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ISPOR 18° Annual European MeetingOutcomes Research: Are we ready to put theory into Practice?

Mario Strazzabosco MD, PhD, FACG, FEBTM

School of Medicine and Surgery

International Center for Digestive Health

University of Milano-Bicocca

Yale Liver Center

Department of Internal Medicine

Yale University School of Medicine

Health Care Challenges

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Health Care’s Challenges

Effectiveness

Efficiency

Convenience

Safety

Timeliness

Compassion

Spending

Communication Variation

Access

Courtesy of E. Teisberg

The goal of health care is

HEALTH!

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The Triple Aim of Health CareThe Center for Medicare and Medicaid Services

1. Improve patient

experience of care

2. Improve health

outcomes

3. Reduce per capita

costs of health care

Sustainable care can be achieved without resorting to linear cuts, cost shifting measures

and rationing

INNOVATION

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To obtain the best possible outcomes at an affordable cost

Physician innovators

drive the changes

necessary to achieve

the Triple Aim Goals

Health Outcomes Research

• Few Health Systems can Produce Reliable Health Outcomes• Analysis of health outcomes is needed for decision making

• Measuring outcomes drives clinical improvements and learning• Reduces Medical Errors• Focuses us on what matters to the health of our population • PROs aligns us with our Patients

• Help Me• Don’t Hurt Me• Include Me

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No problem can be solved from the same thinking we used when we created it

A. Einstein

Porter M, N Eng J Med 2009Porter M, N Eng J Med 2010Porter M, Teisberg OE, Harvard Business SchoolPress, 2006.

Value-Based Competition Can help Health Care Sustainability while Improving Outcomes-The Case for Value Based Medicine-

LONG-TERM OUTCOMES

COSTS

VALUE =

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• Clinical Outcomes measured along the full cycle of care

• Quality of Life & PROs

• Global costs

Data Needed for VBMH

“You cannot manage… what you do not measure!”

Demings

A validated set of outcomes indicators for the major liver conditions is not yet available

Demings

“In God we trust, all others must show data”

Measuring outcomes drives value improvement and learning

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PHASE 1: IDENTIFICATION Of OUTCOMES

INDICATORS

PHASE 2: CLINICAL TEST OF INDICATORS

3 Major GI Divisions in Lumbardy

3300 patients

enrolled between March 2011 and Nov 2012

ongoing F/U now median is 31 months

EQ5D collected at every visit

PHASE 1: IDENTIFICATION of OUTCOME

INDICATORS for the MAJOR LIVER CONDITIONS

• HCV Hepatitis

• HBV Hepatitis

• Autoimmune Hepatitis and Cholangiopathies

• Metabolic liver diseases

• Cirrhosis

• Hepatocellular Carcinoma

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Sets of indicators designed along the natural history of chronic liver diseases

Liver

Function

Years

Tre

atm

ent

Com

ple

xity

HepatitsCirrhosis Dec

CirrhosisHCC

Generation of outcomes indicators

Delphi Consensus and its application to VBMH Study.

Project TeamClinical Epidemiology experts

HepatologistPrincipal Investigator

Focus Group11 Experts

(1 Group Leader)

Review of Literature

Candidate Indicators

(with preference for outcome, as broad as possible, easy to retrieve

Group DiscussionAgreement/disagreement

External adviceCorrection-synthesis-

rewording

ExternalAdvisors

AISF, Yale University

Final list of Candidate Indicators

VotingSession I

Voting Session IIRAND/UCLA

Rowe G, Wright G. The Delphi technique as a forecasting tool: issues and analysis. Int J Forecasting 1999;15:353-375

Indicators

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PHASE 2: Testing Indicators in the Fieldthe Case for HCV hepatits

DIAGNOSISTOTAL PTS

(%pts enrolled)

CIRRHOSIS 1774 (55%)

HEPATOCARCINOMA 738 (23%)

HEPATITIS C 1545 (48%)

HEPATITIS B 554 (17%)

NAFLD-NASH 304 (9%)

HEMOCHROMATOSIS 16 (0,5%)

AUTOIMMUNE HEPATITIS 77 (2%)

PRIMARY BILIARY

CIRRHOSIS85 (3%)

PRIMARY SCLEROSING

CHOLANGITIS63 (2%)

ORTHOTOPIC LIVER

TRANSPLANTATION315 (10%)

S.Gerardo

Hospital MONZA

(Strazzabosco)

Papa Giovanni XXIII Hospital

BERGAMO(Fagiuoli)

Niguarda Cà

Granda Hospital

MILAN

(Belli)

