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Getting to Zero and other Possible Dreams. Don Goldmann, M.D. Senior Vice President Institute for Healthcare Improvement Professor of Pediatrics Harvard Medical School. No conflicts to declare. 100,000 Lives Campaign Objectives (December 2004 – June 2006).

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Getting to zero and other possible dreams l.jpg

Getting to Zero and other Possible Dreams

Don Goldmann, M.D.

Senior Vice President

Institute for Healthcare Improvement

Professor of Pediatrics

Harvard Medical School

No conflicts to declare


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100,000 Lives Campaign Objectives (December 2004 – June 2006)

  • Avoid 100,000 unnecessary deaths in participating hospitals

  • Enroll more than 2,000 facilities

  • Raise the profile of the problem - and hospitals’ proactive response

  • Build a reusable national infrastructure for change

Some is not a number, soon is not a time - Berwick


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100,000 Lives Campaign “Planks”

  • Rapid response teams

  • Evidence-based care for acute myocardial infarction

  • Prevention of adverse drug events (medication reconciliation)

  • Prevention of central line infections (Central Line Bundle)

  • Prevention of surgical site infections (correct perioperative antibiotics at the proper time and other elements of the Surgical Infection Bundle)

  • Prevention of ventilator-associated pneumonia (Ventilator Bundle)


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Campaign Field Operations

Introduction, expert support/science, ongoing orientation, learning network development, national environment for change

IHI and Campaign Leadership

Ongoing

communication

Local recruitment and support of a smaller network through communication/collaboratives

NODES (> 55)

*Each Node Chairs 1 Network

Implementation (with roles for each stakeholder in hospital and use of existing spread strategies

FACILITIES (3000-plus)

*30 to 60 Facilities per Network


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Measurement Strategy

  • Change in aggregate hospital mortality, compared to 2004, in terms of “lives saved”

    • Case mix adjustment from three sources, but not yet Hospital Standardized Mortality Ration (HSMR)

  • Direct submission of monthly raw mortality data (deaths/discharges) to IHI

  • Optional data at the intervention-level (e.g., ventilator pneumonia rates, process measures)


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100,000 Lives Campaign Results

  • Estimated 120,000 lives saved by participating hospitals through overall improvement (IHI cannot attribute change in mortality to the Campaign per se – research studies pending)

  • Over 3,100 Hospitals Enrolled

    • Over 78% of all acute care beds

  • Participation in Campaign Interventions

    • Rapid Response Teams: 60%

    • AMI Care Reliability: 77%

    • Medication Reconciliation: 73%

    • Surgical Site Infection Bundles: 72%

    • Ventilator Bundles: 67%

    • Central Venous Line Bundles: 65%

    • All six: 42%


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    100,000 Lives Campaign Results

    • Over 55 field offices (“nodes”) and over 130 mentor hospitals

    • Strong national partner support (CDC, AHRQ, Joint Commission, ACC/AHA, etc.)

    • Thousands on national calls

    • Large increase in web activity and downloads of Campaign tool kits

    • Great media coverage (Newsweek, US News and World Report, Wall Street Journal, NY Times)

    • Related campaigns forming nationally and globally (Canada, Australia, Denmark, England)

    • Changes in expectations for care (“getting to zero”) in some participating facilities (many reports of zero ventilator-associated pneumonia or catheter-related BSIs)


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    Success Factors

    • Inspiring goal and clear deadline

    • Easy sign-up

    • Minimal reporting requirements

    • Straightforward interventions

    • Optimism, personal motivation, volunteerism

    • Practical direction for hospital leaders

      • Demonstrated link between quality and cost

    • Useful tools

    • Vibrant, distributed national learning network

    • Young, dedicated field team, logistics


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    5 Million Lives Campaign

    • A campaign against harm (injuries/adverse events)

    • Harm is defined as levels e-i using NCC MERP* Index criteria

      • Level e is temporary harm that required intervention

      • Level i is death

    • Harm is counted…

      • Whether or not it is considered preventable

      • Even if present on admission to the hospital if attributable to medical care

    * National Coordinating Council for Medication Error Reporting and Prevention


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    How did IHI Decide on 5 Million Harms?

