Presentation on theme: "Getting to Zero and other Possible Dreams"— Presentation transcript:
1 Getting to Zero and other Possible Dreams Don Goldmann, M.D.Senior Vice PresidentInstitute for Healthcare ImprovementProfessor of PediatricsHarvard Medical SchoolNo conflicts to declare
2 100,000 Lives Campaign Objectives (December 2004 – June 2006) Avoid 100,000 unnecessary deaths in participating hospitalsEnroll more than 2,000 facilitiesRaise the profile of the problem - and hospitals’ proactive responseBuild a reusable national infrastructure for changeSome is not a number, soon is not a time - Berwick
3 100,000 Lives Campaign “Planks” Rapid response teamsEvidence-based care for acute myocardial infarctionPrevention 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 changeIHI and Campaign LeadershipOngoingcommunicationLocal recruitment and support of a smaller network through communication/collaborativesNODES (> 55)*Each Node Chairs 1 NetworkImplementation (with roles for each stakeholder in hospital and use of existing spread strategiesFACILITIES (3000-plus)*30 to 60 Facilities per Network
5 Measurement StrategyChange 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 IHIOptional 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 EnrolledOver 78% of all acute care bedsParticipation in Campaign InterventionsRapid 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%Still lots of room for improvement in basic areas of harm reduction. Note Priority Partners/NQF priority.
7 100,000 Lives Campaign Results Over 55 field offices (“nodes”) and over 130 mentor hospitalsStrong national partner support (CDC, AHRQ, Joint Commission, ACC/AHA, etc.)Thousands on national callsLarge increase in web activity and downloads of Campaign tool kitsGreat 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)Still anecdotal intervention-level data, which is limiting. Problem verifying validity of detection.
8 Success Factors Inspiring goal and clear deadline Easy sign-up Minimal reporting requirementsStraightforward interventionsOptimism, personal motivation, volunteerismPractical direction for hospital leadersDemonstrated link between quality and costUseful toolsVibrant, distributed national learning networkYoung, 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 criteriaLevel e is temporary harm that required interventionLevel i is deathHarm is counted…Whether or not it is considered preventableEven 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 annuallyAHA National Hospital Survey, 200540-50 level e-i harms per 100 admissionsChart 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 years5 million seemed like a good stretch goalWe know that even perfect compliance with all of the planks will not be enough to avoid 5 million harmsFurther validation of GTT psychometrics pending*IHIGlobalTriggerToolforMeasuringAEs.htm
11 5 Million Lives Campaign Planks Reduce Surgical Complications – Adopt “SCIP”Prevent Harm from High Alert MedicationsPrevent MRSA InfectionsReduce Readmissions in patients with Congestive Heart FailurePrevent Pressure UlcersGet Boards on BoardWon’t talk further about Boards, but arguably the best traction and most important.
12 Tough QuestionsIHI claims that organizations need to have leadership commitment, improvement expertise and capacity, and the ability to apply QI methods (rapid cycle PDSAs) – just for startersBut contact with many participating hospitals suggests that such capability is not widespreadSo….are weEncouraging 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
14 S. aureus bacteraemia: methicillin sensitivity (English NHS acute Trusts, voluntary surveillance )Mandatory enhanced surveillance October 2005Baseline year for targets 2003/04Mandatory surveillance introduced April 2001Provisional data
15 Temporal trends in MRSA bacteraemia rates, by region Introduction of national targetEstimated overall rate decrease 3% per quarterHomogeneous regional patternsEstimated overall rate increase % per quarterHeterogeneous regional patterns 0.5Provisional data
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 eventsVermont Oxford NICQ visits to “best of breed” NICUs
18 A Modest Proposal…Improve reliability of basic infection control proceduresHand hygieneIsolation proceduresScreening 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 patient’s point of view, it’s “all or nothing”Reliability science offers robust approaches to reducing defects and harm in health care
