IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF)
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Purpose
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.
| Condition |
|---|
|
Heart Failure, Congestive Myocardial Infarction Ventricular Dysfunction, Left |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting |
- To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline. [ Time Frame: 24 Month ] [ Designated as safety issue: No ]The percent of patients that conformed to each performance measure will be calculated at baseline and 24 months. Based on the definition of each performance measure as defined in the performance measure constructs, each performance measure's baseline percentage and 24 month percentage will be calculated. The change in percentages from baseline is the baseline percentage subtracted from the 24 month percentage. Each performance measure will be evaluated separately to determine whether there is a relative 20% or greater improvement from baseline. The difference in percentages from baseline to 24 months and associated 95% confidence intervals on the differences will be presented. The percent improvement from baseline for each performance measure will be tested using a large sample test (z-test) on a proportion.
- Evaluate the Proportion 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. [ Time Frame: Study Completion ] [ Designated as safety issue: No ]The proportion 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 will be presented.
- Observe the Relative Improvement From Baseline to 24M in Composite Score for the Aggregate Practices. [ Time Frame: 24 months ] [ Designated as safety issue: No ]Performance measure improvement for Composite Score analyzed at a practice level for Cohort A (longitudinal) will be presented.
- Observe the Relative Improvement From Baseline to 6M in Composite Score for the Aggregate Practices. [ Time Frame: 6 Month ] [ Designated as safety issue: No ]Performance measure improvement for Composite Score analyzed at a practice level for Cohort B (6 Month) will be presented.
- Observe the Relative Improvement From Baseline to 18M in Composite Score for the Aggregate Practices. [ Time Frame: 18 Month ] [ Designated as safety issue: No ]Performance measure improvement for Composite Score analyzed at a practice level for Cohort C (18 Month) will be presented.
| Enrollment: | 34810 |
| Study Start Date: | May 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Heart failure patients in outpatient cardiology practices
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Cardiovascular Associates of Montclair | |
| Birmingham, Alabama, United States, 36608 | |
| Cardiology Associates | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Cardiovascular Associates of Mesa | |
| Mesa, Arizona, United States, 85205 | |
| Heart Care, PC | |
| Scottsdale, Arizona, United States, 85258 | |
| Southern Arizona VA Health Care System | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Central Arkansas Cardiovascular Institute | |
| Hot Springs, Arkansas, United States, 71913 | |
| Arkansas Cardiology Clinic | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| St. Jude Heritage Medical Group | |
| Fullerton, California, United States, 92835 | |
| Scripps Clinic Green Hospital | |
| La Jolla, California, United States, 92037 | |
| University Cardiovascular Medical Group | |
| Los Angeles, California, United States, 94115 | |
| Veterans Administration Hospital | |
| Los Angeles, California, United States, 92357 | |
| Cardio-Pulmonary Associates | |
| Monterey, California, United States, 93940 | |
| Temecula Valley Cardiology | |
| Murrieta, California, United States, 92562 | |
| California Pacific Cardiovascular Medical | |
| San Francisco, California, United States, 94115 | |
| East Bay Cardiology | |
| San Pablo, California, United States, 94803 | |
| Cardiology Consultants Medical Group | |
| Tarzana, California, United States, 91335 | |
| United States, Colorado | |
| Medical Center of the Rockies | |
| Fort Collins, Colorado, United States, 80521 | |
| United States, Connecticut | |
| Connecticut Heart & Vascular Center | |
| Bridgeport,, Connecticut, United States, 06606 | |
| United States, Delaware | |
| Cardiology Consultants, PA | |
| Newark, Delaware, United States, 19702 | |
| United States, Florida | |
| Heart and Vascular Center of Bradenton | |
| Bradenton, Florida, United States, 34209 | |
| Clearwater Cardiovascular & Intervention | |
| Clearwater, Florida, United States, 33756 | |
| Mahesh Amin, MD PA | |
| Clearwater, Florida, United States, 33756 | |
| Pasco Cardiology | |
| Hudson, Florida, United States, 34667 | |
| Cardiovascular Associates | |
| Kissimmee, Florida, United States, 34741 | |
| Clark and Daughtrey Medical Group | |
| Lakeland, Florida, United States, 33803 | |
| OMNI | |
| Melbourne, Florida, United States, 32901 | |
| Miami Cardiology Group | |
| Miami, Florida, United States, 33176 | |
| Florida Heart Group | |
| Orlando, Florida, United States, 32803 | |
| Cardiology Associates | |
| Port Charlotte, Florida, United States, 33952 | |
| Cardiovascular Consultants, | |
| Tamarac, Florida, United States, 33309 | |
| Indian River Cardiovascular Associate | |
