Come misurare la qualità delle cure nell’infarto miocardico acuto

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Leonardo BologneseCardiovascular Department, Arezzo, Italy

Health care has experienced an explosion in knowledge, innovation,explosion in knowledge, innovation,

and capacity to manage previously fatal conditions. Yet, paradoxically, it falls

short on such fundamentals as quality, outcomes, cost, and equity. Each action that could improve quality is marred bythat could improve quality is marred by

significant shortcomings and inefficiencies that result in missedinefficiencies that result in missed opportunities, waste, and harm to

patients

International Comparisons of Health Care Costs, Quality, and Outcomes

Organisation for Economic Co-operation and Development. Health at a glance 2007: OECD indicators.

http://oberon.sourceoecd.org/vl=1643589/cl=22/nw=1/rpsv/health2007/index.htm.

Sources of waste and excess costs in health careOBSTACLES TO HIGH-VALUE CARESources of waste and excess costs in health care

Value in health care: Accounting for cost, quality, safety, outcomes, and innovation: Workshop summary. Washington, DC: The National Academies Press 2010

The Value of Low-Value Listsidentify and reduce the use of health care services that provide little

or no benefit whether through overuse or misuse

There are strong imperatives for identifying such waste:

An ethical imperative to ensure patient safety and benefit; A quality imperative to measure and reward best practices; p ;An economic imperative to reduce spending and enhance the diffusion of cost effective innovationsthe diffusion of cost-effective innovations

A call for improvement in quality of health care

A critical feature of high-quality medicine is that patients receive, or at least to be considered for, pall treatments where the benefits outweigh the

risks and costsrisks and costs

However even for acute myocardial infarctionHowever, even for acute myocardial infarction, where a wealth of evidence had led to clinical

id li ith ifi i di ti idguidelines with specific indications, a wide variability in clinical practice remains.

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Global Differences in STEMI Process and P dProcedure

E t f i diff th STEMI “ d ”Except for minor differences, the STEMI “procedure” in experienced hands (speed + skills), is a relatively

i l d d it i t lit dsimple procedure and it improves mortality and morbidity in >95% of patients This amazing “procedure” remains the finest indication for PCI However, the STEMI “process” is complex and difficult; it has enormous regional variations and it isdifficult; it has enormous regional variations and it is hugely constrained by resources of skilled personnel and labs

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personnel and labs.

The rationale for improving quality of care

The focus on improving the quality of medical p g q ycare is based on the belief that measuring quality of care is an essential first step in q y pimproving quality of care

Without measurement, it is implored, it will be impossible to know if the care clinicians pdeliver is good or bad

As a result, quality measurement has flourished and has been the foundation for quality

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q yimprovements initiatives

How quickly the health care system is making improvement

Annual Median rate of ChangeHow quickly the health care system is making improvement

across the report’s core measure

The annual rate of change from 1994 to 2005 was 2.3%

From 2000 to 2005, the annual median rate of change was 1 5%change was 1.5%

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www.ahrq.gov/qual/nhqr2007.pdf

Why so little progress?Why so little progress?? Current quality improvement interventions

are poorly conceived and communicated and p ycomplicated to deliver

? The measures used to codify quality of care are poor predictors of quality and do not p p q yreflect the underlying causes leading to variation in measures

? Quality is not even measurable

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y

Conceptualizing Quality in Cardiovascular MedicineDonabedian’s approach: domains of quality

Structure: aspects of care that exists independently of the patientindependently of the patient

Process: actions performed in delivery care toProcess: actions performed in delivery care topatients

Outcomes: the events that occur as a result of th di d/the disease process and/or care provided

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StructureThe systems responsible for the provision of care theThe systems responsible for the provision of care, the

material resources on which those systems depend, and the organizational structures that guide the interaction of both

Patient care systems

g g

Prehospitalization, emergency department, inpatient, discharge planning, and outpatient care

Material resourcesPersonnel and equipment available for patient treatment

OOrganizational systemsInstitution’s policies and procedures, disease

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p p ,management programs

Potential Structural Performance MeasuresSTE Acute Coronary Syndromes

Training and experience

Availability of specialized treatmentsAvailability of specialized treatments

Nurse-to-patient ratiop

Treatment and discharge plans

Procedures to facilitate rapid triage of ACS patients in ER

Network ACS-focused (organized emergency medical response system are critical to ACS care)

