Improving Evidence-Based Care for Heart Failure in Outpatient Cardiology Practices: Primary Results of the Registry to Improve Heart Failure Therapies

Improving Evidence-Based Care for Heart Failure in Outpatient Cardiology Practices: Primary

Results of the Registry to Improve Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)

Gregg C. Fonarow, Nancy M. Albert, Anne B. Curtis, Wendy Gattis Stough, Mihai Gheorghiade, J. Thomas Heywood, Mark L. McBride,

Patches Johnson Inge, Mandeep R. Mehra, Christopher M. O'Connor, Dwight Reynolds Mary N. Walsh , Clyde W. Yancy

Fonarow GC et al. Circulation. 2010;122:585-596

Disclosures

• Medtronic provided financial/material support for the IMPROVE HF registry but had no role or input into selection of endpoints or quality measures used in the study.

• Outcome Sciences, Inc, a contract research organization, independently performed the practice site chart abstractions for IMPROVE HF, stored the data, and provided benchmarked quality of care reports to practice sites. Outcome Sciences received funding from Medtronic.

• Individually identifiable practice site data were not shared with either the steering committee or the sponsor.

• Individual author disclosures are provided in the manuscript.

Fonarow GC, et al. Circulation. 2010;122:585-596.

Heart Failure Care in the Outpatient Cardiology Practice Setting

• There are well documented gaps, variations, and disparities in the use of evidence-based, guideline recommended therapies for heart failure in inpatient and outpatient care settings.

• As a result many heart failure patients may have hospitalizations and fatal events that might have been prevented.

• Hospital-based performance improvement programs have improved the quality of care for heart failure patients.

• Similar programs in the outpatient setting have not been tested.


ACC/AHA 2005 HF Guidelines: Implementation of Guidelines

Academic detailing or educational outreach visits are useful to facilitate the implementation of practice guidelines

Chart audit and feedback of results can be effective to facilitate implementation of practice guidelines

The use of reminder systems can be effective to facilitate implementation of practice guidelines

The use of performance measures based on practice guidelines may be useful to improve quality of care

Hunt SA, et al. ACC/AHA 2005 Practice Guidelines. Available at http://www.acc.org.

I IIa IIb III

I IIa IIb III

I IIa IIb III

IMPROVE HF Study Overview

• Largest, most comprehensive performance improvement study for HF patients in the outpatient setting

• Designed to enhance quality of care of HF patients by facilitating adoption of evidence-based, guideline-recommended therapies:

– Evaluate utilization rates of evidence-based, guideline-recommended HF therapies at baseline and over the course of the performance improvement intervention (chart audit and feedback; use of performance measures)

– Multifaceted, practice-specific performance improvement toolkit including clinical decision support tools (reminder systems)

– Sites attended an educational workshop to set treatment goals and develop a customized clinical care pathway (educational outreach)

Fonarow GC et al. Am Heart J, 2007;154:12-38.

Methods: Guideline-Recommended Quality Measures

• Seven quality measures with strong evidence prospectively selected:– Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor

blocker (ARB)*– ß-blocker*– Aldosterone antagonist– Anticoagulation therapy for atrial fibrillation/flutter (AF)*– Cardiac resynchronization therapy with or without ICD (CRT)– Implantable cardioverter defibrillator with or without CRT (ICD)– Heart failure (HF) education*

• Patients deemed eligible for individual quality measure based on meeting guideline criteria, without contraindications, intolerance, or other documented reasons for non-treatment.

• Steering committee selected quality measures based on potential to improve patient outcomes, definition precision, construct and content validity, feasibility.

* Included as ACC/AHA outpatient HF performance measure, endorsed by National Quality Forum.* Included as ACC/AHA outpatient HF performance measure, endorsed by National Quality Forum.


Methods: Patient Selection, Practice Selection, Data Collection and Management

• Patient Inclusion:– Clinical diagnosis of HF or prior MI

with at least 2 prior clinic visits within 2 years

– LVEF ≤ 35% or moderate to severe left ventricular dysfunction

• Patient Exclusion:– Cardiac transplantation– Estimated survival <1 year from

non-cardiovascular condition

• Average of 90 eligible patients per practice randomly selected for each of 3 study cohorts

• Practices: Outpatient cardiology (single specialty or multi-specialty) practices from all regions of the country

• Data quality measures– 34 trained, tested chart review

specialists– Training oversight by study

steering committee members– Monthly quality reports– Automated data field range, format,

unit checks

• Chart abstraction quality– Interrater reliability averaged 0.82

(kappa statistic)– Source documentation audit

sample concordance rate range of 92.3% to 96.3%

• Coordinating center: Outcome Sciences, Inc. (Cambridge, MA)