    • 37 million admissions to acute care US hospitals annually

      • AHA National Hospital Survey, 2005

    • 40-50 level e-i harms per 100 admissions

      • Chart reviews in 3 hospitals using IHI Global Trigger Tool (GTT)*

    • Therefore, about 15 million harms occur per year (37 million admissions X 40 harms per 100 admissions)

    • If best known results can be replicated, might avoid 3.5 million harms per year = 7 million in 2 years

      • 5 million seemed like a good stretch goal

      • We know that even perfect compliance with all of the planks will not be enough to avoid 5 million harms

    • Further validation of GTT psychometrics pending

    * http://www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral/Literature/

    IHIGlobalTriggerToolforMeasuringAEs.htm


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    5 Million Lives Campaign Planks

    • Reduce Surgical Complications – Adopt “SCIP”

    • Prevent Harm from High Alert Medications

    • Prevent MRSA Infections

    • Reduce Readmissions in patients with Congestive Heart Failure

    • Prevent Pressure Ulcers

    • Get Boards on Board


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    Tough Questions

    • IHI claims that organizations need to have leadership commitment, improvement expertise and capacity, and the ability to apply QI methods (rapid cycle PDSAs) – just for starters

    • But contact with many participating hospitals suggests that such capability is not widespread

    • So….are we

      • Encouraging brute force (“hire-a-nurse”) projects to implement a few “planks?” Relying on charismatic champions? ….or….

      • Creating fertile soil for true institutional transformation?

    • How good is the evidence? When is it good “good enough” to spread?

      • MRSA and RRTs: more later


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    Prevent MRSA Infection


    Slide14 l.jpg

    S. aureus bacteraemia: methicillin sensitivity (English NHS acute Trusts, voluntary surveillance 1990-2006)

    Mandatory enhanced surveillance October 2005

    Baseline year for targets 2003/04

    Mandatory surveillance introduced April 2001

    Provisional data


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    Temporal trends in MRSA bacteraemia rates, by region

    Introduction of national target

    Estimated overall ratedecrease3% per quarter

    Homogeneous regional patterns

    Estimated overall rateincrease% per quarter

    Heterogeneous regional patterns 0.5

    Provisional data


    Slide16 l.jpg

    MRSA in Europe


    Is this remarkable variation due to l.jpg

    Is this remarkable variation due to:

    • Transmissibility and virulence of distinct genotypes?

    • Size, design, or type of hospital?

    • Case mix?

    • Practice variation?

      • Compliance with known, measurable evidence based practices?

      • Less tangible features, such as culture and organization of an intensive care unit?

        • Are nosocomial infections an “expected” consequences of caring for very sick, complex patients, or intolerable, potentially preventable adverse events

          • Vermont Oxford NICQ visits to “best of breed” NICUs


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    A Modest Proposal…

    • Improve reliability of basic infection control procedures

      • Hand hygiene

      • Isolation procedures

      • Screening cultures


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    Reliability Science

    Health care is riddled with defects

    40-50% compliance with hand hygiene!!??

    What happens at Intel…

    What happens in Bowling Green…

    From the patient’s point of view, it’s “all or nothing”

    Reliability science offers robust approaches to reducing defects and harm in health care


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    Component vs. Composite AdherenceContact Precautions

    • COMPONENT:80% hand hygiene, gloves on entering room

    • COMPONENT:78% gowns on entering room

    • COMPONENT:65% hand hygiene after removing gloves

    • COMPOSITE:50% get all three


    Reliability is failure free operation over time from the viewpoint of the patient l.jpg

    Reliability is failure free operation over time from the viewpoint of the patient