| Vero Beach, Florida, United States, 32960 | |
| Florida Medical Clinic | |
| Zephyrhills, Florida, United States, 33542 | |
| United States, Georgia | |
| Northside Cardiology | |
| Atlanta, Georgia, United States, 30342 | |
| Cardiology of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Northeast Georgia Heart Center | |
| Gainesville, Georgia, United States, 30501 | |
| Southcoast Cardiology | |
| Savannah, Georgia, United States, 31406 | |
| United States, Hawaii | |
| Pacific Cardiology | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Idaho | |
| St. Luke's Idaho Cardiology Associates | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| Heart Care Center of Illinois | |
| Blue Island, Illinois, United States, 60406 | |
| MidAmerica Cardiovascular Consultants | |
| Frankfort, Illinois, United States, 60453 | |
| Cardiovascular Associates of Glenbrook and Evanston, LLC | |
| Glenview, Illinois, United States, 60026 | |
| United States, Indiana | |
| St. Vincent's 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 | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Iowa Heart Center PC, | |
| West Des Moines, Iowa, United States, 50266 | |
| United States, Kansas | |
| Mid America Cardiology | |
| Kansas City, Kansas, United States, 66102 | |
| Cardiology Consultants | |
| Topeka, Kansas, United States, 66102 | |
| Cardiovascular Consultants of Kansas | |
| Wichita, Kansas, United States, 67226 | |
| United States, Kentucky | |
| Medical Center Cardiologists P.S.C | |
| Louisville, Kentucky, United States, 40201 | |
| Louisville Cardiology Medical Group P.S | |
| Louisville, Kentucky, United States, 40026 | |
| Louisville Cardiology Medical Group P.S | |
| Louisville, Kentucky, United States, 40207 | |
| Owensboro Heart and Vascular | |
| Owensboro, Kentucky, United States, 42303 | |
| United States, Louisiana | |
| Tchefuncte Cardiovascular Associates, | |
| Covington, Louisiana, United States, 70433 | |
| Heart Clinic of Louisiana | |
| Marrero, Louisiana, United States, 70072 | |
| United States, Maryland | |
| Maryland Heart, PC | |
| Bethesda, Maryland, United States, 20817 | |
| Heart Center of Southern Maryland | |
| Clinton, Maryland, United States, 20735 | |
| Arundel Heart Associates | |
| Glen Burnie, Maryland, United States, 21061 | |
| Peninsula Cardiology | |
| Salisbury, Maryland, United States, 21804 | |
| United States, Massachusetts | |
| Primary Care Specialists Inc | |
| Ayer, Massachusetts, United States, 01432 | |
| Merrimack Valley Cardiology | |
| Chelmsford, Massachusetts, United States, 01824 | |
| Harbor Medical AssociatesSo Weymouth | |
| Weymouth, Massachusetts, United States, 02190 | |
| United States, Michigan | |
| Consultants in Cardiology | |
| Farmington Hills, Michigan, United States, 48331 | |
| Cardiovascular Consultants PC | |
| Rochester, Michigan, United States, 48312 | |
| Eastside Cardiology, Roseville | |
| Roseville, Michigan, United States, 48066 | |
| United States, Minnesota | |
| St. Paul Cardiology | |
| St. Paul, Minnesota, United States, 55102 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Missouri Cardiovascular Specialists | |
| Columbia, Missouri, United States, 65201 | |
| University Hospital Healthcare | |
| Columbia, Missouri, United States, 65210 | |
| Freeman Heart Institute | |
| Joplin, Missouri, United States, 64804 | |
| Cardiology Diagnostics, Ltd, | |
| St. Louis, Missouri, United States, 63131 | |
| Mercy Cardiology | |
| St. Louis, Missouri, United States, 63101 | |
| United States, New Hampshire | |
| Cardiac Associates of New Hampshire | |
| Concord, New Hampshire, United States, 03303 | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03766 | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Medicor | |
| Bridgewater, New Jersey, United States, 08807 | |
| Cross County Cardiology | |
| Edgewater, New Jersey, United States, 07020 | |
| Heart-Lung Center | |
| Hawthorne, New Jersey, United States, 07506-1919 | |
| Southern New Jersey Cardiac Specialists | |
| Voorhees, New Jersey, United States, 08043 | |
| Diagnostic and Clinical Cardiologists | |
| West Orange, New Jersey, United States, 07052 | |
| Westwood Cardiology | |
| Westwood, New Jersey, United States, 07675 | |
| United States, New York | |
| Albany Associates in Cardiology, | |
| Albany, New York, United States, 12205 | |
| Cardiology Associates of Brooklyn | |
| Brooklyn, New York, United States, 11219 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| United Medical Associates | |
| Brooklyn, New York, United States, 11219 | |
| Concorde Medical Group/NYU Hospital | |
| Manhattan, New York, United States, 10001 | |
| Island Cardiac Specialists | |
| Mineola, New York, United States, 11501 | |
| Island Cardiac Specialist | |
| Mineola, New York, United States, 11501 | |
| Gotham Cardiovascular Research | |
| New York, New York, United States, 10001 | |
| Westchester Medical Group | |
| Scarsdale, New York, United States, 10583 | |
| Vazzana and Bogin Cardiology Associates | |
| Staten Island, New York, United States, 10305 | |
| Cardiology PC | |
| Syracuse, New York, United States, 13210 | |
| Southbay Cardiology | |
| West Islip, New York, United States, 11795 | |
| United States, North Carolina | |