• High Prevalence

• Severe long-term consequences

• Curable

• High upfront costs

• Delayed (?) benefits

• Needs specialized care (increased % of advanced cases, oncologic potential, extrahepatic manifestations, co-morbidities, multidisciplinary approach)

• Resources allocated on Center-based volumes, rather than on clinical and PRO outcomes measured along the full cycle of care

The Hepatitis C Care Dilemma

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CMS : Physician Quality Reporting System

• HCV-RNA testing before treatment

• HCV genotype testing before Tx

• HCV-RNA testin after 4 and 12 w of Tx

• Screening for HCC

• HAV vaccination

• Preventive care on tobacco use

VBM : Outcome Indicators in HCV patients

• SVR/entire HCV population

• SVR/compensated HCV cirrhosis• Yearly rate of decompensation

• % with treatment-induced functional improvement

• Survival stratified by MEDL and CPT score

• Incidence of HCC and BCLC stage at presentation

• Survival and recurrence by BCLC stage in HCV-related HCC

• Appropriateness and safety of HCC treatment

Benchmarks using Score Cards for Outcomes Indicators (Cirrhosis)

Compensated cirhosis

1) Decompensation rate: overal HCV 8 %, HBV 1.5%

2) Bleeding rate: 2%, year.

3) Efficacy of HCC surveillance: 81% detection at an early stage (BCLC 0-A)

De-compensated cirrhosis

1) 1 year Survivial stratified or CPT A,B or C 93%, 78%, 40%

2) 1 year survival stratified for MELD score < or > 15 88%, 50%

3) First bleeding, early survival (6 weeks) 91%

5) First episode of PBS, early survival (6 weeks) 87%

6) PBS recurrence rate (1 year) 13%

7) Re-admission rate per patient and length of stay 0.29, 11 days.

?

EqualBetterWorseNot known

legend

?

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What are the implication of VBM on how we practice Hepatology?

Liver Services designed:

• around the natural history of Liver Diseases

• to meet the need of patients having in common a specific condition requiring integration of care (IPU)

• to facilitate the measurement of VALUE (outcomes, QoL, costs).

• to improve the outcomes and the QoL of patients while reducing the burden to the families and the cost of the illness.

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The HCV Program Nebulosa

Psychiatrist/

Psychologist

Visit

FibroscanSocial Worker

Primary

Care Physician

Pathology

MIcrobiology

HCV

Nurse

Education

Visit

Haematology

Nutritionist

24/7 call service

Clinical Chemistry

Lab

Radiology

Scheduler Addiction clinic

HCV-APRN visitsHepatologist

Liver biopsy

HCC program

CLD program

Oltx Program

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Integrated Practice Units = Patient-Centered Care = Patient-Centered Practice Model

• Meet the Triple Aim

– Excellent Experience for Individual Patients

– Improved Population Health

– Reduction in Cost

• Care Coordination

– Chronic care model involving home care

– Enhance sharing of medical information

– Self-assessment and self-care programs

• Care Integration

– Diagnosis (Prevention) to Palliative Care

– Behavioural Health Integration

– Self Assessment and Self-care program

Clinical Redesign

What is an IPU or Disease-Specific Program?

• Activities to treat a certain condition organized around the patient’s needs

• Provides the full cycle of care for a medical condition, including patient education, engagement and follow-up

• May encompass inpatient, outpatient, and rehabilitative care as well as supporting services (e.g. nutrition, social work)

• Involves a dedicated leader who devotes a significant portion of time to the medical condition

• May or may not be localized in dedicated facilities

• Utilizes a single administrative and scheduling structure

• The team meets formally and informally as a group and in subgroups on a regular basis

• Measures processes and outcomes and QoL and accepts accountability for outcomes and costs 24

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……… and it may even work!

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Morando et al.: How to improve care in outpatients with cirrhosis and ascites: a new model of care coordination …. J. Hepatology 2013

Lower mortality

Reduction in 30-days readmissions

Lower global cost per patient-month of life

Tapper et al.: A quality improvement initiative reduces 30 readmission for patients with cirrhosis. Clinical Gastroenterology and Hepatology In press

Reduction in 30-days readmissions

Reduction in patient’s length of stay

Reimbursement should be aligned with value

Financial success of system participants

Pa

tie

nt

Su

cce

ss

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ACKNOWLEDGMENTS

AISF FADE REGIONE LOMBARDIA

OSPEDALE SAN GERARDO MONZA

OSPEDALE NIGUARDA CA’ GRANDA MILANO

OSPEDALE PAPA GIOVANNI XXIII BERGAMO

MINISTERO DELLA SALUTEUNIVERSITA’ DI MILANO-BICOCCA

YALE UNIVERSITY