IMPROVE HF: Registry to Improve the Use of Evidence-Based... | NCT00303979

Status Module

Name	Class
Medtronic	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A (longitudinal)		Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months
Cohort B (6 Month)		6 Month Cohort: Approximately 10,000 patients reviewed at single time point
Cohort C (18 Month)		18 Month Cohort: Approximately 10,000 patients reviewed at single time point

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change.	7 performance measures: angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEI/ARB), beta-blokers, aldosterone receptor antagonists, anticoagulation for atrial fibrillation (AF), cardiac resynchronization therapy (CRT-P/CRT-D), cardioverter-defibrillator (ICD/CRT-D), heart failure (HF) education. We first calcuated % of patients who were eligible for a performance measure that were treated by it at baseline and 24 months. We then calculated the relative change as (% treated at 24 months - % treated at baseline)/% treated at baseline. The 95% confidence interval (CI) was calculated and the relative change of each performance measure was evaluated using a z-test for one-sample proportion. The number of performance measures with >= 20% relative improvement was determined. The intervention was considered successful if a relative 20% or greater improvement in at least 2 of the 7 performance measures at 24 months compared with baseline was achieved.	24 Month

Secondary Outcomes

Measure	Description	Time Frame
Observe the Number of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline in Cohort A.	The number of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline of cohort A is presented.	24 months

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Associates of Montclair		Birmingham	Alabama	36608	United States
Cardiology Associates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23380000	Derived	Shukla A, Curtis AB, Mehra MR, Albert NM, Gheorghiade M, Heywood JT, Liu Y, O'Connor CM, Reynolds D, Walsh MN, Yancy CW, Fonarow GC. Factors associated with improvement in utilization of cardiac resynchronization therapy in eligible heart failure patients: findings from IMPROVE HF. Pacing Clin Electrophysiol. 2013 Apr;36(4):433-43. doi: 10.1111/pace.12090. Epub 2013 Feb 4.
23130114

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.7± 13.2 BG00168.3± 13.2 BG00268.2± 13.6 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

<=64 years

Title	Measurements
	BG0005274 BG0013606 BG002

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG0004383 BG0012918 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00015177 BG0019992 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants in aggregate

24 Month

ID	Title	Description
OG000	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 all the atients at baseline. Percentage of patients who were eligible for a performance measure that were treated by it at baseline was calculated.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00015177 OG0017605 OG0027605

Title

Denominators

Categories

Performance Measure 1: ACEI/ARB

Title	Measurements
	OG00079.8(79.2 to 80.5) OG00186.5(85.6 to 87.3) OG0028.4(7.0 to 9.7)

Performance Measure 2: Beta-blocker

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG002	Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).	a large sample test (z-test)		<0.001		Relative Improvement (%)	8.4			2-Sided	95	7.0	9.7					Superiority or Other
OG002	Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.

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.

Posted

Number

Sites

24 months

Sites

ID	Title	Description
OG000	Practice Sites in Cohort A	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

percentage

24 months

Sites

ID	Title	Description
OG000	Cohort A (at Baseline)	Cohort A at baseline included 15177 patients from 167 study sites (practices).
OG001	Cohort A (at 24 Months)	Cohort A at 24 months included 7605 patients from 155 study sites (practices).
OG002	Cohort A (Relative Change 24 Months vs. Baseline)

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.

Posted

Mean

Standard Deviation

percentage of participants

Baseline and 6 Months

Sites

ID	Title	Description
OG000	Cohort A: Baseline	In this analysis, data of Cohort A at baseline were used. This included 15177 patients from 167 cardiology practices.
OG001	Cohort B: 6 Months	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.
OG002	Cohort B 6 Months vs. Cohort A Baseline (Relative Change)	The relative changes in performance measures and composite score of Cohort B (6 months) compared with those of Cohort A at baseline were calculated

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.

Posted

Mean

Standard Deviation

percentage of participants

baseline and 18 Months

Sites

ID	Title	Description
OG000	Cohort A: Baseline	In this analysis, data of Cohort A at baseline were used. This included 15177 patients from 167 cardiology practices.
OG001	Cohort C (18 Months)	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.
OG002	Cohort C 18 Months vs. Cohort A Baseline (Relative Change)	The relative changes in performance measures and composite score of Cohort C (18 months) compared with those of Cohort A at baseline were calculated.

Arm/Groups

ID	Title	Description
EG000	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.
EG001	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.
EG002	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.

ID	Term
D006333	Heart Failure
D009203	Myocardial Infarction
D018487	Ventricular Dysfunction, Left
D054143	Heart Failure, Systolic

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D018754	Ventricular Dysfunction

Participants	OG00015177 OG0019992 OG00225169
Sites	OG000167 OG001154 OG002167

Participants	OG00015177 OG0019641 OG00224818
Sites	OG000167 OG001150 OG002167