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Prepared December 2010

Prepared December 2010. Equitable Improvement for Women and Men in the Use of Guideline-Recommended Therapies for Heart Failure: Findings From IMPROVE HF.

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Prepared December 2010

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  1. Prepared December 2010

  2. Equitable Improvement for Women and Men in the Use of Guideline-Recommended Therapies for Heart Failure: Findings From IMPROVE HF Mary Norine Walsh, Clyde W. Yancy, Nancy M. Albert, Anne B. Curtis, Mihai Gheorghiade, J. Thomas Heywood, Patches Johnson Inge, Mark L. McBride, Mandeep R. Mehra, Christopher M. O'Connor, Dwight Reynolds,Gregg C. Fonarow J Cardiac Fail. 2010;16:940-949

  3. Disclosures • The IMPROVE HF registry is sponsored by Medtronic. • Outcome Sciences was the registry coordinating center. • CommGeniX provided technical copyediting support with funding from Medtronic. • Individual author disclosures are provided in the manuscript. Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  4. Background Chronic heart failure (HF) Similar numbers of men and women affected Substantial mortality and morbidity in women and men > 12 million outpatient visits annually in the US. Fewer women than men included in trials showing reductions in mortality and morbidity for patients with HF and left ventricular dysfunction. Analyses, with few exceptions, demonstrated similar efficacy of guideline-recommended HF therapies for men and women. Sex-based disparities in the use of guideline-recommended pharmacologic and device therapies have been demonstrated in both inpatient and outpatient settings. Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  5. Objective To determine whether a cardiology practice-based performance improvement initiative produces equitable improvement in guideline-recommended therapies in women and men. Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  6. 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.

  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 Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  8. Methods: Guideline-Recommended Quality Measures Seven quality measures with strong evidence prospectively selected by study Steering Committee: 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) HF education Patients deemed eligible for individual quality measure based on meeting guideline criteria, without contraindications, intolerance, or other documented reasons for non-treatment. Two summary measures of care also calculated Composite score: Percentage of the total indicated quality measures provided to eligible patients. All-or-none care: Proportion of patients who received each quality measure for which they were eligible. Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  9. Methods: Study Design Longitudinal cohort patients’ medical records reviewed at baseline and at 24 months following completion of the process improvement intervention. For this analysis, absolute changes in the 7 quality measures and in the composite score and all-or none care measure were compared between men and women. Baseline Chart Review 167 sites 15,170 patients 24 Month Chart Review 155 sites 7,603 patients Longitudinal Cohort Process Improvement Intervention Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

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

  11. Baseline Patient Demographics & Clinical Characteristics Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  12. Baseline Patient Demographics & Clinical Characteristics (Continued) Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  13. Practice Characteristics by Patient Sex at Baseline Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  14. Absolute Improvement in Quality Measures for All Patients by Patient Sex Similar for 5 quality measures, but significantly better in women for CRT, ICD, and composite care * Comparison of % of men vs. women receiving quality measure † Difference in absolute change percentage between sexes Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  15. Improvement in Composite and All-or-None Quality Measures by Patient Sex AI = Absolute Improvement RI = Relative Improvement Comparisons of Men vs Women Difference in AI: P=0.53 Difference in RI: P<0.001 Baseline adherence: P<0.001 24-month adherence: P=0.311 Comparisons of Men vs Women Difference in AI: P<0.001 Difference in RI: P=0.002 Baseline adherence: P<0.001 24-month adherence: P=0.025 Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  16. Absolute Improvement in Quality Measures for Only Patients With Baseline and 24-Month Data by Patient Sex * Comparison of % of men vs. women receiving quality measure † Difference in absolute change percentage between sexes Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  17. Adjusted Odds Ratios for Achieving the Upper 75th Percentile of Improvements in Treatment Adjusted Odds Ratio with 95% CI ACEI/ARB ß-blocker Aldosterone antagonist Anticoagulation for AF CRT-P/CRT-D ICD/CRT-D HF education Composite score All-or-none care Women more likely Men more likely Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  18. Unadjusted and Adjusted Analysis of Patient Sex as a Predictor of Percent Absolute Improvement Analyzed as a Continuous Variable Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  19. Results Summary • Baseline rates of use for anticoagulation and ICD therapy were significantly lower in women compared with men. • After implementation of performance improvement intervention, significant improvements in 6 of 7 quality measures at 24 months for both women and men. • Similar absolute improvement for men and women for 4 measures • Greater improvement for women in 2 quality measures (CRT and ICD) and in composite care. Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  20. 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 Aldosterone antagonist, CRT, ICD have Class I recommendation in guidelines, but not include as ACC/AHA outpatient performance measures Potential for ascertainment bias with self-selected cardiology practices Not randomized—secular trends may have influenced results Less likely since there were no known concurrent performance improvement initiatives underway Clinical outcomes were not evaluated Patient adherence not evaluated Unable to measure use of therapies outside of guidelines Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  21. Conclusions IMPROVE HF study is among first to show similar or greater increases in the use of guideline-recommended HF therapies for women compared with men. This study demonstrates that participation in IMPROVE HF resulted in increased physician provision of guideline-recommended therapies over time regardless of sex for patients with HF and reduced LVEF. Clinical decision support and performance feedback may help to ensure improved and equitable care for men and women with HF. Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  22. Backup Slides

  23. Absolute Improvement in Quality Measures for Women and Men Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  24. Improvement in Composite and All-or-None Quality Measures by Patient Sex A.I. = Absolute Improvement Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

  25. Absolute Improvement in Quality Measures for Patients with Both Baseline and 24 Month Data Walsh MN, et al. J Cardiac Fail. 2010;16:940-949 Sex and Improvements in HF Therapies

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