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

Myocardial Infarction Clinical Trial

— IMPROVE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303979
• Other study ID #: 258
• Status: Completed
• Start date: May 2005
• Est. completion date: August 2009

Study information

• Verified date: January 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34810
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Infarction
• Myocardial Infarction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
United States	Abington Medical Specialists	Abington	Pennsylvania
United States	Northeast Ohio Cardiovascular Specialists	Akron	Ohio
United States	Albany Associates in Cardiology,	Albany	New York
United States	Heart Place North Arlington	Arlington	Texas
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Cardiology of Atlanta	Atlanta	Georgia
United States	Northside Cardiology	Atlanta	Georgia
United States	Primary Care Specialists Inc	Ayer	Massachusetts
United States	Maryland Heart, PC	Bethesda	Maryland
United States	Cardiovascular Associates of Montclair	Birmingham	Alabama
United States	Heart Care Center of Illinois	Blue Island	Illinois
United States	St. Luke's Idaho Cardiology Associates	Boise	Idaho
United States	Heart and Vascular Center of Bradenton	Bradenton	Florida
United States	Connecticut Heart & Vascular Center	Bridgeport	Connecticut
United States	Medicor	Bridgewater	New Jersey
United States	Cardiology Associates of Brooklyn	Brooklyn	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	United Medical Associates	Brooklyn	New York
United States	University Associates in Cardiology	Burlington	Vermont
United States	Medical University of South	Charleston	South Carolina
United States	Sanger Clinic	Charlotte	North Carolina
United States	Merrimack Valley Cardiology	Chelmsford	Massachusetts
United States	Clearwater Cardiovascular & Intervention	Clearwater	Florida
United States	Mahesh Amin, MD PA	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Muhammed H. Zahra	Cleveland	Ohio
United States	Heart Center of Southern Maryland	Clinton	Maryland
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	University Hospital Healthcare	Columbia	Missouri
United States	Doctors Hospital Heart Failure Clinic	Columbus	Ohio
United States	Cardiac Associates of New Hampshire	Concord	New Hampshire
United States	Tchefuncte Cardiovascular Associates,	Covington	Louisiana
United States	University of Texas South Western Medical Center at Dallas	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Central Bucks Specialists, Ltd.,	Doylestown	Pennsylvania
United States	Cross County Cardiology	Edgewater	New Jersey
United States	Cardiology Associates of Lakeview	Fairfax	Virginia
United States	The Cardiovascular Group	Fairfax	Virginia
United States	Meritcare Medical Center	Fargo	North Dakota
United States	Consultants in Cardiology	Farmington Hills	Michigan
United States	Medical Center of the Rockies	Fort Collins	Colorado
United States	MidAmerica Cardiovascular Consultants	Frankfort	Illinois
United States	St. Jude Heritage Medical Group	Fullerton	California
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Carolina Heart Specialists	Gastonia	North Carolina
United States	Sutherland Clinic	Germantown	Tennessee
United States	Arundel Heart Associates	Glen Burnie	Maryland
United States	Cardiovascular Associates of Glenbrook and Evanston, LLC	Glenview	Illinois
United States	Cardiology Associates of Green Bay	Green Bay	Wisconsin
United States	Southeastern Heart and Vascular	Greensboro	North Carolina
United States	Upstate Cardiology	Greenville	South Carolina
United States	Tidewater Heart Specialists, Inc.,	Hampton	Virginia
United States	Associated Cardiologists	Harrisburg	Pennsylvania
United States	Heart-Lung Center	Hawthorne	New Jersey
United States	Hickory Cardiology	Hickory	North Carolina
United States	Carolina Cardiology Associates	High Point	North Carolina
United States	Pacific Cardiology	Honolulu	Hawaii
United States	Central Arkansas Cardiovascular Institute	Hot Springs	Arkansas
United States	Cardiology Consultants of Houston	Houston	Texas
United States	Comprehensive Heart Care, PA	Houston	Texas
United States	Pasco Cardiology	Hudson	Florida
United States	Methodist Hospital	Indianapolis	Indiana
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	St. Vincent's Hospital Indianapolis	Indianapolis	Indiana
United States	St. Vincent's Hospital,	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Freeman Heart Institute	Joplin	Missouri
United States	Mid America Cardiology	Kansas City	Kansas
United States	Schuster Cardiology Associates	Kettering	Ohio
United States	Cardiovascular Associates	Kissimmee	Florida
United States	Scripps Clinic Green Hospital	La Jolla	California
United States	Clark and Daughtrey Medical Group	Lakeland	Florida
United States	The Heart Group, Ltd	Lancaster	Pennsylvania
