Open Classroom Series Fall 2013: Policy for a Healthy America

1. Open Classroom Series Fall 2013: Policy for a Healthy America • Every Wednesday, 6pm – 8pm • September 4 through December 4 • West Village F, Room 20 • Northeastern University • School of Public Policy and Urban Affairs

2. This Week (September 25, 2013) “If Health Care Is So Good For Us, Why Are We Still Dying From It?” Don Goldmann Chief Medical and Scientific Officer, Institute for Healthcare Improvement Wendy Parmet Professor of Law, Northeastern University School of Law Deborah Wachenheim Health Quality Manager, Health Care For All School of Public Policy & Urban Affairs | Northeastern University

4. Northeastern University September 25, 2013 Approaches to Improving Patient Safety in Hospitals Don Goldmann , MD Chief Medical and Scientific Officer, IHI Clinical Professor of Pediatrics, Harvard Medical School Professor if Immunology and Infectious Diseases, and Epidemiology, Harvard School of Public Health dgoldmann@ihi.org

5. IHI Essentials • Small not-for-profit in Cambridge with the goal of improving health and healthcare in the US and globally for all people • Collaboration and coordination with partners, allies, and an extensive faculty network, without which we cannot attain our goal • Determination to “change the conversation” about what is possible • Focus on innovation and results • Grounded in the science of improvement • Relentless optimism

6. Scope of the Patient Safety Problem • Imagine that you are an elderly patient undergoing emergency surgery in a Boston academic hospital…. • Oft-quoted estimates from the Harvard Medical Practice Study and the IOM Report, To Err is Human • A medical record review “Trigger Tool” developed by IHI provides a more reliable estimate of the rate of harm in hospitalized patients • Other methods in common use: CMS and AHRQ Patient Safety Indicators

7. North Carolina Hospital Safety Study Landrigan et al., NEJM 2010;363:2124-34 • Stratified random sample of 10 North Carolina hospital • Conducted by independent health services researchers (Landrigan and Sharek) and a Clinical Research Organization (Battelle, Inc.) • Random charts from 2002-07 reviewed with GTT (external and internal reviewers) • Internal reviewers more reliable, so hospitals can do the reviews themselves • Sensitive, specific, good psychometric properties • Suitable for evaluating change in harm rates at hospital, regional and national levels

8. North Carolina Patient Safety Study • 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)

9. 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 (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)

10. Or just keep your eyes open when seeing patients on daily rounds….

11. 100,000 Lives Campaign Objectives (December 2004 – June 2006) Some is not a number, soon is not a time - Berwick • 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

12. 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)

13. Campaign Theory Strong national partners - CDC, Joint Commission, SHEA APIC, ACC, AHA IHI and Campaign Leadership Active communication and field staff; Campaign bus State “Nodes” Each Node runs a hospital network Hospitals (3000+) 30 to 60 hospitals per network, >130 “Mentor Hospitals”

14. Measurement Strategy • Change in hospital mortality, compared to 2004, in terms of “lives saved” • Case mix adjustment from three sources • Direct submission of monthly raw mortality data (deaths/discharges) to IHI • Optional data at the intervention-level (e.g., ventilator pneumonia rates, process measures)

15. 100,000 Lives Campaign Results • Estimated 120,000 lives saved by participating hospitals • > 3,100 Hospitals Enrolled • > 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%

16. Selected “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

18. 5 Million Lives Campaign * National Coordinating Council for Medication Error Reporting and Prevention • A campaign against harm (injuries/adverse events) • Planks: • Reduce surgical complications – Adopt “SCIP” • Prevent Harm from high alert medications • Prevent MRSA infections • Reduce Readmissions in patients with heart failure • Prevent pressure ulcers • Get Boards on board

19. BUT… Multivariate analyses of harms identified by internal reviewers showed no significant changes in the overall rate of harms per 1000 patient-days (reduction factor, 0.99 per year; 95% CI, 0.94 to 1.04; P=0.61). N Engl J Med. 2010;363:2124-34.

20. How should the success of a campaign be measured? • “Changing the conversation” • For example, Partnership for Patients and numerous regional and local initiatives • Demonstrating results • Trust and verify

21. Tough Questions • IHI claims that organizations need to have leadership commitment and improvement expertise and capacity • But contact with many participating hospitals suggests that such capability and capacity are 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? • Rapid response teams

22. Project JOINTS • Three year grant awarded to IHI through Federal “stimulus” $$ • Ten states, 2 matched five-state cohorts (Apr 2011 – Sept 2012) • National Spread (Jan 2013 – Aug 2013) • Disseminate and increase adoption of three evidence-based practices (“enhanced SSI prevention bundle”) via the IHI Multimodal Rapid Spread Network • Use of an alcohol-containing antiseptic agent for preoperative skin preparation • Preoperative bathing or showering with chlorhexidine gluconate (CHG) soap • Staphylococcus aureus screening and use of intranasal mupirocin and CHG bathing or showering to decolonize carriers (both methicillin-sensitive and methicillin-resistant strains) • Evaluation partners: RAND (adoption of practices and role of the network) and UCSD (surgical site infection (SSI) rates)

23. Two Main Analyses • Intention to treat, state level, all hospitals • The impact of Project JOINTS on practice in all hospitals in intervention states compared to those in comparison states (independent of participation in Project JOINTS) • Difference-in-differences approach • Model allows for node and network effects • Treatment effect in participating hospitals • Within the intervention states, the impact of Project JOINTS on hospitals that participated directly vs. those that did not

24. Activities Outputs Outcomes Actors End Goals • Nodes • Create linkages to related state-wide initiative and priorities • Recruit hospitals • Develop/strengthen relationships with and among hospitals • Develop capacity to coach hospitals • Track hospital progress • Link hospitals to IHI resources • Provide feedback to IHI Develop Tools How-to Guide Business Case Measurement Info Improvement Tools IHI Patient/Family Materials Reduction of SSI’s Up-take of three SSI prevention processes Surgeon/MD Materials State Nodes • Hospitals • Set aims • Form teams • Increase knowledge of the importance of specific practices • Increase buy-in among leadership • Increase buy-in among surgeons • Develop capacity to implement and test new processes and tools • Use tools to better inform patients of their role Disseminate and Coach Monthly node calls Hospitals Webinar Call Series Site-visits, town hall meetings, presentations Electronic Communications (website, list-serve, etc.)

25. RAND Evaluation: Summary of State-Level Impact on Orthopedic Practices • Hospitals in Project JOINTS intervention states improved performance significantly on 3 of the 4 enhanced bundle components. • Screening for Staphylococcus aureuscarriage • Treatment for Staphylococcus aureus • Use of CHG soap at least three times before surgery • (Alcohol-based surgical antiseptic was used in the great majority of hospitals at baseline (near ceiling) so significant improvement not seen) • Improvement was significantly greater in intervention states than in comparison states on 3 of the 4 components.

26. Project JOINTS: Summary of State and Hospital-level Impact on Orthopedic Practices Based on a high-reliability measure,* performance increased by nearly 20% in intervention states compared to a slight decline in comparison states. Within participating states, participating hospitals improved 30% compared to 12% in non-participants. * All bundle components used in at least 90% of patients receiving hip and knee surgery (all-or-none measure) Intervention vs. Comparison DID p<.01

27. Mandates are Proliferating • Public Reporting of infection control rates and other health outcomes may: • Accelerate improvement in focused areas • Improve accountability • Improve consumer information and choice and/or • Provide a false sense of security and mask other deficiencies • Lead to unintended adverse consequences • Drain resources and will from other worthy quality and safety goals (“opportunity costs”)

28. Targets and their Unintended Consequences

29. Mandates are Proliferating • Public Reporting of infection control rates and other health outcomes may: • Accelerate improvement in focused areas • Improve accountability • Improve consumer information and choice and/or • Provide a false sense of security and mask other deficiencies • Lead to unintended adverse consequences • Drain resources and will from other worthy quality and safety goals (“opportunity costs”)

30. The UK Healthcare System Offers a Case Study in Target-Based Accountability • Numerous government mandated targets • Exploitation by an inflammatory press • Extreme executive accountability • Large-scale disenchantment with the multiplicity of targets in narrowly defined areas without additional resources or help with systems improvement • ….But some exceptional results

31. July 25th2006 MRSA Press

32. UK 4- Hour A&E Disposition Target

33. NHS trusts meet A&E waiting time targets… Regional performance • North East: 98.6 per cent • North West: 97.8 per cent • Yorkshire and the Humber: 98.2 per cent • East Midlands: 98.1 per cent • West Midlands: 97.7 per cent • East of England: 98.2 per cent • London: 97.9 per cent • South East Coast: 98.1 per cent • South Central: 98.4 per cent • South West: 98.4 per cent Health Services Journal May 21, 2009

34. NHS Celebrates Success And Progress In A&E Medical News Today June 4, 2009 2008-09 4th Q Mid Staffordshire NHS Foundation Trust • Total attendances = 17,953 • Percent disposition with 4 hours = 98.7%

35. Healthcare Commission highlights "appalling" emergency care at Mid Staffordshire NHS Foundation Trust Healthcare Commission report, 3/17/09

36. Failing hospital to review cases Tribute wall to patients who died at Stafford Hospital BBC News, 3/17/09 • Treatment of more than 3,000 patients at a hospital where the NHS's watchdog has said up to 400 people died needlessly could be reviewed. • Bosses at Stafford Hospital have pledged to look at 3,200 cases in the wake of a Healthcare Commission report. • The Commission said 400 more patients than normal died between 2005-08 as the emergency care was "appalling".

37. CMS/Joint Commission Core Measure for Community-Acquired Pneumonia • Antibiotics for pneumonia within 4 hours of ED admission (later increased to 6) • Antibiotics administered to patients with a differential diagnosis including pneumonia (but who turn out not to have pneumonia) to improve performance on a publicly reported measure • Quinolone antibiotics often given for community-acquired pneumonia, supported by IDSA guideline • Quinolone antibiotics a risk factor for C. difficile • Increased use of antibiotics associated with increased antibiotic resistance

38. CMS “No-Pay” for Catheter-associated UTI • Pressure to have a “present on admission” (POA) code for UTI • Very complex coding scheme • MD diagnosis required; nursing notes ignored • Burdensome communication with MDs required • Increase in screening cultures, especially for at-risk elderly women • Asymptomatic bacteriuria discovered • Antibiotics administered despite evidence-based guidelines • Increased risk of C. diff and antibiotic resistance

40. Deborah Wachenheim Health Quality Manager, Health Care For All • Silent Killer • Ginny's Story

42. The Curious Case of Medical Malpractice Wendy E. Parmet Northeastern University School of Law

43. The Medical View • Malpractice law lowers the quality of care by causing defensive medicine and making physicians reluctant to admit errors and work to improve health care quality.

44. The Legal Perspective • Malpractice law improves the quality of care by creating a financial incentive for providers to practice with care and weed out “bad apples.” • Malpractice law provides an incentive for patients who suffer from medical errors to come forward. • Malpractice law compensates patients injured by medical errors.

45. When is a Medical Injury Malpractice? • When it is caused by negligence • Most adverse events are not malpractice • Injured patients must show that the physician failed to conform to the generally recognized and standard practices of the profession • Injured patients must also show that the act of malpractice caused their injuries.

46. The Cost of Malpractice • Mello and colleagues estimate that $55.6 billion was spent on malpractice in 2008. • This was 2.4% of total health care spending. • Administrative costs associated with malpractice claims are estimated at $52,521 per claim.

47. The Cost of Defensive Medicine Michelle M. Mello et al., National Costs Of the Medical Liability System, 29 Health Aff. 1569, 1570, Exhibit 1 (2010). Defensive medicine may be linked to a doctor’s perception of the risk of malpractice not actual risk.

48. Does malpractice deter medical errors? • We don’t know! • The vast majority of cases of malpractice do not lead to litigation. • Litigation has declined since 1995. • Most empirical studies have looked at the link between the law and legal filings; not between the law and care outcomes.

49. The Link Between Claims & Errors David M. Studdert et al.,Claims, Errors, and Compensation Payments in Medical Malpractice Litigation, 354 New Eng. J. Med. 2024, 2028 (2006).

50. Defensive Medicine • “Assurance behavior” is very common, but in one survey 42 percent of high risk specialists stated that they limited their practice, including avoiding complicated procedures and avoiding certain patients. • A 1994 survey showed that only 8 percent of procedures were done primarily as defensive medicine. • We don’t know if practices that may be done because of fears of malpractice cause more harm than good.