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Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects
This study has been completed.
Study NCT00013039   Information provided by Department of Veterans Affairs
First Received: March 14, 2001   Last Updated: August 6, 2009   History of Changes

March 14, 2001
August 6, 2009
 
 
 
 
Complete list of historical versions of study NCT00013039 on ClinicalTrials.gov Archive Site
 
 
 
Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects
Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects

Physician compliance with practice guidelines is imperfect. Computer-generated reminders from electronic medical record systems have been shown to increase compliance with guidelines, but they often require symptom and history data, which limits computer facilitation. Heart failure is a serious condition for which compliance with established guidelines is suboptimal. Physicians� compliance with heart failure guidelines may improve if such reminders use symptom and history data.

Background:

Physician compliance with practice guidelines is imperfect. Computer-generated reminders from electronic medical record systems have been shown to increase compliance with guidelines, but they often require symptom and history data, which limits computer facilitation. Heart failure is a serious condition for which compliance with established guidelines is suboptimal. Physicians� compliance with heart failure guidelines may improve if such reminders use symptom and history data.

Objectives:

1) Program standard computer-based guidelines for heart failure using data from the electronic medical record systems at the Indianapolis and Seattle VAMCs. 2) Establish a system for capturing data on symptoms and history from heart failure patients before scheduled primary care visits. 3) Incorporate these data into enhanced computer reminders. 4) Conduct a randomized, controlled trial comparing these two types of reminders� effects on physician prescribing, patient objective and subjective outcomes, and health care utilization.

Methods:

This controlled trial targets patients with objective evidence of left ventricular dysfunction on cardiac imaging studies and a current outpatient diagnosis of heart failure. Primary care physicians in the Indianapolis and Seattle VAMCs have been randomized to receive either standard heart failure treatment reminders or reminders enhanced by history/symptom data. Study data come from the VAMCs electronic medical record systems (i.e., clinical data, utilization, and costs) and patient interviews (heart failure symptoms and medication compliance, heart failure-specific quality of life, and patients� satisfaction with their primary care). Data analysis will be performed at the patient level using general estimating equations to account for patient and physician characteristics and clustering of patients within physicians.

Status:

Data Collection: Enrollment has been completed, with 503 patients enrolled from the Roudebush VAMC in Indianapolis and 250 from the VA Puget Sound Health Care System in Seattle. The trial continues without irregularities in both places. More than 80 percent of eligible patients were enrolled from both sites. Subjective data are being collected prior to scheduled visits on more than 95 percent of enrolled subjects.

 
Interventional
Other, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Heart Failure
Behavioral: Computer reminders
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1000
February 2001
 

Inclusion Criteria:

Left ventricular systolic dysfunction by echocardiogram or cardiac MUGA scan and the outpatient diagnosis of heart failure and the primary care physician's statement that he or she is actively treating the patient for heart failure.

Exclusion Criteria:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013039
Tierney, William - Principal Investigator, Department of Veterans Affairs
CPG 97-001
Department of Veterans Affairs
 
Principal Investigator: William M. Tierney, MD Richard L. Roudebush VA Medical Center
Department of Veterans Affairs
January 2005

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