Heart Failure, Congestive, Myocardial Infarction, Ventricular Dysfunction, Left
Conditions
Keywords
Systolic Heart Failure, Quality of Care, Outcomes, Evidence-based Guidelines, Recommended Therapies
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.
Interventions
None listed
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
The study sites included outpatient cardiology practices in the United States. Patients diagnosed with heart failure or prior myocardial infarction or developed moderate-severe left ventricular dysfunction were included. Each cardiology practice had five chart reviews and an educational workshop as a part of the process improvement intervention.
Pre-assignment details
The study included 3 mutually exclusive patient cohorts. Patients in cohort A were reviewed at baseline, 12 and 24 months. This is also called the longitudinal cohort. Patients in cohort B and C were reviewed at 6 and 18 months, respectively. These two cohorts are referred to as the single time point cohorts.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A (Baseline, 12 and 24 Months) 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. | 15,177 |
| Cohort B (6 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. | 9,992 |
| Cohort C (18 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. | 9,641 |
| Total | 34,810 |
Baseline characteristics
| Characteristic | Cohort C (18 Months) | Cohort B (6 Months) | Cohort A (Baseline, 12 and 24 Months) | Total |
|---|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 13.6 | 68.3 years STANDARD_DEVIATION 13.2 | 68.7 years STANDARD_DEVIATION 13.2 | 68.4 years STANDARD_DEVIATION 13.3 |
| Age, Customized <=64 years | 3539 participants | 3606 participants | 5274 participants | 12419 participants |
| Age, Customized >76 years | 3010 participants | 3041 participants | 4748 participants | 10799 participants |
| Age, Customized Between 64 and 76 years | 3089 participants | 3344 participants | 5127 participants | 11560 participants |
| Age, Customized Missing | 3 participants | 1 participants | 28 participants | 32 participants |
| Region of Enrollment United States | 9641 participants | 9992 participants | 15177 participants | 34810 participants |
| Sex/Gender, Customized Female | 2827 participants | 2918 participants | 4383 participants | 10128 participants |
| Sex/Gender, Customized Male | 6814 participants | 7069 participants | 10787 participants | 24670 participants |
| Sex/Gender, Customized Missing | 0 participants | 5 participants | 7 participants | 12 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 24 Month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A (at Baseline) | 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. | Performance Measure 5: CRT-P/CRT-D | 37.7 percentage of participants in aggregate |
| Cohort A (at Baseline) | 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. | Performance Measure 7: HF education | 61.8 percentage of participants in aggregate |
| Cohort A (at Baseline) | 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. | Performance Measure 6: ICD/CRT-D | 48.8 percentage of participants in aggregate |
| Cohort A (at Baseline) | 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. | Performance Measure 2: Beta-blocker | 86.2 percentage of participants in aggregate |
| Cohort A (at Baseline) | 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. | Performance Measure 1: ACEI/ARB | 79.8 percentage of participants in aggregate |
| Cohort A (at Baseline) | 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. | Performance Measure 3: Aldosterone antagonist | 34.4 percentage of participants in aggregate |
| Cohort A (at Baseline) | 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. | Performance Measure 4: Anticoagulation for AF | 68.6 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 5: CRT-P/CRT-D | 68.5 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 4: Anticoagulation for AF | 69.3 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 3: Aldosterone antagonist | 61.8 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 6: ICD/CRT-D | 79.1 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 1: ACEI/ARB | 86.5 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 7: HF education | 70.8 percentage of participants in aggregate |
| Cohort A (at 24 Months) | 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. | Performance Measure 2: Beta-blocker | 93.6 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 7: HF education | 14.7 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 1: ACEI/ARB | 8.4 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 2: Beta-blocker | 8.6 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 3: Aldosterone antagonist | 79.7 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 5: CRT-P/CRT-D | 81.9 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 6: ICD/CRT-D | 62.1 percentage of participants in aggregate |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 4: Anticoagulation for AF | 1.0 percentage of participants in aggregate |
Comparison: Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).p-value: <0.00195% CI: [7, 9.7]a large sample test (z-test)
Comparison: Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.p-value: <0.00195% CI: [7.7, 9.6]a large sample test (z-test)
Comparison: Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.p-value: <0.00195% CI: [70.5, 89]a large sample test (z-test)
Comparison: Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.p-value: 0.54695% CI: [-2.2, 4.2]a large sample test (z-test)
Comparison: Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).p-value: <0.00195% CI: [72.2, 91.7]a large sample test (z-test)
Comparison: Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.p-value: <0.00195% CI: [59.1, 65.1]a large sample test (z-test)
Comparison: Performance Measure #7: relative change in % of eligible patients with HF education.p-value: <0.00195% CI: [12.6, 16.8]a large sample test (z-test)
Secondary
Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.
