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.

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

Heart Failure, Congestive

Myocardial Infarction

Ventricular Dysfunction, Left

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.

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

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.

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.

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.

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.

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.

Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months

6 Month Cohort: Approximately 10,000 patients reviewed at single time point

18 Month Cohort: Approximately 10,000 patients reviewed at single time point

Cardiovascular Associates of Montclair

Cardiology Associates

Cardiovascular Associates of Mesa

Heart Care, PC

Southern Arizona VA Health Care System

Central Arkansas Cardiovascular Institute

Arkansas Cardiology Clinic

St. Jude Heritage Medical Group

Scripps Clinic Green Hospital

Veterans Administration Hospital

University Cardiovascular Medical Group

Cardio-Pulmonary Associates

Temecula Valley Cardiology

California Pacific Cardiovascular Medical

East Bay Cardiology

Cardiology Consultants Medical Group

Medical Center of the Rockies

Connecticut Heart & Vascular Center

Cardiology Consultants, PA

Heart and Vascular Center of Bradenton

Clearwater Cardiovascular & Intervention

Mahesh Amin, MD PA

Pasco Cardiology

Cardiovascular Associates

Clark and Daughtrey Medical Group

OMNI

Miami Cardiology Group

Florida Heart Group

Cardiovascular Consultants,

Indian River Cardiovascular Associate

Florida Medical Clinic

Cardiology of Atlanta

Northside Cardiology

Northeast Georgia Heart Center

Southcoast Cardiology

Pacific Cardiology

St. Luke's Idaho Cardiology Associates

Heart Care Center of Illinois

MidAmerica Cardiovascular Consultants

Cardiovascular Associates of Glenbrook and Evanston, LLC

St. Vincent's Hospital

Methodist Hospital

St. Vincent's Hospital Indianapolis

St. Vincent's Hospital,

Iowa Heart Center PC,

Mid America Cardiology

Cardiology Consultants

Cardiovascular Consultants of Kansas

Louisville Cardiology Medical Group P.S

Medical Center Cardiologists P.S.C

Owensboro Heart and Vascular

Tchefuncte Cardiovascular Associates,

Heart Clinic of Louisiana

Maryland Heart, PC

Heart Center of Southern Maryland

Arundel Heart Associates

Peninsula Cardiology

Primary Care Specialists Inc

Merrimack Valley Cardiology

Harbor Medical AssociatesSo Weymouth

Consultants in Cardiology

Cardiovascular Consultants PC

Eastside Cardiology, Roseville

St. Paul Cardiology

University of Mississippi Medical Center

Missouri Cardiovascular Specialists

University Hospital Healthcare

Freeman Heart Institute

Mercy Cardiology

Cardiology Diagnostics, Ltd,

Cardiac Associates of New Hampshire

Dartmouth-Hitchcock Medical Center

Medicor

Cross County Cardiology

Heart-Lung Center

Southern New Jersey Cardiac Specialists

Diagnostic and Clinical Cardiologists

Westwood Cardiology

Albany Associates in Cardiology,

SUNY Downstate Medical Center

Cardiology Associates of Brooklyn

United Medical Associates

Concorde Medical Group/NYU Hospital

Island Cardiac Specialists

Island Cardiac Specialist

Gotham Cardiovascular Research

Westchester Medical Group

Vazzana and Bogin Cardiology Associates

Cardiology PC

Southbay Cardiology

Asheville Cardiology Associates

Sanger Clinic

Carolina Heart Specialists

Southeastern Heart and Vascular

Hickory Cardiology

Carolina Cardiology Associates

Heart Center of Eastern Carolina,

Adverse events were not collected for this study.

Cohort A: The charts of 15,177 patients were reviewed at baseline, 12 months and 24 months. The principal investigator and HF nurse of the study sites attended an educational workshop at baseline, 12 and 24 months as well where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort A is a longitudinal cohort.

Cohort A (Baseline, 12 and 24 Months)

Cohort B: The charts of 9,992 patients were reviewed at 6 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort B is a single time point cohort.

Cohort B (6 Months)

Cohort C: The charts of 9,641 patients were reviewed at 18 months. The principal investigator and HF nurse of the study sites attended an educational workshop at the same time where they were provided with tools meant to improve HF care at their practices. The tools included tip cards, worksheets, and patient education materials. Cohort C is a single time point cohort.

Cohort C (18 Months)

Total

Age, Continuous

<=64 years

Between 64 and 76 years

>76 years

Missing

Age, Customized

Female

Male

Sex/Gender, Customized

United States

Region of Enrollment

IMPROVE HF, Clinical Research Specialist

Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).

Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.

Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.

Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.

Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).

Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.

Performance Measure #7: relative change in % of eligible patients with HF education.

Performance Measure 1: ACEI/ARB

Performance Measure 2: Beta-blocker

Performance Measure 3: Aldosterone antagonist

Performance Measure 4: Anticoagulation for AF

Performance Measure 5: CRT-P/CRT-D

Performance Measure 6: ICD/CRT-D

Performance Measure 7: HF education

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.

For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. This arm includes all the atients at baseline. Percentage of patients who were eligible for a performance measure that were treated by it at baseline was calculated.

Cohort A (at Baseline)

For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. This arm includes the completers, i.e. patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months. Percentage of the patients who were eligible for a performance measure that were treated by it at the 24 months was calculated.

Cohort A (at 24 Months)

For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. This arm includes the completers, i.e. patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months. The relative changes in the percentages from 24 months to baseline were calculated for the 7 performance measures.

Cohort A (Relative Change 24 Months vs. Baseline)

167 practices contributed data to the baseline chart review. Twelve of the practices withdrew from the study prior to the next chart review milestone. 155 of those practices' data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop.

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.

>=20% relative change in 2 or more measures

In this analysis, 167 practices contributed data to the baseline chart review of Cohort A. Of them, 12 practices withdrew from the study prior to the next chart review milestone. Therefore, 155 practices' data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop. Correspondingly there were 7605 patients whose chart review was completed at both baseline and 24 months.

Practice Sites in Cohort A

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.

Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.

Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.

Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.

Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.

Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.

Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.

Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.

Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.

Composite Score

Cohort A at baseline included 15177 patients from 167 study sites (practices).

Cohort A at 24 months included 7605 patients from 155 study sites (practices).

The ralative changes in performance measures and compsite score at 24 months compared to baseline were calculated based on 155 study sites that involved 7605 patients.

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

Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.

Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.

Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.

Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.

Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.

Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.

Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.

Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.

In this analysis, data of Cohort A at baseline were used. This included 15177 patients from 167 cardiology practices.

Cohort A: Baseline

In this analysis, data of Cohort B (i.e. 6 months single time point cohort) were used. This included 9992 patients from 154 cardiology practices.

Cohort B: 6 Months

The relative changes in performance measures and composite score of Cohort B (6 months) compared with those of Cohort A at baseline were calculated

Cohort B 6 Months vs. Cohort A Baseline (Relative Change)

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.

Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.

Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.

Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.

Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.

Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.

Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.

Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.

Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.

In this analysis, data of Cohort C (i.e. 18 months single time point cohort) were used. This included 9641 patients from 150 cardiology practices.

The relative changes in performance measures and composite score of Cohort C (18 months) compared with those of Cohort A at baseline were calculated.

Cohort C 18 Months vs. Cohort A Baseline (Relative Change)

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.

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?