MedPath

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

Completed
Conditions
Myocardial Infarction
Ventricular Dysfunction, Left
Heart Failure, Congestive
Registration Number
NCT00303979
Lead Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34810
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.24 Month

7 performance measures: angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEI/ARB), beta-blokers, aldosterone receptor antagonists, anticoagulation for atrial fibrillation (AF), cardiac resynchronization therapy (CRT-P/CRT-D), cardioverter-defibrillator (ICD/CRT-D), heart failure (HF) education.

We first calcuated % of patients who were eligible for a performance measure that were treated by it at baseline and 24 months. We then calculated the relative change as (% treated at 24 months - % treated at baseline)/% treated at baseline. The 95% confidence interval (CI) was calculated and the relative change of each performance measure was evaluated using a z-test for one-sample proportion.

The number of performance measures with \>= 20% relative improvement was determined. The intervention was considered successful if a relative 20% or greater improvement in at least 2 of the 7 performance measures at 24 months compared with baseline was achieved.

Secondary Outcome Measures
NameTimeMethod
Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.24 months

performance measure improvement for each performance measure was analyzed at a practice level from baseline to 24 months. Performance measure adherence was calculated at the individual practice level and then combined and summarized. Mean, standard deviation, and 95% confidence intervals for performance measure adherence, composite score and relative change (24 months compared with baseline) are reported.

The Composite Score is based on the ratio of the sum of the numerators of all individual performance measures to the sum of the denominators of all individual performances measures. The numerator of a performance measure is the number of patients treated with that measure. The denomiator of a performance measure is the number of patients eligible for being treated with that measure.

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.baseline and 18 Months

The relative changes between baseline of cohort A and 18 months of cohort C in performance measures and composite score for the aggregate practices were calculated using mean, standard deviation and 95% CI.

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.24 months

The number 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 of cohort A is presented.

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.Baseline and 6 Months

The relative changes between baseline of cohort A and 6 months of cohort B in performance measures and composite score for the aggregate practices were calculated using mean, standard deviation and 95% CI.

Trial Locations

Locations (138)

Northside Cardiology

🇺🇸

Atlanta, Georgia, United States

Temecula Valley Cardiology

🇺🇸

Murrieta, California, United States

University Cardiovascular Medical Group

🇺🇸

Los Angeles, California, United States

Medical Center of the Rockies

🇺🇸

Fort Collins, Colorado, United States

Connecticut Heart & Vascular Center

🇺🇸

Bridgeport, Connecticut, United States

Mahesh Amin, MD PA

🇺🇸

Clearwater, Florida, United States

Cardio-Pulmonary Associates

🇺🇸

Monterey, California, United States

Cardiology PC

🇺🇸

Syracuse, New York, United States

Primary Care Specialists Inc

🇺🇸

Ayer, Massachusetts, United States

Drexel University College of Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

