Strategies to Improve the Use of EvidenceBased Heart Failure Therapies: OPTIMIZEHF

1
Strategies to Improve the Use of Evidence-Based
Heart Failure Therapies OPTIMIZE-HF
(Organized Program To Initiate life-saving
treatMentIn hospitaliZEd patients with Heart
Failure)

• Gregg C. Fonarow, MDEliot Corday Professor of
  Cardiovascular MedicineUCLA Division of
  CardiologyDirector, Ahmanson-UCLA Cardiomyopathy
  CenterDirector, UCLA Cardiology Fellowship
  Training ProgramLos Angeles, California

2
Opportunities to Improve Care for Patients With
Heart Failure

• Despite overwhelming clinical trial evidence,
  expert opinion, national guidelines, and a vast
  array of educational conferences, evidence-based,
  life-saving therapies continue to be
  underutilized
• New approaches to improving the use of proven,
  guideline-recommended, life-saving therapies are
  clearly needed

Fonarow GC. Rev Cardiovasc Med. 20023S2S10.
3
Utilization of Evidence-Based Therapies in Heart
Failure
LVEF Documented and ?0.40
100
90
80
68
70
60
Patients Treated ()
44.3
50
40.9
40
31.9
30
20
10
10
0
ACE Inhibitor
ARB
b- Blocker
Diuretic
Digoxin
Outpatient HF Medication
Excludes patients with documented
contraindications. 2300/7883 patients
hospitalized with HF prior known dx of systolic
dysfunction HF outpatient medical
regimen. ADHERE Registry Report Q1 2002
(4/01-3/02) of 180 US hospitals. Presented by GC
Fonarow at the Heart Failure Society of America
Satellite Symposium, September 23, 2002.
4
Utilization of Evidence-BasedTherapies in Heart
Failureat University Hospitals
100
90
80
69
70
60
Patients Treated ()
50
40
29
30
19
20
10
0
b- Blockers
ACE Inhibitors
Spironolactone
University Hospital Consortium HF Registry 33
centers, 1239 patients, Year 2000. Outpatient
regimen before HF hospitalization in patients
with Stage C HF. Unpublished data provided
courtesy of Dr GC Fonarow, UCLA Medical Center.
5
Utilization of Evidence-BasedHF Therapies
IMPROVEMENTInternational Survey
100
90
80
70
60
60
Patients Treated ()
50
34
40
30
20
12
20
10
0
?- Blockers
ACE Inhibitors
ACEI BB
Sprionolactone
International survey 15 countries, 1363
physicians, 11,062 patients Year
2000. Outpatient regimen in patients with Stage C
HF, documented systolic dysfunction. Cleland JG.
Lancet. 20023601631-1639.
6
Percentages of ADHERE Patientsin Whom HF Quality
of Care Indicators Addressed
Diet/sodiumrestriction
Follow-up appointment
Monitoring of weight
Discharge medications
Smoking cessation
Activity recommendations
What to do if symptoms worsen
All 6 Components 21
100
84
90
78
74
80
69
70
60
Patients Treated ()
50
42
40
27
30
22
20
10
0
Performance Indicator
11,288 Patients hospitalized with HF. ADHERE
Registry Report Q2 2002 (7/01-6/02) of 180 US
hospitals. Presented by GC Fonarow at the Heart
Failure Society of America Satellite Symposium,
September 23, 2002.
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Benefits and Drawbacks of Heart Failure Disease
Management Programs

• Benefits
• Improved use ofevidence-based therapy
• Improved symptom status and functional capacity
• Improved QOL
• Reduction in hospitalization
• Decrease in total medical costs
• Improved survival suggested in some studies

• Drawbacks

Usual Care
96
4
HF Disease Management Program
Moser DK, Mann DL. Circulation.
200210528102812.
8
Why a Hospital-Based System forHF Management?

