NCT00303979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34,810

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

144 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

December 27, 2012

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

4.3 years

First QC Date

March 15, 2006

Results QC Date

November 21, 2012

Last Update Submit

January 29, 2019

Conditions

Keywords

Systolic Heart FailureQuality of CareOutcomesEvidence-based GuidelinesRecommended Therapies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.

    24 months

  • 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

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Heart failure patients in outpatient cardiology practices

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (144)

Cardiovascular Associates of Montclair

Birmingham, Alabama, 36608, United States

Location

Cardiology Associates

Mobile, Alabama, 36608, United States

Location

Cardiovascular Associates of Mesa

Mesa, Arizona, 85205, United States

Location

Heart Care, PC

Scottsdale, Arizona, 85258, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Central Arkansas Cardiovascular Institute

Hot Springs, Arkansas, 71913, United States

Location

Arkansas Cardiology Clinic

Little Rock, Arkansas, 72202, United States

Location

St. Jude Heritage Medical Group

Fullerton, California, 92835, United States

Location

Scripps Clinic Green Hospital

La Jolla, California, 92037, United States

Location

Veterans Administration Hospital

Los Angeles, California, 92357, United States

Location

University Cardiovascular Medical Group

Los Angeles, California, 94115, United States

Location

Cardio-Pulmonary Associates

Monterey, California, 93940, United States

Location

Temecula Valley Cardiology

Murrieta, California, 92562, United States

Location

California Pacific Cardiovascular Medical

San Francisco, California, 94115, United States

Location

East Bay Cardiology

San Pablo, California, 94803, United States

Location

Cardiology Consultants Medical Group

Tarzana, California, 91335, United States

Location

Medical Center of the Rockies

Fort Collins, Colorado, 80521, United States

Location

Connecticut Heart & Vascular Center

Bridgeport, Connecticut, 06606, United States

Location

Cardiology Consultants, PA

Newark, Delaware, 19702, United States

Location

Heart and Vascular Center of Bradenton

Bradenton, Florida, 34209, United States

Location

Clearwater Cardiovascular & Intervention

Clearwater, Florida, 33756, United States

Location

Mahesh Amin, MD PA

Clearwater, Florida, 33756, United States

Location

Pasco Cardiology

Hudson, Florida, 34667, United States

Location

Cardiovascular Associates

Kissimmee, Florida, 34741, United States

Location

Clark and Daughtrey Medical Group

Lakeland, Florida, 33803, United States

Location

OMNI

Melbourne, Florida, 32901, United States

Location

Miami Cardiology Group

Miami, Florida, 33176, United States

Location

Florida Heart Group

Orlando, Florida, 32803, United States

Location

Cardiology Associates

Port Charlotte, Florida, 33952, United States

Location

Cardiovascular Consultants,

Tamarac, Florida, 33309, United States

Location

Indian River Cardiovascular Associate

Vero Beach, Florida, 32960, United States

Location

Florida Medical Clinic

Zephyrhills, Florida, 33542, United States

Location

Cardiology of Atlanta

Atlanta, Georgia, 30342, United States

Location

Northside Cardiology

Atlanta, Georgia, 30342, United States

Location

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

Southcoast Cardiology

Savannah, Georgia, 31406, United States

Location

Pacific Cardiology

Honolulu, Hawaii, 96817, United States

Location

St. Luke's Idaho Cardiology Associates

Boise, Idaho, 83702, United States

Location

Heart Care Center of Illinois

Blue Island, Illinois, 60406, United States

Location

MidAmerica Cardiovascular Consultants

Frankfort, Illinois, 60453, United States

Location

Cardiovascular Associates of Glenbrook and Evanston, LLC

Glenview, Illinois, 60026, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46201, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

