Clinical trial NCT00303979: IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
Official title: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Myocardial Infarction
Ventricular Dysfunction, Left
Keywords: Systolic Heart Failure
Quality of Care
Outcomes
Evidence-based Guidelines
Recommended Therapies
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-03-17
Enrollment: 34810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart failure patients in outpatient cardiology practices

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 24 Month
Secondary outcomes:
measure: 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.
timeFrame: 24 months
measure: Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.
timeFrame: 24 months
measure: 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.
timeFrame: Baseline and 6 Months
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.
timeFrame: baseline and 18 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates of Montclair
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates
state: Alabama
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Scottsdale
country: United States
facility: Heart Care, PC
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Cardiovascular Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Cardiology Clinic
state: Arkansas
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Green Hospital
state: California
city: Los Angeles
country: United States
facility: Veterans Administration Hospital
state: California
city: Los Angeles
country: United States
facility: University Cardiovascular Medical Group
state: California
city: Monterey
country: United States
facility: Cardio-Pulmonary Associates
state: California
city: Murrieta
country: United States
facility: Temecula Valley Cardiology
state: California
city: San Francisco
country: United States
facility: California Pacific Cardiovascular Medical
state: California
city: San Pablo
country: United States
facility: East Bay Cardiology
state: California
city: Tarzana
country: United States
facility: Cardiology Consultants Medical Group
state: California
city: Fort Collins
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Bridgeport
country: United States
facility: Connecticut Heart & Vascular Center
state: Connecticut
city: Newark
country: United States
facility: Cardiology Consultants, PA
state: Delaware
city: Bradenton
country: United States
facility: Heart and Vascular Center of Bradenton
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular & Intervention
state: Florida
city: Clearwater
country: United States
facility: Mahesh Amin, MD PA
state: Florida
city: Hudson
country: United States
facility: Pasco Cardiology
state: Florida
city: Kissimmee
country: United States
facility: Cardiovascular Associates
state: Florida
city: Lakeland
country: United States
facility: Clark and Daughtrey Medical Group
state: Florida
city: Melbourne
country: United States
facility: OMNI
state: Florida
city: Miami
country: United States
facility: Miami Cardiology Group
state: Florida
city: Orlando
country: United States
facility: Florida Heart Group
state: Florida
city: Port Charlotte
country: United States
facility: Cardiology Associates
state: Florida
city: Tamarac
country: United States
facility: Cardiovascular Consultants,
state: Florida
city: Vero Beach
country: United States
facility: Indian River Cardiovascular Associate
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Atlanta
country: United States
facility: Cardiology of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Northside Cardiology
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Savannah
country: United States
facility: Southcoast Cardiology
state: Georgia
city: Honolulu
country: United States
facility: Pacific Cardiology
state: Hawaii
city: Boise
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Blue Island
country: United States
facility: Heart Care Center of Illinois
state: Illinois
city: Frankfort
country: United States
facility: MidAmerica Cardiovascular Consultants
state: Illinois
city: Glenview
country: United States
facility: Cardiovascular Associates of Glenbrook and Evanston, LLC
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital Indianapolis
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital,
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center PC,
state: Iowa
city: Kansas City
country: United States
facility: Mid America Cardiology
state: Kansas
city: Topeka
country: United States
facility: Cardiology Consultants
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Consultants of Kansas
state: Kansas
city: Louisville
country: United States
facility: Louisville Cardiology Medical Group P.S
state: Kentucky
city: Louisville
country: United States
facility: Medical Center Cardiologists P.S.C
state: Kentucky
city: Louisville
country: United States
facility: Louisville Cardiology Medical Group P.S
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Heart and Vascular
state: Kentucky
city: Covington
country: United States
facility: Tchefuncte Cardiovascular Associates,
state: Louisiana
city: Marrero
country: United States
facility: Heart Clinic of Louisiana
state: Louisiana
city: Bethesda
country: United States
facility: Maryland Heart, PC
state: Maryland
city: Clinton
country: United States
facility: Heart Center of Southern Maryland
state: Maryland
city: Glen Burnie
country: United States
facility: Arundel Heart Associates
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Cardiology
state: Maryland
city: Ayer
country: United States
facility: Primary Care Specialists Inc
state: Massachusetts
city: Chelmsford
country: United States
facility: Merrimack Valley Cardiology
state: Massachusetts
city: Weymouth
country: United States
facility: Harbor Medical AssociatesSo Weymouth
state: Massachusetts
city: Farmington Hills
country: United States
facility: Consultants in Cardiology
state: Michigan
city: Rochester
country: United States
facility: Cardiovascular Consultants PC
state: Michigan
city: Roseville
country: United States
facility: Eastside Cardiology, Roseville
state: Michigan
city: Saint Paul
country: United States
facility: St. Paul Cardiology
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Columbia
country: United States
facility: University Hospital Healthcare
state: Missouri
city: Joplin
country: United States