• Patients
• Patient capture point
• Have patients/familys attention teachable
  moment
• Predictor of care in community
• Hospital structure
• Standardized processes/protocols/orders/teams
• Accrediting bodies for standards of care
• Centers for Medicare and Medicaid Servicespeer
  review organizations
• JCAHO (in-hospital)
• HEDIS (post-discharge)

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Institutional Heart Failure Discharge Medication
Program Reduces Readmissions and Mortality
95
100
90
80
Hazard ratio 0.80 P70
65
60
Treatment Rates ()
38
Hazard ratio 0.77 P46
50
40
18
30
23
20
10
0
ACEI Rx
Readmissions
1-year Mortality
Intermountain Health Care 10 hospitals
pre-1/96-12/98, n11,038 to 1/99-3/00,
n8,045. Pearson TA. Circulation. 2001104II-838.
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The Association Between the Quality of Inpatient
Care and Outcomes

• Early HF readmission and 30-day mortality are
  associated with the process of inpatient care
• Meta-analysis of 13 studies The risk of early
  readmission is increased by 55 when inpatient
  care is of relatively low quality

The quality of inpatient care was measured
through a scoring process that evaluated
predefined elements of essential technical care
of the hospitalized patient. Elements were
admission workup (history, physical examination,
and initial tests), criteria for evaluation and
treatment during the stay, and criteria for
readiness for discharge. Kahn KL et al. JAMA.
199026419691973. Ashton CM et al. Ann Intern
Med. 1995122415421. Ashton CM et al. Med
Care. 19973510441059.
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Resources in Usual Hospital Setting vs Usual
Outpatient Office Setting
Outpatient Practice Resources
Hospital Resources
Case managers
Nurses
Physical therapists
Systems
Physician
Physicians
Pharmacists
Nutritionists
Medical social workers
Consultants
Approx HCP time spent with patient
15 minutes
96 hours
HCP, health care provider.
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Benefits of In-Hospital Initiation of
Cardiovascular Therapies

• Long-term therapy more likely to be continued by
  physician
• Patients more likely to view therapy as essential
  (heart medication)
• Patients more likely to be compliant(lower
  discontinuation rates)
• Patients more likely to achieve treatment goals
• Early event reduction not missed

Fonarow GC, Ballantyne CM. Circulation.
200110327682770.
13
Outpatient Adherence to?-Blocker Therapy Post
Acute MI
80
Discharged on ?-blockers
60
Percent ?-Blocker Users
40
Not discharged on ?-blockers
20
0
0
30
90
180
270
365
Days Since Discharge
Butler J et al. J Am Coll Cardiol.
20024015891595.
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Initiation of ?-Blockers in Hospitalized Heart
Failure Patients Concerns

• Despite established benefits in chronic HF,
  ?-blockade remains contraindicated in
  decompensated HF
• Although most hospitalized patients stabilize
  within a few days, conventional wisdom was to
  wait 24 weeks after hospitalization to initiate
  therapy
• Concern that initiation of ?-blockers in patients
  with recent decompensation would worsen outcome
• No sense of urgency because it was believed that
  it takes months before the benefits of ?-blocker
  therapy in patients with HF are realized

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IMPACT-HF
Screening hospitalized patients
Eligible based on inclusion/exclusion
Randomization N363
Carvedilol initiation (3.125 mg bid)predischarge
Initiation of any ?-blocker(?2 weeks
postdischarge)at physician discretion
Follow-up at 60 days
All patients were treated with other HF therapy
including ACE inhibitors at the physicians
discretion. Any ?-blocker. Gattis W et al. Rev
Cardiovasc Med. 20023(suppl 3)S48S54.
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IMPACT-HF Primary End PointPatients Receiving a
?-Blocker at 60 Days

• Original assumptions 50 of predischarge
  initiation groupand 35 of postdischarge
  initiation group on ?-blocker at 60 days