St. Vincent's Hospital Indianapolis

Indianapolis, Indiana, 46278, United States

Location

St. Vincent's Hospital,

Indianapolis, Indiana, 46278, United States

Location

Iowa Heart Center PC,

West Des Moines, Iowa, 50266, United States

Location

Mid America Cardiology

Kansas City, Kansas, 66102, United States

Location

Cardiology Consultants

Topeka, Kansas, 66102, United States

Location

Cardiovascular Consultants of Kansas

Wichita, Kansas, 67226, United States

Location

Louisville Cardiology Medical Group P.S

Louisville, Kentucky, 40026, United States

Location

Medical Center Cardiologists P.S.C

Louisville, Kentucky, 40201, United States

Location

Louisville Cardiology Medical Group P.S

Louisville, Kentucky, 40207, United States

Location

Owensboro Heart and Vascular

Owensboro, Kentucky, 42303, United States

Location

Tchefuncte Cardiovascular Associates,

Covington, Louisiana, 70433, United States

Location

Heart Clinic of Louisiana

Marrero, Louisiana, 70072, United States

Location

Maryland Heart, PC

Bethesda, Maryland, 20817, United States

Location

Heart Center of Southern Maryland

Clinton, Maryland, 20735, United States

Location

Arundel Heart Associates

Glen Burnie, Maryland, 21061, United States

Location

Peninsula Cardiology

Salisbury, Maryland, 21804, United States

Location

Primary Care Specialists Inc

Ayer, Massachusetts, 01432, United States

Location

Merrimack Valley Cardiology

Chelmsford, Massachusetts, 01824, United States

Location

Harbor Medical AssociatesSo Weymouth

Weymouth, Massachusetts, 02190, United States

Location

Consultants in Cardiology

Farmington Hills, Michigan, 48331, United States

Location

Cardiovascular Consultants PC

Rochester, Michigan, 48312, United States

Location

Eastside Cardiology, Roseville

Roseville, Michigan, 48066, United States

Location

St. Paul Cardiology

Saint Paul, Minnesota, 55102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Missouri Cardiovascular Specialists

Columbia, Missouri, 65201, United States

Location

University Hospital Healthcare

Columbia, Missouri, 65210, United States

Location

Freeman Heart Institute

Joplin, Missouri, 64804, United States

Location

Mercy Cardiology

St Louis, Missouri, 63101, United States

Location

Cardiology Diagnostics, Ltd,

St Louis, Missouri, 63131, United States

Location

Cardiac Associates of New Hampshire

Concord, New Hampshire, 03303, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Medicor

Bridgewater, New Jersey, 08807, United States

Location

Cross County Cardiology

Edgewater, New Jersey, 07020, United States

Location

Heart-Lung Center

Hawthorne, New Jersey, 07506-1919, United States

Location

Southern New Jersey Cardiac Specialists

Voorhees Township, New Jersey, 08043, United States

Location

Diagnostic and Clinical Cardiologists

West Orange, New Jersey, 07052, United States

Location

Westwood Cardiology

Westwood, New Jersey, 07675, United States

Location

Albany Associates in Cardiology,

Albany, New York, 12205, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Cardiology Associates of Brooklyn

Brooklyn, New York, 11219, United States

Location

United Medical Associates

Brooklyn, New York, 11219, United States

Location

Concorde Medical Group/NYU Hospital

Manhattan, New York, 10001, United States

Location

Island Cardiac Specialists

Mineola, New York, 11501, United States

Location

Island Cardiac Specialist

Mineola, New York, 11501, United States

Location

Gotham Cardiovascular Research

New York, New York, 10001, United States

Location

Westchester Medical Group

Scarsdale, New York, 10583, United States

Location

Vazzana and Bogin Cardiology Associates

Staten Island, New York, 10305, United States

Location

Cardiology PC

Syracuse, New York, 13210, United States

Location

Southbay Cardiology

West Islip, New York, 11795, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