– Individual practice data not shared with sponsor or steering committee


Methods: Study Objectives

Practice Level

Patient Level

Primary Analyses of Quality Measures:

Changes for each of the 7 quality measures at 24 months X X

≥ 20% relative improvement in 2 or more quality measures at 24 months

X Xa

Changes in 7 quality measures patients with both baseline and 24 month data

X X

Other Analyses:

Changes in 2 summary care measures at 24 months X X

Changes in 7 quality measures in single-time point cohorts compared with baseline

X X

Practice level analysis: proportion of eligible patients receiving therapy for each practicePatient level analysis: proportion of eligible patients receiving therapy for aggregate of all practicesPractice level analysis: proportion of eligible patients receiving therapy for each practicePatient level analysis: proportion of eligible patients receiving therapy for aggregate of all practices


a Pre-specified primary objectivea Pre-specified primary objective

Methods: Study Design and Patient Disposition

LongitudinalCohortLongitudinalCohort

Two Single-Time-PointCohorts

Two Single-Time-PointCohorts

Process Improvement Intervention (165 sites)

Baseline Chart Review

167 sites15,177 patients

Baseline Chart Review


12 Month Chart Review












Total Sites 167Patients Enrolled 34,810

Total Chart Reviews 63,143Total # of Site Visits 782





• Longitudinal cohort included the same patients reviewed at 3 time points.

• Single-time-point cohorts included separate patients from the same practices and unique from the longitudinal cohort, as well as from each other.

• Longitudinal cohort included the same patients reviewed at 3 time points.

• Single-time-point cohorts included separate patients from the same practices and unique from the longitudinal cohort, as well as from each other.


Methods: Practice Specific Performance Improvement Intervention

1-day workshop after baseline data collectedIncluded study goals, guidelines, intervention tool kit, performance improvement methods, tips to promote practice change, effective use of collected data.

Guideline-based, clinical decision tool kit*Treatment algorithms, clinical pathways, standardized encounter forms, checklists, pocket cards, chart stickers, patient education materials.

Tools available at www.ImproveHF.com.

Web-based quality of care reports*Practice specific reports from chart audit data with benchmarking capability.

Bimonthly educational, collaborative Web based seminars*

Practice Survey:

• 96% adopted one or more performance improvement strategies

• 85% used benchmarked quality reports

• 60% employed one or more IMPROVE HF tools

* Use or participation was encouraged but not mandatory. Practices could adopt or modify tools.* Use or participation was encouraged but not mandatory. Practices could adopt or modify tools.


IMPROVE HF Practice Specific Education and Implementation Tools

www.improvehf.comwww.improvehf.com

Evidence Based Algorithmsand Pocket Cards

Patient Education Materials

Clinical Assessment and Management Forms

Clinical Trials and Current Guidelines

Dissemination of best practices:- Webcasts- Online Education- Newsletters

IMPROVE HF Performance Intervention:Benchmarked Practice Profile Report

Benchmarking

On-DemandPerformance Measures across all physicians within practice

Benchmarking Capability:region,practice, individual physician

Practice or Single Physician

Adherence to Guidelines

Patient Characteristics

Longitudinal Cohort18-Month

CohortN = 9,641Characteristic

All PatientsN = 15,177

24-MonthN = 7,605

Age, median, years 70.0 71.0 70.0

Male, % 71.1 71.3 70.7

Race: White, black, unavailable, % 42.4, 9.2, 46.7 42.6, 9.0, 46.5 55.9, 11.5, 31.0

Insured, not documented, uninsured, % 92.2, 6.3, 1.2 95.2, 3.7, 1.0 90.6, 7.6, 1.8

Heart failure origin, ischemic, % 65.4 67.0 65.9

Prior MI, % 40.0 51.7 41.6

History of CABG, % 31.2 34.1 31.2

History of PCI, % 25.6 30.0 29.1

History of atrial fibrillation/flutter, % 30.7 41.2 34.0

History of peripheral vascular disease, % 11.5 16.0 12.3

History of diabetes, % 34.1 37.8 35.6

History of hypertension, % 62.2 75.1 69.7

History of COPD, % 16.7 21.8 18.0

History of depression, % 9.0 15.7 10.7Fonarow GC, et al. Circulation. 2010;122:585-596.