P
100
91
73
75
Patients ()
50
25
0
CarvedilolPredischarge Initiation (n185)
Physician Discretion Postdischarge
Initiation (n178)
Any ?-blocker. Presented by Mihai Gheorghiade,
MD, Christopher OConnor, MD, and Wendy Gattis,
PharmD, at GSK Satellite Symposium at AHA
Scientific Sessions, Nov. 18, 2002, Chicago, Ill.
17
IMPACT-HF Length of Hospital Stay
15
10
6.6
5.9
Mean Number of Days
5
0
CarvedilolPredischarge Initiation (n185) 5 (3,
8)
Physician Discretion Postdischarge
Initiation (n178) 5 (3, 8)
Median Number of Days (25th, 75th percentiles)
Any ?-blocker. Presented by Mihai Gheorghiade,
MD, Christopher OConnor, MD, and Wendy Gattis,
PharmD, at GSK Satellite Symposium at AHA
Scientific Sessions, Nov. 18, 2002, Chicago, Ill.
18
IMPACT-HF Serious Adverse Events
Any ?-blocker. Presented by Mihai Gheorghiade,
MD, Christopher OConnor, MD, and Wendy Gattis,
PharmD, at GSK Satellite Symposium at AHA
Scientific Sessions, Nov. 18, 2002, Chicago, Ill.
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Comparative Percentages of HF Patients Receiving
a ?-Blocker
100
91
75
67
Patients Rx with ?-Blocker ()
50
27
25
16
0
IMPACT-HF Carvedilol Predischarge Initiation
Usual Care
Provider/Patient Notification
Nurse Facilitator
Ansari M. Circulation. 200310727992804 IMPACT
HF Presented by Mihai Gheorghiade, MD,
Christopher OConnor, MD, and Wendy Gattis,
PharmD, at GSK Satellite Symposium at AHA
Scientific Sessions, Nov. 18, 2002, Chicago, Ill.
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JCAHO Quality-of-Care Indicators for HF

• HF-1 Discharge instructions
• HF-2 Assessment of LV function
• HF-3 ACEI at discharge in appropriate patients
• HF-4 Smoking cessation advice/counseling

• Daily weights 4. What to do if Sx worsen
• 2-gram sodium diet 5. Follow-up appointment
• Activity Rx 6. List of medications

www.jcaho.org
21
ADHERE Quality of CareConformity to JCAHO HF
Performance Indicators
Fonarow GC. Circulation. 2003108IV-447.
22
ADHERE Variation in ACEI Use
ORYX Core Measure HF-3 - LVEF ACEI at discharge
100
80
60
Rate ()
40
20
0
ADHERE Hospitals
ADHERE Dec 2002, 206 hospitals 23,193 patients
(subset with LVEF Fail. 20039S79.
23
ADHERE Variation inb-Blocker Use
100
Use of b-blocker at Discharge for Patients with
LVEF 40
80
60
Rate ()
40
20
0
ADHERE Hospitals
ADHERE Dec 2002, 206 hospitals (Subset with LVEF
24
ADHERE Variation inDischarge Instructions
100
JCAHO HF-1 Discharge Instructions
80
60
Rate ()
40
20
0
ADHERE Hospitals
The ADHERE database, data from 23,193 patients
collected between July 2001 and December 2002.
Fonarow GC. Card Fail. 20039S79.
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What Is OPTIMIZE-HF?

• OPTIMIZE-HF (Organized Program To Initiate
  life-saving treatMent In HospitaliZEd patients
  with Heart Failure)
• Heart failure hospital-based process of care
  improvement program
• Web-based registry and comprehensive hospital
  tool kits, educational materials, provides
  JCAHO/ORYX indicators
• Approximately 500 hospitals will work
  collaboratively to measure and improve the
  management of heart failure patients
• Up to 50,000 heart failure patients
• Patients with heart failure as primary or
  secondary discharge diagnosis
• All regions and all types of institutions
  represented in the U.S.

