1. To Tell or Not to Tell ? Disclosing Medical Errors Contributing Author Cherri Hobgood, MD,FACEP Associate Dean Curriculum and Educational Development UNC School of Medicine

2. “Life is short, the art long, experience treacherous, judgment difficult” Hippocrates

3. Objectives Review the current literature on disclosure Review the current literature on disclosure –Physician behaviors and culture –Ethics of disclosure –Patient preferences for disclosure Discuss personal barriers to disclosing errors Discuss personal barriers to disclosing errors Develop a method for disclosing error Develop a method for disclosing error Apply key concepts to simulated clinical scenarios Apply key concepts to simulated clinical scenarios

4. To err is human……… to forgive divine. Alexander Pope Essay on Criticism 1711

5. Mandates for Reporting JCAHO 2001 Standards JCAHO 2001 Standards “Inform patients and, when appropriate, their families about the outcomes of care, including unanticipated outcomes” http://www.jointcommission.org/

6. What is a Medical Error? “An act or omission that would have been judged wrong by knowledgeable peers at the time it occurred” Institute of Medicine

7. Non-Preventable adverse events Potential adverse events Near Misses Medical Error Adverse Events (complications) Errors and Adverse Events Negligent adverse events

8. What does this mean for our practices? 1. We will all commit errors & cause adverse events 2. Many of our patients will have already experienced a medical error –Blendon et al. NEJM 2002 347(24) 42% of public (24% serious) 42% of public (24% serious) 35% of physicians (18% serious) 35% of physicians (18% serious) Variable disclosure (~1/3) Variable disclosure (~1/3)

9. Why is there a gap?

10. What are the ethical principles that support disclosing errors to our patients?

11. Ethics of Disclosure Informed Consent Informed Consent –Conveys important info to patients – Required for informed medical decision making Truth Telling Truth Telling –Ethical premise that telling the truth is paramount even when data is not required for medical decision making Demonstrates respect for patient Demonstrates respect for patient –as a person and partner in care/ health

12. Ethics of Disclosure Honors physician’s commitment to act solely in the patients best interest Honors physician’s commitment to act solely in the patients best interest Maintains trust between patient and physician Maintains trust between patient and physician Adheres to principle of justice Adheres to principle of justice –Patients should be able to seek appropriate restitution or recompense

13. Ethics of Disclosure Full and Honest Disclosure –Allows for Correction of Error –Maintains Mutual Trust –Respects Pt’s Self Determination –Meets our Personal Standards “Honesty the Best Policy”

14. Why are Physicians Reluctant to Disclose Errors? Or Adverse Outcomes?

15. Traditional Approach “ We have been trained to feel that if we were just alert enough, smart enough, and dedicated enough, we should have been able to overcome whatever [ergonomic] impediments we encountered.” Wears RL, & Perry SJ. Human factors and ergonomics in the emergency department. Ann Emerg Med. 2002 Aug;40:206-212

16. First Do No Harm

17. Barriers to Disclosure Expectations Expectations –Medical profession should be infallible Fear Fear –Loss of reputation, status –Limiting professional advancement –Loss of authority –Litigation Uncertainty Uncertainty –What do the patients want??

18. Barriers to Disclosure Reasons Doctors Do Not Disclose –uncertain if “event is an error” –has “No useful purpose” –  patients’ pain and suffering –  patients’ confidence in MD & system –patients will avoid future care –fear of litigation –difficult to admit “I made a Mistake” “I made a Mistake” –“no one taught us how” Rosner F, et al. Disclosure and prevention of medical errors. Arch Int Med. 2000;160:2089-92.

19. “Medical Culture” Focus: responsibility & accountability Individual responsibility & accountability Professional culture ~> “1 st do no harm”Professional culture ~> “1 st do no harm” Catch-22Catch-22 Behavioral Results ~> the 3-DsBehavioral Results ~> the 3-Ds DenialDenial DistancingDistancing DiscountingDiscounting Obscure eventsObscure events GuiltGuilt Baylis F. Errors in medicine: nurturing truthfulness. J Clin Ethics. 1997 Winter; 8(4):336-40.