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.
Time frame: 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 3: Aldosterone antagonist | 34.5 percentage | Standard Deviation 18.5 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 6: ICD/CRT-D | 50.1 percentage | Standard Deviation 17.5 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 4: Anticoagulation for AF | 68.0 percentage | Standard Deviation 16.1 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 5: CRT-P/CRT-D | 37.2 percentage | Standard Deviation 30.5 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Composite Score | 67.1 percentage | Standard Deviation 8.9 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 2: Beta-blocker | 86.0 percentage | Standard Deviation 10.8 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 1: ACEI/ARB | 78.3 percentage | Standard Deviation 11.5 |
| Cohort A (at Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 7: HF education | 59.5 percentage | Standard Deviation 23.7 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 3: Aldosterone antagonist | 60.3 percentage | Standard Deviation 25.9 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 1: ACEI/ARB | 85.1 percentage | Standard Deviation 10.6 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 2: Beta-blocker | 92.2 percentage | Standard Deviation 9.8 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 4: Anticoagulation for AF | 67.8 percentage | Standard Deviation 18 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 5: CRT-P/CRT-D | 66.3 percentage | Standard Deviation 29 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 6: ICD/CRT-D | 77.5 percentage | Standard Deviation 16.8 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 7: HF education | 72.1 percentage | Standard Deviation 24 |
| Cohort A (at 24 Months) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Composite Score | 79.0 percentage | Standard Deviation 9.3 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 1: ACEI/ARB | 19.4 percentage | Standard Deviation 128.9 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 6: ICD/CRT-D | 70.9 percentage | Standard Deviation 62.4 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 2: Beta-blocker | 7.6 percentage | Standard Deviation 16.1 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Composite Score | 19.2 percentage | Standard Deviation 18.1 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 4: Anticoagulation for AF | 1.0 percentage | Standard Deviation 28.5 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 7: HF education | 50.6 percentage | Standard Deviation 147.7 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 5: CRT-P/CRT-D | 48.4 percentage | Standard Deviation 62.3 |
| Cohort A (Relative Change 24 Months vs. Baseline) | Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices. | Performance Measure 3: Aldosterone antagonist | 30.0 percentage | Standard Deviation 33.8 |
Comparison: Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.p-value: 0.00495% CI: [-1.1, 39.8]t-test, 2 sided
Comparison: Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.p-value: <0.00195% CI: [5.1, 10.2]t-test, 2 sided
Comparison: Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.p-value: <0.00195% CI: [24.6, 35.5]t-test, 2 sided
Comparison: Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.p-value: 0.51395% CI: [-3.6, 5.5]t-test, 2 sided
Comparison: Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.p-value: <0.00195% CI: [37.9, 58.8]t-test, 2 sided
Comparison: Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.p-value: <0.00195% CI: [61, 80.8]t-test, 2 sided
Comparison: Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.p-value: <0.00195% CI: [27.1, 74.2]t-test, 2 sided
Comparison: Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.p-value: <0.00195% CI: [16.3, 22]t-test, 2 sided
Secondary
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.
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.
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A (at Baseline) | 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: ACEI/ARB | 15 Sites |
| Cohort A (at Baseline) | 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 2: Beta-blocker | 9 Sites |
| Cohort A (at Baseline) | 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 3: Aldosterone antagonist | 82 Sites |
| Cohort A (at Baseline) | 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 4: Anticoagulation for AF | 14 Sites |
| Cohort A (at Baseline) | 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 5: CRT-P/CRT-D | 83 Sites |
| Cohort A (at Baseline) | 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 6: ICD/CRT-D | 114 Sites |
| Cohort A (at Baseline) | 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 7: HF education | 59 Sites |
| Cohort A (at Baseline) | 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. | >=20% relative change in 2 or more measures | 123 Sites |
Secondary
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.