facility: Freeman Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Cardiology
state: Missouri
city: Saint Louis
country: United States
facility: Cardiology Diagnostics, Ltd,
state: Missouri
city: Concord
country: United States
facility: Cardiac Associates of New Hampshire
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bridgewater
country: United States
facility: Medicor
state: New Jersey
city: Edgewater
country: United States
facility: Cross County Cardiology
state: New Jersey
city: Hawthorne
country: United States
facility: Heart-Lung Center
state: New Jersey
city: Voorhees
country: United States
facility: Southern New Jersey Cardiac Specialists
state: New Jersey
city: West Orange
country: United States
facility: Diagnostic and Clinical Cardiologists
state: New Jersey
city: Westwood
country: United States
facility: Westwood Cardiology
state: New Jersey
city: Albany
country: United States
facility: Albany Associates in Cardiology,
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Brooklyn
country: United States
facility: Cardiology Associates of Brooklyn
state: New York
city: Brooklyn
country: United States
facility: United Medical Associates
state: New York
city: Manhattan
country: United States
facility: Concorde Medical Group/NYU Hospital
state: New York
city: Mineola
country: United States
facility: Island Cardiac Specialists
state: New York
city: Mineola
country: United States
facility: Island Cardiac Specialist
state: New York
city: New York
country: United States
facility: Gotham Cardiovascular Research
state: New York
city: Scarsdale
country: United States
facility: Westchester Medical Group
state: New York
city: Staten Island
country: United States
facility: Vazzana and Bogin Cardiology Associates
state: New York
city: Syracuse
country: United States
facility: Cardiology PC
state: New York
city: West Islip
country: United States
facility: Southbay Cardiology
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Clinic
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Heart Specialists
state: North Carolina
city: Greensboro
country: United States
facility: Southeastern Heart and Vascular
state: North Carolina
city: Hickory
country: United States
facility: Hickory Cardiology
state: North Carolina
city: High Point
country: United States
facility: Carolina Cardiology Associates
state: North Carolina
city: New Bern
country: United States
facility: Heart Center of Eastern Carolina,
state: North Carolina
city: New Bern
country: United States
facility: Heart Center of Eastern Carolina
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Cardiology Consultants
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Cardiology Consultants
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Cardiology
state: North Carolina
city: Fargo
country: United States
facility: Meritcare Medical Center
state: North Dakota
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Cleveland
country: United States
facility: Muhammed H. Zahra
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital Heart Failure Clinic
state: Ohio
city: Kettering
country: United States
facility: Schuster Cardiology Associates
state: Ohio
city: Lima
country: United States
facility: The Heart Institute of Northwest Ohio
state: Ohio
city: Newark
country: United States
facility: Bryce Morrice MD and Debra Heldman MD Inc
state: Ohio
city: Parma
country: United States
facility: Cardiovascular Clinic, Inc.
state: Ohio
city: Toledo
country: United States
facility: North West Ohio Cardiology Consultants
state: Ohio
city: Abington
country: United States
facility: Abington Medical Specialists
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Doylestown
country: United States
facility: Central Bucks Specialists, Ltd.,
state: Pennsylvania
city: Harrisburg
country: United States
facility: Associated Cardiologists
state: Pennsylvania
city: Lancaster
country: United States
facility: The Heart Group, Ltd
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Wynnewood
country: United States
facility: Cardiology Associates of Southeastern PA
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Pawtucket
country: United States
facility: Blackstone Cardiology Associates
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South
state: South Carolina
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Myrtle Beach
country: United States
facility: Cardiology Associates
state: South Carolina
city: Spartanburg
country: United States
facility: Cardiology Consultants, PA
state: South Carolina
city: Sumter
country: United States
facility: Sumter Medical Consultants
state: South Carolina
city: West Columbia
country: United States
facility: Columbia Cardiology Consultants
state: South Carolina
city: Germantown
country: United States
facility: Sutherland Clinic
state: Tennessee
city: Lexington
country: United States
facility: Dela Clinic
state: Tennessee
city: Arlington
country: United States
facility: Heart Place North Arlington
state: Texas
city: Dallas
country: United States
facility: University of Texas South Western Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Comprehensive Heart Care, PA
state: Texas
city: Houston
country: United States
facility: Cardiology Consultants of Houston
state: Texas
city: Plano
country: United States
facility: Legacy Heart Center
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Burlington
country: United States
facility: University Associates in Cardiology
state: Vermont
city: Fairfax
country: United States
facility: Cardiology Associates of Lakeview
state: Virginia
city: Fairfax
country: United States
facility: The Cardiovascular Group
state: Virginia
city: Hampton
country: United States
facility: Tidewater Heart Specialists, Inc.,
state: Virginia
city: Green Bay
country: United States
facility: Cardiology Associates of Green Bay
state: Wisconsin
Study officials:
affiliation: University of California at Los Angeles
name: Gregg Fonarow, MD
role: STUDY_CHAIR
affiliation: UT Southwestern Medical Center at Dallas
name: Clyde Yancy, MD
role: STUDY_CHAIR
References:
citation: Shukla A, Curtis AB, Mehra MR, Albert NM, Gheorghiade M, Heywood JT, Liu Y, O'Connor CM, Reynolds D, Walsh MN, Yancy CW, Fonarow GC. Factors associated with improvement in utilization of cardiac resynchronization therapy in eligible heart failure patients: findings from IMPROVE HF. Pacing Clin Electrophysiol. 2013 Apr;36(4):433-43. doi: 10.1111/pace.12090. Epub 2013 Feb 4.