Patient Characteristics (Continued)

Longitudinal Cohort

18-Month Cohort

N = 9,641CharacteristicBaseline

N = 15,17724-MonthN = 7,605

NYHA I, II, III, IV, unavailable, %

34.7, 36.6, 20.7, 2.6, 5.5

38.0, 43.5, 16.4, 1.4, 0.7

32.0, 44.8, 21.1, 1.6, 0.5

LVEF, median, % 25.0 30.0 25.0

Systolic blood pressure, median, mmHg 120 120 120

Diastolic blood pressure, median, mmHg 70 70 70

Resting heart rate, median, bpm 71 70 72

Sodium, median, mEq/L 139 139 139

Blood urea nitrogen, median, mg/dL 22 22 21

Creatinine, median, mg/dL 1.2 1.2 1.2

BNP, median, pg/mL 387 314 373

QRS duration, median, ms 124(n = 10,225)

132(n = 3,788)

122(n = 7,511)


IMPROVE HF Practice Characteristics

Characteristic Practice Sites (N = 167*)

Census region: South, Northeast, Central, West, Missing, % 38.9, 32.3, 15.6, 12.0, 1.2

Practice setting: University, Non-university teaching, Non-university, non-teaching, % (n=157)

7.8, 21.6, 64.7

Multispecialty, % 24.0

Hospital-based, % 27.5

Transplant center, % 9.6

Suburban or rural location, % 71.3

HF clinic in practice, % (n=163) 41.3

HF nurse in practice, % 34.7

Device clinic in practice, % 78.4

No. of physicians in practice, 1-10, 11-20, >20, % 48.5, 27.5, 18.0

Number of electrophysiologists in practice, median 1.0

Interventionalist in practice, % 87.4

Annual number of patients managed by practice, median 1837.5

*Two sites did not provide any survey data. N=165 for these characteristics unless otherwise noted.*Two sites did not provide any survey data. N=165 for these characteristics unless otherwise noted.


Results: Improvement in Quality Measures at 24 Months (Practice Level Analysis)

Quality Measure

Baseline (95% CI)N = 167

24 Months(95% CI)N = 155

Absolute Improvement

(95% CI)

Relative Improvement

(95% CI) P-value

ACEI/ARB78.3%

(76.5 – 80.2)85.1%

(83.4 – 86.8)+ 6.8%

(4.8 – 8.8)+ 19.4%

(-1.1 – 39.8) 0.063

ß-blocker86.0%

(84.3 – 87.7)92.2%

(90.6 – 93.8)+ 6.2%

(4.8 – 7.6)+ 7.6%

(5.1 – 10.2) <0.001

Aldosterone antagonist

34.5%(31.5 – 37.4)

60.3%(56.1 – 64.4)

+ 25.1%(20.7 – 29.6)

+ 86.5%(67.1 – 105.9) <0.001

Anticoagulationfor AF

68.0%(65.5 – 70.5)

67.8%(65.0 – 70.7)

- 0.1%(-3.0 – 2.8)

+ 1.0%(-3.6 – 5.5) 0.673

CRT-P/CRT-D37.2%

(32.2 – 42.2)66.3%

(61.6 – 71.1)+ 29.9%

(23.6 – 36.2)+ 124.5%

(85.5 – 163.5) <0.001

ICD/CRT-D50.1%

(47.3 – 52.8)77.5%

(74.8 – 80.1)+ 27.4%

(24.6 – 30.2)+ 70.9%

(61.0 – 80.8) <0.001

HF education59.5%

(55.7 – 63.2)72.1%

(68.3 – 75.9)+ 12.6%

(8.2 – 17.0)+ 50.6%

(27.1 – 74.2) <0.001

Longitudinal Cohort123 of 155 practices (79%) with ≥ 20% relative improvement in 2 or more care measures

Longitudinal Cohort123 of 155 practices (79%) with ≥ 20% relative improvement in 2 or more care measures


Results: Improvement in Quality Measures at 24 Months (Patient Level Analysis)

Quality Measure

Baseline (95% CI)

N = 15,177

24 Months(95% CI)N = 7,605


(95% CI)


(95% CI) P-value

ACEI/ARB79.8%

(79.2 – 80.5)86.5%

(85.6 – 87.3)+ 6.7%

(5.6 – 7.8)+ 8.4%

(7.0 – 9.7) <0.001

ß-blocker86.2%

(85.6 – 86.8)93.6%

(93.0 – 94.2)+ 7.4%

(6.6 – 8.2)+ 8.6%

(7.7 – 9.6) <0.001


34.4%(32.7 – 36.1)

61.8%(59.2 – 64.5)

+ 27.4%(24.3 – 30.6)

