Trial Outcomes & Findings for IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (NCT NCT00303979)
NCT ID: NCT00303979
Last Updated: 2019-01-31
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
34810 participants
Primary outcome timeframe
24 Month
Results posted on
2019-01-31
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15177
|
9992
|
9641
|
|
Overall Study
COMPLETED
|
7605
|
9992
|
9641
|
|
Overall Study
NOT COMPLETED
|
7572
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
Baseline characteristics by cohort
| Measure |
Cohort A (Baseline, 12 and 24 Months)
n=15177 Participants
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 B (6 Months)
n=9992 Participants
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 C (18 Months)
n=9641 Participants
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.
|
Total
n=34810 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 13.2 • n=93 Participants
|
68.3 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
68.2 years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
68.4 years
STANDARD_DEVIATION 13.3 • n=483 Participants
|
|
Age, Customized
<=64 years
|
5274 participants
n=93 Participants
|
3606 participants
n=4 Participants
|
3539 participants
n=27 Participants
|
12419 participants
n=483 Participants
|
|
Age, Customized
Between 64 and 76 years
|
5127 participants
n=93 Participants
|
3344 participants
n=4 Participants
|
3089 participants
n=27 Participants
|
11560 participants
n=483 Participants
|
|
Age, Customized
>76 years
|
4748 participants
n=93 Participants
|
3041 participants
n=4 Participants
|
3010 participants
n=27 Participants
|
10799 participants
n=483 Participants
|
|
Age, Customized
Missing
|
28 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
32 participants
n=483 Participants
|
|
Sex/Gender, Customized
Female
|
4383 participants
n=93 Participants
|
2918 participants
n=4 Participants
|
2827 participants
n=27 Participants
|
10128 participants
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
10787 participants
n=93 Participants
|
7069 participants
n=4 Participants
|
6814 participants
n=27 Participants
|
24670 participants
n=483 Participants
|
|
Sex/Gender, Customized
Missing
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
0 participants
n=27 Participants
|
12 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
15177 participants
n=93 Participants
|
9992 participants
n=4 Participants
|
9641 participants
n=27 Participants
|
34810 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 MonthPopulation: 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.
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.
Outcome measures
| Measure |
Cohort A (at Baseline)
n=15177 Participants
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 24 Months)
n=7605 Participants
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 (Relative Change 24 Months vs. Baseline)
n=7605 Participants
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.
|
|---|---|---|---|
|
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
Interval 79.2 to 80.5
|
86.5 percentage of participants in aggregate
Interval 85.6 to 87.3
|
8.4 percentage of participants in aggregate
Interval 7.0 to 9.7
|
|
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
Interval 85.6 to 86.8
|
93.6 percentage of participants in aggregate
Interval 93.0 to 94.2
|
8.6 percentage of participants in aggregate
Interval 7.7 to 9.6
|
|
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
Interval 32.7 to 36.1
|
61.8 percentage of participants in aggregate
Interval 59.2 to 64.5
|
79.7 percentage of participants in aggregate
Interval 70.5 to 89.0
|
|
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
Interval 67.2 to 70.0
|
69.3 percentage of participants in aggregate
Interval 67.5 to 71.0
|
1.0 percentage of participants in aggregate
Interval -2.2 to 4.2
|
|
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
Interval 35.2 to 40.1
|
68.5 percentage of participants in aggregate
Interval 65.8 to 71.3
|
81.9 percentage of participants in aggregate
Interval 72.2 to 91.7
|
|
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
Interval 47.8 to 49.8
|
79.1 percentage of participants in aggregate
Interval 78.0 to 80.2
|
62.1 percentage of participants in aggregate
Interval 59.1 to 65.1
|
|
To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change.
Performance Measure 7: HF education
|
61.8 percentage of participants in aggregate
Interval 61.0 to 62.5
|
70.8 percentage of participants in aggregate
Interval 69.8 to 71.9
|
14.7 percentage of participants in aggregate
Interval 12.6 to 16.8
|
SECONDARY outcome
Timeframe: 24 monthsThe 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.
Outcome measures
| Measure |
Cohort A (at Baseline)
n=155 Sites
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 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. Percentage of the patients who were eligible for a performance measure that were treated by it at the 24 months was calculated.
|
Cohort A (Relative Change 24 Months vs. 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. The relative changes in the percentages from 24 months to baseline were calculated for the 7 performance measures.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: 24 monthsperformance 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.