20 Component vs. Composite Adherence Contact Precautions COMPONENT: 80% hand hygiene, gloves on entering roomCOMPONENT: 78% gowns on entering roomCOMPONENT: 65% hand hygiene after removing glovesCOMPOSITE: 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 careAcute asthma attackAdmission through dischargeDefects in outpatient careYears/MonthsDaysYears/MonthsDefect free care overtime from the patient’s viewpoint
23 Levels of ReliabilityChaotic process: Failure in greater than 20% of opportunities10-1: 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 opportunities10-4: 5 failures or fewer out of 10,000 opportunitiesBlood banking and anesthesiology alone achievethe higher levels of reliability in medicine
24 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)Howard Cohen
25 Guidelines v. Bundles (Intervention Packages) Guidelines tend to be long, all-inclusive, and confusingMany potential interventions are supported by some evidenceGuidelines are difficult to translate into action and often are ignored by cliniciansWhat 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 improvementThe science behind the bundle is so well established that it should be considered standard of careBundle elements are dichotomous and compliance can be measured: yes/no answersBundles 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 siteMaximal barrier precautions for line insertionHand hygieneNon-sterile cap and maskSterile gown and glovesLarge sterile drapeAntiseptic prep used for catheter insertion as per hospital protocol2% chlorhexidine supported by evidence (but FDA warning for neonates)Site selectionTimely removalDaily assessment to determine if central venous catheter is still necessary; if not, removal within 8 hours
28 Central line-associated bloodstream infection rate in 66 ICUs, Central line-associated bloodstream infection rate in 66 ICUs, Southwestern Pennsylvania, April 2001-March 2005CDCPronovost et al.,N Engl J Med; 2006;355:2725Decrease from 7.7 to 1.4 per 1000 catheter days in 103 ICUs
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 knowledgeStaff competencyAlcohol and gloves available at the point of careOperational, full dispensers providing correct volume of rubAt least 2 sizes of glovesCorrect performance of hand hygiene + gloves worn for standard precautionsConcurrent monitoring and feedbackFocus on leaving the bedsideStaff 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 infectionNearly 1/3 develop infection, often after dischargeColonization is long-lasting, and patients can transmit MRSA to patients in other health care settings (e.g., nursing homes), as well as to family membersMention C. diff as effect of antibiotics
33 Five Key Interventions Compliance with Central Venous Catheter and Ventilator BundlesHand hygiene*Active surveillance cultures (ASCs)Decontamination of the environment and equipmentContact precautions for infected and colonized patientsAlready mentioned CVC and hand hygiene bundles* Especially before contact with the patient and after contactwith the patient and environment
34 What Changes Can We Make? Understanding the System Color code the drivers, make Aim box large – transfer to HAI diagram- move ‘drives’ to avoid getting lost – make the whole thing bigger, or must move downCauseEffectDrives
35 What Changes Can We Make? Understanding the System for Weight Loss “Every system is perfectly designed to achieve the results that it gets”Repeat the ‘every system is designed’ box here.Consider donabedian slide: outcome = structure (physiology, genes, also stuff in my fridge, exercise equipment. etc. Some can change, some are fixed) + process (how we do things, methods, habits)Outcome = Structure + Process -Donabedian
36 How Will We Know We Are Improving How Will We Know We Are Improving? Understanding the System for Weight Loss with MeasuresEmphasize importance of secondary drivers, sequence.Measures let us• Monitor progress in improving the system• Identify effective changes
37 What Changes Can We Make What Changes Can We Make? Understanding the System for Reducing Hospital Acquired InfectionsSee the‘Change Package’Use colors in previous diagram
38 How Will We Know We Are Improving How Will We Know We Are Improving? Understanding the System for Reducing Hospital Acquired Infections with MeasuresUse colors in previous diagram
39 Active SurveillancePerform active surveillance cultures (ASCs) to detect colonized patients on admissionNecessity 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 problemAdded 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 measuresNose +/- perineum/axilla +/- rectum and skin lesions/broken skinSuccessful programs combine ASCs with reliable implementation of other interventionsControversy regarding ASCs for high-risk areas (ICUs) vs. entire hospitalSo what is the evidence?