    Slide22 l.jpg

    Defects in outpatient asthma care

    Defects in hospital care

    Acute asthma attack

    Admission through discharge

    Defects in outpatient care

    Years/Months

    Days

    Years/Months

    Defect free care overtime from the patient’s viewpoint


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    Levels of Reliability

    • Chaotic process: Failure in greater than 20% of opportunities

    • 10-1: 80 or 90 percent success: 1 or 2 failures out of 10 opportunities (no consistent articulated process)

    • 10-2: 5 failures or fewer out of 100 opportunities (process is articulated by front line)

    • 10-3: 5 failures or fewer out of 1000 opportunities

    • 10-4: 5 failures or fewer out of 10,000 opportunities

    Blood banking and anesthesiology alone achieve

    the higher levels of reliability in medicine


    Reliability in healthcare l.jpg

    Reliability in Healthcare

    • Remember, it’s “all or nothing” – not compliance with each individual component of “best practice”

    • Most institutions do fairly well with individual components of evidence-based practice, but performance drops dramatically when the standard is “all or nothing”

    • We are trying to decrease the “defect rate” and to achieve a reliability of performance to the 10-2 level (at least 95% compliance with the entire package of evidence-based practice)


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    Guidelines v. Bundles (Intervention Packages)

    • Guidelines tend to be long, all-inclusive, and confusing

      • Many potential interventions are supported by some evidence

    • Guidelines are difficult to translate into action and often are ignored by clinicians

    • What if just a few key, actionable interventions, supported by strong evidence, were culled from the guidelines?


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    What Is a Bundle?

    • A grouping of best practices with respect to a disease process that individually improve care, but when applied together result in substantially greater improvement

    • The science behind the bundle is so well established that it should be considered standard of care

    • Bundle elements are dichotomous and compliance can be measured: yes/no answers

    • Bundles eschew the piecemeal application of proven therapies in favor of an “all or none” approach


    Central venous catheter bundle l.jpg

    Central Venous Catheter Bundle

    • Hand hygiene before inserting a catheter or manipulating the system and catheter site

    • Maximal barrier precautions for line insertion

      • Hand hygiene

      • Non-sterile cap and mask

      • Sterile gown and gloves

      • Large sterile drape

    • Antiseptic prep used for catheter insertion as per hospital protocol

      • 2% chlorhexidine supported by evidence (but FDA warning for neonates)

    • Site selection

    • Timely removal


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    Central line-associated bloodstream infection rate in 66 ICUs, Southwestern Pennsylvania, April 2001-March 2005

    CDC

    Pronovost et al.,N Engl J Med; 2006;355:2725

    Decrease from 7.7 to 1.4 per 1000 catheter days in 103 ICUs


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    Imagine what would happen to the MRSA infection rate in there were nearly zero central venous catheter infections…


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    A Hand Hygiene “Bundle”

    • Staff knowledge

    • Staff competency

    • Alcohol and gloves available at the point of care

      • Operational, full dispensers providing correct volume of rub

      • At least 2 sizes of gloves

    • Correct performance of hand hygiene + gloves worn for standard precautions

      • Concurrent monitoring and feedback

      • Focus on leaving the bedside

      • Staff accountability


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    Prevent MRSA Infection and Colonization

    • Colonized patients comprise the reservoir for transmission (“colonization pressure”)

    • High rates of MRSA colonization complicate empiric antibiotic therapy (e.g., vancomycin)

    • Colonized patients have a high rate of MRSA infection

      • Nearly 1/3 develop infection, often after discharge

    • Colonization is long-lasting, and patients can transmit MRSA to patients in other health care settings (e.g., nursing homes), as well as to family members


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    Five Key Interventions

    • Compliance with Central Venous Catheter and Ventilator Bundles

    • Hand hygiene*

    • Active surveillance cultures (ASCs)

    • Decontamination of the environment and equipment

    • Contact precautions for infected and colonized patients

    * Especially before contact with the patient and after contact

    with the patient and environment


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    Drives

    Effect

    Cause

    What Changes Can We Make? Understanding the System


    What changes can we make understanding the system for weight loss l.jpg

    “Every system is perfectly designed to achieve the results that it gets”

