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

  Hide Study Locations
Locations
United States, Alabama
Cardiovascular Associates of Montclair
Birmingham, Alabama, United States, 36608
Cardiology Associates
Mobile, Alabama, United States, 36608
United States, Arizona
Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85205
Heart Care, PC
Scottsdale, Arizona, United States, 85258
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, Arkansas
Central Arkansas Cardiovascular Institute
Hot Springs, Arkansas, United States, 71913
Arkansas Cardiology Clinic
Little Rock, Arkansas, United States, 72202
United States, California
St. Jude Heritage Medical Group
Fullerton, California, United States, 92835
Scripps Clinic Green Hospital
La Jolla, California, United States, 92037
University Cardiovascular Medical Group
Los Angeles, California, United States, 94115
Veterans Administration Hospital
Los Angeles, California, United States, 92357
Cardio-Pulmonary Associates
Monterey, California, United States, 93940
Temecula Valley Cardiology
Murrieta, California, United States, 92562
California Pacific Cardiovascular Medical
San Francisco, California, United States, 94115
East Bay Cardiology
San Pablo, California, United States, 94803
Cardiology Consultants Medical Group
Tarzana, California, United States, 91335
United States, Colorado
Medical Center of the Rockies
Fort Collins, Colorado, United States, 80521
United States, Connecticut
Connecticut Heart & Vascular Center
Bridgeport,, Connecticut, United States, 06606
United States, Delaware
Cardiology Consultants, PA
Newark, Delaware, United States, 19702
United States, Florida
Heart and Vascular Center of Bradenton
Bradenton, Florida, United States, 34209
Clearwater Cardiovascular & Intervention
Clearwater, Florida, United States, 33756
Mahesh Amin, MD PA
Clearwater, Florida, United States, 33756
Pasco Cardiology
Hudson, Florida, United States, 34667
Cardiovascular Associates
Kissimmee, Florida, United States, 34741
Clark and Daughtrey Medical Group
Lakeland, Florida, United States, 33803
OMNI
Melbourne, Florida, United States, 32901
Miami Cardiology Group
Miami, Florida, United States, 33176
Florida Heart Group
Orlando, Florida, United States, 32803
Cardiology Associates
Port Charlotte, Florida, United States, 33952
Cardiovascular Consultants,
Tamarac, Florida, United States, 33309
Indian River Cardiovascular Associate
Vero Beach, Florida, United States, 32960
Florida Medical Clinic
Zephyrhills, Florida, United States, 33542
United States, Georgia
Northside Cardiology
Atlanta, Georgia, United States, 30342
Cardiology of Atlanta
Atlanta, Georgia, United States, 30342
Northeast Georgia Heart Center
Gainesville, Georgia, United States, 30501
Southcoast Cardiology
Savannah, Georgia, United States, 31406
United States, Hawaii
Pacific Cardiology
Honolulu, Hawaii, United States, 96817
United States, Idaho
St. Luke's Idaho Cardiology Associates
Boise, Idaho, United States, 83702
United States, Illinois
Heart Care Center of Illinois
Blue Island, Illinois, United States, 60406
MidAmerica Cardiovascular Consultants
Frankfort, Illinois, United States, 60453
Cardiovascular Associates of Glenbrook and Evanston, LLC
Glenview, Illinois, United States, 60026
United States, Indiana
St. Vincent's Hospital
Indianapolis, Indiana, United States, 46201
St. Vincent's Hospital,
Indianapolis, Indiana, United States, 46278
St. Vincent's Hospital Indianapolis
Indianapolis, Indiana, United States, 46278
Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa Heart Center PC,
West Des Moines, Iowa, United States, 50266
United States, Kansas
Mid America Cardiology
Kansas City, Kansas, United States, 66102
Cardiology Consultants
Topeka, Kansas, United States, 66102
Cardiovascular Consultants of Kansas
Wichita, Kansas, United States, 67226
United States, Kentucky
Medical Center Cardiologists P.S.C
Louisville, Kentucky, United States, 40201
Louisville Cardiology Medical Group P.S
Louisville, Kentucky, United States, 40026
Louisville Cardiology Medical Group P.S
Louisville, Kentucky, United States, 40207
Owensboro Heart and Vascular
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Tchefuncte Cardiovascular Associates,
Covington, Louisiana, United States, 70433
Heart Clinic of Louisiana
Marrero, Louisiana, United States, 70072
United States, Maryland
Maryland Heart, PC
Bethesda, Maryland, United States, 20817
Heart Center of Southern Maryland
Clinton, Maryland, United States, 20735
Arundel Heart Associates
Glen Burnie, Maryland, United States, 21061
Peninsula Cardiology
Salisbury, Maryland, United States, 21804
United States, Massachusetts
Primary Care Specialists Inc
Ayer, Massachusetts, United States, 01432
Merrimack Valley Cardiology
Chelmsford, Massachusetts, United States, 01824
Harbor Medical AssociatesSo Weymouth
Weymouth, Massachusetts, United States, 02190
United States, Michigan
Consultants in Cardiology
Farmington Hills, Michigan, United States, 48331
Cardiovascular Consultants PC
Rochester, Michigan, United States, 48312
Eastside Cardiology, Roseville
Roseville, Michigan, United States, 48066
United States, Minnesota
St. Paul Cardiology
St. Paul, Minnesota, United States, 55102
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Missouri Cardiovascular Specialists
Columbia, Missouri, United States, 65201
University Hospital Healthcare
Columbia, Missouri, United States, 65210
Freeman Heart Institute
Joplin, Missouri, United States, 64804