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.
Time frame: baseline and 18 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (at Baseline) | 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. | Performance Measure 1: ACEI/ARB | 78.7 percentage of participants | Standard Deviation 11.3 |
| Cohort A (at Baseline) | 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. | Performance Measure 2: Beta-blocker | 85.9 percentage of participants | Standard Deviation 10.9 |
| Cohort A (at Baseline) | 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. | Performance Measure 3: Aldosterone antagonist | 34.7 percentage of participants | Standard Deviation 18.7 |
| Cohort A (at Baseline) | 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. | Performance Measure 4: Anticoagulation for AF | 67.9 percentage of participants | Standard Deviation 15.8 |
| Cohort A (at Baseline) | 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. | Performance Measure 5: CRT-P/CRT-D | 37.6 percentage of participants | Standard Deviation 30.7 |
| Cohort A (at Baseline) | 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. | Performance Measure 6: ICD/CRT-D | 49.9 percentage of participants | Standard Deviation 17 |
| Cohort A (at Baseline) | 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. | Performance Measure 7: HF education | 59.4 percentage of participants | Standard Deviation 23.6 |
| Cohort A (at Baseline) | 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. | Composite Score | 67.1 percentage of participants | Standard Deviation 8.8 |
| Cohort A (at 24 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. | Performance Measure 3: Aldosterone antagonist | 36.6 percentage of participants | Standard Deviation 23.1 |
| Cohort A (at 24 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. | Performance Measure 7: HF education | 75.0 percentage of participants | Standard Deviation 22.6 |
| Cohort A (at 24 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. | Performance Measure 4: Anticoagulation for AF | 69.6 percentage of participants | Standard Deviation 17.1 |
| Cohort A (at 24 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. | Performance Measure 5: CRT-P/CRT-D | 43.5 percentage of participants | Standard Deviation 30.1 |
| Cohort A (at 24 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. | Performance Measure 6: ICD/CRT-D | 54.0 percentage of participants | Standard Deviation 17.2 |
| Cohort A (at 24 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. | Performance Measure 1: ACEI/ARB | 80.3 percentage of participants | Standard Deviation 12.2 |
| Cohort A (at 24 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. | Performance Measure 2: Beta-blocker | 91.8 percentage of participants | Standard Deviation 7 |
| Cohort A (at 24 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. | Composite Score | 73.2 percentage of participants | Standard Deviation 8.4 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 3: Aldosterone antagonist | 5.8 percentage of participants | Standard Deviation 58.3 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 2: Beta-blocker | 14.3 percentage of participants | Standard Deviation 87.7 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 1: ACEI/ARB | 10.5 percentage of participants | Standard Deviation 97.9 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 4: Anticoagulation for AF | 6.7 percentage of participants | Standard Deviation 38.3 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 7: HF education | 59.5 percentage of participants | Standard Deviation 158.5 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 6: ICD/CRT-D | 17.6 percentage of participants | Standard Deviation 51.3 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Performance Measure 5: CRT-P/CRT-D | 9.3 percentage of participants | Standard Deviation 59.7 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Composite Score | 10.6 percentage of participants | Standard Deviation 18.5 |
Comparison: Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.p-value: 0.1995% CI: [-5.3, 26.3]t-test, 2 sided
Comparison: Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.p-value: 0.04895% CI: [0.1, 28.4]t-test, 2 sided
Comparison: Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.p-value: 0.2495% CI: [-3.9, 15.4]t-test, 2 sided
Comparison: 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.p-value: 0.03395% CI: [0.5, 13]t-test, 2 sided
Comparison: 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.p-value: 0.08595% CI: [-1.3, 19.8]t-test, 2 sided
Comparison: 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.p-value: <0.00195% CI: [9.3, 25.8]t-test, 2 sided
Comparison: Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.p-value: <0.00195% CI: [33.9, 85.2]t-test, 2 sided
Comparison: Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.p-value: <0.00195% CI: [7.6, 13.6]t-test, 2 sided
Secondary
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.
