IMPROVE HF Primary Results

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(No Transcript)
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Associations Between Outpatient Heart Failure
Process of Care Measures and Mortality
Gregg C. Fonarow, Nancy M. Albert, Anne B.
Curtis, 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.
2011123(15)1601-1610.
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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.
2011123(15)1601-1610.
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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
  (HF) in inpatient and outpatient care settings.
• IMPROVE HF showed a performance improvement
  program can increase the use of guideline
  recommended HF therapies in the outpatient
  setting.
• It is assumed that use of process based
  performance measures are associated with improved
  clinical outcomes however that has not been
  evaluated for current or emerging outpatient HF
  measures.

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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IMPROVE HF Outpatient Process Measures
Yancy CW, et al. Circulation. 2005112154-e235. B
onow RO, et al. J Am Coll Cardiol.
2005461144-1178.
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Study Objectives


To examine associations between patient level process measures and patient level survival for each performance measure and two summary measures (total composite score and all-or-none care).



Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Statistical Methods

• For primary analysis, patients who were eligible
  for treatment but not treated at baseline and who
  crossed over within first 12 months of the
  performance initiative were excluded from each
  measure
• The composite score for each patient was
  calculated as the sum of individual quality
  measure numerators divided by the sum of
  individual quality measure denominators for which
  patient was eligible
• The all-or-none care measure was defined for each
  patient in terms of whether they received all
  individual measures for which they were eligible
• Process-of-care measure conformity at baseline
  stratified by vital status at 24 months was
  summarized and compared in patients alive vs.
  those who died by Chi-square test or t test
• For each quality measure, composite score and
  all-or-none care measure, Generalized Estimating
  Equation (GEE) methodology was used to estimate
  unadjusted and adjusted relationships between
  each process measure and patient-level mortality
  in first 24 months. The GEE models accounted for
  correlation of patients within practices.
• Appropriate clinical and/or statistical
  meaningful baseline patient demographic and
  clinical characteristics and practice
  characteristics were included in the multivariate
  GEE model for adjusted odds ratio estimation

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Patient Population

• To be enrolled in IMPROVE HF, patients had to
  have heart failure or post-myocardial infarction
  left ventricular dysfunction with left
  ventricular ejection fraction of 35 or less.
• There were 15,177 patients from 167 cardiology
  and multispecialty practices in the US evaluated
  at baseline and enrolled in the longitudinal
  cohort.
• At the 24 month follow-up 11,621 of the 15,177
  patients (76.6) had documentation of vital
  status.
• A total of 2507 patients (16.5) were lost to
  follow-up and 1048 (6.9) were seen in practices
  (n12) that did not complete the follow-up
  assessment.

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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IMPROVE HF Patient Characteristics
Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Patient Characteristics (Continued)
Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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IMPROVE HF Practice Characteristics
Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Patient 24 Month Follow-up Mortality

• At 24 months, 2569 of the 11,621 patients
  (22.1) with complete vital status had died.
• Patients who died were significantly more
  likely to have ischemic HF origin and
  comorbidities, including diabetes mellitus,
  hypertension, chronic obstructive pulmonary
  disease, peripheral vascular disease, and
  depression.
• Statistically significant differences were also
  evident for laboratory evaluations, including BUN
  and creatinine, with higher levels in patients
  who had died during the 24-month follow-up.
• The baseline process measure conformity was
  significantly lower among patients who died
  compared with those who survived for 5 of the 7
  individual measures.

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Baseline Measure Conformity Alive vs. Dead at
24-Month Follow-Up
The baseline process measure conformity was
significantly lower among patients who died
compared with those who survived for 5 of 7
individual measures.
Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Association Between HF Process Measures and
Mortality Univariate and Multivariate GEE Models
Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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6 of 7 Process Measures Associated with Reduced
Mortality
Mortality Adjusted Odds Ratios with 95 CI
Displayed
Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Composite Measures Associated with Reduced 24
Month Mortality

• Each 10 improvement in composite care was
  associated with a 13 lower odds of 24-month
  mortality (adjusted odds ratio, 0.87 95
  confidence interval, 0.84 to 0.90 Plt0.0001).
• The adjusted odds for mortality risk for
  patients with conformity to each measure for
  which they were eligible was 38 lower than for
  those whose care did not conform for 1 or more
  measures for which they were eligible (adjusted
  odds ratio, 0.62 95 confidence interval, 0.52
  to 0.75 Plt0.0001).

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Results Summary

• Baseline process measure conformity was
  significantly lower among patients who died
  compared to those who survived for 5 of 7
  measures (ACEI/ARB, beta-blockers,
  anticoagulation for atrial fibrillation, ICD,
  CRT).
• Baseline process measure composite score was
  70.0 for patients alive at 24 months compared to
  63.4 for those who died (p lt 0.0001).
• Adjusted odds ratio for mortality risk for
  patients with conformity to all eligible measures
  was 38 lower than those without conformity to
  one or more eligible measure.
• Every 10 improvement in composite care was
  associated with a 13 lower odds of 24 month
  mortality risk.

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Study Limitations

• Patient eligibility and utilization rates were
  determined by accuracy and completeness of
  medical records and their abstraction
• Reasons for preventing treatment may not have
  been documented
• NYHA was not quantified in many records and
  instead was based on qualitative description of
  the patients functional status
• 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
• Study analyzed medications prescribed rather than
  patient adherence
• Associations between care processes and outcomes
  do not determine causality
• Did not assess health-related quality of life,
  symptom control, functional capacity, patient
  satisfaction, hospitalization rates, or other
  clinical outcomes that may be of interest

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Conclusions

• These data are among the first to demonstrate
  that adherence to HF process measures for
  ACEI/ARB, beta blocker, anticoagulation for
  atrial fibrillation, and HF education is
  significantly associated with survival in
  outpatients with heart failure.
• Process measures for ICD use and CRT use could
  also be considered for inclusion in HF outpatient
  performance measure sets.

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Clinical Implications

• These HF process measures appear to discriminate
  the quality of HF care at the patient level and
  may be useful for assessing and improving HF
  care.

Fonarow GC, et al. Circulation.
2011123(15)1601-1610.
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Back-Up Slides
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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. 200715412-38.
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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. 2010122585-596.
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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 lt 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. 2010122585-596.
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Methods Study Design and Patient Disposition

• Patients who were eligible for treatment but not
  treated at baseline and who crossed over within
  the first 12 months of the intervention were
  excluded from each measure

Fonarow GC, et al. Circulation. 2010122585-596.
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Methods Practice Specific Performance
Improvement Intervention
Use or participation was encouraged but not
mandatory. Practices could adopt or modify tools.

• Practice Survey
• 96 adopted one or more performance improvement
  strategies
• 85 used benchmarked quality reports
• 60 employed one or more IMPROVE HF tools

Fonarow GC, et al. Circulation. 2010122585-596.
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IMPROVE HF Performance InterventionBenchmarked
Practice Profile Report
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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. 2010122585-596.
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IMPROVE HF Practice Specific Education and
Implementation Tools
Evidence Based Algorithms and Pocket Cards
Clinical Assessment and Management Forms
Clinical Trials and Current Guidelines
www.improvehf.com
Patient Education Materials

• Dissemination of best practices
• Webcasts
• Online Education
• Newsletters