Missouri Cardiovascular Specialists

🇺🇸

Columbia, Missouri, United States

Cardiovascular Consultants PC

🇺🇸

Rochester, Michigan, United States

Tchefuncte Cardiovascular Associates,

🇺🇸

Covington, Louisiana, United States

Clearwater Cardiovascular & Intervention

🇺🇸

Clearwater, Florida, United States

Sutherland Clinic

🇺🇸

Germantown, Tennessee, United States

Legacy Heart Center

🇺🇸

Plano, Texas, United States

Florida Medical Clinic

🇺🇸

Zephyrhills, Florida, United States

East Bay Cardiology

🇺🇸

San Pablo, California, United States

Southcoast Cardiology

🇺🇸

Savannah, Georgia, United States

Cardiac Associates of New Hampshire

🇺🇸

Concord, New Hampshire, United States

Raleigh Cardiology

🇺🇸

Raleigh, North Carolina, United States

Island Cardiac Specialist

🇺🇸

Mineola, New York, United States

Cardiovascular Consultants of Kansas

🇺🇸

Wichita, Kansas, United States

Northeast Georgia Heart Center

🇺🇸

Gainesville, Georgia, United States

Cross County Cardiology

🇺🇸

Edgewater, New Jersey, United States

Medicor

🇺🇸

Bridgewater, New Jersey, United States

Eastside Cardiology, Roseville

🇺🇸

Roseville, Michigan, United States

Harbor Medical AssociatesSo Weymouth

🇺🇸

Weymouth, Massachusetts, United States

University Hospital Healthcare

🇺🇸

Columbia, Missouri, United States

Cardiology Associates of Brooklyn

🇺🇸

Brooklyn, New York, United States

United Medical Associates

🇺🇸

Brooklyn, New York, United States

Cardiology Diagnostics, Ltd,

🇺🇸

Saint Louis, Missouri, United States

Pasco Cardiology

🇺🇸

Hudson, Florida, United States

Concorde Medical Group/NYU Hospital

🇺🇸

Manhattan, New York, United States

Cardiovascular Consultants,

🇺🇸

Tamarac, Florida, United States

Iowa Heart Center PC,

🇺🇸

West Des Moines, Iowa, United States

Carolina Heart Specialists

🇺🇸

Gastonia, North Carolina, United States

Heart-Lung Center

🇺🇸

Hawthorne, New Jersey, United States

Hickory Cardiology

🇺🇸

Hickory, North Carolina, United States

Cardiology of Atlanta

🇺🇸

Atlanta, Georgia, United States

Diagnostic and Clinical Cardiologists

🇺🇸

West Orange, New Jersey, United States

Blackstone Cardiology Associates

🇺🇸

Pawtucket, Rhode Island, United States

Tidewater Heart Specialists, Inc.,

🇺🇸

Hampton, Virginia, United States

Westchester Medical Group

🇺🇸

Scarsdale, New York, United States

Dela Clinic

🇺🇸

Lexington, Tennessee, United States

Columbia Cardiology Consultants

🇺🇸

West Columbia, South Carolina, United States

Cardiology Associates of Lakeview

🇺🇸

Fairfax, Virginia, United States

Gotham Cardiovascular Research

🇺🇸

New York, New York, United States

Northeast Ohio Cardiovascular Specialists

🇺🇸

Akron, Ohio, United States

Sanger Clinic

🇺🇸

Charlotte, North Carolina, United States

Carolina Cardiology Associates

🇺🇸

High Point, North Carolina, United States

North West Ohio Cardiology Consultants

🇺🇸

Toledo, Ohio, United States

The Heart Group, Ltd

🇺🇸

Lancaster, Pennsylvania, United States

Cardiovascular Clinic, Inc.

