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Getting to Zero and other Possible Dreams

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Title: Getting to Zero and other Possible Dreams


1
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
2
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
3
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)

4
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 (gt 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
5
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)

6
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

7
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)

8
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

9
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
10
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/Safe
tyGeneral/Literature/ IHIGlobalTriggerToolforMeasu
ringAEs.htm
11
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

12
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

13
Prevent MRSA Infection
14
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
15
Temporal trends in MRSA bacteraemia rates, by
region
Introduction of national target
Estimated overall rate decrease 3 per
quarter Homogeneous regional patterns
Estimated overall rate increase per
quarter Heterogeneous regional patterns 0.5
Provisional data
16
MRSA in Europe
17
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

18
A Modest Proposal
  • Improve reliability of basic infection control
    procedures
  • Hand hygiene
  • Isolation procedures
  • Screening cultures

19
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 patients point of view, its all or
    nothing
  • Reliability science offers robust approaches to
    reducing defects and harm in health care

20
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

21
Reliability is failure free operation over time
from the viewpoint of the patient
22
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 patients
viewpoint
23
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
24
Reliability in Healthcare
  • Remember, its 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)

25
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?

26
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

27
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

28
Central line-associated bloodstream infection
rate in 66 ICUs, Southwestern Pennsylvania,
April 2001-March 2005
CDC
Pronovost et al.,N Engl J Med 20063552725 Decre
ase from 7.7 to 1.4 per 1000 catheter days in 103
ICUs
29
(No Transcript)
30
Imagine what would happen to the MRSA infection
rate in there were nearly zero central venous
catheter infections
31
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

32
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

33
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
34
What Changes Can We Make? Understanding the System
35
What Changes Can We Make?Understanding the
System for Weight Loss
Outcome Structure Process -Donabedian
36
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
37
What Changes Can We Make? Understanding the
System for Reducing Hospital Acquired Infections
See the Change Package
38
How Will We Know We Are Improving? Understanding
the System for Reducing Hospital Acquired
Infections with Measures
39
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
    2007195330-8)
  • 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

40
Evidence for ASCs
  • European experience
  • Control of nosocomial MRSA outbreaks
  • Mathematical models
  • Observational studies from individual hospitals
  • Interrupted time series study
  • Cluster randomized trial

41
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 19911283-88.
42
Impact of Active Surveillance in ICUs
Huang SS et al., Clin Infect Dis 200643971-8
43
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
    2007195330-8)
  • 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

44
Beware.
  • Pseudomonas
  • Acinetobacter
  • Stenotrophomonas
  • Burkholderia
  • ESBL and carbapenemase-producing Gram-negative
    bacilli
  • And many others.

45
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

46
Transition from Descriptive Theory to Normative
Theory ?Degree of Belief
Carlile and Christensen Practice and
Malpractice In Management Research
p.6
47
Pawson and Tilley Realistic Evaluation

47
48
Pawson and Tilley
The Classic Experimental Design OXO
48
Pawson R, Tilley N. Realistic Evaluation. London
Sage Publications, Ltd. 1997.
49
Pawson and Tilley
  • Context New Mechanism Outcome
  • C M O

49
Pawson R, Tilley N. Realistic Evaluation. London
Sage Publications, Ltd. 1997.
50
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.
51
Is life this simple? X Y
(If only it was this simple!)
52
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
53
Or, probably more like this
In this case, there are numerous direct and
indirect 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
54
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
55
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

56
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 2007357608-613
57
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
20053652091-2097
58
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

59
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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