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

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00303979
• Collaborator: Medtronic (Industry)
• Enrollment: 34,810
• Locations: 144
• Duration (Months): 51
• Patients Per Site: 241.7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive; Myocardial Infarction; Ventricular Dysfunction, Left

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 34810 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Associates of Montclair	Birmingham	Alabama	United States	36608
2	Cardiology Associates	Mobile	Alabama	United States	36608
3	Cardiovascular Associates of Mesa	Mesa	Arizona	United States	85205
4	Heart Care, PC	Scottsdale	Arizona	United States	85258
5	Southern Arizona VA Health Care System	Tucson	Arizona	United States	85723
6	Central Arkansas Cardiovascular Institute	Hot Springs	Arkansas	United States	71913
7	Arkansas Cardiology Clinic	Little Rock	Arkansas	United States	72202
8	St. Jude Heritage Medical Group	Fullerton	California	United States	92835
9	Scripps Clinic Green Hospital	La Jolla	California	United States	92037
10	Veterans Administration Hospital	Los Angeles	California	United States	92357
11	University Cardiovascular Medical Group	Los Angeles	California	United States	94115
12	Cardio-Pulmonary Associates	Monterey	California	United States	93940
13	Temecula Valley Cardiology	Murrieta	California	United States	92562
14	California Pacific Cardiovascular Medical	San Francisco	California	United States	94115
15	East Bay Cardiology	San Pablo	California	United States	94803
16	Cardiology Consultants Medical Group	Tarzana	California	United States	91335
17	Medical Center of the Rockies	Fort Collins	Colorado	United States	80521
18	Connecticut Heart & Vascular Center	Bridgeport	Connecticut	United States	06606
19	Cardiology Consultants, PA	Newark	Delaware	United States	19702
20	Heart and Vascular Center of Bradenton	Bradenton	Florida	United States	34209
21	Clearwater Cardiovascular & Intervention	Clearwater	Florida	United States	33756
22	Mahesh Amin, MD PA	Clearwater	Florida	United States	33756
23	Pasco Cardiology	Hudson	Florida	United States	34667
24	Cardiovascular Associates	Kissimmee	Florida	United States	34741
25	Clark and Daughtrey Medical Group	Lakeland	Florida	United States	33803
26	OMNI	Melbourne	Florida	United States	32901
27	Miami Cardiology Group	Miami	Florida	United States	33176
28	Florida Heart Group	Orlando	Florida	United States	32803
29	Cardiology Associates	Port Charlotte	Florida	United States	33952
30	Cardiovascular Consultants,	Tamarac	Florida	United States	33309
31	Indian River Cardiovascular Associate	Vero Beach	Florida	United States	32960
32	Florida Medical Clinic	Zephyrhills	Florida	United States	33542
33	Cardiology of Atlanta	Atlanta	Georgia	United States	30342
34	Northside Cardiology	Atlanta	Georgia	United States	30342
35	Northeast Georgia Heart Center	Gainesville	Georgia	United States	30501
36	Southcoast Cardiology	Savannah	Georgia	United States	31406
37	Pacific Cardiology	Honolulu	Hawaii	United States	96817
38	St. Luke's Idaho Cardiology Associates	Boise	Idaho	United States	83702
39	Heart Care Center of Illinois	Blue Island	Illinois	United States	60406
40	MidAmerica Cardiovascular Consultants	Frankfort	Illinois	United States	60453
41	Cardiovascular Associates of Glenbrook and Evanston, LLC	Glenview	Illinois	United States	60026
42	St. Vincent's Hospital	Indianapolis	Indiana	United States	46201
43	Methodist Hospital	Indianapolis	Indiana	United States	46202
44	St. Vincent's Hospital Indianapolis	Indianapolis	Indiana	United States	46278
