Computerized Guidelines Enhanced by Symptoms and History: Clinical Effects

NCT ID: NCT00013039

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2001-02-28

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: OTHER

Computer reminders

Intervention Type: BEHAVIORAL

Interventions

Computer reminders

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William M. Tierney, MD

Role: PRINCIPAL_INVESTIGATOR

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Stephan D. Fihn, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Countries

United States

References

Subramanian U, Fihn SD, Weinberger M, Plue L, Smith FE, Udris EM, McDonell MB, Eckert GJ, Temkit M, Zhou XH, Chen L, Tierney WM. A controlled trial of including symptom data in computer-based care suggestions for managing patients with chronic heart failure. Am J Med. 2004 Mar 15;116(6):375-84. doi: 10.1016/j.amjmed.2003.11.021.

Reference Type: RESULT

PMID: 15006586 (View on PubMed)

Udris EM, Au DH, McDonell MB, Chen L, Martin DC, Tierney WM, Fihn SD. Comparing methods to identify general internal medicine clinic patients with chronic heart failure. Am Heart J. 2001 Dec;142(6):1003-9. doi: 10.1067/mhj.2001.119130.

Reference Type: RESULT

PMID: 11717604 (View on PubMed)

Other Identifiers

CPG 97-001

Identifier Type: -

Identifier Source: org_study_id