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
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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/Safe
tyGeneral/Literature/ IHIGlobalTriggerToolforMeasu
ringAEs.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

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
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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

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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

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
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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
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?

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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

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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