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IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00303979
First received: March 15, 2006
Last updated: November 21, 2012
Last verified: November 2012

March 15, 2006
November 21, 2012
May 2005
August 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
To evaluate the proportion of practices that demonstrate a relative 20% or greater improvement in 2 or more of the performance measures at 24 months compared with baseline
Complete list of historical versions of study NCT00303979 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Performance measure improvement for Composite Score analyzed at a practice level for Cohort C (18 Month) will be presented.
  • At 24 months: summarize the distribution of practices’ and the overall composite quality measurement scores
  • evaluate additional performance measures in patients who are receiving indicated therapy
  • summarize the utilization rate of each component of the IMPROVE HF process improvement intervention toolkit by practices.
Not Provided
Not Provided
 
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Heart failure patients in outpatient cardiology practices

  • Heart Failure, Congestive
  • Myocardial Infarction
  • Ventricular Dysfunction, Left
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34810
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00303979
258
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Medtronic
Study Chair: Gregg Fonarow, MD University of California at Los Angeles
Study Chair: Clyde Yancy, MD UT Southwestern Medical Center at Dallas
Medtronic Cardiac Rhythm Disease Management
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP