Richard C. Boothman, JD Thomas H. Gallagher, MD Timothy B. McDonald, MD, JD

1. Linking Transparency, Patient Safety, and Quality of CareInnovative Institutional Programs and Future Directions Richard C. Boothman, JD Thomas H. Gallagher, MD Timothy B. McDonald, MD, JD Eric J. Thomas, MD, MPH

2. Session Objectives • Describe innovative institutional transparency efforts, including programs to promote reporting of adverse events and errors to institutions and disclosing these events to patients. • Describe the conceptual and practical linkages between event reporting, safety culture, and quality improvement. • Highlight future developments that could strengthen transparency and the link between transparency and quality at the institutional and national level.

3. Agenda

4. Case • 29 year-old healthy male cared for by PCP and local hospital for recurring epistaxis • After several months, referred to academic medical center ED—presented ill, with SOB, epistaxis, hemopytsis, low platelets. • CT scan shows large lung mass, thought to be tumor (less likely blood clot). • Bronchoscopy attempted, finds free blood in lungs. • Continued deterioration, recommendation for interventional radiology to embolize bleeding source

5. (Case continued) • IR attempts biopsy, retrieves only clot. Neoplasm still highest on differential. • While healthcare team is meeting, patient arrests and dies. Autopsy finds large PE with pulmonary hemorrhage. • Communication with family immediately after death is challenging-cultural barriers, uncertainty about what happened, sudden and unexpected demise of young patient. • Security called to remove distraught family—first time risk management becomes aware of event.

6. Follow-up disclosure meeting • One week later meeting held with 10 family members, unannounced trial lawyer, 5 physicians, 2 risk managers. • Clinical care thought to be reasonable; MD thought process shared with family. • Family perceptions addressed, misconceptions corrected. • Family could see shared grief. • Family’s anger heard, appropriate apologies made, lessons taken back to management for follow-up.

7. Transparency, safety, and quality • Transparency long recognized as key to safety culture and healthcare quality • Yet a decade after To Err Is Human, major gaps in transparency persist • Healthcare workers experience multiple mixed messages about transparency • No accountability around transparency • Limited transparency becomes path of least resistance • Missed opportunities to promote greater synergy among transparency practices

8. Practices in transparent healthcare organizations • Discuss events with colleagues, other team members • Formal event reporting • Disclose event to patient • Share lessons learned back with clinicians • Required external reporting • Optional external reporting • Standard quality measures • Extreme transparency • CEO blog • Other aspects of transparency • Clinical information (shared decision-making) • Price

9. How transparent are we? • Event reporting • 2009 AHRQ Patient Safety Culture survey-52% of staff reported no errors in the last 12 months • 2005 Physician survey (n>2000)-65% unaware their hospital had an error reporting system • Disclosure to patient • Only 1/3 of harmful errors disclosed to patients • Those disclosures that do occur often go poorly • Feedback of lessons learned to clinicians • 2005 Physician survey-18% of physicians agreed that current mechanisms to inform them about safety problems were adequate • Suggests shortcomings in our current approach to promoting transparency

10. Comparing Patient and Physician Ratings of Disclosure Quality

11. Transparency, accountability, and quality • Current paradigm • Culture of blame, shame, fear inhibit openness • Errors mostly represent system breakdowns • Greater openness promotes quality through event analysis, implementing prevention plans • Reality check • Errors mixture of individual and system breakdown • Transparency also promotes quality by encouraging low performers to improve and by deterrent effect • Performing poorly on report cards a potent stimulus • Accountability for transparency required • Current approaches to transparency not integrated

12. Are current approaches to transparency integrated? • Key transparency practices largely segregated by specialty • Nurses report events to institution • Physicians disclose events to patients • Most safety culture surveys measure event reporting but not disclosure attitudes or practices • Risk management and quality/safety programs often separated • Training usually addresses one transparency practice in isolation • Disclosure training rarely addresses event reporting to institution or communicating about events with colleagues

13. Are different transparency attitudes correlated? • 2005 Physician survey • Physicians who strongly agreed that serious errors should be disclosed to patients twice as likely to strongly agree that serious errors should be reported to hospital • Similar relationship between MD support for disclosing minor errors to patients and reporting minor errors to hospital • Considerable anecdotal experience supports hypothesis that different transparency practices may be related

14. Implications of an integrated approach to transparency • What our are goals for transparency? • Are transparency’s deterrent, embarrassment effects good or bad? • Transparency is a skill, not just an attitude • Should training address reporting, communicating with colleagues, and disclosure in tandem? • Interprofessionalimplications • What are the real barriers to “speaking up?” • Will organizations adopt processes to ensure accountability around transparency? • Which of these will be publicly reported? • Will organizations compete on transparency?

15. Enhancing transparency, improving quality • Transparency and safety culture: Eric Thomas • Innovative institutional transparency programs: Tim McDonald • Future developments in transparency: Rick Boothman

16. Transparency and Safety Culture

17. Safety Climate The culture in this ICU makes it easy to learn from the errors of others. Medical errors are handled appropriately in this ICU. I know the proper channels to direct questions regarding patient safety in this ICU. I am encouraged by my colleagues to report any patient safety concerns I may have. I receive appropriate feedback about my performance. I would feel safe being treated here as a patient. Sexton et al. BMC Health Services Research 2006;6:44.

18. Safety Climate • Improve safety climate by: • improving incident report systems • executive walkrounds or safety rounds • increasing staff participation in RCAs and other efforts to learn from errors • Hudson et al. Contemporary Critical Care 2009;7:

19. Safety Climate • Executive Walkrounds Study: • Randomized 24 clinical units to receive EWRs or usual patient safety activities and measured safety climate of nurses before and after the walkrounds • At baseline the experimental and control groups had similar safety climate scores • After the intervention, 72.9% of nurses in the walkrounds group reported a positive safety climate versus only 52.5% in the control group • Thomas et al. BMC Health Services Research 2005;5:28. For other data on walkrounds also see Frankel et al. Health Serv Res 2008;Jul 20:2.

20. Teamwork Climate It is easy for personnel in this ICU to ask questions when there is something that they do not understand. I have the support I need from other personnel to care for patients. Nurse input is well received in this ICU. In this ICU, it is difficult to speak up if I perceive a problem with patient care. Disagreements in this ICU are resolved appropriately (i.e., not who is right, but what is best for the patient). The physicians and nurses here work together as a well-coordinated team. Sexton et al. BMC Health Services Research 2006;6:44.

21. Teamwork Climate and BSIs Across Michigan ICUs: “No BSI” is > 5 consecutive months without BSI. No BSI 21% No BSI 44% No BSI 31% % of respondents within an ICU reporting good teamwork climate Strongest item level predictor: caregivers feel comfortable speaking up if they perceive a problem with patient care. Slide from Bryan Sexton

22. Red numbers indicate RN Turnover in that Quartile 3 years later 40% 43% 27% 23% RN reports of Teamwork Climate and Subsequent RN Turnover Data from the University of Texas at Houston Memorial Hermann Center for Healthcare Quality and Safety

23. Teamwork climate • Improve teamwork climate by: • SBAR training • Briefings • daily goals checklists • shadowing other providers • Hudson et al. Contemporary Critical Care 2009;7:

24. Transparency and Safety Culture

25. Promoting Transparency at the Institutional Level

26. Condition Predicate to “Transparency”

27. Condition Predicate to “Transparency” • Courage…… and Leadership

28. How can we “encourage” institutions and care givers to be transparent?

29. How can we “encourage” institutions and care givers to be transparent? • Deal with the drivers of human behavior

30. How can we “encourage” institutions and care givers to be transparent? • Deal with the drivers of human behavior • Fear • Greed • Ego – soul • One we can leave out

31. How can we “encourage” institutions and care givers to be transparent? • Deal with the drivers of human behavior • Fear • Support structure–patients, families and providers • Education • Attack “truth to power” problems head-on • Greed • Financial incentives, disincentives for reporting • Tie to employment, privileges – OPPE, credentialing • Show the ROI – process improvements, claims • Ego – soul • Adopt principles of “just culture” • Handle occurrence reports with discretion • Focus on systems unless reckless, repetitive behavior

32. On the educational front:ACGME program director survey data • Most believe being transparent and honest is important • Future depends on resident physicians • Few feel competent • Little training • Lack of infrastructure in “real life” • Mixed messages from institutional leadership, insurers, risk management • Desire for clear articulated and approved principles

33. ACGME core competencies • Patient Care • Medical Knowledge • Practice-Based Learning & Improvement • Interpersonal and Communication Skills • Professionalism • Systems-based Practices

34. Elements of a “Transparent” Response to Adverse Event Process • Reporting • Investigation • Communication • Apology with remediation • Process and performance improvement • Data tracking and analysis

35. Elements of a “Transparent” Response to Adverse Event Process • Within the context of the Core Competencies • Reporting – all six competencies involved • Investigation – SBP & PBL & I • Communication – Professionalism and com skills • Apology with remediation - Professionalism • Process and performance improvement • Data tracking and analysis - PBL & I • All done in the context of institutional oversight

36. ResidentReporting • Must report 5 unsafe conditions or “near misses per year”

37. After reporting • Degree of harm assessed • If harm, investigation ensues • Must engage the family • RCA depending on severity • Consideration of “care for the care giver” • Life After Death: The Aftermath of Perioperative CatastrophesGazoni et al. Anesth Analg.2008; 107: 591-600 • Hold bills

38. Power of engaging families in the aftermath of a tragic event

39. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study • West et al. JAMA. 2006 296(6): 1071-8. “Self-perceived medical errors are common among I.M. residents and are associated with substantial personal distress. Personal distress and decreased empathy are associated with increased odds of future errors…reciprocal cycle.” Must consider “care for the care giver” and methods to maintain trust between provider and patient/family.

40. Future possibilities and opportunities • Deal with the drivers of human behavior • Fear • Federal & state legislative changes • NPDB & State licensing • Greed • Personal asset protection if transparent • Ego – soul • Expanded adoption of “just culture” • Screening prior to medical school • Emotional intelligence assessment tools • Values drive behaviors which drive performance

41. In a time of universal deceit, telling the truth becomes a revolutionary act. George Orwell

42. Habit #2: Begin with the End in Mind. Stephen R. Covey

43. What do patients want? What do patients deserve?

44. Truthful Explanation

45. Accountability

46. Apology and Compensation when warranted

47. What do caregivers want? What do caregivers deserve?

48. Truthful Explanation

49. Reasonable Benchmark against which you judge their actions

50. Support