Outcome measures
| Measure |
Cohort A (at Baseline)
n=167 Sites
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 24 Months)
n=155 Sites
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 (Relative Change 24 Months vs. Baseline)
n=155 Sites
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.
|
|---|---|---|---|
|
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
|
85.1 percentage
Standard Deviation 10.6
|
19.4 percentage
Standard Deviation 128.9
|
|
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
|
92.2 percentage
Standard Deviation 9.8
|
7.6 percentage
Standard Deviation 16.1
|
|
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
|
60.3 percentage
Standard Deviation 25.9
|
30.0 percentage
Standard Deviation 33.8
|
|
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
|
67.8 percentage
Standard Deviation 18.0
|
1.0 percentage
Standard Deviation 28.5
|
|
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
|
66.3 percentage
Standard Deviation 29.0
|
48.4 percentage
Standard Deviation 62.3
|
|
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
|
77.5 percentage
Standard Deviation 16.8
|
70.9 percentage
Standard Deviation 62.4
|
|
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
|
72.1 percentage
Standard Deviation 24.0
|
50.6 percentage
Standard Deviation 147.7
|
|
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
|
79.0 percentage
Standard Deviation 9.3
|
19.2 percentage
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsThe 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.
Outcome measures
| Measure |
Cohort A (at Baseline)
n=167 Sites
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 24 Months)
n=154 Sites
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 (Relative Change 24 Months vs. Baseline)
n=167 Sites
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.
|
|---|---|---|---|
|
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
|
70.7 percentage of participants
Standard Deviation 8.0
|
6.6 percentage of participants
Standard Deviation 15.1
|
|
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
|
80.2 percentage of participants
Standard Deviation 10.6
|
10.3 percentage of participants
Standard Deviation 97.1
|
|
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
|
90.0 percentage of participants
Standard Deviation 7.2
|
10.6 percentage of participants
Standard Deviation 68.9
|
|
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
|
33.4 percentage of participants
Standard Deviation 20.7
|
-1.1 percentage of participants
Standard Deviation 27.4
|
|
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
|
68.9 percentage of participants
Standard Deviation 17.4
|
6.2 percentage of participants
Standard Deviation 38.2
|
|
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
|
34.9 percentage of participants
Standard Deviation 27.8
|
-1.8 percentage of participants
Standard Deviation 53.7
|
|
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 17.0
|
52.7 percentage of participants
Standard Deviation 17.4
|
14.4 percentage of participants
Standard Deviation 46.9
|
|
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
|
67.5 percentage of participants
Standard Deviation 20.8
|
38.5 percentage of participants
Standard Deviation 94.8
|
SECONDARY outcome
Timeframe: baseline and 18 MonthsThe 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.
Outcome measures
| Measure |
Cohort A (at Baseline)
n=167 Sites
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 24 Months)
n=150 Sites
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 (Relative Change 24 Months vs. Baseline)
n=167 Sites
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.
|
|---|---|---|---|
|
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
|
80.3 percentage of participants
Standard Deviation 12.2
|
10.5 percentage of participants
Standard Deviation 97.9
|
|
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
|
91.8 percentage of participants
Standard Deviation 7.0
|
14.3 percentage of participants
Standard Deviation 87.7
|
|
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
|
36.6 percentage of participants
Standard Deviation 23.1
|
5.8 percentage of participants
Standard Deviation 58.3
|
|
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
|
69.6 percentage of participants
Standard Deviation 17.1
|
6.7 percentage of participants
Standard Deviation 38.3
|
|
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
|
43.5 percentage of participants
Standard Deviation 30.1
|
9.3 percentage of participants
Standard Deviation 59.7
|
|
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 17.0
|
54.0 percentage of participants
Standard Deviation 17.2
|
17.6 percentage of participants
Standard Deviation 51.3
|
|
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
|
75.0 percentage of participants
Standard Deviation 22.6
|
59.5 percentage of participants
Standard Deviation 158.5
|
|
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
|
73.2 percentage of participants
Standard Deviation 8.4
|
10.6 percentage of participants
Standard Deviation 18.5
|
Adverse Events
Cohort A (Baseline, 12 and 24 Months)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B (6 Months)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort C (18 Months)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
IMPROVE HF, Clinical Research Specialist
Medtronic Cardiac Rhythm Disease Management
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PI's may not publish single-site data until the main multi-site publication has occurred.
- Publication restrictions are in place
Restriction type: OTHER