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.
Time frame: Baseline and 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (at Baseline) | 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: ACEI/ARB | 78.7 percentage of participants | Standard Deviation 11.3 |
| Cohort A (at Baseline) | 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 2: Beta-blocker | 85.9 percentage of participants | Standard Deviation 10.9 |
| Cohort A (at Baseline) | 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 3: Aldosterone antagonist | 34.7 percentage of participants | Standard Deviation 18.7 |
| Cohort A (at Baseline) | 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 4: Anticoagulation for AF | 67.9 percentage of participants | Standard Deviation 15.8 |
| Cohort A (at Baseline) | 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 5: CRT-P/CRT-D | 37.6 percentage of participants | Standard Deviation 30.7 |
| Cohort A (at Baseline) | 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 6: ICD/CRT-D | 49.9 percentage of participants | Standard Deviation 17 |
| Cohort A (at Baseline) | 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 7: HF education | 59.4 percentage of participants | Standard Deviation 23.6 |
| Cohort A (at Baseline) | 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. | Composite Score | 67.1 percentage of participants | Standard Deviation 8.8 |
| Cohort A (at 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. | Performance Measure 3: Aldosterone antagonist | 33.4 percentage of participants | Standard Deviation 20.7 |
| Cohort A (at 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. | Performance Measure 7: HF education | 67.5 percentage of participants | Standard Deviation 20.8 |
| Cohort A (at 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. | Performance Measure 4: Anticoagulation for AF | 68.9 percentage of participants | Standard Deviation 17.4 |
| Cohort A (at 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. | Performance Measure 5: CRT-P/CRT-D | 34.9 percentage of participants | Standard Deviation 27.8 |
| Cohort A (at 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. | Performance Measure 6: ICD/CRT-D | 52.7 percentage of participants | Standard Deviation 17.4 |
| Cohort A (at 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. | Performance Measure 1: ACEI/ARB | 80.2 percentage of participants | Standard Deviation 10.6 |
| Cohort A (at 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. | Performance Measure 2: Beta-blocker | 90.0 percentage of participants | Standard Deviation 7.2 |
| Cohort A (at 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. | Composite Score | 70.7 percentage of participants | Standard Deviation 8 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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 3: Aldosterone antagonist | -1.1 percentage of participants | Standard Deviation 27.4 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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 2: Beta-blocker | 10.6 percentage of participants | Standard Deviation 68.9 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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: ACEI/ARB | 10.3 percentage of participants | Standard Deviation 97.1 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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 4: Anticoagulation for AF | 6.2 percentage of participants | Standard Deviation 38.2 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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 7: HF education | 38.5 percentage of participants | Standard Deviation 94.8 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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 6: ICD/CRT-D | 14.4 percentage of participants | Standard Deviation 46.9 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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 5: CRT-P/CRT-D | -1.8 percentage of participants | Standard Deviation 53.7 |
| Cohort A (Relative Change 24 Months vs. Baseline) | 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. | Composite Score | 6.6 percentage of participants | Standard Deviation 15.1 |
Comparison: Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.p-value: 0.19795% CI: [-5.4, 25.9]t-test, 2 sided
Comparison: Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.p-value: 0.06195% CI: [-0.5, 21.7]t-test, 2 sided
Comparison: Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.p-value: 0.62295% CI: [-5.7, 3.4]t-test, 2 sided
Comparison: 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.p-value: 0.0595% CI: [0, 12.4]t-test, 2 sided
Comparison: 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.p-value: 0.71195% CI: [-11.2, 7.7]t-test, 2 sided
Comparison: 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.p-value: <0.00195% CI: [6.9, 22]t-test, 2 sided
Comparison: Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.p-value: <0.00195% CI: [23.2, 53.8]t-test, 2 sided
Comparison: Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.p-value: <0.00195% CI: [4.2, 9]t-test, 2 sided