    What Changes Can We Make?Understanding the System for Weight Loss

    Outcome = Structure + Process -Donabedian


    How will we know we are improving understanding the system for weight loss with measures l.jpg

    How Will We Know We Are Improving?Understanding the System for Weight Loss with Measures

    Measures let us

    •Monitor progress in improving the system

    •Identify effective changes


    What changes can we make understanding the system for reducing hospital acquired infections l.jpg

    What Changes Can We Make? Understanding the System for Reducing Hospital Acquired Infections

    See the

    ‘Change Package’


    Slide38 l.jpg

    How Will We Know We Are Improving? Understanding the System for Reducing Hospital Acquired Infections with Measures


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    Active Surveillance

    • Perform active surveillance cultures (ASCs) to detect colonized patients on admission

      • Necessity of ASCs per se in controlling MRSA is controversial – why are we recommending it?

        • “Knowledge is power” – clinical cultures miss many colonized patients and vastly underestimate the magnitude of the problem

          • Added value varies by institution (Huang SS: JID 2007;195:330-8)

        • ASCs on admission, followed by testing weekly and/or at discharge, is necessary to document the extent of transmission and the success of control measures

        • Nose +/- perineum/axilla +/- rectum and skin lesions/broken skin

        • Successful programs combine ASCs with reliable implementation of other interventions

      • Controversy regarding ASCs for high-risk areas (ICUs) vs. entire hospital


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    Evidence for ASCs

    • European experience

    • Control of nosocomial MRSA outbreaks

    • Mathematical models

    • Observational studies from individual hospitals

    • Interrupted time series study

    • Cluster randomized trial


    Slide41 l.jpg

    Antimicrobial Resistance in Staphylococcus aureus Blood Isolates, Denmark 1960-1995

    100%

    90%

    80%

    70%

    60%

    50%

    Methicillin resistance

    40%

    30%

    20%

    10%

    0%

    1960 1965 1970 1975 1980 1985 1990 1995

    DANMAP Report, 1997.

    Rosdahl VT et al. Infect Control Hosp Epidemiol 1991;12:83-88.


    Slide42 l.jpg

    Impact of Active Surveillance in ICUs

    Huang SS et al., Clin Infect Dis 2006;43:971-8


    Active surveillance43 l.jpg

    Active Surveillance

    • Perform active surveillance cultures (ASCs) to detect colonized patients on admission

      • Necessity of ASCs per se in controlling MRSA is controversial – why are we recommending it?

        • “Knowledge is power” – clinical cultures miss many colonized patients and vastly underestimate the magnitude of the problem

          • Added value varies by institution (Huang SS: JID 2007;195:330-8)

        • ASCs on admission, followed by testing weekly and/or at discharge, is necessary to document the extent of transmission and the success of control measures

        • Nose +/- perineum/axilla +/- rectum and skin lesions/broken skin

        • Successful programs combine ASCs with reliable implementation of other interventions

      • Controversy regarding ASCs for high-risk areas (ICUs) vs. entire hospital


    Beware l.jpg

    Beware….

    • Pseudomonas

    • Acinetobacter

    • Stenotrophomonas

    • Burkholderia

    • ESBL and carbapenemase-producing Gram-negative bacilli

    • And many others….


    Weighing the evidence l.jpg

    Weighing the Evidence

    • How much evidence is required before deciding to spread change?

    • What kind of evidence is appropriate?

      • Randomized controlled trials

        • Cluster randomized trials

      • Quasi-experimental studies

        • Statistical process control

        • Time-series analysis

      • Qualitative studies

        • Behavioral science, Sociology, Anthropology

      • Mixed methods


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    Transition from Descriptive Theory to Normative Theory – ⇧Degree of Belief

    Carlile and Christensen

    Practice and Malpractice

    In Management Research

    p.6


    Pawson and tilley realistic evaluation l.jpg

    Pawson and Tilley: Realistic Evaluation

    47


    Pawson and tilley l.jpg

    Pawson and Tilley

    The Classic Experimental Design: “OXO”

    48

    Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997.