citation: Barkoudah E, Skali H, Uno H, Solomon SD, Pfeffer MA. Mortality rates in trials of subjects with type 2 diabetes. J Am Heart Assoc. 2012 Feb;1(1):8-15. doi: 10.1161/JAHA.111.000059. Epub 2012 Feb 20.
citation: Reynolds D, Albert NM, Curtis AB, Gheorghiade M, Heywood JT, Mcbride ML, Inge PJ, Mehra MR, O'Connor CM, Walsh MN, Yancy CW, Fonarow GC. Race and improvements in the use of guideline-recommended therapies for patients with heart failure: findings from IMPROVE HF. J Natl Med Assoc. 2012 May-Jun;104(5-6):287-98. doi: 10.1016/s0027-9684(15)30156-5.
citation: Fonarow GC, Albert NM, Curtis AB, Gheorghiade M, Heywood JT, Liu Y, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. Associations between outpatient heart failure process-of-care measures and mortality. Circulation. 2011 Apr 19;123(15):1601-10. doi: 10.1161/CIRCULATIONAHA.110.989632. Epub 2011 Apr 4.
citation: Walsh MN, Yancy CW, Albert NM, Curtis AB, Gheorghiade M, Heywood JT, Inge PJ, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Fonarow GC. Equitable improvement for women and men in the use of guideline-recommended therapies for heart failure: findings from IMPROVE HF. J Card Fail. 2010 Dec;16(12):940-9. doi: 10.1016/j.cardfail.2010.07.250.
citation: Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Inge PJ, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF). Circulation. 2010 Aug 10;122(6):585-96. doi: 10.1161/CIRCULATIONAHA.109.934471. Epub 2010 Jul 26.
citation: Heywood JT, Fonarow GC, Yancy CW, Albert NM, Curtis AB, Gheorghiade M, Inge PJ, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Walsh MN. Comparison of medical therapy dosing in outpatients cared for in cardiology practices with heart failure and reduced ejection fraction with and without device therapy: report from IMPROVE HF. Circ Heart Fail. 2010 Sep;3(5):596-605. doi: 10.1161/CIRCHEARTFAILURE.109.912683. Epub 2010 Jul 15.
citation: Walsh MN, Yancy CW, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Fonarow GC. Electronic health records and quality of care for heart failure. Am Heart J. 2010 Apr;159(4):635-642.e1. doi: 10.1016/j.ahj.2010.01.006.
citation: Mehra MR, Yancy CW, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, O'Connor CM, Reynolds D, Walsh MN, Fonarow GC. Evidence of clinical practice heterogeneity in the use of implantable cardioverter-defibrillators in heart failure and post-myocardial infarction left ventricular dysfunction: Findings from IMPROVE HF. Heart Rhythm. 2009 Dec;6(12):1727-34. doi: 10.1016/j.hrthm.2009.08.022. Epub 2009 Aug 22.
citation: Curtis AB, Yancy CW, Albert NM, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Mehra MR, Oconnor CM, Reynolds D, Walsh MN, Fonarow GC. Cardiac resynchronization therapy utilization for heart failure: findings from IMPROVE HF. Am Heart J. 2009 Dec;158(6):956-64. doi: 10.1016/j.ahj.2009.10.011.