45	St. Vincent's Hospital,	Indianapolis	Indiana	United States	46278
46	Iowa Heart Center PC,	West Des Moines	Iowa	United States	50266
47	Mid America Cardiology	Kansas City	Kansas	United States	66102
48	Cardiology Consultants	Topeka	Kansas	United States	66102
49	Cardiovascular Consultants of Kansas	Wichita	Kansas	United States	67226
50	Louisville Cardiology Medical Group P.S	Louisville	Kentucky	United States	40026
51	Medical Center Cardiologists P.S.C	Louisville	Kentucky	United States	40201
52	Louisville Cardiology Medical Group P.S	Louisville	Kentucky	United States	40207
53	Owensboro Heart and Vascular	Owensboro	Kentucky	United States	42303
54	Tchefuncte Cardiovascular Associates,	Covington	Louisiana	United States	70433
55	Heart Clinic of Louisiana	Marrero	Louisiana	United States	70072
56	Maryland Heart, PC	Bethesda	Maryland	United States	20817
57	Heart Center of Southern Maryland	Clinton	Maryland	United States	20735
58	Arundel Heart Associates	Glen Burnie	Maryland	United States	21061
59	Peninsula Cardiology	Salisbury	Maryland	United States	21804
60	Primary Care Specialists Inc	Ayer	Massachusetts	United States	01432
61	Merrimack Valley Cardiology	Chelmsford	Massachusetts	United States	01824
62	Harbor Medical AssociatesSo Weymouth	Weymouth	Massachusetts	United States	02190
63	Consultants in Cardiology	Farmington Hills	Michigan	United States	48331
64	Cardiovascular Consultants PC	Rochester	Michigan	United States	48312
65	Eastside Cardiology, Roseville	Roseville	Michigan	United States	48066
66	St. Paul Cardiology	Saint Paul	Minnesota	United States	55102
67	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
68	Missouri Cardiovascular Specialists	Columbia	Missouri	United States	65201
69	University Hospital Healthcare	Columbia	Missouri	United States	65210
70	Freeman Heart Institute	Joplin	Missouri	United States	64804
71	Mercy Cardiology	Saint Louis	Missouri	United States	63101
72	Cardiology Diagnostics, Ltd,	Saint Louis	Missouri	United States	63131
73	Cardiac Associates of New Hampshire	Concord	New Hampshire	United States	03303
74	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
75	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
76	Medicor	Bridgewater	New Jersey	United States	08807
77	Cross County Cardiology	Edgewater	New Jersey	United States	07020
78	Heart-Lung Center	Hawthorne	New Jersey	United States	07506-1919
79	Southern New Jersey Cardiac Specialists	Voorhees	New Jersey	United States	08043
80	Diagnostic and Clinical Cardiologists	West Orange	New Jersey	United States	07052
81	Westwood Cardiology	Westwood	New Jersey	United States	07675
82	Albany Associates in Cardiology,	Albany	New York	United States	12205
83	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
84	Cardiology Associates of Brooklyn	Brooklyn	New York	United States	11219
85	United Medical Associates	Brooklyn	New York	United States	11219
86	Concorde Medical Group/NYU Hospital	Manhattan	New York	United States	10001
87	Island Cardiac Specialists	Mineola	New York	United States	11501
88	Island Cardiac Specialist	Mineola	New York	United States	11501
89	Gotham Cardiovascular Research	New York	New York	United States	10001
90	Westchester Medical Group	Scarsdale	New York	United States	10583
91	Vazzana and Bogin Cardiology Associates	Staten Island	New York	United States	10305
92	Cardiology PC	Syracuse	New York	United States	13210
93	Southbay Cardiology	West Islip	New York	United States	11795
94	Asheville Cardiology Associates	Asheville	North Carolina	United States	28803
95	Sanger Clinic	Charlotte	North Carolina	United States	28202