    Pawson and tilley49 l.jpg

    Pawson and Tilley

    Context + New Mechanism = Outcome

    C + M = O

    49

    Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997.


    Pawson and tilley50 l.jpg

    Pawson and Tilley

    “Programs work (have successful ‘outcomes’) only in so far as they introduce the appropriate ideas and opportunities (‘mechanisms’) to groups in the appropriate social and cultural conditions (‘contexts’).”

    50

    Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997.


    Slide51 l.jpg

    Is life this simple?

    X Y

    (If only it was this simple!)


    Slide52 l.jpg

    No, it looks more like this…

    In this model there are numerous direct effects between the independent and variables (the Xs) and the dependent variable (Y).

    X1

    X4

    Dependent or outcome variable

    Y

    X2

    Independent Variables

    X5

    Time 3

    X3

    Time 2

    Time 1


    Slide53 l.jpg

    Or, probably more like this…

    In this case, there are numerous direct andindirect effects between the independent variables and the dependent variable. For example, X1 and X4 both have direct effects on Y plus there is an indirect effect due to the interaction of X1 and X4 conjointly on Y.

    R1

    Key Reference on Causal Modeling

    Blalock HM, ed. Causal Models in the Social Sciences. Chicago: Aldine; 1999.

    X1

    R4

    X4

    RY

    Y

    X2

    R2

    X5

    Time 3

    R = residuals or error terms representing the effects of variables omitted in the model.

    X3

    Time 2

    R5

    Time 1

    R3


    Rigorous learning in complex systems l.jpg

    Rigorous Learning in Complex Systems

    • “Dynamic” Cluster RCTs

    • Statistical Process Control

    • Time Series Methods

    • Mixed Methods

    • Anthropology

    • Ethnography

    • Journalism

    “Rigorous”

    Learning

    Traditional

    RCTs

    Simple

    Linear

    Cause-and

    -Effect

    Complex

    Non-Linear

    Chaotic

    Case Series

    “Anecdotes”

    Static RCTs

    Poor Learning


    Weighing the evidence55 l.jpg

    Weighing the Evidence

    • How much evidence is required before deciding to spread change?

    • What kind of evidence is appropriate?

      • Randomized controlled trials

        • Cluster randomized trials

      • Quasi-experimental studies

        • Statistical process control

        • Time-series analysis

      • Qualitative studies

        • Behavioral science, Sociology, Anthropology

      • Mixed methods


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    The Case of Rapid Response Teams

    • “Early trials of medical emergency teams suggested a large potential benefit – to the point that some observers regarded further study as unethical. However, a large, randomized trial subsequently showed that medical emergency teams had no effect on patient outcomes.”

    Auerbach, et al., NEJM 2007:357:608-613


    The merit cluster randomized trial l.jpg

    The MERIT Cluster Randomized Trial

    • 23 Australian hospitals randomized

    • 2-month baseline, 4-month preparation period, 6-month intervention

    • Superb statistical analytic plan

    • More inter- and intra-hospital variance than expected, much lower event rate than expected

    • Increased call rate in intervention hospitals, but no effect on outcomes

      • Reduction in mortality in both arms of study

    • Sub-optimal team activation in patients with call criteria

    MERIT Study Investigators, Lancet 2005;365:2091-2097


    What if l.jpg

    What If….

    • Baseline period was used to adjust power

      • Study would have been “futile”

    • Performance data were fed back in real time

    • QI was encouraged to improve performance

    • Mixed methods were used to understand context and outcomes in individual sites


    Lessons l.jpg

    Lessons

    • Every QI “experiment” should use the most appropriate evaluation method for the question and context

    • The broadest possible palette of methods should be utilized

    • No opportunity to learn should be wasted


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