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Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects

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ClinicalTrials.gov Identifier: NCT00013039
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Computer reminders Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects
Actual Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Arm 1 Behavioral: Computer reminders




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013039


Locations
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William M. Tierney, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
Principal Investigator: Stephan D. Fihn, MD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA