Ambitious Goals to Reduce Harm: Why Has Progress Been Slow and What Can We Do to Bend the Curve?

Transcription

1 Ambitious Goals to Reduce Harm: Why Has Progress Been Slow and What Can We Do to Bend the Curve? Don Goldmann, M.D. Senior Vice President Institute for Healthcare Improvement Professor of Pediatrics Harvard Medical School Professor of Immunology and Infectious Disease and Epidemiology Harvard School of Public Health

2 Patient Safety in the United States Institute of Medicine report (1999) 44,000-98,000 deaths/yr in US hosp Lay press/public (credibility) Based on Harvard Medical Practice Study and Utah-Colorado Study 2%-4% of all hospitalized patients suffer adverse events Most preventable Medical systems increasingly complex Skepticism about progress since this seminal report

3 Were We Better Off 5 Years After IOM? JAMA 2005;294: not close to meeting recommendations of IOM patient safety systems progress is slow and cause for great concern

4 What about 2008? BMJ 2008;337: Considerable efforts have been made to improve patient safety and it is natural to ask are patients any safer? The answer to this simple question is curiously elusive we believe that the lack of reliable information on safety and quality of care is hindering improvement in safety across the world.

5 Temporal Trends in Patient Harm Resulting from Medical Care* Stratified random sample of 10 North Carolina hospitals (rural/urban, teaching/non-teaching, small/large) North Carolina chosen because strong Campaign node and exemplary commitment to safety Courageous volunteer hospitals Conducted by independent health services researchers and a Clinical Research Organization (Battelle, Inc.) Review of random sample of charts from (10 records/quarter/hospital) with IHI Global Trigger Tool (GTT), excluding children, hospice and rehab, psychiatric patients External reviewers hired by Battelle Internal reviewers from hospital Gold standard review of 10% sample by IHI team *Landrigan et al., N Engl J Med. 2010;363:

6 What is the IHI Global Trigger Tool? Aggregate of more specific tools (ICU, adverse drug event, etc.) Triggers indicate which medical records are likely to include documentation of a harm 20 minute chart review finds most adverse events The GTT is far more sensitive than voluntary reporting But voluntary reporting to detect errors and near misses is an important adjunct to harm detection with the GTT Harms present on admission and related to medical care are counted, as are all harms whether or not considered preventable The GTT is not designed to detect diagnostic errors or errors of omission, so rates of harm found with the GTT underestimate the total harm burden

7 Harm Study Review Process 1 primary reviewer (non MD, usually RN) All suspected harms presented to 2 MD reviewers (verbally) MD reviewers independently determined if harm occurred or not; rated severity and preventability Pre-discussion Kappa calculated Reached consensus on event Inter- and intra-rater reliability calculated 10% of charts at each hospital reviewed by gold standard IHI team Sensitivity and specificity of external and internal reviewers compared to IHI review

8 Severity Rating of Adverse Events* Category E: Category F: Category G: Category H: contributed to or resulted in temporary harm to the patient and required intervention contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization contributed to or resulted in permanent patient harm required intervention to sustain life Category I: contributed to or resulted in the patient s death * Source: National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

9 Reliability and Validity Good to excellent psychometrics Inter- and intra-rater reliability on occurrence of harm, preventability, severity External reviewers less reliable than internal reviewers Good news hospitals probably can use their own staff to conduct reviews Both external and internal reviewers detected fewer harms than IHI team (reasonable sensitivity, internal reviewers better than external); very good specificity

10 Number, Rate, Severity of Harms 25.1 harms/100 admissions Procedures, medications, healthcare associated infections most common Most harms minor and transient, but some serious 41.7% temporary with intervention required 44.7% temporary with prolonged hospitalization 2.9% permanent 8.5% life threatening 2.4% caused or contributed to death 63.1% preventable No detectable improvement over the 6 year study period (adjusted for case mix)

11 Harm Trends (Total) Internal External a y s d t n tie a p r 30 e p s 20 a rm 10 H 0 Slope (adjusted*): 0.99 (0.94, 1.04) p = 0.61 a y s d t n a tie p r 30 e p s 20 a rm 10 H 0 Slope (adjusted*): 0.98 (0.93,1.04) p = *adjusted for gender, age, ICU admission, hospital service, race, Insurance group and high risk of harm condition

12 Harm Trends (Preventable) Internal External a y s d t n tie a p r 30 e p s 20 a rm 10 H 0 Slope (adjusted*): 1.00 (0.94, 1.06) p = 0.92 a y s d t n tie a p r 30 e p s 20 a rm 10 H 0 Slope (adjusted*): 0.92 (0.85,1.00) p = *adjusted for gender, age, ICU admission, hospital service, race, Insurance group and high risk of harm condition

13 Harm Trends (High Severity Harms Levels F-I) Internal External a y s d t n tie a p r 30 e p s 20 a rm 10 H 0 Slope (adjusted*): 0.98 (0.92, 1.04) p = 0.49 a y s d t n a tie p r 30 e p s 20 a rm 10 H 0 Slope (adjusted*): 0.98 (0.91, 1.04) p = *adjusted for gender, age, ICU admission, hospital service, race, Insurance group and high risk of harm condition