20. “Culture of Silence” We fear: embarrassment loss of clinical reputation denied opportunities to advance weakened authority We feel: loss of self esteem shame guilt fear Origins in Survival Value

21. What about losing it all? Litigation risk Litigation risk –Being sued is a life changing event –Even if you win you will spend yrs on the case –Currently only 3-5% of patients who are injured by negligent care sue –WHY IS THIS RATE SO LOW? –What will ↑ rates of disclosure do to the litigation rate? Gallagher TH, & Levinson W. Disclosing harmful medical errors to patients: a time for professional action. Arch Intern Med. 2005 Sep 12;165(16):1819-24

22. Why Do People Sue Doctors? Greed? A chance to hit the jackpot? Greed? A chance to hit the jackpot? Major motivators Major motivators “the A list” –feeling Abandoned –lack of Answers & information –lack of Accountability –lack of Apology People don't expect doctors to be perfect, but they want them to be honest and forthcoming, especially when mistakes happen People don't expect doctors to be perfect, but they want them to be honest and forthcoming, especially when mistakes happen

23. Data Families litigating for perinatal injury Families litigating for perinatal injury 20% seeking information 20% seeking information 24% perceived a cover-up, lack of MD honesty 24% perceived a cover-up, lack of MD honesty 32% felt the MD would not talk to them 32% felt the MD would not talk to them Study of malpractice plaintiff depositions Study of malpractice plaintiff depositions 71% ID physician-patient relationship issues 71% ID physician-patient relationship issues –32% felt deserted –26% stated information was dysfunctionally delivered –13% failed to solicit patients’ opinions, need for info, or feelings of discomfort Hickson GB, et al. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA 1992 Sep 16;268(11):1413-4. Vincent C. et al. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994 Jun25;343(8913):1609-13.

24. Data Study of medical negligence claims Study of medical negligence claims –91% indicated the “desire for an explanation” was a reason to litigate –“Could anything have averted legal action?” –41% said YES –Answers and an Apology Patients injured through medical treatment Patients injured through medical treatment –Lower frequency of explanations associated with: –↑ distress –↑ difficulty with adjustment –These findings were not associated with global negative view of physicians or excess pain levels –Those who litigated were significantly more dissatisfied than those who did not Vincent C. et al. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994 Jun25;343(8913):1609-13. Vincent CA, et al. Patients’ experience of surgical accidents. Qual Health Care 1993 Jun;2(2):77-82.

25. Impact of Outcome Severity High Outcome Severity Events –More likely to be: Identified as an error Identified as an error Reported to system Reported to system Low Outcome Severity Events –Less likely to be: Identified as error Identified as error Reported to the system Reported to the system “oops” no harm no foul approach “oops” no harm no foul approach Hobgood C, et al. Identifying medical errors: developing consensus on classifications and consequences. Journal of Patient Safety 2005 Sept; 1(3):138-144.

26. Relationship between Disclosure and Outcome Severity Parents informed of error by MD vs. another source Change in likelihood of legal action: Change in likelihood of legal action: –Less likely to sue36% –No change 63% –More likely to sue 1% Severity of error identified as: Severity of error identified as: –Moderate~> POSITIVE influence of disclosure & greater decrease in likelihood of seeking legal action RR 1.25; 95% CI 1.05-1.45 –Severe ~> Desire for legal action influenced less by disclosure RR 0.74; 95% CI 0.59-0.90 Hobgood C, et al. Parenteral preferences for error disclosure, reporting, and legal action after medical error in the care of their children. Pediatrics, 2005; 116: 1276-86.