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OPTIMIZE-HF Steering Committee

• Gregg Fonarow, MD (Chair)David Geffen School of
  Medicine at UCLA
• Nancy Albert, MSN, RN, CCNSCleveland Clinic
  Foundation
• Wendy Gattis, PharmDDuke Clinical Research
  Institute
• Mihai Gheorghiade, MDNorthwestern University
• Barry Greenberg, MDUniversity of California, San
  Diego
• Christopher OConnor, MDDuke Clinical Research
  Institute
• Clyde Yancy, MDUT Southwestern Medical Center at
  Dallas
• James Young, MDCleveland Clinic Foundation

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OPTIMIZE-HF Process of Care Goals

• Identify and initiate guideline-recommended
  treatments in appropriate patients without
  contraindications
• Identify and not initiate treatments in patients
  with contraindications or who are not yet
  clinically stabilized
• Discontinue therapies that are Class III (type-1
  AA, NSAIDS, CCB unless indicated for other
  reasons)
• Identify and manage factors that may exacerbate
  heart failure, major comorbidities, and
  concomitant risk factors (sudden death risk,
  lipids, diabetes, COPD, depression)
• Enhance provision of patient education,
  assessment of social support, discharge planning,
  follow-up and monitoring plan

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Implementing OPTIMIZE-HF

• What are the components of OPTIMIZE-HF?

Web-based Registry Measure and benchmark heart
failure quality of care and meaningful outcomes
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Web-Based Registry Inputs

• Intuitive, Web-based form
• Real-time data quality checks
• Automated documentation (e.g., patient
  instructions, discharge notes)
• Full training and support
• Embeds JCAHO HF core measures
• Secure and confidential
• Compensation provided for each completed form

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Web-Based Registry Outputs

• Real-time reports
• Benchmarking against multiple categories of
  similar hospitals
• JCAHO and CMS indicators plus many others
• Drill down from reports to individual patient
  level
• Printable or downloadable reports that are
  presentation ready
• Full data download on demand

Centers for Medicare Medicaid Services
(formerly HCFA).
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Process-of-Care Improvement Component

• Structured educational opportunities
• Regional educational forums
• Access to faculty

• Hospital toolkit
• Algorithms
• Care paths
• Standing orders
• Patient education materials
• Wall charts
• Flash cards
• PowerPoint presentation

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OPTIMIZE-HF Toolkit
7/12/2009 83923 PM

• Standard Orders and Discharge Checklist for HF
• How would you customize these forms?

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OPTIMIZE-HF Toolkit
7/12/2009 83923 PM
SCBO0096 Regional Meeting ORLANDO FINAL

• Patient education materials are also generated
  electronically

Also available in Spanish
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OPTIMIZE-HF Toolkit

• Dear doctor letter
• Can be customized for each hospital

-- DRAFT
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OPTIMIZE-HFA Cycle of Quality Improvement
Find and Support a Champion
Assess HFTreatment Rates Measure current
treatment rates and process-of-care indicators
Implement Refined Protocol Hospital team
coordinates implementation of refined protocols
Assessment Hospital team reviews summary reports
and current protocols
Refine Protocol Hospital team identifies areas
for improvement
36
Implications of OPTIMIZE-HF

• OPTIMIZE-HF
• Will be the largest HF quality of care
  improvement project ever undertaken
• Will improve process-of-care procedures in the
  hospital setting
• Will improve patient adherence through
  in-hospital initiation and a system of patient
  educational interventions
• Will facilitate the communication of
  evidence-based medicine and guidelines to health
  care providers in both the inpatient and
  outpatient settings
• Will provide one of the largest dataset for
  analyses of hospitalized HF population and impact
  of process-of-care improvements

37
Conclusions

• A large treatment gap between guidelines and
  practice exists for heart failure patients
• Hospital-based management programs can
  significantly increase the utilization of
  life-saving therapies
• Hospital-based programs are increasingly
  desirable as a means of meeting standards of HF
  treatment
• OPTIMIZE-HF, by assisting hospitals to improve HF
  process of care and measure outcomes, will
  accelerate the use of evidence-based, guideline
  recommended therapies, and save lives