96	Carolina Heart Specialists	Gastonia	North Carolina	United States	28054
97	Southeastern Heart and Vascular	Greensboro	North Carolina	United States	27403
98	Hickory Cardiology	Hickory	North Carolina	United States	28602
99	Carolina Cardiology Associates	High Point	North Carolina	United States	27262
100	Heart Center of Eastern Carolina,	New Bern	North Carolina	United States	28562
101	Heart Center of Eastern Carolina	New Bern	North Carolina	United States	28562
102	Pinehurst Cardiology Consultants	Pinehurst	North Carolina	United States	28370
103	Pinehurst Cardiology Consultants	Pinehurst	North Carolina	United States	28374
104	Raleigh Cardiology	Raleigh	North Carolina	United States	27610
105	Meritcare Medical Center	Fargo	North Dakota	United States	58122
106	Northeast Ohio Cardiovascular Specialists	Akron	Ohio	United States	44301
107	Muhammed H. Zahra	Cleveland	Ohio	United States	44125
108	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
109	Doctors Hospital Heart Failure Clinic	Columbus	Ohio	United States	43228
110	Schuster Cardiology Associates	Kettering	Ohio	United States	45336
111	The Heart Institute of Northwest Ohio	Lima	Ohio	United States	45801
112	Bryce Morrice MD and Debra Heldman MD Inc	Newark	Ohio	United States	43055
113	Cardiovascular Clinic, Inc.	Parma	Ohio	United States	44129
114	North West Ohio Cardiology Consultants	Toledo	Ohio	United States	43615
115	Abington Medical Specialists	Abington	Pennsylvania	United States	19001
116	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
117	Central Bucks Specialists, Ltd.,	Doylestown	Pennsylvania	United States	18901
118	Associated Cardiologists	Harrisburg	Pennsylvania	United States	17103
119	The Heart Group, Ltd	Lancaster	Pennsylvania	United States	17603
120	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19129
121	Cardiology Associates of Southeastern PA	Wynnewood	Pennsylvania	United States	19064
122	York Hospital	York	Pennsylvania	United States	17403
123	Blackstone Cardiology Associates	Pawtucket	Rhode Island	United States	02860
124	Medical University of South	Charleston	South Carolina	United States	29406
125	Upstate Cardiology	Greenville	South Carolina	United States	29605
126	Cardiology Associates	Myrtle Beach	South Carolina	United States	29572
127	Cardiology Consultants, PA	Spartanburg	South Carolina	United States	29301
128	Sumter Medical Consultants	Sumter	South Carolina	United States	29150
129	Columbia Cardiology Consultants	West Columbia	South Carolina	United States	29204
130	Sutherland Clinic	Germantown	Tennessee	United States	38119
131	Dela Clinic	Lexington	Tennessee	United States	38351
132	Heart Place North Arlington	Arlington	Texas	United States	75284
133	University of Texas South Western Medical Center at Dallas	Dallas	Texas	United States	75201
134	Comprehensive Heart Care, PA	Houston	Texas	United States	77024
135	Cardiology Consultants of Houston	Houston	Texas	United States	77030
136	Legacy Heart Center	Plano	Texas	United States	75024
137	Cardiology Clinic of San Antonio	San Antonio	Texas	United States	78229
138	Wilford Hall Medical Center	San Antonio	Texas	United States	78229
139	Tyler Cardiovascular Consultants	Tyler	Texas	United States	75701
140	University Associates in Cardiology	Burlington	Vermont	United States	05401
141	Cardiology Associates of Lakeview	Fairfax	Virginia	United States	05454
142	The Cardiovascular Group	Fairfax	Virginia	United States	22031
143	Tidewater Heart Specialists, Inc.,	Hampton	Virginia	United States	23666
144	Cardiology Associates of Green Bay	Green Bay	Wisconsin	United States	54301

