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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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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
100,000 Lives Campaign
“Planks”
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•
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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)
Campaign Field Operations
Ongoing
communication
IHI and
Campaign
Leadership
Introduction, expert
support/science, ongoing
orientation, learning
network development,
national environment for
change
NODES (> 55)
*Each Node Chairs 1 Network
FACILITIES (3000-plus)
*30 to 60 Facilities per Network
Local recruitment and
support of a smaller network
through
communication/collaboratives
Implementation (with
roles for each
stakeholder in hospital
and use of existing
spread strategies
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)
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
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•
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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%
100,000 Lives Campaign Results
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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)
Success Factors
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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
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
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
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
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
Prevent MRSA Infection
S. aureus bacteraemia: methicillin
sensitivity (English NHS acute Trusts,
voluntary surveillance 1990-2006) Mandatory enhanced
surveillance October 2005
Baseline year for
targets 2003/04
16000
14000
Mandatory surveillance
introduced April 2001
Number of reports
12000
10000
8000
6000
4000
2000
0
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
Year
No susceptibility information
Provisional data
MSSA
MRSA
2003
2004
2005
2006
Temporal trends in MRSA bacteraemia
rates, by region
East of England
London
North East
North West
South East
Ap Estimated incidence rate per 10,000 bedr0
days
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East Midlands
South West
2.5
West Midlands
Yorkshire & the Humber
2
1.5
Introduction of
national target
1
0.5
Estimated overall rate increase % per quarter
Heterogeneous regional patterns 0.5
0
Provisional data
Quarter
Estimated overall rate
decrease 3% per
quarter
Homogeneous regional
patterns
MRSA in Europe
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
A Modest Proposal…
• Improve reliability of basic infection
control procedures
• Hand hygiene
• Isolation procedures
• Screening cultures
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
Component vs. Composite Adherence
Contact 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
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
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
• 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)
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?
What Is a Bundle?
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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
• 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
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
Imagine what would happen to
the MRSA infection rate in there
were nearly zero central venous
catheter infections…
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
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
Five Key Interventions
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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
What Changes Can We Make?
Understanding the System
Outcome
Primary
Drivers
Secondary
Drivers
Process
Changes
Change 1
S. Driver 1
P. Driver
Change 2
S. Driver 2
Aim: An
improved
system
Change 3
S. Driver 3
P. Driver
S. Driver 1
Effect
Drives
Cause
S. Driver 2
What Changes Can We Make?
Understanding the System for Weight Loss
Primary
Drivers
Outcome
Secondary
Drivers
drives
Limit daily
intake
Process
Changes
Track
Calories
Calories In
drives
drives
drives
AIM:
A New
ME!
Substitute
low calorie
foods
Avoid
alcohol
Plan
Meals
Drink H2O
Not Soda
drives
drives
Calories
Out
drives
Work out 5
days
drives
“Every system is perfectly
designed to achieve the results
that it gets”
Walk to
errands
Outcome =
Structure +
Process
-Donabedian
How Will We Know We Are Improving?
Understanding the System for Weight Loss with Measures
Primary
Drivers
Outcome
Secondary
Drivers
Process
Changes
• Avg cal/day
drives
Track
Calories
Limit daily
intake
• Running
calorie total
Calories In
drives
• Daily calorie
count
drives
drives
AIM:
A New
ME!
• Weight
• BMI
• Body Fat
• Waist size
• % of
Substitute opportunities
used
low calorie
foods
Avoid
alcohol
Drink H2O
Not Soda
• Avg drinks/
week
• Sodas/
week
drives
drives
Calories
Out
Measures let us
• Exercise
calorie count
• Monitor progress in
improving the system
• Identify effective changes
drives
Work out 5 • Days between
workouts
days
drives
Walk to
errands
Plan
• Meals
Meals offplan/week
Etc...
What Changes Can We Make?