Sanger Clinic

Charlotte, North Carolina, 28202, United States

Location

Carolina Heart Specialists

Gastonia, North Carolina, 28054, United States

Location

Southeastern Heart and Vascular

Greensboro, North Carolina, 27403, United States

Location

Hickory Cardiology

Hickory, North Carolina, 28602, United States

Location

Carolina Cardiology Associates

High Point, North Carolina, 27262, United States

Location

Heart Center of Eastern Carolina,

New Bern, North Carolina, 28562, United States

Location

Heart Center of Eastern Carolina

New Bern, North Carolina, 28562, United States

Location

Pinehurst Cardiology Consultants

Pinehurst, North Carolina, 28370, United States

Location

Pinehurst Cardiology Consultants

Pinehurst, North Carolina, 28374, United States

Location

Raleigh Cardiology

Raleigh, North Carolina, 27610, United States

Location

Meritcare Medical Center

Fargo, North Dakota, 58122, United States

Location

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, 44301, United States

Location

Muhammed H. Zahra

Cleveland, Ohio, 44125, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Doctors Hospital Heart Failure Clinic

Columbus, Ohio, 43228, United States

Location

Schuster Cardiology Associates

Kettering, Ohio, 45336, United States

Location

The Heart Institute of Northwest Ohio

Lima, Ohio, 45801, United States

Location

Bryce Morrice MD and Debra Heldman MD Inc

Newark, Ohio, 43055, United States

Location

Cardiovascular Clinic, Inc.

Parma, Ohio, 44129, United States

Location

North West Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Abington Medical Specialists

Abington, Pennsylvania, 19001, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Central Bucks Specialists, Ltd.,

Doylestown, Pennsylvania, 18901, United States

Location

Associated Cardiologists

Harrisburg, Pennsylvania, 17103, United States

Location

The Heart Group, Ltd

Lancaster, Pennsylvania, 17603, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19129, United States

Location

Cardiology Associates of Southeastern PA

Wynnewood, Pennsylvania, 19064, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Blackstone Cardiology Associates

Pawtucket, Rhode Island, 02860, United States

Location

Medical University of South

Charleston, South Carolina, 29406, United States

Location

Upstate Cardiology

Greenville, South Carolina, 29605, United States

Location

Cardiology Associates

Myrtle Beach, South Carolina, 29572, United States

Location

Cardiology Consultants, PA

Spartanburg, South Carolina, 29301, United States

Location

Sumter Medical Consultants

Sumter, South Carolina, 29150, United States

Location

Columbia Cardiology Consultants

West Columbia, South Carolina, 29204, United States

Location

Sutherland Clinic

Germantown, Tennessee, 38119, United States

Location

Dela Clinic

Lexington, Tennessee, 38351, United States

Location

Heart Place North Arlington

Arlington, Texas, 75284, United States

Location

University of Texas South Western Medical Center at Dallas

Dallas, Texas, 75201, United States

Location

Comprehensive Heart Care, PA

Houston, Texas, 77024, United States

Location

Cardiology Consultants of Houston

Houston, Texas, 77030, United States

Location

Legacy Heart Center

Plano, Texas, 75024, United States

Location

Cardiology Clinic of San Antonio

San Antonio, Texas, 78229, United States

Location

Wilford Hall Medical Center

San Antonio, Texas, 78229, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

University Associates in Cardiology

Burlington, Vermont, 05401, United States

Location

Cardiology Associates of Lakeview

Fairfax, Virginia, 05454, United States

Location

The Cardiovascular Group

Fairfax, Virginia, 22031, United States

Location

Tidewater Heart Specialists, Inc.,

Hampton, Virginia, 23666, United States

Location

Cardiology Associates of Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heart FailureMyocardial InfarctionVentricular Dysfunction, LeftHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisVentricular Dysfunction

Results Point of Contact

Title
IMPROVE HF, Clinical Research Specialist
Organization
Medtronic Cardiac Rhythm Disease Management

Study Officials

  • Gregg Fonarow, MD

    University of California at Los Angeles

    STUDY CHAIR
  • Clyde Yancy, MD

    UT Southwestern Medical Center at Dallas

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

May 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 31, 2019

Results First Posted

December 27, 2012

Record last verified: 2019-01

Locations