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p y )

Stent for Lifein ESC STEMI Guidelines

ESC Guidelines 2012: “experience acquired through this

in ESC STEMI Guidelines

Sh t th ti d l

initiative provides tips and resources to improve theimplementation of primary PCI (www.stentforlife.com”)

• Shorten the time delays• Facilitate the evolution of effective regional STEMI networks• Open the STEMI networks for other critical situations in

acute myocardial infarction (AMI), such as ST-depression myocardial infarction with ongoing ischaemia and AMI withmyocardial infarction with ongoing ischaemia and AMI with acute heart failure

• Facilitate implementation of new technologies and• Facilitate implementation of new technologies and medications as evidence is collected to prove the benefit of these new strategies for patients with AMI.g p

ProcessProcess

Process measures are the most direct application of clinical trials and the guidelines that interpret these trialsguidelines that interpret these trials

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Processe of Care: Appeal and Drawbackspp

Measuring process of care is appealing because:Measuring process of care is appealing because:

It can be based on strong scientific evidence

It can be relatively easily assessed and comparedcompared

the processes considered are arguably withinthe processes considered are arguably within clinicians’ direct control

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Processe of Care: Appeal and Drawbackspp

Process measures have limitations:Process measures have limitations:

only a fraction of care is evidence-based

clinicians will “practice to the test”

process measures are less transparent to patients, and publicizing these measures is less pat e ts, a d pub c g t ese easu es s esslikely to engage patients in quality improvement.

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Strategies for Reducing the Door-to-Balloon Time in Acute Myocardial Infarction

Adjusted Associations between Hospital

Time in Acute Myocardial Infarction

Process for activating catheterization team

j pStrategies and Door-to-Balloon Times

g

Process after emergency medical service transmits ECG results

Expected interval between page and arrival of staff in catheterization laboratoryy

An attending cardiologist is always at the hospitalp

Hospital gives real-time feedback to staff in emergency department and cath lab

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g y p

E H Bradley et al. NEJM 2006;355:2308

Shortcomings of Door-to-Balloon Measure

It does not provide insight into the upstreamIt does not provide insight into the upstream processes of patients selection

Patients excludedPatients excludedPatients who should be treated, but the system fails to provide PPCI (false negatives)fails to provide PPCI (false negatives)Patients referred to PPCI when reperfusion is not necessary (false positives)not necessary (false positives)

It assesses process of care (D2B), not p ( ),outcome of care (restoring normal flow)

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Association of Door-In to Door-Out (DIDO) Time with In-Hospital Mortalitywith In Hospital Mortality

Retrospective cohort of 14,821 STEMI pts transferred to p , p298 STEMI receiving centers for p-PCI in the

ACTION Registry – Get with the Guidelines (Jan 2007–Mar 2010)

Adjusted Odds Ratio (95% CI)

Mortality, No ofPatients/Total (%)DIDO Time, min

≤3031-6061-90

43/1600 (2.7)192/4841 (4.0)146/3013 (4.9)

1.0 (ref.)1.34 (0.96-1.86)1 41 (0 96-2 06)

( )( )

61 90>90

146/3013 (4.9)430/8176 (8.3)

1.41 (0.96 2.06)1.86 (1.36-2.54)

0.5 1.0 3.0Adjusted Odds Ratio (95% CI)Adjusted Odds Ratio (95% CI)

Wang TY et al. JAMA 2011;305:2540

Impact of Door-to-Activation Time on Door-to-Balloon Time in pPCI The Activate-SF RegistryDoor to Balloon Time in pPCI The Activate SF Registry

Achieving a door-to-activation time of ≤20 minutes resulted in an 89% chance of achieving a door-to-balloon time of ≤90 minutes compared withachieving a door to balloon time of ≤90 minutes compared with only 28% for patients with a door-to-activation time >20 minutes

McCabe JM, et al. Circ Cardiovasc Qual Outcomes. 2012;5:672

Are Process (Performance) M l t d t t lit ?Measures related to mortality?

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Association Between Hospital Composite Guideline Adh R t d I H it l M t litAdherence Rate and In-Hospital Mortality

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Peterson DE et al. JAMA 2006; 295:1912-1920.