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Dela Clinic	Lexington	Tennessee
United States	The Heart Institute of Northwest Ohio	Lima	Ohio
United States	Arkansas Cardiology Clinic	Little Rock	Arkansas
United States	University Cardiovascular Medical Group	Los Angeles	California
United States	Veterans Administration Hospital	Los Angeles	California
United States	Louisville Cardiology Medical Group P.S	Louisville	Kentucky
United States	Louisville Cardiology Medical Group P.S	Louisville	Kentucky
United States	Medical Center Cardiologists P.S.C	Louisville	Kentucky
United States	Concorde Medical Group/NYU Hospital	Manhattan	New York
United States	Heart Clinic of Louisiana	Marrero	Louisiana
United States	OMNI	Melbourne	Florida
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	Miami Cardiology Group	Miami	Florida
United States	Island Cardiac Specialist	Mineola	New York
United States	Island Cardiac Specialists	Mineola	New York
United States	Cardiology Associates	Mobile	Alabama
United States	Cardio-Pulmonary Associates	Monterey	California
United States	Temecula Valley Cardiology	Murrieta	California
United States	Cardiology Associates	Myrtle Beach	South Carolina
United States	Heart Center of Eastern Carolina	New Bern	North Carolina
United States	Heart Center of Eastern Carolina,	New Bern	North Carolina
United States	Gotham Cardiovascular Research	New York	New York
United States	Bryce Morrice MD and Debra Heldman MD Inc	Newark	Ohio
United States	Cardiology Consultants, PA	Newark	Delaware
United States	Florida Heart Group	Orlando	Florida
United States	Owensboro Heart and Vascular	Owensboro	Kentucky
United States	Cardiovascular Clinic, Inc.	Parma	Ohio
United States	Blackstone Cardiology Associates	Pawtucket	Rhode Island
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Pinehurst Cardiology Consultants	Pinehurst	North Carolina
United States	Pinehurst Cardiology Consultants	Pinehurst	North Carolina
United States	Legacy Heart Center	Plano	Texas
United States	Cardiology Associates	Port Charlotte	Florida
United States	Raleigh Cardiology	Raleigh	North Carolina
United States	Cardiovascular Consultants PC	Rochester	Michigan
United States	Eastside Cardiology, Roseville	Roseville	Michigan
United States	Cardiology Diagnostics, Ltd,	Saint Louis	Missouri
United States	Mercy Cardiology	Saint Louis	Missouri
United States	St. Paul Cardiology	Saint Paul	Minnesota
United States	Peninsula Cardiology	Salisbury	Maryland
United States	Cardiology Clinic of San Antonio	San Antonio	Texas
United States	Wilford Hall Medical Center	San Antonio	Texas
United States	California Pacific Cardiovascular Medical	San Francisco	California
United States	East Bay Cardiology	San Pablo	California
United States	Southcoast Cardiology	Savannah	Georgia
United States	Westchester Medical Group	Scarsdale	New York
United States	Heart Care, PC	Scottsdale	Arizona
United States	Cardiology Consultants, PA	Spartanburg	South Carolina
United States	Vazzana and Bogin Cardiology Associates	Staten Island	New York
United States	Sumter Medical Consultants	Sumter	South Carolina
United States	Cardiology PC	Syracuse	New York
United States	Cardiovascular Consultants,	Tamarac	Florida
United States	Cardiology Consultants Medical Group	Tarzana	California
United States	North West Ohio Cardiology Consultants	Toledo	Ohio
United States	Cardiology Consultants	Topeka	Kansas
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Tyler Cardiovascular Consultants	Tyler	Texas
United States	Indian River Cardiovascular Associate	Vero Beach	Florida
United States	Southern New Jersey Cardiac Specialists	Voorhees	New Jersey
United States	Columbia Cardiology Consultants	West Columbia	South Carolina
United States	Iowa Heart Center PC,	West Des Moines	Iowa
United States	Southbay Cardiology	West Islip	New York
United States	Diagnostic and Clinical Cardiologists	West Orange	New Jersey
United States	Westwood Cardiology	Westwood	New Jersey
United States	Harbor Medical AssociatesSo Weymouth	Weymouth	Massachusetts
United States	Cardiovascular Consultants of Kansas	Wichita	Kansas
United States	Cardiology Associates of Southeastern PA	Wynnewood	Pennsylvania
United States	York Hospital	York	Pennsylvania
United States	Florida Medical Clinic	Zephyrhills	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	24 Month
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.	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.	24 months
Secondary	Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.	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.	24 months
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.	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.	Baseline and 6 Months
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.	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.	baseline and 18 Months