Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013039
First received: March 14, 2001
Last updated: April 6, 2015
Last verified: February 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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
Arm 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
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