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure
• Medtronic

Investigators

• Study Chair: Gregg Fonarow, MD, University of California at Los Angeles
• Study Chair: Clyde Yancy, MD, UT Southwestern Medical Center at Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00303979
• Other Study ID Numbers: 258
• First Posted: Mar 17, 2006
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: Systolic Heart Failure; Quality of Care; Outcomes; Evidence-based Guidelines; Recommended Therapies
• Additional relevant MeSH terms: Heart Failure; Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left; Infarction

Study Results

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 Detail	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.

Arm/Group Title	Cohort A (Baseline, 12 and 24 Months)	Cohort B (6 Months)	Cohort C (18 Months)
Arm/Group Description	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: 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: 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.
Period Title: Overall Study
STARTED	15177	9992	9641
COMPLETED	7605	9992	9641
NOT COMPLETED	7572	0	0

Baseline Characteristics

Arm/Group Title	Cohort A (Baseline, 12 and 24 Months)	Cohort B (6 Months)	Cohort C (18 Months)	Total
Arm/Group Description	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: 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: 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 of all reporting groups
Overall Participants	15177	9992	9641	34810
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.7 (13.2)	68.3 (13.2)	68.2 (13.6)	68.4 (13.3)
Age, Customized (participants) [Number]
<=64 years	5274 34.7%	3606 36.1%	3539 36.7%	12419 35.7%
Between 64 and 76 years	5127 33.8%	3344 33.5%	3089 32%	11560 33.2%
>76 years	4748 31.3%	3041 30.4%	3010 31.2%	10799 31%
Missing	28 0.2%	1 0%	3 0%	32 0.1%
Sex/Gender, Customized (participants) [Number]
Female	4383 28.9%	2918 29.2%	2827 29.3%	10128 29.1%
Male	10787 71.1%	7069 70.7%	6814 70.7%	24670 70.9%
Missing	7 0%	5 0.1%	0 0%	12 0%
Region of Enrollment (participants) [Number]
United States	15177 100%	9992 100%	9641 100%	34810 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cohort A (at Baseline)	Cohort A (at 24 Months)	Cohort A (Relative Change 24 Months vs. Baseline)
Arm/Group Description	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.	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.	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.
Measure Participants	15177	7605	7605
Performance Measure 1: ACEI/ARB	79.8 0.5%	86.5 0.9%	8.4 0.1%
Performance Measure 2: Beta-blocker	86.2 0.6%	93.6 0.9%	8.6 0.1%
Performance Measure 3: Aldosterone antagonist	34.4 0.2%	61.8 0.6%	79.7 0.8%
Performance Measure 4: Anticoagulation for AF	68.6 0.5%	69.3 0.7%	1.0 0%
Performance Measure 5: CRT-P/CRT-D	37.7 0.2%	68.5 0.7%	81.9 0.8%
Performance Measure 6: ICD/CRT-D	48.8 0.3%	79.1 0.8%	62.1 0.6%
Performance Measure 7: HF education	61.8 0.4%	70.8 0.7%	14.7 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative Improvement (%)
	Estimated Value	8.4
	Confidence Interval	(2-Sided) 95%; 7.0 to 9.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative improvement (%)
	Estimated Value	8.6
	Confidence Interval	(2-Sided) 95%; 7.7 to 9.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative improvement (%)
	Estimated Value	79.7
	Confidence Interval	(2-Sided) 95%; 70.5 to 89.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.546
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative Improvement (%)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -2.2 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative Improvement (%)
	Estimated Value	81.9
	Confidence Interval	(2-Sided) 95%; 72.2 to 91.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative Improvement (%)
	Estimated Value	62.1
	Confidence Interval	(2-Sided) 95%; 59.1 to 65.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #7: relative change in % of eligible patients with HF education.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	a large sample test (z-test)
	Comments
Method of Estimation	Estimation Parameter	Relative Improvement (%)
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 12.6 to 16.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Practice Sites in Cohort A
Arm/Group Description	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.
Measure Participants	7605
Measure Sites	155
Performance Measure 1: ACEI/ARB	15
Performance Measure 2: Beta-blocker	9
Performance Measure 3: Aldosterone antagonist	82
Performance Measure 4: Anticoagulation for AF	14
Performance Measure 5: CRT-P/CRT-D	83
Performance Measure 6: ICD/CRT-D	114
Performance Measure 7: HF education	59
>=20% relative change in 2 or more measures	123