Cardiology Diagnostics, Ltd,
St. Louis, Missouri, United States, 63131
Mercy Cardiology
St. Louis, Missouri, United States, 63101
United States, New Hampshire
Cardiac Associates of New Hampshire
Concord, New Hampshire, United States, 03303
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Medicor
Bridgewater, New Jersey, United States, 08807
Cross County Cardiology
Edgewater, New Jersey, United States, 07020
Heart-Lung Center
Hawthorne, New Jersey, United States, 07506-1919
Southern New Jersey Cardiac Specialists
Voorhees, New Jersey, United States, 08043
Diagnostic and Clinical Cardiologists
West Orange, New Jersey, United States, 07052
Westwood Cardiology
Westwood, New Jersey, United States, 07675
United States, New York
Albany Associates in Cardiology,
Albany, New York, United States, 12205
Cardiology Associates of Brooklyn
Brooklyn, New York, United States, 11219
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United Medical Associates
Brooklyn, New York, United States, 11219
Concorde Medical Group/NYU Hospital
Manhattan, New York, United States, 10001
Island Cardiac Specialists
Mineola, New York, United States, 11501
Island Cardiac Specialist
Mineola, New York, United States, 11501
Gotham Cardiovascular Research
New York, New York, United States, 10001
Westchester Medical Group
Scarsdale, New York, United States, 10583
Vazzana and Bogin Cardiology Associates
Staten Island, New York, United States, 10305
Cardiology PC
Syracuse, New York, United States, 13210
Southbay Cardiology
West Islip, New York, United States, 11795
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Sanger Clinic
Charlotte, North Carolina, United States, 28202
Carolina Heart Specialists
Gastonia, North Carolina, United States, 28054
Southeastern Heart and Vascular
Greensboro, North Carolina, United States, 27403
Hickory Cardiology
Hickory, North Carolina, United States, 28602
Carolina Cardiology Associates
High Point, North Carolina, United States, 27262
Heart Center of Eastern Carolina,
New Bern, North Carolina, United States, 28562
Heart Center of Eastern Carolina
New Bern, North Carolina, United States, 28562
Pinehurst Cardiology Consultants
Pinehurst, North Carolina, United States, 28370
Pinehurst Cardiology Consultants
Pinehurst, North Carolina, United States, 28374
Raleigh Cardiology
Raleigh, North Carolina, United States, 27610
United States, North Dakota
Meritcare Medical Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States, 44301
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Muhammed H. Zahra
Cleveland, Ohio, United States, 44125
Doctors Hospital Heart Failure Clinic
Columbus, Ohio, United States, 43228
Schuster Cardiology Associates
Kettering, Ohio, United States, 45336
The Heart Institute of Northwest Ohio
Lima, Ohio, United States, 45801
Bryce Morrice MD and Debra Heldman MD Inc
Newark, Ohio, United States, 43055
Cardiovascular Clinic, Inc.
Parma, Ohio, United States, 44129
North West Ohio Cardiology Consultants
Toledo, Ohio, United States, 43615
United States, Pennsylvania
Abington Medical Specialists
Abington, Pennsylvania, United States, 19001
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Central Bucks Specialists, Ltd.,
Doylestown, Pennsylvania, United States, 18901
Associated Cardiologists
Harrisburg, Pennsylvania, United States, 17103
The Heart Group, Ltd
Lancaster, Pennsylvania, United States, 17603
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19129
Cardiology Associates of Southeastern PA
Wynnewood, Pennsylvania, United States, 19064
York Hospital
York, Pennsylvania, United States, 17403
United States, Rhode Island
Blackstone Cardiology Associates
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Medical University of South
Charleston, South Carolina, United States, 29406
Upstate Cardiology
Greenville, South Carolina, United States, 29605
Cardiology Associates
Myrtle Beach, South Carolina, United States, 29572
Cardiology Consultants, PA
Spartanburg, South Carolina, United States, 29301
Sumter Medical Consultants
Sumter, South Carolina, United States, 29150
Columbia Cardiology Consultants
West Columbia, South Carolina, United States, 29204
United States, Tennessee
Sutherland Clinic
Germantown, Tennessee, United States, 38119
Dela Clinic
Lexington, Tennessee, United States, 38351
United States, Texas
Heart Place North Arlington
Arlington, Texas, United States, 75284
University of Texas South Western Medical Center at Dallas
Dallas, Texas, United States, 75201
Cardiology Consultants of Houston
Houston, Texas, United States, 77030
Comprehensive Heart Care, PA
Houston, Texas, United States, 77024
Legacy Heart Center
Plano, Texas, United States, 75024
Cardiology Clinic of San Antonio
San Antonio, Texas, United States, 78229
Wilford Hall Medical Center
San Antonio, Texas, United States, 78229
Tyler Cardiovascular Consultants
Tyler, Texas, United States, 75701
United States, Vermont
University Associates in Cardiology
Burlington, Vermont, United States, 05401
United States, Virginia
The Cardiovascular Group
Fairfax, Virginia, United States, 22031
Cardiology Associates of Lakeview
Fairfax, Virginia, United States, 05454
Tidewater Heart Specialists, Inc.,
Hampton, Virginia, United States, 23666
United States, Wisconsin
Cardiology Associates of Green Bay
Green Bay, Wisconsin, United States, 54301
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, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014