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

1. 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

2. 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.

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

4. ACC/AHA 2005 HF Guidelines: Implementation of Guidelines I IIa IIb III 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 I IIa IIb III I IIa IIb III Hunt SA, et al. ACC/AHA 2005 Practice Guidelines. Available at http://www.acc.org.

5. 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-recommendedHF 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.

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

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

8. Methods: Study Objectives a Pre-specified primary objective Practice level analysis: proportion of eligible patients receiving therapy for each practice Patient level analysis: proportion of eligible patients receiving therapy for aggregate of all practices Fonarow GC, et al. Circulation. 2010;122:585-596.

9. Methods: Study Design and Patient Disposition Baseline Chart Review 167 sites 15,177 patients 12 Month Chart Review 155 sites 9,386 patients 24 Month Chart Review 155 sites 7,605 patients Longitudinal Cohort Process Improvement Intervention (165 sites) 6 Month Chart Review 154 sites 9,992 patients 18 Month Chart Review 151 sites 9,641 patients Two Single- Time-Point Cohorts • 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. Fonarow GC, et al. Circulation. 2010;122:585-596.

10. Methods: Practice Specific Performance Improvement Intervention 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. Fonarow GC, et al. Circulation. 2010;122:585-596.

11. IMPROVE HF Practice Specific Education and Implementation Tools Evidence Based Algorithms and Pocket Cards Clinical Trials and Current Guidelines Clinical Assessment and Management Forms www.improvehf.com Patient Education Materials Dissemination of best practices: - Webcasts - Online Education - Newsletters

12. IMPROVE HF Performance Intervention:Benchmarked Practice Profile Report Adherence to Guidelines Practice or Single Physician On-Demand Performance Measures across all physicians within practice Benchmarking Capability: region, practice, individual physician Benchmarking

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

14. Patient Characteristics (Continued) Fonarow GC, et al. Circulation. 2010;122:585-596.

15. IMPROVE HF Practice Characteristics *Two sites did not provide any survey data. N=165 for these characteristics unless otherwise noted. Fonarow GC, et al. Circulation. 2010;122:585-596.

16. Results: Improvement in Quality Measures at 24 Months (Practice Level Analysis) Longitudinal Cohort 123 of 155 practices (79%) with ≥ 20% relative improvement in 2 or more care measures Fonarow GC, et al. Circulation. 2010;122:585-596.

17. Results: Improvement in Quality Measures at 24 Months (Patient Level Analysis) Longitudinal Cohort Prespecified primary objective met: Relative improvement ≥ 20% in 3 quality measures Fonarow GC, et al. Circulation. 2010;122:585-596.

18. Results: Improvement in Quality Measures at 24 Months (Patient Level Analysis) Significant Improvement in 6 of 7 Quality Measures at 12 and 24 Months Pre-specified Primary Objective Met: Relative Improvement ≥ 20% in 3 Quality Measures Eligible Patients Treated * P<0.001 vs. baseline P-values are for relative change Fonarow GC, et al. Circulation. 2010;122:585-596.

19. Longitudinal Cohort with Complete Follow-up at 24 Months: Modified Intention to Treat Analyses Patient Level Analysis Improvement in 6 of 7 Quality Measures Fonarow GC, et al. Circulation. 2010;122:585-596.

20. Newly Documented Contraindications/Intolerance and Newly Treated patients at 24 months—Paired Longitudinal Cohort Fonarow GC, et al. Circulation. 2010;122:585-596.

21. Results: Summary Measures Significantly Improved at the Patient Level Fonarow GC, et al. Circulation. 2010;122:585-596.

22. Single Time Point Cohorts: Improvement at 18 Months Directionally similar, smaller magnitude improvements than longitudinal cohort Patient level analysis Fonarow GC, et al. Circulation. 2010;122:585-596.

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

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

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

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