Getting to Zero and other Possible Dreams
Don Goldmann, M.D.Senior Vice President
Institute for Healthcare ImprovementProfessor of PediatricsHarvard Medical School
No conflicts to declare
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
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)
Campaign Field Operations
FACILITIES (3000-plus)
NODES (> 55)
*Each Node Chairs 1 Network
*30 to 60 Facilities per Network
Introduction, expert support/science, ongoing
orientation, learning network development,
national environment for change
Ongoing communication
IHI and Campaign Leadership
Local recruitment and support of a smaller network
through communication/collaborative
s
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• 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• 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
• 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
• 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
5 Million Lives Campaign Planks
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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1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
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No susceptibility information MSSA MRSA
Mandatory surveillance introduced April 2001
Baseline year for targets 2003/04
Mandatory enhanced surveillance October 2005
S. aureus bacteraemia: methicillin sensitivity (English NHS acute Trusts,
voluntary surveillance 1990-2006)
Provisional data
Temporal trends in MRSA bacteraemia rates, by region
Provisional data
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1.5
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Apr 0
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Jun
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ec 0
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Jun
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Quarter
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ate
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bed
-d
ays
East Midlands East of England London
North East North West South East
South West West Midlands Yorkshire & the Humber
Introduction of national target
Estimated overall rate increase % per quarter
Heterogeneous regional patterns 0.5
Estimated overall rate decrease 3% per quarter
Homogeneous regional patterns
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 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
Defects in outpatient
asthma care
Acute asthma attack
Admission through discharge
Defects in outpatient
care
Years/Months Days Years/Months
Defects in hospital care
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 achievethe higher levels of reliability in medicine
• 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)
Reliability in Healthcare
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?• 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
Pronovost et al.,N Engl J Med; 2006;355:2725Decrease from 7.7 to 1.4 per 1000 catheter days in 103 ICUs
CDC
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
• 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 contactwith the patient and environment
What Changes Can We Make? Understanding the System
PrimaryDriversOutcome
SecondaryDrivers
ProcessChanges
Aim: Animprovedsystem
P. Driver
S. Driver 1Change 1
P. Driver
S. Driver 2
S. Driver 3
S. Driver 1
S. Driver 2
Change 2
Change 3
CauseEffectDrives
PrimaryDriversOutcome
SecondaryDrivers
ProcessChanges
AIM:A New
ME!
Calories In
Limit dailyintake
TrackCalories
CaloriesOut
Substitutelow calorie
foods
Avoidalcohol
Work out 5days
Walk toerrands
PlanMeals
Drink H2ONot Soda
drives
drives
drives
drives
drives
drives
drives
drives
What Changes Can We Make?Understanding the System for Weight Loss
“Every system is perfectly designed to achieve the results that it gets”
Outcome = Structure + Process -Donabedian
How Will We Know We Are Improving?Understanding the System for Weight Loss with Measures
PrimaryDriversOutcome
SecondaryDrivers
ProcessChanges
AIM:A New
ME!
Calories In
Limit dailyintake
TrackCalories
CaloriesOut
Substitutelow calorie
foods
Avoidalcohol
Work out 5days
Walk toerrands
PlanMeals
Drink H2ONot Soda
drives
drives
drives
drives
drives
drives
drives
drives
• Weight• BMI• Body Fat• Waist size
• Daily caloriecount
• Exercisecalorie count • Days between
workouts
• Avg drinks/week
• Runningcalorie total
• % ofopportunitiesused
• Sodas/week
• Meals off-plan/week
• Avg cal/day
Etc...
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
See the ‘Change Package’
How Will We Know We Are Improving? Understanding the System for Reducing Hospital Acquired Infections with Measures
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
• European experience
• Control of nosocomial MRSA outbreaks
• Mathematical models
• Observational studies from individual hospitals
• Interrupted time series study
• Cluster randomized trial
Methicillin resistance
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Antimicrobial Resistance in Antimicrobial Resistance in Staphylococcus Staphylococcus aureusaureus Blood Isolates, Denmark 1960-1995 Blood Isolates, Denmark 1960-1995
DANMAP Report, 1997.Rosdahl VT et al. Infect Control Hosp Epidemiol 1991;12:83-88.
1960 1965 1970 1975 1980 1985 1990 1995
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
p.6
Carlile and ChristensenPractice and MalpracticeIn Management Research
Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997. 48
Pawson and Tilley
Pre-Test Treatment Post-Test
Experimental Group
O1 X O2
Control Group O1 O2
The Classic Experimental Design: “OXO”
Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997. 49
Pawson and Tilley
Context + New Mechanism = Outcome
C + M = O
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’).”
No, it looks more like this…
X3
X2
X1
X5
X4
Y
In this model there are numerous direct effects between the independent and variables (the Xs) and the dependent
variable (Y).
Time 1
Time 3
Time 2
Dependent or outcome variable
Ind
ep
en
den
t V
ari
ab
les
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.
Y
Or, probably more like this…
X3
X2
X1
X5
X4
Time 1
Time 3
Time 2
R3
R2
R1
R5
R4
RY
Key Reference on Causal Modeling
Blalock HM, ed. Causal Models in the Social Sciences. Chicago:
Aldine; 1999.
R = residuals or error terms representing the effects of variables
omitted in the model.
Rigorous Learning in Complex Systems
SimpleLinear
Cause-and-Effect
ComplexNon-Linear
Chaotic
“Rigorous”Learning
Poor Learning
TraditionalRCTs
Case Series“Anecdotes” Static RCTs
•“Dynamic” Cluster RCTs•Statistical Process Control•Time Series Methods•Mixed Methods•Anthropology•Ethnography•Journalism
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, 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….
• 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
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