27. “Our Current Medical Culture” Silence, Shame, & Blame Undesirable Results Errors are not disclosed Patients Other providers Attending physicians Limits feedback on performance Limits systems and safety improvements System-wide attribution errorSystem-wide attribution error Assigning blame to individuals not to the systemAssigning blame to individuals not to the system May actually increase our risk for litigationMay actually increase our risk for litigation

28. Patient Preferences for Disclosure

29. Patients’ Perspective Error is inevitable Error is inevitable –Understand the concept that doctors are “only human” Have a Broad definition of Error Have a Broad definition of Error –Includes poor service quality significant delay in treatment significant delay in treatment –Non-preventable Adverse Events –Deficient interpersonal skills Afraid of Errors Afraid of Errors Gallagher TH, et al. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA 2003 Feb 26;289(8):1001-7.

30. Our Perspective Error is inevitable Error is inevitable –Understand the concept that doctors are “only human” –Catch 22~> Training paradigm seeks perfection Have a Narrow definition of Error Have a Narrow definition of Error –Deviations from standard of care Afraid of Errors Afraid of Errors –Harm our patients –Impact on Career/ reputation/ status –Litigation potential Gallagher TH, et al. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA 2003 Feb 26;289(8):1001-7.

31. Our Perspective Results: We seldom disclose We seldom disclose –1/3 of Pts who experienced an error learned of it from their physician (Blendon et al NEJM) When we do disclose we When we do disclose we “choose our words carefully” “choose our words carefully” Gallagher TH, et al. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA 2003 Feb 26;289(8):1001-7.

32. The Disclosure A-list 1. Accurate Explicit statement that error occurred Explicit statement that error occurred 2. Answers and Info What the error was What the error was Clinical implications of the error Clinical implications of the error 3. Accountability Why the error occurred Why the error occurred How recurrences will be prevented How recurrences will be prevented 4. Apology 5. Active listening 6. Acknowledge and Address The emotions & feelings experienced by pts The emotions & feelings experienced by pts Desire to change physicians Desire to change physicians

33. Accurate Explicit statement of error Consistent Data ~> Patients want to know Gallagher – focus group (JAMA 2003) Gallagher – focus group (JAMA 2003) Pts wished to learn of “All errors that cause harm” Whitman –survey IM out pts (Arch IM1996) Whitman –survey IM out pts (Arch IM1996) 98% desired or expected MD to acknowledge error Hobgood – survey Emergency Department patients (Acad EM 2002) Hobgood – survey Emergency Department patients (Acad EM 2002) 88% want to know everything about the mistake Mazor- survey health plan members (Ann IM 2004) Mazor- survey health plan members (Ann IM 2004) 91.2% “pts should always be told if an error is made—even if the pt is not injured or harmed”

34. What about Parents? Hobgood et al. Parental preferences for error disclosure, reporting, and legal action after medical error in the care of their children. Pediatrics. 116(6):1276-86, 2005 Dec. Hobgood et al. Parental preferences for error disclosure, reporting, and legal action after medical error in the care of their children. Pediatrics. 116(6):1276-86, 2005 Dec. Vignette based survey of parents in Peds Emergency Department Vignette based survey of parents in Peds Emergency Department –99% wanted: “to be told everything as soon as it was discovered” –No change with: Parental race/ethnicity Parental race/ethnicity Gender Gender Educational level Educational level Vignette severity Vignette severity

35. When To Tell Empiric evidence –Emergency Department patients (Hobgood et al. Acad EM 2002) 76% when detected 76% when detected 23% when full extent of error known 23% when full extent of error known –Focus Groups (Gallagher et al. JAMA 2003) Provided expeditiously Provided expeditiously –Health Plan members (Mazor Ann IM 2004) 98% “as soon as it was discovered” 98% “as soon as it was discovered”

36. Answers and Info What happened? – –What we know about the event – –Information up to the point of your knowledge –What does this mean for them now? –Will future treatment be required? –Additional procedures? –Monitoring? –Increased length of stay? –What are the implications for their health –Temporary or permanent disability?

