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| 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 |
| 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 |
| Estimated Enrollment: | 1000 |
| Study Completion Date: | February 2001 |
| Arms | Assigned Interventions |
| 1 | Behavioral: Computer reminders |
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 |
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| 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 | |||||
| Principal Investigator: | William M. Tierney, MD | Richard L. Roudebush VA Medical Center |
More Information
| Responsible Party: | Department of Veterans Affairs ( Tierney, William - Principal Investigator ) |
| Study ID Numbers: | CPG 97-001 |
| First Received: | March 14, 2001 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00013039 |
| Health Authority: | United States: Federal Government |
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