Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013039
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Computerized Guidelines Enhanced by Symptoms and History Clinical Effects
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Computerized Guidelines Enhanced by Symptoms and History Clinical Effects
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 historysymptom data Study data come from the VAMCs electronic medical record systems ie 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
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 historysymptom data Study data come from the VAMCs electronic medical record systems ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None