37. Accountability Why did this error occur? How are you going to fix it? –Responsibility –Be as honest and forthcoming as possible –If the info is unknown promise to find out –Don’t rationalize or become defensive –How will future errors be prevented –What will you do to insure that this does not happen to others Reporting to healthcare system Reporting to healthcare system Change care delivery process Change care delivery process

38. Apology Types of apology 1.Full complete Apology Personal and sincere Personal and sincere Accepts responsibility for physician or hospital Accepts responsibility for physician or hospital “I am sorry we did this to you” 2.Non-specific apology of sympathy of sympathy or benevolence Impersonal of sympathy or benevolence Impersonal Does not accept personal responsibility Does not accept personal responsibility “I’m sorry this happened to you” “I'm sorry you are hurt” 3.No Apology

39. Active Listening Demonstrate that you are actively listening – –Use empathic communication skills assume an attentive posture let people speak uninterrupted tolerate silence ask them what they feel – –Provide a summary pts statements

40. Partial vs Full Apologies Three groups were presented with a scenario of an injury due to wrongdoing & offered settlement Three groups were presented with a scenario of an injury due to wrongdoing & offered settlement –The first offer was communicated without apology or comment –the second was communicated with a sympathetic (ie, partial) apology –the third was communicated with an authentic (ie, full) apology multiple trials demonstrated multiple trials demonstrated –a full apology made the offer more acceptable –a partial apology had the opposite effect & was worse than no apology at all

41. Empathy Goal Recognizing & Acknowledging a Patients Emotion Outcome Identify how emotions are expressed Understand our response to these expressions of emotion

42. Acknowledge and Address Acknowledge the patients emotions –“I can tell that you are angry” –“I get the feeling that you are afraid of what will happen next” –“I sense that you are disappointed in me” –“I understand your desire to change physicians and if you would like I will help you find another provider.”

43. Policies on Disclosure Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Joint Commission on Accreditation of Healthcare Organizations (JCAHO) –http://www.jointcommission.org/ American Medical Association American Medical Association –Council on Ethical and Judicial Affairs –http://www.ama-assn.org/ American College of Physicians American College of Physicians –Ethics Manual –http://www.acponline.org/ American College of Emergency Physicians American College of Emergency Physicians –Policy on disclosure of Medical Errors –http://www.acep.org/

44. States with Disclosure Laws Arizona Arizona California California Colorado Colorado Connecticut Connecticut Georgia Georgia Illinois Illinois (awaiting Governor’s signature) (awaiting Governor’s signature) Maryland Maryland Massachusetts Massachusetts Montana Montana North Carolina North Carolina Ohio Ohio Oklahoma Oklahoma Oregon Oregon Texas Texas Virginia Virginia Washington Washington West Virginia West Virginia

45. Emerging Disclosure Concepts Disclosure teams Disclosure teams Extreme disclosure Extreme disclosure –Kentucky; Virginia –Univ. of Michigan 50% reduction claims 50% reduction claims 50% in attorneys fees 50% in attorneys fees

46. “Sorry Works” Coalition Three goals: 1) educate medical malpractice stakeholders about the “Sorry Works” approach to reducing liability costs from medical errors 2) serve as organizer and a central clearinghouse for information, news, ideas, and research on “Sorry Works” and related full-disclosure efforts 3) promote the development of Sorry Works! pilot programs in different states

47. Disclosure & Systems Improvement Errors are the Diamonds of Improvement Errors are the Diamonds of Improvement Open dialog about error events Open dialog about error events –Results in meaningful discussion about care quality at every level –Focuses the institutions commitment to improve commitment to improve –Shifts the culture from “Blame and Shame” to “Blame and Shame” to Patient Centered Patient Centered

48. How do you feel about it? Do you consider an error in care a personal failure as a physician? How will you deal with this topic in your practice?