| Asheville Cardiology Associates | |
| Asheville, North Carolina, United States, 28803 | |
| Sanger Clinic | |
| Charlotte, North Carolina, United States, 28202 | |
| Carolina Heart Specialists | |
| Gastonia, North Carolina, United States, 28054 | |
| Southeastern Heart and Vascular | |
| Greensboro, North Carolina, United States, 27403 | |
| Hickory Cardiology | |
| Hickory, North Carolina, United States, 28602 | |
| Carolina Cardiology Associates | |
| High Point, North Carolina, United States, 27262 | |
| Heart Center of Eastern Carolina, | |
| New Bern, North Carolina, United States, 28562 | |
| Heart Center of Eastern Carolina | |
| New Bern, North Carolina, United States, 28562 | |
| Pinehurst Cardiology Consultants | |
| Pinehurst, North Carolina, United States, 28370 | |
| Pinehurst Cardiology Consultants | |
| Pinehurst, North Carolina, United States, 28374 | |
| Raleigh Cardiology | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, North Dakota | |
| Meritcare Medical Center | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Northeast Ohio Cardiovascular Specialists | |
| Akron, Ohio, United States, 44301 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Muhammed H. Zahra | |
| Cleveland, Ohio, United States, 44125 | |
| Doctors Hospital Heart Failure Clinic | |
| Columbus, Ohio, United States, 43228 | |
| Schuster Cardiology Associates | |
| Kettering, Ohio, United States, 45336 | |
| The Heart Institute of Northwest Ohio | |
| Lima, Ohio, United States, 45801 | |
| Bryce Morrice MD and Debra Heldman MD Inc | |
| Newark, Ohio, United States, 43055 | |
| Cardiovascular Clinic, Inc. | |
| Parma, Ohio, United States, 44129 | |
| North West Ohio Cardiology Consultants | |
| Toledo, Ohio, United States, 43615 | |
| United States, Pennsylvania | |
| Abington Medical Specialists | |
| Abington, Pennsylvania, United States, 19001 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Central Bucks Specialists, Ltd., | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Associated Cardiologists | |
| Harrisburg, Pennsylvania, United States, 17103 | |
| The Heart Group, Ltd | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19129 | |
| Cardiology Associates of Southeastern PA | |
| Wynnewood, Pennsylvania, United States, 19064 | |
| York Hospital | |
| York, Pennsylvania, United States, 17403 | |
| United States, Rhode Island | |
| Blackstone Cardiology Associates | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| Medical University of South | |
| Charleston, South Carolina, United States, 29406 | |
| Upstate Cardiology | |
| Greenville, South Carolina, United States, 29605 | |
| Cardiology Associates | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| Cardiology Consultants, PA | |
| Spartanburg, South Carolina, United States, 29301 | |
| Sumter Medical Consultants | |
| Sumter, South Carolina, United States, 29150 | |
| Columbia Cardiology Consultants | |
| West Columbia, South Carolina, United States, 29204 | |
| United States, Tennessee | |
| Sutherland Clinic | |
| Germantown, Tennessee, United States, 38119 | |
| Dela Clinic | |
| Lexington, Tennessee, United States, 38351 | |
| United States, Texas | |
| Heart Place North Arlington | |
| Arlington, Texas, United States, 75284 | |
| University of Texas South Western Medical Center at Dallas | |
| Dallas, Texas, United States, 75201 | |
| Cardiology Consultants of Houston | |
| Houston, Texas, United States, 77030 | |
| Comprehensive Heart Care, PA | |
| Houston, Texas, United States, 77024 | |
| Legacy Heart Center | |
| Plano, Texas, United States, 75024 | |
| Cardiology Clinic of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Wilford Hall Medical Center | |
| San Antonio, Texas, United States, 78229 | |
| Tyler Cardiovascular Consultants | |
| Tyler, Texas, United States, 75701 | |
| United States, Vermont | |
| University Associates in Cardiology | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| The Cardiovascular Group | |
| Fairfax, Virginia, United States, 22031 | |
| Cardiology Associates of Lakeview | |
| Fairfax, Virginia, United States, 05454 | |
| Tidewater Heart Specialists, Inc., | |
| Hampton, Virginia, United States, 23666 | |
| United States, Wisconsin | |
| Cardiology Associates of Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Study Chair: | Gregg Fonarow, MD | University of California at Los Angeles |
| Study Chair: | Clyde Yancy, MD | UT Southwestern Medical Center at Dallas |
More Information
No publications provided by Medtronic Cardiac Rhythm Disease Management
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Cardiac Rhythm Disease Management |
| ClinicalTrials.gov Identifier: | NCT00303979 History of Changes |
| Other Study ID Numbers: | 258 |
| Study First Received: | March 15, 2006 |
| Results First Received: | November 21, 2012 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medtronic Cardiac Rhythm Disease Management:
|
Systolic Heart Failure Quality of Care Outcomes Evidence-based Guidelines Recommended Therapies |
Additional relevant MeSH terms:
|
Heart Failure Infarction Myocardial Infarction Ventricular Dysfunction, Left Ventricular Dysfunction Heart Diseases |
Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013