Risk-Standardized 30-Day All-Cause Hospital Mortality Rate Based on Performance on Process Measures by Quintileon Performance on Process Measures by Quintile

Core Measuresβ-blocker prescription at

d i i d di hadmission and discharge

ASA prescritpion at admission and discharge

Only 6% of the variation in mortality was explained by variations in the processadmission and discharge

ACEI prescription at discharge

explained by variations in the process measures they examined

Smoking counseling

Time to reperfusion Rx

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Bradley EH et al. JAMA. 2006;296:72-78

Process and Outcome measures: appeals and drawbackspp

Both studies examined how processes of care relate pto outcomes for patients hospitalized for an AMI

Peterson found a robust relationship, whearas Bradley found a weak relationship

Whatever the reasons for the differences, the takeway f th t di i th d fmessage from these studies is the need for

improvement in measuring and enhancing the quality of care Although the current measures are a goodof care. Although the current measures are a good start, they are to few in mumber and only capture a small subset of clinical care

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small subset of clinical care

ACC/AHA 2008 Performance Measures

ISO 9001Krumholz HK, Normand SL. Circulation 2008.

Quantitative Analysis of Strategies to Improve AMI CareImprove AMI Care

1. Clinicians meet regularly with EMS to review g yAMI care

2 Cardiologist always on site 24x72. Cardiologist always on site 24x7 3. Clinicians encouraged to creatively solve

bl l t d t AMIproblems related to AMI care processes 4. Nurses are not cross-trained to cover both

CCU and cath lab 5. Having both physician & nurse champions, g p y p ,

rather than nurse champion alone, for AMI care

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care Bradley EA, et al: Annals Intern Med. 2012; 156:618-626

Strategies to Improve AMI Mortality g p y

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Bradley EA, et al: Annals Intern Med. 2012; 156:618-626

Evidence-Based Treatment and Survival for Pts With STEMIThe RIKS-HIA Registry

Long-term mortality

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Jernberg T et al. JAMA. 2011;305:1677-1684

The 'BLITZ 4 Qualità' campaign for performance measurement and quality improvement q y p

in-hospital mortality was 4% in phases I and 4.2% in phase II in patients with

STEMI (4.0 vs. 4.2%, p=0.79)

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Olivari Z et al. E Heart J: Acute Cardiovascular Care 2012; 1: 143

Association of Performance Measure adherence with long-term mortalityadherence with long-term mortality

Shahian DM et al. BMJ Qual Saf 2012;21:325

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Association of Performance Measure adherence with long-term mortality

Focusing on measures without a strong evidence base may divert scarce quality improvementbase may divert scarce quality improvement

resources, encourage marginally effective care ti d i l if idpractices and misclassify providers.

Shahian DM et al. BMJ Qual Saf 2012;21:325

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S a a et a J Qua Sa 0 ; 3 5

Inconsistent association between process measures and outcomes

Even efficacious care processes may explain only aEven efficacious care processes may explain only a small proportion of variation in patient outcomesSome PM may derive from randomised trials with rigid eligibility and exclusion criteria. Results may not generalise well to broader, real-world scenariosThe value of some PM may be offset by theirThe value of some PM may be offset by their unintended adverse consequencesImpact of nmeas red processes of care or theImpact of unmeasured processes of care or the confounding effect of subsequent outpatient care

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Outcome Measures: Appeal and Drawbacks

Patients clearly value outcomes

pp

y

The goal of clinical care is to improve outcomesg p

BUTBUTThey are heavily confounded by patient mix

issues of statistical power and risk adjustment models

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Administrative data are not designed to profile performance!

Coding accuracy

Difficulty in distinguishing complications fromDifficulty in distinguishing complications from comorbities (Circulation. 2007;116:2960 –2968)

Absence of critical clinical variables

Failure to code chronic conditions or secondaryFailure to code chronic conditions or secondary diagnoses

Adequacy of risk adjustment

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The risks of risk adjustmentPercentages of Hospitals with Mortality Rates Higher or Lower Than Expected forPercentages of Hospitals with Mortality Rates Higher or Lower Than Expected for

Fiscal Years 2005 through 2007, According to Four Risk-adjustment Methods.

different methods rated the same individual hospitals at peither end of the spectrum of mortality categories (higher than expected vs. lower than expected).