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A (at Baseline)	Cohort A (at 24 Months)	Cohort A (Relative Change 24 Months vs. Baseline)
Arm/Group Description	Cohort A at baseline included 15177 patients from 167 study sites (practices).	Cohort A at 24 months included 7605 patients from 155 study sites (practices).	The ralative changes in performance measures and compsite score at 24 months compared to baseline were calculated based on 155 study sites that involved 7605 patients.
Measure Participants	15177	7605	7605
Measure Sites	167	155	155
Performance Measure 1: ACEI/ARB	78.3 (11.5)	85.1 (10.6)	19.4 (128.9)
Performance Measure 2: Beta-blocker	86.0 (10.8)	92.2 (9.8)	7.6 (16.1)
Performance Measure 3: Aldosterone antagonist	34.5 (18.5)	60.3 (25.9)	30.0 (33.8)
Performance Measure 4: Anticoagulation for AF	68.0 (16.1)	67.8 (18.0)	1.0 (28.5)
Performance Measure 5: CRT-P/CRT-D	37.2 (30.5)	66.3 (29.0)	48.4 (62.3)
Performance Measure 6: ICD/CRT-D	50.1 (17.5)	77.5 (16.8)	70.9 (62.4)
Performance Measure 7: HF education	59.5 (23.7)	72.1 (24.0)	50.6 (147.7)
Composite Score	67.1 (8.9)	79.0 (9.3)	19.2 (18.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	19.4
	Confidence Interval	(2-Sided) 95%; -1.1 to 39.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	7.6
	Confidence Interval	(2-Sided) 95%; 5.1 to 10.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	30.0
	Confidence Interval	(2-Sided) 95%; 24.6 to 35.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.513
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	1.0
	Confidence Interval	() 95%; -3.6 to 5.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	48.4
	Confidence Interval	(2-Sided) 95%; 37.9 to 58.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	70.9
	Confidence Interval	(2-Sided) 95%; 61.0 to 80.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	50.6
	Confidence Interval	(2-Sided) 95%; 27.1 to 74.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	19.2
	Confidence Interval	(2-Sided) 95%; 16.3 to 22.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A: Baseline	Cohort B: 6 Months	Cohort B 6 Months vs. Cohort A Baseline (Relative Change)
Arm/Group Description	In this analysis, data of Cohort A at baseline were used. This included 15177 patients from 167 cardiology practices.	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.	The relative changes in performance measures and composite score of Cohort B (6 months) compared with those of Cohort A at baseline were calculated
Measure Participants	15177	9992	25169
Measure Sites	167	154	167
Performance Measure 1: ACEI/ARB	78.7 (11.3) 0.5%	80.2 (10.6) 0.8%	10.3 (97.1) 0.1%
Performance Measure 2: Beta-blocker	85.9 (10.9) 0.6%	90.0 (7.2) 0.9%	10.6 (68.9) 0.1%
Performance Measure 3: Aldosterone antagonist	34.7 (18.7) 0.2%	33.4 (20.7) 0.3%	-1.1 (27.4) -0%
Performance Measure 4: Anticoagulation for AF	67.9 (15.8) 0.4%	68.9 (17.4) 0.7%	6.2 (38.2) 0.1%
Performance Measure 5: CRT-P/CRT-D	37.6 (30.7) 0.2%	34.9 (27.8) 0.3%	-1.8 (53.7) -0%
Performance Measure 6: ICD/CRT-D	49.9 (17.0) 0.3%	52.7 (17.4) 0.5%	14.4 (46.9) 0.1%
Performance Measure 7: HF education	59.4 (23.6) 0.4%	67.5 (20.8) 0.7%	38.5 (94.8) 0.4%
Composite Score	67.1 (8.8) 0.4%	70.7 (8.0) 0.7%	6.6 (15.1) 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.197
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; -5.4 to 25.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	10.6
	Confidence Interval	(2-Sided) 95%; -0.5 to 21.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.622
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -5.7 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	6.2
	Confidence Interval	(2-Sided) 95%; 0.0 to 12.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.711