+ 79.7%(70.5 – 89.0) <0.001


68.6%(67.2 – 70.0)

69.3%(67.5 – 71.0)

+ 0.7%(-1.5 – 2.9)

+ 1.0%(-2.2 – 4.2) 0.546

CRT-P/CRT-D37.7%

(35.2 – 40.1)68.5%

(65.8 – 71.3)+ 30.9%

(27.2 – 34.5)+ 81.9%

(72.2 – 91.7) <0.001

ICD/CRT-D48.8%

(47.8 – 49.8)79.1%

(78.0 – 80.2)+ 30.3%

(28.8 – 31.8)+ 62.1%

(59.1 – 65.1) <0.001

HF education61.8%

(61.0 – 62.5)70.8%

(69.8 – 71.9)+ 9.1%

(7.8 – 10.4)+ 14.7%

(12.6 – 16.8) <0.001

Longitudinal CohortPrespecified primary objective met: Relative improvement ≥ 20% in 3 quality measures

Longitudinal CohortPrespecified primary objective met: Relative improvement ≥ 20% in 3 quality measures


Results: Improvement in Quality Measures at 24 Months (Patient Level Analysis)

80%

86%

34%

69%

38%

49%

62%

84%

93%

51%

69%

58%

71% 69%

87%

94%

62%

69% 69%

79%

71%

0%

20%

40%

60%

80%

100%

Baseline 12 months 24 months

ACEI/ARB ß-blocker Aldosterone Antagonist

Anticoagulant for AF

CRT ICD HF Education

*

*

*

*

*

**

*

*

*

* *

Eli

gib

le P

atie

nts

Tre

ate

dE

lig

ible

Pat

ien

ts T

rea

ted


* P<0.001 vs. baseline

Significant Improvement in 6 of 7 Quality Measures at 12 and 24 MonthsPre-specified Primary Objective Met: Relative Improvement ≥ 20% in 3 Quality Measures

Significant Improvement in 6 of 7 Quality Measures at 12 and 24 MonthsPre-specified Primary Objective Met: Relative Improvement ≥ 20% in 3 Quality Measures

P-values are for relative change

Longitudinal Cohort with Complete Follow-up at 24 Months: Modified Intention to Treat Analyses

Quality Measure

Baseline (95% CI)N = 7,605

24 Months(95% CI)N = 7,605


(95% CI)


(95% CI) P-value

ACEI/ARB 83.0%(82.1 – 83.8)

86.5%(85.6 – 87.3)

+ 3.5%(2.3 – 4.8)

+ 4.3%(2.8 – 5.7) <0.001

ß-blocker88.5%

(87.7 – 89.2)93.6%

(93.0 – 94.2)+ 5.1%(4. – 6.1)

+ 5.8%(4.7 – 6.9) <0.001


35.4%(32.8 – 38.1)

61.8%(59.2 – 64.5)

+ 26.4%(22.6 – 30.1)

+ 74.4%(63.9 – 84.9) <0.001


72.2%(70.3 – 74.1)

69.3%(67.5-71.0)

- 2.9%(-5.5 – -0.3)

- 4.1%-7.7 – -0.5) 0.026

CRT-P/CRT-D 41.2%(37.4 – 44.9)

68.5%(65.8 – 71.3)

+ 27.4%(22.7 – 32.0)

+ 66.5%(55.2 – 77.7) <0.001

ICD/CRT-D 54.4%(53.0 – 55.8)

79.1%(78.0 – 80.2)

+ 24.7%(23.0 – 26.5)

+ 45.4%(42.4 – 48.6) <0.001

HF education 59.7%(58.6 – 60.8)

70.8%(69.8 – 71.9)

+ 11.2%(9.7 – 12.7)

+ 18.7%(16.2 – 21.2) <0.001

Patient Level AnalysisImprovement in 6 of 7 Quality Measures

Patient Level AnalysisImprovement in 6 of 7 Quality Measures


Newly Documented Contraindications/Intolerance and Newly Treated patients at 24 months—Paired Longitudinal Cohort

Quality Measure

Newly documented contraindication/

Intolerance at 24 mo. in patients initially eligible at baseline

(N=7,605), %

Newly treated at 24 mo. in patients

initially eligible at baseline

(N=7,605), %

Newly treated at 24 mo. in patients not initially eligible at

baseline, but eligible at 24 mo.

