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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).

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slide1

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
  • 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
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.

slide4

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.

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-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.

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

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.

methods study design and patient disposition
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.

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

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

improve hf performance intervention benchmarked practice profile report
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

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 analysis18
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.

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.

slide20
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

Directionally similar, smaller magnitude improvements than longitudinal cohort

Patient level analysis

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

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.

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.