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Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013039
  Purpose

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 Intervention
Heart Failure
Behavioral: Computer reminders

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   1000
Study Completion Date:   February 2001

Arms Assigned Interventions
1 Behavioral: Computer reminders

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013039

Locations
United States, Indiana
Richard L. Roudebush VA Medical Center    
      Indianapolis, Indiana, United States, 46202-2884
United States, North Carolina
Durham VA Medical Center    
      Durham, North Carolina, United States, 27705
United States, Washington
VA Puget Sound Health Care System, Seattle    
      Seattle, Washington, United States, 98101

Sponsors and Collaborators

Investigators
Principal Investigator:     William M. Tierney, MD     Richard L. Roudebush VA Medical Center    
  More Information


Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Tierney, William - Principal Investigator )
Study ID Numbers:   CPG 97-001
First Received:   March 14, 2001
Last Updated:   October 31, 2008
ClinicalTrials.gov Identifier:   NCT00013039
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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