N/A
N=34,810
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
Heart Failure, Congestive · Myocardial Infarction · Ventricular Dysfunction, Left
Bottom Line
View on ClinicalTrials.gov: NCT00303979 ↗Enrolled (actual)
34,810
Serious AEs
—
Results posted
Dec 2012
Primary outcome: Primary: To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change. — 79.8; 86.5; 8.4; 86.2 percentage of participants in aggregate — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change. |
79.8; 86.5; 8.4; 86.2; 93.6; 8.6 | <0.001 sig |
| SECONDARY Observe the Number 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 in Cohort A. |
15; 9; 82; 14; 83; 114 | — |
| SECONDARY Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. |
78.3; 85.1; 19.4; 86.0; 92.2; 7.6 | 0.004 sig |
| SECONDARY Observe the Relative Change Between Baseline of Cohort A and 6 Months of Cohort B in Performance Measures and Composite Score for the Aggregate Practices. |
78.7; 80.2; 10.3; 85.9; 90.0; 10.6 | 0.197 |
| SECONDARY Observe the Relative Change Between Baseline of Cohort A and 18 Months of Cohort C in Performance Measures and Composite Score for the Aggregate Practices. |
78.7; 80.3; 10.5; 85.9; 91.8; 14.3 | 0.190 |
Summary
The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical guidelines, reminder systems, comprehensive disease state management tools, benchmarked quality reports, and academic detailing on the use of evidence-based heart failure therapies in cardiology practices. This study is a quality improvement initiative that is being conducted through review of patient records.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Primary or secondary diagnosis of heart failure or prior myocardial infarction (heart attack)
- Moderate-to-severe left ventricular dysfunction (LVD) as demonstrated by an ejection fraction < or = 35% and/or a qualitative assessment of LVD of moderate-to-severe or severe LVD
- Patient has been seen at the clinic at least twice in the past 2 years
- Patient received care from the physician participating in the study
Exclusion Criteria
- Patient has died
- Patient is not expected to survive for 12 months due to medical conditions other than heart failure
- Patient has undergone heart transplant surgery
Data sourced from ClinicalTrials.gov (NCT00303979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.