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

January 29, 2019 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

34810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Heart failure patients in outpatient cardiology practices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Time Frame: 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.	24 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Time Frame: 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.	24 months
Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. Time Frame: 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.	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. Time Frame: 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.	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. Time Frame: 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.	baseline and 18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

Study Chair: Gregg Fonarow, MD, University of California at Los Angeles
Study Chair: Clyde Yancy, MD, UT Southwestern Medical Center at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 15, 2006

First Submitted That Met QC Criteria