Understanding the System for Reducing Hospital Acquired Infections
Outcomes
Primary Drivers
Secondary Drivers
S1. Identify patients with ASC
S2. Use contact precautions for
colonized or infected patients
S3. Use appropriate room
cleaning and disinfection
P1. Prevention of
transmission
O1. Reduce infections
from MRSA, VRE
and C. difficile by
30%
S4. Use dedicated equipment for
colonized and infected
patients
S5. Reliable hand hygiene
S6. Comply with all central line
bundle components
P2. Prevention of
infection
S7. Comply with all ventilator
bundle components
S8. Use decolonization to
decrease burden of
organisms
See the
‘Change
Package’
How Will We Know We Are Improving?
Understanding the System for Reducing Hospital Acquired Infections with Measures
Outcomes
Primary Drivers
Secondary Drivers
• Percent of appropriate
patients with admission
S1. Identify patientssurveillance
with ASC culture collected
• Percent of patient encounters with
S2. Use contact precautions for
compliance for contact precautions
colonized or infected patients
• Percent of environmental cleanings
S3. Use appropriate
room appropriately
completed
cleaning and disinfection
P1. Prevention of
transmission
O1. Reduce infections
from MRSA, VRE
and C. difficile by
30%
1.Rate of occurrence of
MRSA BSI and HAP
per 1000 patient days
2.Rate of occurrence of
VRE BSI and UTI per
1000 patient days
3.Percent of of patients
with C. difficile
associated disease
S4. Use dedicated equipment for
colonized and infected
patients
• Percent of successful opportunities
appropriate
S5. Reliablefor
hand
hygiene hand hygiene
• Compliance
with central line
S6. Comply with all central
line
bundle
bundle components
P2. Prevention of
infection
• Compliance with ventilator
S7. Comply with all ventilator
bundle
bundle components
S8. Use decolonization to
decrease burden of
organisms
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
Evidence for ASCs
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European experience
Control of nosocomial MRSA outbreaks
Mathematical models
Observational studies from individual
hospitals
• Interrupted time series study
• Cluster randomized trial
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.
Impact of Active Surveillance in ICUs
Huang SS et al., Clin Infect Dis 2006;43:971-8
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….
•
•
•
•
•
Pseudomonas
Acinetobacter
Stenotrophomonas
Burkholderia
ESBL and carbapenemase-producing
Gram-negative bacilli
• And many others….
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
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
47
Pawson and Tilley
The Classic Experimental Design: “OXO”
Pre-Test Treatment Post-Test
48
Experimental
Group
O1
Control Group
O1
X
Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications,
Ltd.; 1997.
O2
O2
Pawson and Tilley
Context + New Mechanism = Outcome
C + M = O
49
Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications,
Ltd.; 1997.
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.
Is life this simple?
X
Y
(If only it was this simple!)
No, it looks more like this…
Independent Variables
In this model there are numerous direct effects between the
independent and variables (the Xs) and the dependent variable (Y).
X
1
X
4
X
2
X
Y
5
Time 3
X
3
Time 2
Time 1
Dependent
or outcome
variable
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
X
Blalock HM, ed. Causal Models in the
Social Sciences. Chicago: Aldine; 1999.
1
R4
R2
X
4
X
2
Y
X
RY
5
Time 3
X
3
R3
Time 2
Time 1
R5
R = residuals or error terms
representing the effects of variables
omitted in the model.
Rigorous Learning in
Complex Systems
“Rigorous”
Learning
Traditional
RCTs
Simple
Linear
Cause-and
-Effect
•“Dynamic” Cluster RCTs
•Statistical Process Control
•Time Series Methods
•Mixed Methods
•Anthropology
•Ethnography
•Journalism
Complex
Non-Linear
Chaotic
Case Series
“Anecdotes”
Static RCTs
Poor Learning
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
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
• 23 Australian hospitals randomized
• 2-month baseline, 4-month preparation period, 6month 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….
• 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
• 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