ISO 9001Shahian DM et al.,N Engl J Med 2010;363:2530-9

Is there a potential downside of public reporting of hospital performance?hospital performance?

Gaming Hospitals can be made to look better than they reallyGaming Hospitals can be made to look better than they really are by, for example, up-coding the principal diagnosis and coding every possible comorbidity on every patient to lowercoding every possible comorbidity on every patient to lower risk-adjusted death rates

Risk Aversion Avoidance of high-risk patientsRisk Aversion Avoidance of high risk patients

Outsourcing of high-risk patients Interhospitals transfer

Tunnel vision Remedial efforts may concentrate on the services being measured, with neglect of equally important

t f th t t b i daspects of care that are not being measured

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Proportion of Patients Undergoing PCI in Massachusetts for Cardiogenic Shock 2003 Through 2005for Cardiogenic Shock, 2003 Through 2005

43% declining43% decliningThis dramatic decline was coincident with the first 3 years of public reporting of PCI outcomes in the3 years of public reporting of PCI outcomes in the state and was associated with an observed decline in the overall crude mortality from 1 71% to 1 56%!in the overall crude mortality from 1.71% to 1.56%!

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Resnic FS, and Welt FGP J. Am. Coll. Cardiol. 2009;53;825-830

Association of Public Reporting for PCI With Utilizationand Outcomes Among Medicare Beneficiaries With STEMIg

MORTALITY

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Joynt KE et al. JAMA. 2012;308:1460

The Next Frontier in QualityQ y

Assessing Dimensions of Quality

Structure ProcessO tOutcomesEfficiencyEfficiencyAppropriateness

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EfficiencyEfficiencyEffi i B fit t C t / C t / TiEfficiency = Benefit to Customer / Cost / Time

W ft t h t & h tWe often cannot agree on what & how to measure benefit, but measures of costs, resources used, or time (length of stay) associated with an episode of care are preadily available

At the system- and provider-level

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The debate on Efficiency … Strong focus to improve efficiency, through:

Decentralisation and budget devolution Hospital restructuring, alternatives to hospital careHospital restructuring, alternatives to hospital care Service re-engineering Demand-side cost containmentNational service frameworksNational service frameworks The changing nature of health professions Extensive private provision

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Current problems with efficiency measuresp y

M lti li it f ti ( ti tMultiplicity of perspectives (patients, providers, payers, purchasers, and regulators)

Gap between peer-reviewed measures versus th ithose in use

Sil f th lit di i i ffi iSilence of the quality dimension in efficiency measures

Dearth of validation and evaluation

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Appropriateness of Reperfusionpp p p

U d ( f i )Underuse (no reperfusion)

Overuse (fibrinolytic in a NSTEMI)

Misuse (D2B>90 min or >120 min in a lytic-eligible patient)eligible patient)

Ph i i /H it l l / tiPhysician/Hospital volume/expertize

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Gaps Between Ideal and Actual Carep

a shift is needed from the…..a shift is needed from the “science of recommendation” to a

“science of implementation”

Alegria M. Health Services Research 2009; 44:1

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The “3T’s” Road Map to transform Health care: The How of High-Quality careThe long journey from science to action

The How of High-Quality care

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Dougherty D, Conway PH JAMA 2008; 19:2319

Linking Comparative-effectiveness Research with Implementation Research to Improve Qualityp p y

The remarkable example of Primary PCI

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Naik AD, Petersen LA NEJM 2009;360:19

New strategies to improve quality for STEMI

Current quality measures are designed to identify problem l di t lit th th t i litareas leading to poor quality rather than to improve quality

The focus of quality improvement initiatives should be tied to local actions and local results rather than national norms

Efficiency and appropriateness should be incorporated into y pp p pthe domains of quality of care for STEMI

Developing and disseminating effectiveness reviews is anDeveloping and disseminating effectiveness reviews is an essential, but not a sufficient, step toward the routine provision of high-quality care

The remarkable improvement in the quality of primary PCI is one encouraging example, although uncommon, of the fruits

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g g p , g ,of linking CER with implementation research