1. Disclosing Medical Errors: 2008 and Beyond Wendy Levinson, MD Professor of Medicine University of Toronto

2. Goals 1.To describe physicians’ attitudes and experience re disclosure. 2.To describe changing regulatory and legal environment in North America. 3.To anticipate changes over the next five years.

4. Patient Attitudes Regarding Disclosure of Errors Want full information about error: What happened? How? Consequences and management? Prevention of future errors Apology Fear professionals hiding information JAMA 2003

5. Physician Attitudes in US & Canada Survey of 4,500 physicians; 63% response Canada national sample; US Washington and Missouri Content a) attitudes b) sample scenarios c) Impact of errors on physicians Arch Intern Med 2006

6. General Attitudes About Patient Safety Statement % AgreeCountry Difference Specialty Difference “Medical errors are one of the most serious problems in health care.” 64%-- “Medical errors are usually caused by failures of care delivery systems, not the failure individuals.” 50%-* (lower in surgery) “Disclosing a SERIOUS error would make it less likely that the patient would sue me.” 66% agree-* (lower in surgery)

7. General Attitudes About Disclosure Statement % AgreeCountry Difference Specialty Difference “NEAR MISSES should be disclosed to patients.” 35%* (lower in US) * (lower in surgery) “MINOR errors should be disclosed to patients.” 78%-- “SERIOUS errors should be disclosed to patients.” 98%--

8. What Would They Disclose? 42% use the word “error”; 56% “adverse event” 50% provide specific details (13% only if asked) 61% express regret; 31% apologize Few describe future error prevention plans Less likely to disclose information if error is not apparent

9. Disclosure Experiences of Physicians 58% had disclosed a serious error 85% satisfied with most recent disclosure conversation 74% reported a positive effect on the relationship

10. Have Errors Impacted Your Life? ResidentsAttendings Your job satisfaction 34.6%42.1% Your confidence in your ability as a physician 45.4%47.2% Your professional reputation 11.9%12.6% Your anxiety about future errors 64.9%60.5% Your ability to sleep 24.3%40.3%

11. Criteria for Judging Disclosure Explanation of medical facts Honesty and truthfulness Empathy Apology Prevention of future errors JAMA 2003

12. Wrong Side Breast Surgery ● Mrs. Jones is a 48 year old woman on which you performed a left lumpectomy and axillary dissection for a malignant lesion ● The final pathology specimen is benign. You realize that you made a mistake labeling the biopsy specimens and operated on the wrong breast ● You are about to meet with Mrs. Jones two weeks post-operative

13. Surgeons scores on individual items Error caseExplanationHonestyEmpathyPrevention General Communication skills Wrong-side lumpectomy (n=20) 4.154.133.652.304.00 Retained surgical sponge (n=20) 4.203.883.831.754.08 Hyperkalemia- induced arrhythmia (n=20) 3.933.853.582.403.78 Surgery 2005

14. Bottom Line in 2006 Physicians still uncertain of how open to be Worried about malpractice Don’t have specific training High degree in interest in disclosure

15. Development of Standards 2001: Joint Commission standard on disclosure of “unanticipated outcomes” 2006: Harvard Hospitals publish “When Things Go Wrong” 2006: NQF Safe Practice NEJM 2007

16. Key Elements of the Safe Practice Content to be disclosed to patient Provide facts about the event Presence of error or system failure, if known Results of event analysis to support informed decision making by the patient Express regret for unanticipated outcome Give formal apology if unanticipated outcome caused by error or system failure

17. Key Elements of the Safe Practice Institutional requirements Integrate disclosure, patient-safety, and risk management activities Establish disclosure support system Disclosure education Ensure disclosure coaching is available Provide emotional support for health care workers, administrators, patients, and families Use performance-improvement tools to track and enhance disclosure

18. Why is Safe Practice a Big Step Forward? Frames disclosure as a safety and improvement issue Recognizes challenging conversation and provides support Includes expression of apology Encourages performance improvement and tracking

19. Legal Context Standards for disclosure vs. concern about increase in malpractice Legal system designed to assign fault

20. “Apology Laws” 35 states have “Apology Laws” 26 protect expression of remorse 6 remorse plus explanation 4 disclosure plus apology (includes admission of fault) 9 states have laws that mandate disclosure of serious unanticipated outcomes Impact on malpractice? T. Gallagher, personal communication

21. Prominent Disclosure Programs VA (Lexington) U of Michigan – reported decrease in claims and costs COPIC in Colorado

22. Key Elements for COPIC’s 3R’s Program Key Features: Disclosure linked to no-fault compensation for patient’s out-of-pocket expenses (up to $30,000) Disclosure training for physicians Exclusion criteria: death, clear negligence, attorney involvement, complaint to state board, written demand for payment Disclosure coaching for physician and case management for patient provided by 3R’s administrators Payments not reportable to National Practitioner Data Bank

23. Summary 1.Evolving legal environment. 2.Experiments report no impact or a decrease in malpractice claims and costs. 3.Very little evaluation of these new disclosure programs.

25. 2008 and Beyond 1.Training programs for physicians and other health professionals Standardized patients for practice and feedback

26. 2008 and Beyond 2. Institutional supports as outlined in the “Safe Practice”

27. 2008 and Beyond 3. Evidence of Impact Patient safety improvements Process of care Patient satisfaction and trust Malpractice

28. 2008 and Beyond 4. Change in culture over time from blame and shame to transparency and quality improvement

30. References 1.Gallagher TH, Studdert D, Levinson W. Disclosing harmful medical errors to patients: recent developments and future direction. N Engl J Med. 2007 356 (26): 2713-2719. 2.Gallagher TH, Waterman MD, Garbutt JM, Krygiel JM, Chan DK, Dunagan WC, Fraser VJ, Levinson W. United States and Canadian physician’s attitudes and experiences regarding disclosing errors to patients. Arch Intern Med, August 2006;166:1605-11. 3.Gallagher TH, Waterman A, Weikal R, Flum D, Levinson W, Fraser V, Waterman B. Choosing your words carefully: How physicians would disclose harmful medical errors to patients. Arch of Intern Med 2006; 166(15):1585-93. 4.Chan DK, Gallagher TH, Reznick R, Levinson W. How surgeons disclose medical errors to patients: a study using standardized patients. Surgery 2005;138(5):851- 58. 5.Gallagher T, Waterman AD, Ebers AG, Fraser V, Levinson W. Patients’ and Physicians’ Attitudes Regarding the Disclosure of Medical Errors. JAMA 2003;289(8):1001-07.