🇺🇸

Parma, Ohio, United States

The Cardiovascular Group

🇺🇸

Fairfax, Virginia, United States

Cardiology Associates of Southeastern PA

🇺🇸

Wynnewood, Pennsylvania, United States

Bryce Morrice MD and Debra Heldman MD Inc

🇺🇸

Newark, Ohio, United States

Tyler Cardiovascular Consultants

🇺🇸

Tyler, Texas, United States

University Associates in Cardiology

🇺🇸

Burlington, Vermont, United States

Abington Medical Specialists

🇺🇸

Abington, Pennsylvania, United States

Schuster Cardiology Associates

🇺🇸

Kettering, Ohio, United States

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

Heart and Vascular Center of Bradenton

🇺🇸

Bradenton, Florida, United States

York Hospital

🇺🇸

York, Pennsylvania, United States

Heart Place North Arlington

🇺🇸

Arlington, Texas, United States

Cardiovascular Associates

🇺🇸

Kissimmee, Florida, United States

Owensboro Heart and Vascular

🇺🇸

Owensboro, Kentucky, United States

Southeastern Heart and Vascular

🇺🇸

Greensboro, North Carolina, United States

Cardiovascular Associates of Glenbrook and Evanston, LLC

🇺🇸

Glenview, Illinois, United States

Freeman Heart Institute

🇺🇸

Joplin, Missouri, United States

Southern New Jersey Cardiac Specialists

🇺🇸

Voorhees, New Jersey, United States

Peninsula Cardiology

🇺🇸

Salisbury, Maryland, United States

Heart Center of Southern Maryland

🇺🇸

Clinton, Maryland, United States

Arundel Heart Associates

🇺🇸

Glen Burnie, Maryland, United States

Muhammed H. Zahra

🇺🇸

Cleveland, Ohio, United States

Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

Doctors Hospital Heart Failure Clinic

🇺🇸

Columbus, Ohio, United States

Miami Cardiology Group

🇺🇸

Miami, Florida, United States

St. Vincent's Hospital

🇺🇸

Indianapolis, Indiana, United States

Methodist Hospital

🇺🇸

Indianapolis, Indiana, United States

St. Vincent's Hospital Indianapolis

🇺🇸

Indianapolis, Indiana, United States

Comprehensive Heart Care, PA

🇺🇸

Houston, Texas, United States

Cardiology Consultants of Houston

🇺🇸

Houston, Texas, United States

Cardiology Clinic of San Antonio

🇺🇸

San Antonio, Texas, United States

Wilford Hall Medical Center

🇺🇸

San Antonio, Texas, United States

Mid America Cardiology

🇺🇸

Kansas City, Kansas, United States

Cardiology Consultants

🇺🇸

Topeka, Kansas, United States

California Pacific Cardiovascular Medical

🇺🇸

San Francisco, California, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

Dartmouth-Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

Mercy Cardiology

🇺🇸

Saint Louis, Missouri, United States

Cardiovascular Associates of Montclair

🇺🇸

Birmingham, Alabama, United States

Maryland Heart, PC

🇺🇸

Bethesda, Maryland, United States

Island Cardiac Specialists

🇺🇸

Mineola, New York, United States

St. Vincent's Hospital,

🇺🇸

Indianapolis, Indiana, United States

Indian River Cardiovascular Associate

🇺🇸

Vero Beach, Florida, United States

Heart Center of Eastern Carolina

🇺🇸

New Bern, North Carolina, United States

Pinehurst Cardiology Consultants

🇺🇸

Pinehurst, North Carolina, United States

Vazzana and Bogin Cardiology Associates

🇺🇸

Staten Island, New York, United States

Cardiology Associates

🇺🇸

Myrtle Beach, South Carolina, United States

Cardiovascular Associates of Mesa

🇺🇸

Mesa, Arizona, United States

Heart Care, PC

🇺🇸

Scottsdale, Arizona, United States

Southern Arizona VA Health Care System

🇺🇸

Tucson, Arizona, United States

Central Arkansas Cardiovascular Institute

🇺🇸

Hot Springs, Arkansas, United States

St. Jude Heritage Medical Group

🇺🇸

Fullerton, California, United States

Veterans Administration Hospital

🇺🇸

Los Angeles, California, United States

Arkansas Cardiology Clinic

🇺🇸

Little Rock, Arkansas, United States

OMNI

🇺🇸

Melbourne, Florida, United States

Scripps Clinic Green Hospital

🇺🇸

La Jolla, California, United States

Cardiology Consultants Medical Group

🇺🇸

Tarzana, California, United States

Clark and Daughtrey Medical Group

🇺🇸

Lakeland, Florida, United States

Cardiology Consultants, PA

🇺🇸

Spartanburg, South Carolina, United States

St. Luke's Idaho Cardiology Associates

🇺🇸

Boise, Idaho, United States

MidAmerica Cardiovascular Consultants

🇺🇸

Frankfort, Illinois, United States

Heart Care Center of Illinois

🇺🇸

Blue Island, Illinois, United States

Heart Clinic of Louisiana

🇺🇸

Marrero, Louisiana, United States

Consultants in Cardiology

🇺🇸

Farmington Hills, Michigan, United States

St. Paul Cardiology

🇺🇸

Saint Paul, Minnesota, United States

Merrimack Valley Cardiology

🇺🇸

Chelmsford, Massachusetts, United States

SUNY Downstate Medical Center

🇺🇸

Brooklyn, New York, United States

Westwood Cardiology

🇺🇸

Westwood, New Jersey, United States

Albany Associates in Cardiology,

🇺🇸

Albany, New York, United States

Southbay Cardiology

🇺🇸

West Islip, New York, United States

Meritcare Medical Center

🇺🇸

Fargo, North Dakota, United States

Asheville Cardiology Associates

🇺🇸

Asheville, North Carolina, United States

Heart Center of Eastern Carolina,

🇺🇸

New Bern, North Carolina, United States

The Heart Institute of Northwest Ohio

🇺🇸

Lima, Ohio, United States

Central Bucks Specialists, Ltd.,

🇺🇸

Doylestown, Pennsylvania, United States

Associated Cardiologists

🇺🇸

Harrisburg, Pennsylvania, United States

Sumter Medical Consultants

🇺🇸

Sumter, South Carolina, United States

Upstate Cardiology

🇺🇸

Greenville, South Carolina, United States

University of Texas South Western Medical Center at Dallas

🇺🇸

Dallas, Texas, United States

Cardiology Associates of Green Bay

🇺🇸

Green Bay, Wisconsin, United States

Florida Heart Group

🇺🇸

Orlando, Florida, United States

Louisville Cardiology Medical Group P.S

🇺🇸

Louisville, Kentucky, United States

Medical Center Cardiologists P.S.C

🇺🇸

Louisville, Kentucky, United States

Medical University of South

🇺🇸

Charleston, South Carolina, United States

Pacific Cardiology

🇺🇸

Honolulu, Hawaii, United States

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