IMPROVE_HF_Primary_R esults

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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) : 

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 : 

Disclosures The IMPROVE HF registry is sponsored by Medtronic. The sponsor had no role or input into the 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 : 

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.

Slide 5: 

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 : 

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 : 

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.

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

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.

Methods: Study Objectives : 

Methods: Study Objectives 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. a Pre-specified primary objective

Methods: Study Design and Patient Disposition : 

Methods: Study Design and Patient Disposition Longitudinal Cohort Two Single- Time-Point Cohorts Process Improvement Intervention (165 sites) 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 6 Month Chart Review 154 sites 9,992 patients 18 Month Chart Review 151 sites 9,641 patients 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.

Methods: Practice Specific Performance Improvement Intervention : 

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.

IMPROVE HF Practice Specific Education and Implementation Tools : 

IMPROVE HF Practice Specific Education and Implementation Tools www.improvehf.com Evidence Based Algorithms and 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 : 

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

Patient Characteristics : 

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

Patient Characteristics (Continued) : 

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

IMPROVE HF Practice Characteristics : 

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.

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

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.

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

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.

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

Results: Improvement in Quality Measures at 24 Months (Patient Level Analysis) Eligible Patients Treated Fonarow GC, et al. Circulation. 2010;122:585-596. * P<0.001 vs. baseline 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 P-values are for relative change

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

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.

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

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

Results: Summary Measures Significantly Improved at the Patient Level : 

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

Single Time Point Cohorts: Improvement at 18 Months : 

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

Study Limitations : 

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.

Conclusions : 

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.

Clinical Implications : 

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.

Back-up Slides : 

Back-up Slides

Practice-Level Use of Guideline-Recommended Therapies in the Longitudinal Cohort with Complete Follow-up at 24 Months : 

Practice-Level Use of Guideline-Recommended Therapies in the Longitudinal Cohort with Complete Follow-up at 24 Months N=155 practices Fonarow GC, et al. Circulation. 2010;122:585-596.

Odds Ratios for the Use of Guideline-Recommended Therapies in the Longitudinal Cohort with Complete Follow-up at 24 months Relative to Baseline in GEE Models : 

Odds Ratios for the Use of Guideline-Recommended Therapies in the Longitudinal Cohort with Complete Follow-up at 24 months Relative to Baseline in GEE Models Fonarow GC, et al. Circulation. 2010;122:585-596. Model controlled for within-patient and within-practice correlations. The multivariate model included all patient and practice characteristics that were significant at the P < 0.10 level in univariate analysis.

Use of Guideline-Recommended Therapies in the Longitudinal Cohort at Baseline for the Entire Cohort, and by Patient status at 24 Months : 

Use of Guideline-Recommended Therapies in the Longitudinal Cohort at Baseline for the Entire Cohort, and by Patient status at 24 Months Fonarow GC, et al. Circulation. 2010;122:585-596.

Odds Ratios for the Use of Guideline-Recommended Therapies in the 18-Month Single-Point-in-Time Cohort Relative to the Longitudinal Baseline Cohort in GEE Models : 

Odds Ratios for the Use of Guideline-Recommended Therapies in the 18-Month Single-Point-in-Time Cohort Relative to the Longitudinal Baseline Cohort in GEE Models Fonarow GC, et al. Circulation. 2010;122:585-596. Model controlled for within-practice correlations. The multivariate model included all patient and practice characteristics that were significant at the P < 0.10 level in univariate analysis.

Eligible Patients for Each Quality Measure by Cohort : 

Eligible Patients for Each Quality Measure by Cohort Fonarow GC, et al. Circulation. 2010;122:585-596.

Results: Summary of Baseline Patient Characteristics : 

Results: Summary of Baseline Patient Characteristics Mean and median age: 68.7 and 70.0 years Sex: 71.1% male Mean LVEF: 25.4% Ischemic etiology: 65.4% Comorbidities: Hypertension 62.2% Diabetes 34.1% AF 30.7% Chronic obstructive pulmonary disease 16.7% Median blood pressure: 120/70 mm Hg Median Creatinine: 1.2 mg/dL NYHA functional class: 34.7% Class I, 36.6% Class II, 20.7% Class III, 2.6% Class IV, 5.5% undocumented Fonarow GC, et al. Circulation. 2010;122:585-596.

IMPROVE HF Primary Objective : 

IMPROVE HF Primary Objective To observe over the aggregate of IMPROVE HF practice sites a relative ≥20% improvement in at least 2 of the 7 performance measures at 24 months compared with baseline Fonarow GC et al. Improving the use of evidence-based heart failure therapies in the outpatient setting: the IMPROVE HF performance improvement registry. Am Heart J, 2007; 154:12-38.

Results: Baseline Practice Characteristics : 

Results: Baseline Practice Characteristics APN, advanced practice nurse. * n=163 Fonarow GC, et al. Circulation. 2010;122:585-596.

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

Results: Improvement in Quality Measures at 24 Months (Practice Level Analysis) Eligible Patients Treated Fonarow GC, et al. Circulation. 2010;122:585-596. * P<0.001 vs. baseline (P-values for 12 months vs. baseline not reported) N = 167 practices at baseline and 155 practices at 12 and 24 months Improvement in 5 of 7 Quality Measures 123 of 155 practices (79%) with ≥ 20% Relative Improvement in 2 or more Quality Measures P-values are for relative change

Longitudinal Cohort with Complete Follow-up at 24 Months : 

Longitudinal Cohort with Complete Follow-up at 24 Months Eligible Patients Treated Fonarow GC, et al. Circulation. 2010;122:585-596. * P<0.001 vs. baseline † P=0.026 vs. baseline Improvement in 6 of 7 quality measures P-values are for relative change Patient level analyses

Single Time Point Cohorts: Quality Measures at 18 Months : 

Single Time Point Cohorts: Quality Measures at 18 Months Eligible Patients Treated Fonarow GC, et al. Circulation. 2010;122:585-596. * P ≤ 0.001 vs. baseline † P = 0.006 vs. baseline ‡ P = 0.012 vs. baseline P-values are for relative change Directionally similar, smaller magnitude improvements than longitudinal cohort Patient level analyses

Results: Summary Measures at Practice Level : 

Results: Summary Measures at Practice Level Fonarow GC, et al. Circulation. 2010;122:585-596.

Baseline Quality of Outpatient HF Care : 

Baseline Quality of Outpatient HF Care Conformity with Quality Measures at Baseline

Methods: Study Design and Patient Disposition : 

Methods: Study Design and Patient Disposition Longitudinal Cohort Two Single- Time-Point Cohorts Process Improvement Intervention (165 sites) 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 6 Month Chart Review 154 sites 9,992 patients 18 Month Chart Review 151 sites 9,641 patients 34,810 patients enrolled • 167 total sites • 63,143 chart reviews FU, Follow Up 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 Patient Disposition Fonarow GC, et al. Circulation. 2010;122:585-596.

IMPROVE HF Performance Improvement Tools : 

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.

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