14 Office of the Inspector General (OIG) Medicare Study IHI GTT, but harms present on admission excluded 13.5 harms/100 admissions (excluding temporary harms that did not require prolonged hospitalization) Estimated 134,000 Medicare patients had at least one adverse event in the one month study period (contributing to 15,000 deaths) Another 13.5/100 admissions had temporary harms Small minority NQF serious reportable events or Medicare hospital-acquired conditions 44% clearly or likely preventable Medication, patient care, infection most common causes Total cost $324 million in the study month (3.5% Medicare hospital expenditures) Implications Recommended CMS and NQF designate more no-pay and serious reportable events Call for annual national measurement of harm

15 Health Affairs Study* Three exemplary, HIT enabled hospitals 2004 data 49 adverse events per 100 admissions based on IHI GTT Much more sensitive than voluntary reporting, and more sensitive than the condition-specific AHRQ Patient Safety Indicators (PSIs) Classen et al., Global Trigger Tool Shows That Adverse Events In Hospitals May Be Ten Times Greater Than Previously Measured. Health Aff :

16 GTT Controversial Issues Criticism GTT inflates harm rates Includes harms present on admission due to health care Includes all harms, whether preventable or not But many CLABSIs once considered nonpreventable Includes less severe, temporary harms OIG approach sensible But does not include harms due to diagnostic errors

17 Partnership for Patients Goal: Reduce preventable hospitalacquired conditions by 40% by the end of 2013 compared to million fewer injuries 60,000 lives saved This is an aspirational goal that is not based on current evidence (even in stellar institutions) of what is achievable Some is not a number, soon is not a time may be a good approach to galvanizing will

18 Partnership for Patients - Terminology Preventable hospital-acquired conditions All-cause adverse events Harms Complications Injuries

19 Pointy-Headed Taxonomy* Adverse event: an event which results in unintended harm to the patient, and is related to the care and/or services provided to the patient, rather than to the patient's underlying medical conditions Harm: an outcome that negatively affects a patient's health and/or quality of life In general terms, if a patient experiences an injury due to care, whether from an error or not, this is harm *Disclosure Working Group. Canadian Disclosure Guidelines. Edmonton, AB: Canadian Patient Safety Institute; 2008.

20 Partnership for Patients Targeted Conditions Adverse drug events CAUTIs CLABSIs VAPs Surgical site infections Injuries from falls or immobility Obstetrical adverse events Pressure ulcers Venous thromboembolism (VTEs) Other hospital-acquired conditions

21 Which Measure to Use? Medicare Patient Safety Monitoring System (MPSMS) as being adapted by AHRQ GTT as adapted by OIG PSAs Rates of specific harms (e.g., CLABSI) Will data be used to compare hospitals? If so, will case adjustment be necessary?

22 A Path Forward for Hospitals? Sequence the work, starting with high-volume causes of harm for which prevention strategies and evidence are strongest (e.g., HAIs) Insure sustainability and hospital-wide spread Understand what proportion of all-cause harm these conditions account for so that there will be realistic expectations for moving the big dot Develop a comprehensive, integrated approach to safety, including multiple data streams and methods

23 Other Critical Data Streams and Methods Voluntary reports of errors, near misses, harms Morbidity and mortality rounds Peer-review with RCA and FMEA Staff and patient feedback Automated triggers (e.g., lab tests) for precise estimates of specific types of harm Safety culture surveys AHRQ Hospital Survey on Patient Safety Culture ( survindex.htm_ Safety Attitudes Questionnaire (Pascal)

24 LEVERAGE RELIABILITY SCIENCE TO ENSURE SUSTAINED HIGH LEVELS OF EXECUTION AND PERFORMANCE HAI Examples

25 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

26 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

27 Reliability is failure-free operation over time from the viewpoint of the patient

28 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

29 Reliability in Health Care 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)

30 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?

31 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 nothing approach

32 Five Key Interventions for MRSA Prevention Compliance with Central Venous Catheter, Ventilator, Surgical Site Infection Bundles Hand hygiene Active surveillance tests (ASTs)(though still mixed evidence) Decontamination of the environment and equipment Contact precautions for infected and colonized patients

33 Counts of MRSA bacteraemia Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q Year and quarter 2 or more days less than 2 days on presentation not categorised * DATA ARE PROVISIONAL NOT FOR WIDER CIRCULATION

34 MRSA Infections Also in Decline in US 28% decline in invasive hospital-acquired MRSA infections, % decline in community-acquired MRSA in patients with healthcare exposure Acute Bacterial Surveillance (ABC) Core report, CDC April 2011

35 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 Site selection Timely removal (alcohol hub prep, other measures)

36 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 Sustained over time

37 Reduce Ventilator-Associated Pneumonia Elevation of the head of the bed to between 30 and 45 degrees Daily Sedation Vacation and daily assessment of readiness to extubate Peptic ulcer disease (PUD) prophylaxis Deep vein thrombosis (DVT) prophylaxis (unless contraindicated) (chlorhexidine mouth care) Note the paradoxes what does this tell us about how bundles may work?

38 Surgical Site Infection Bundle Appropriate use of antibiotics New issues: staph screening, change in first line antibiotic, alcohol-containing preps Appropriate hair removal Post operative glucose control (major cardiac surgery patients cared for in an ICU)* Perioperative normothermia (colorectal surgery patients)* New evidence-based enhancements - Staph screening, change in first line prophylactic antibiotic, alcohol-containing preps

39 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