IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF)
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|ClinicalTrials.gov Identifier: NCT00303979|
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : December 27, 2012
Last Update Posted : December 27, 2012
|Condition or disease|
|Heart Failure, Congestive Myocardial Infarction Ventricular Dysfunction, Left|
IMPROVE HF, the largest US outpatient HF patient registry, has substantially contributed to our knowledge of how systolic HF and post MI left ventricular systolic dysfunction (LVSD) patients are treated in the outpatient setting.
The findings of IMPROVE HF clearly support this guideline and may help to establish a model framework for future performance improvement programs for outpatient cardiology practices.
|Study Type :||Observational|
|Actual Enrollment :||34810 participants|
|Official Title:||Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Cohort A (longitudinal)
Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months
Cohort B (6 Month)
6 Month Cohort: Approximately 10,000 patients reviewed at single time point
Cohort C (18 Month)
18 Month Cohort: Approximately 10,000 patients reviewed at single time point
- To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline. [ Time Frame: 24 Month ]The percent of patients that conformed to each performance measure will be calculated at baseline and 24 months. Based on the definition of each performance measure as defined in the performance measure constructs, each performance measure's baseline percentage and 24 month percentage will be calculated. The change in percentages from baseline is the baseline percentage subtracted from the 24 month percentage. Each performance measure will be evaluated separately to determine whether there is a relative 20% or greater improvement from baseline. The difference in percentages from baseline to 24 months and associated 95% confidence intervals on the differences will be presented. The percent improvement from baseline for each performance measure will be tested using a large sample test (z-test) on a proportion.
- Evaluate the Proportion of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline. [ Time Frame: Study Completion ]The proportion of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline will be presented.
- Observe the Relative Improvement From Baseline to 24M in Composite Score for the Aggregate Practices. [ Time Frame: 24 months ]Performance measure improvement for Composite Score analyzed at a practice level for Cohort A (longitudinal) will be presented.
- Observe the Relative Improvement From Baseline to 6M in Composite Score for the Aggregate Practices. [ Time Frame: 6 Month ]Performance measure improvement for Composite Score analyzed at a practice level for Cohort B (6 Month) will be presented.
- Observe the Relative Improvement From Baseline to 18M in Composite Score for the Aggregate Practices. [ Time Frame: 18 Month ]Performance measure improvement for Composite Score analyzed at a practice level for Cohort C (18 Month) will be presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303979
Show 144 Study Locations
|Study Chair:||Gregg Fonarow, MD||University of California at Los Angeles|
|Study Chair:||Clyde Yancy, MD||UT Southwestern Medical Center at Dallas|