40 Evidence for ASCs European experience Control of nosocomial MRSA outbreaksMathematical modelsObservational studies from individual hospitalsInterrupted time series studyCluster randomized trial
41 Antimicrobial Resistance in Staphylococcus aureus Blood Isolates, Denmark 1960-1995 100%90%80%70%60%50%Methicillin resistance40%30%20%10%0%DANMAP Report, 1997.Rosdahl VT et al. Infect Control Hosp Epidemiol 1991;12:83-88.
42 Impact of Active Surveillance in ICUs Huang SS et al., Clin Infect Dis 2006;43:971-8
43 Active SurveillancePerform active surveillance cultures (ASCs) to detect colonized patients on admissionNecessity 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 problemAdded 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 measuresNose +/- perineum/axilla +/- rectum and skin lesions/broken skinSuccessful programs combine ASCs with reliable implementation of other interventionsControversy regarding ASCs for high-risk areas (ICUs) vs. entire hospitalSo what is the evidence?
44 Beware…. Pseudomonas Acinetobacter Stenotrophomonas Burkholderia ESBL and carbapenemase-producing Gram-negative bacilliAnd many others….
45 Weighing the EvidenceHow much evidence is required before deciding to spread change?What kind of evidence is appropriate?Randomized controlled trialsCluster randomized trialsQuasi-experimental studiesStatistical process controlTime-series analysisQualitative studiesBehavioral science, Sociology, AnthropologyMixed methods
46 Transition from Descriptive Theory to Normative Theory – ⇧Degree of Belief Carlile and ChristensenPractice and MalpracticeIn Management Researchp.6
48 Pawson and Tilley The Classic Experimental Design: “OXO” Pre-Test TreatmentPost-TestExperimental GroupO1XO2Control Group48Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997.
49 Context + New Mechanism = Outcome Pawson and TilleyContext + New Mechanism = OutcomeC + M = O49Pawson 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’).”50Pawson R, Tilley N. Realistic Evaluation. London: Sage Publications, Ltd.; 1997.
51 (If only it was this simple!) Is life this simple?X Y(If only it was this simple!)
52 Independent Variables 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).X1X4Dependent or outcome variableIndependent VariablesX2YX5Time 3X3Time 2Time 1
53 Or, probably more like this… Key Reference on Causal Modeling 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.R1Key Reference on Causal ModelingBlalock HM, ed. Causal Models in the Social Sciences. Chicago: Aldine; 1999.X1R4X4RYX2YR2X5Time 3X3Time 2R = residuals or error terms representing the effects of variables omitted in the model.R5Time 1R3
54 Rigorous Learning in Complex Systems “Dynamic” Cluster RCTsStatistical Process ControlTime Series MethodsMixed MethodsAnthropologyEthnographyJournalism“Rigorous”LearningTraditionalRCTsSimpleLinearCause-and-EffectComplexNon-LinearChaoticCase Series“Anecdotes”Static RCTsPoor Learning
55 Weighing the EvidenceHow much evidence is required before deciding to spread change?What kind of evidence is appropriate?Randomized controlled trialsCluster randomized trialsQuasi-experimental studiesStatistical process controlTime-series analysisQualitative studiesBehavioral science, Sociology, AnthropologyMixed 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 2007:357:
57 The MERIT Cluster Randomized Trial 23 Australian hospitals randomized2-month baseline, 4-month preparation period, 6-month interventionSuperb statistical analytic planMore inter- and intra-hospital variance than expected, much lower event rate than expectedIncreased call rate in intervention hospitals, but no effect on outcomesReduction in mortality in both arms of studySub-optimal team activation in patients with call criteriaMERIT Study Investigators, Lancet 2005;365:
58 What If…. Baseline period was used to adjust power Study would have been “futile”Performance data were fed back in real timeQI was encouraged to improve performanceMixed methods were used to understand context and outcomes in individual sites
59 LessonsEvery QI “experiment” should use the most appropriate evaluation method for the question and contextThe broadest possible palette of methods should be utilizedNo opportunity to learn should be wasted