ACEI/ARB 9.8% (699/7138) 7.6% (546/7138) 67.1% (49/73)

ß-blocker 5.5% (381/6905) 6.3% (434/6905) 83.9% (208/248)


16.4% (210/1278) 10.3% (132/1278) 54.2% (396/730)


8.8% (181/2061) 6.9% (143/2061) 58.1% (493/848)

CRT-P/CRT-D 1.8% (12/673) 23.5% (158/673) 59.3% (377/636)

ICD/CRT-D 3.9% (198/5028) 15.3% (769/5028) 71.1% (857/1205)

HF education 0.0% (0/7605) 26.3% (2003/7605) 0.0% (0/0)


Results: Summary Measures Significantly Improved at the Patient Level

68.4%80.1%

Baseline(n=167)

24 months(n=155)

Composite Score: % of total indicated quality measures provided

Patient level analysis

17.0% relative increase, p < 0.001

43.9%

24.3%

Baseline (n=167)

24 months(n=155)

All-or-None Care: % of patients receiving each indicated quality

measure

Patient level analysis

345.5% relative increase, p < 0.001


Single Time Point Cohorts: Improvement at 18 Months

Quality MeasureBaseline (95% CI)

N = 15,177

18 Months(95% CI)N = 7,605


(95% CI)


(95% CI) P-value

ACEI/ARB79.8%

(79.2 – 80.5)81.3%

(80.5 – 82.1)+ 1.5%

(0.4 – 2.5)+ 1.9%

(0.5 – 3.2)0.006

ß-blocker86.2%

(85.6 – 86.8)91.9%

(91.3 – 92.5)+ 5.7%

(4.9 – 6.6)+ 6.7%

(5.7 – 7.6)<0.001


34.4%(32.7 – 36.1)

38.0%(35.8 – 40.3)

+ 3.6%(0.8 – 6.5)

+ 10.6%(2.3 – 18.8)

0.012


68.6%(67.2 – 70.0)

69.9%(68.2 – 71.5)

+ 1.3%(-0.9 – 3.5)

+ 1.9%(-1.3 – 5.1)

0.237

CRT-P/CRT-D37.7%

(35.2 – 40.1)44.1%

(41.1 – 47.1)+ 6.4%

(2.6 – 10.3)+ 17.1%

(6.8 – 27.4)0.001

ICD/CRT-D48.8%

(47.8 – 49.8)55.9%

(54.7 – 57.0)+ 7.0%

(5.5 – 8.6)+ 14.4%

(11.3 – 17.6)<0.001

HF education61.8%

(61.0 – 62.5)75.8%

(75.0 – 76.7)+ 14.1%

(12.9 – 15.2)+ 22.8%

(20.9 – 24.7)<0.001

Fonarow GC, et al. Circulation. 2010;122:585-596. Patient level analysis

Directionally similar, smaller magnitude improvements than longitudinal cohortDirectionally similar, smaller magnitude improvements than longitudinal cohort

Study Limitations

• Patient eligibility and utilization rates determined by accuracy and completeness of medical records and their abstraction– Reasons for preventing treatment may not have been documented

• Potential for ascertainment bias– Self-selected cardiology practices, primary care setting not included

• Not randomized—secular trends may have influenced results

• Follow-up not available for all patients– Practices dropped out, patients died or were lost to follow-up

– Paired analyses revealed similar improvements

• Clinical outcomes could not be evaluated with the design

• Unable to measure use of therapies outside of guidelines

• Relative efficaciousness of intervention components could not be determined


Conclusions

• IMPROVE HF is the largest outpatient cardiology heart failure practice performance improvement program.

• Implementation of a defined and scalable performance improvement intervention may improve the use of evidence-based, guideline-recommended heart failure therapies in real-world cardiology practices.

• Study findings may serve as a model for existing and future performance improvement programs.


Clinical Implications

Implementation of a defined and scalable practice specific performance improvement intervention enhances use of evidence-based, guideline-recommended HF therapies demonstrated to improve outcomes

In all care settings where HF patients are managed, programs to provide practitioners with useful reminders based on the guidelines and to continuously assess the success achieved in providing these recommended therapies to the patients who can benefit from them should be implemented


IMPROVE HF Performance Improvement Tools

• As part of an enhanced treatment plan, IMPROVE HF provided evidence-based best-practices algorithms, clinical pathways, standardized encounter forms, checklists, pocket cards, chart stickers, and patient education and other materials to facilitate improved management of outpatients with HF.

• The materials can be downloaded from www.improvehf.com

• The materials are also included in the Circulation online-only Data Supplement


http://www.improvehf.com/

Documents

Improving Evidence-Based Care for Heart Failure in Outpatient Cardiology Practices: Primary Results of the Registry to Improve Heart Failure Therapies