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -11.2 to 7.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	14.4
	Confidence Interval	(2-Sided) 95%; 6.9 to 22.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	38.5
	Confidence Interval	(2-Sided) 95%; 23.2 to 53.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	6.6
	Confidence Interval	(2-Sided) 95%; 4.2 to 9.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A: Baseline	Cohort C (18 Months)	Cohort C 18 Months vs. Cohort A Baseline (Relative Change)
Arm/Group Description	In this analysis, data of Cohort A at baseline were used. This included 15177 patients from 167 cardiology practices.	In this analysis, data of Cohort C (i.e. 18 months single time point cohort) were used. This included 9641 patients from 150 cardiology practices.	The relative changes in performance measures and composite score of Cohort C (18 months) compared with those of Cohort A at baseline were calculated.
Measure Participants	15177	9641	24818
Measure Sites	167	150	167
Performance Measure 1: ACEI/ARB	78.7 (11.3) 0.5%	80.3 (12.2) 0.8%	10.5 (97.9) 0.1%
Performance Measure 2: Beta-blocker	85.9 (10.9) 0.6%	91.8 (7.0) 0.9%	14.3 (87.7) 0.1%
Performance Measure 3: Aldosterone antagonist	34.7 (18.7) 0.2%	36.6 (23.1) 0.4%	5.8 (58.3) 0.1%
Performance Measure 4: Anticoagulation for AF	67.9 (15.8) 0.4%	69.6 (17.1) 0.7%	6.7 (38.3) 0.1%
Performance Measure 5: CRT-P/CRT-D	37.6 (30.7) 0.2%	43.5 (30.1) 0.4%	9.3 (59.7) 0.1%
Performance Measure 6: ICD/CRT-D	49.9 (17.0) 0.3%	54.0 (17.2) 0.5%	17.6 (51.3) 0.2%
Performance Measure 7: HF education	59.4 (23.6) 0.4%	75.0 (22.6) 0.8%	59.5 (158.5) 0.6%
Composite Score	67.1 (8.8) 0.4%	73.2 (8.4) 0.7%	10.6 (18.5) 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.190
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	10.5
	Confidence Interval	(2-Sided) 95%; -5.3 to 26.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	14.3
	Confidence Interval	(2-Sided) 95%; 0.1 to 28.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.240
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	5.8
	Confidence Interval	(2-Sided) 95%; -3.9 to 15.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	6.7
	Confidence Interval	(2-Sided) 95%; 0.5 to 13.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.085
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	9.3
	Confidence Interval	(2-Sided) 95%; -1.3 to 19.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	17.6
	Confidence Interval	(2-Sided) 95%; 9.3 to 25.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	59.5
	Confidence Interval	(2-Sided) 95%; 33.9 to 85.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Cohort A (Relative Change 24 Months vs. Baseline)
	Comments	Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Relative Change (%)
	Estimated Value	10.6
	Confidence Interval	(2-Sided) 95%; 7.6 to 13.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	Adverse events were not collected for this study.
Arm/Group Title	Cohort A (Baseline, 12 and 24 Months)		Cohort B (6 Months)		Cohort C (18 Months)
Arm/Group Description	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: 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: 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.
All Cause Mortality
	Cohort A (Baseline, 12 and 24 Months)		Cohort B (6 Months)		Cohort C (18 Months)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort A (Baseline, 12 and 24 Months)		Cohort B (6 Months)		Cohort C (18 Months)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cohort A (Baseline, 12 and 24 Months)		Cohort B (6 Months)		Cohort C (18 Months)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.