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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
  Purpose

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.


Condition
Heart Failure, Congestive
Myocardial Infarction
Ventricular Dysfunction, Left

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 34810
Study Start Date: May 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Heart failure patients in outpatient cardiology practices

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303979

  Show 144 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Study Chair: Gregg Fonarow, MD University of California at Los Angeles
Study Chair: Clyde Yancy, MD UT Southwestern Medical Center at Dallas
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00303979     History of Changes
Other Study ID Numbers: 258
Study First Received: March 15, 2006
Results First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Systolic Heart Failure
Quality of Care
Outcomes
Evidence-based Guidelines
Recommended Therapies

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014