among patients with depressed left ventricular function.
Methods:
We are randomizing consecutive patients undergoing echocardiography at one of three VA echocardiography laboratories with reduced left ventricular ejection fraction (<40%) and no echocardiographic contraindication to beta-blockers (e.g. aortic stenosis) to a reminder for use of beta-blockers or to no reminder. The reminder gives starting doses for two commonly used beta-blockers (carvedilol and metoprolol). Patients are excluded from the analysis if they leave the health care system or die within three months of randomization. The primary outcome is a prescription for a beta-blocker between three and nine months following echocardiography
Status:
The project is complete.
- Conditions
- Heart Failure, Congestive
- Being tested
- Clinical Reminder
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ReminderBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Clinical Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription for any beta-blocker
Secondary outcomes (1)
Prescription for carvedilol or metoprolol succinate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startMay 2001
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul A. Heidenreich, MD MS, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414401
- Sponsor's protocol ID
- IIR 01-108
- Status last verified
- Dec 2006
- First submitted
- 19 Dec 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heidenreich PA, Gholami P, Sahay A, Massie B, Goldstein MK. Clinical reminders attached to echocardiography reports of patients with reduced left ventricular ejection fraction increase use of beta-blockers: a randomized trial. Circulation. 2007 Jun 5;115(22):2829-34. doi: 10.1161/CIRCULATIONAHA.106.684753. Epub 2007 May 21.
PubMed 17515459Heidenreich PA, Chacko M, Goldstein MK, Atwood JE. ACE inhibitor reminders attached to echocardiography reports of patients with reduced left ventricular ejection fraction. Am J Med. 2005 Sep;118(9):1034-7. doi: 10.1016/j.amjmed.2004.12.028. No abstract available.
PubMed 16164891
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Reminders in Test Reports to Improve Guideline Compliance
- ClinicalTrials.gov ID
- NCT00414401
- Acronym / sponsor ID
- IIR 01-108
- Conditions
- Heart Failure, Congestive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2001
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Dec 2006 (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.
Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.
Detailed description
Background:
Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.
Objectives:
To determine if a reminder attached to the echocardiography report would increase the use of beta-blockers among patients with depressed left ventricular function.
Methods:
We are randomizing consecutive patients undergoing echocardiography at one of three VA echocardiography laboratories with reduced left ventricular ejection fraction (<40%) and no echocardiographic contraindication to beta-blockers (e.g. aortic stenosis) to a reminder for use of beta-blockers or to no reminder. The reminder gives starting doses for two commonly used beta-blockers (carvedilol and metoprolol). Patients are excluded from the analysis if they leave the health care system or die within three months of randomization. The primary outcome is a prescription for a beta-blocker between three and nine months following echocardiography
Status:
The project is complete.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Clinical Reminder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those undergoing echocardiography at one of the participating laboratories with an ejection fraction < 45%.
Key exclusion criteria (1 listed)
- aortic stenosis, mitral stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Reminder | Behavioural | Arm 1 |
Primary outcome
Prescription for any beta-blocker
1 secondary outcome
Prescription for carvedilol or metoprolol succinate
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 7 Apr 2015.
- Results publication: PubMed 17515459Heidenreich PA, Gholami P, Sahay A, Massie B, Goldstein MK. Clinical reminders attached to echocardiography reports of patients with reduced left ventricular ejection fraction increase use of beta-blockers: a randomized trial. Circulation. 2007 Jun 5;115(22):2829-34. doi: 10.1161/CIRCULATIONAHA.106.684753. Epub 2007 May 21.
- Results publication: PubMed 16164891Heidenreich PA, Chacko M, Goldstein MK, Atwood JE. ACE inhibitor reminders attached to echocardiography reports of patients with reduced left ventricular ejection fraction. Am J Med. 2005 Sep;118(9):1034-7. doi: 10.1016/j.amjmed.2004.12.028. No abstract available.
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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.
Paul A. Heidenreich, MD MS principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Reminder in people with Heart Failure, Congestive, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 1 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 7 Apr 2015. 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 United States. 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?
Prescription for any beta-blocker. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414401, which also lists 2 linked publications.
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 7 Apr 2015.