Clinical Reminders in Test Reports to Improve Guideline Compliance - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00414401

Purpose

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.

Condition	Intervention
Heart Failure, Congestive	Behavioral: Clinical Reminder

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Reminders in Test Reports to Improve Guideline Compliance

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Prescription for any beta-blocker [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prescription for carvedilol or metoprolol succinate [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	May 2001
Study Completion Date:	June 2006

Arms	Assigned Interventions
1	Behavioral: Clinical Reminder

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Those undergoing echocardiography at one of the participating laboratories with an ejection fraction < 45%.

Exclusion Criteria:

aortic stenosis, mitral stenosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414401

Locations

United States, California
VA Palo Alto Health Care System HSR&D COE
Palo Alto, California, United States, 94304

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Paul A. Heidenreich, MD

VA Palo Alto Health Care System

More Information

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. Epub 2007 May 21.

Heidenreich 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. No abstract available.

Responsible Party:	Department of Veterans Affairs ( Heidenreich, Paul - Principal Investigator )
Study ID Numbers:	IIR 01-108
Study First Received:	December 19, 2006
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00414401 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010