Clinical Incidents, Disclosure and Risk

1. The HNEH Quality Exposition and Scientific Program 10-11 September 2009 Clinical Incidents, Disclosure and Risk Rick Iedema Professor of Organisational Communication Executive Director, Centre for Health Communication University of Technology Sydney SYDNEY 2007 NSW Australia

2. Main issues • How many clinical incidents occur (of what severity)? • How many of these incidents are disclosed? • How are disclosures experienced by patients and families? • What are the risks?

3. Three gaps • The gap between incident occurrences and organisational notification • will the incident be properly acknowledged? • The gap between incident occurrences and the disclosure of incidents • will under-notification minimise the patient’s chance of disclosure? • The gap between how different people experience disclosure • why are disclosures experienced as generally less satisfactory for patients than for clinicians?

4. Terminology:Adverse event, Error, Incident Adverse events (undesirable outcomes) Clinical errors (undesirable actions) ‘Preventable’ AEs (involving harm) ‘Near misses’ (undesirable actions intercepted) unexpected, unforeseen & unplanned clinical outcomes, complications, ‘known risks’ Latent (systems) problems (undesirable actions at one or more removes from the clinical present)

5. Determining adverse event rates • Medical record analyses • Harvard Medical practice Study 1991 • Wilson et al 1995 • Incident Reporting • Australian Incident Monitoring System (AIMS) • Improved Incident Monitoring System (IIMS) • Observational Studies • Participant observation (clinicians self-notate) • Non-participant observation (outsider notation) • Interview Studies • Ask clinicians • Ask patients • Routine data collections; Complaint/Coronial investigations … Thomas, E. J., & Petersen, L. A. (2003). Measuring errors and adverse events in health care. Journal for General Internal Medicine, 18(61-67).

6. Medical record analyses: agreement? "the reliance on information extracted from medical records most likely led to a substantial underestimate of the prevalence of injury.“ Leape, L. (2000). Institute of Medicine Medical Error Figures Are Not Exaggerated. Journal of the American Medical Association, 284(1), 95. “the probability that the error actually caused the death was often considered to be low; reviewer assessment of errors had poor reliability and was usually skewed; and the underlying short-term prognosis of the person who died was often judged to be very limited.” Hayward, R. A., & Hofer, T. P. (2001). Estimating Hospital Deaths Due to Medical Errors: Preventability Is in the Eye of the Reviewer. Journal of the American Medical Association, 286(4), 415-420.

7. Asking patients about incidents Weissman, J. S., Schneider, E. C., Weingart, S. N., Epstein, A. M., David-Kasdan, J., Feibelmann, S., et al. (2008). Comparing Patient-Reported Hospital Adverse Events with Medical Record Review: Do Patients Know Something That Hospitals Do Not? Annals of Internal Medicine, 149(2), 100-108. “Among 998 study patients, 23% had at least 1 adverse event detected by an interview and 11% had at least 1 adverse event identified by record review. Record review identified 11 serious, preventable events (1.1% of patients). Interviews identified an additional 21 serious and preventable events that were not documented in the medical record.”

8. Incident reporting analyses ± 2600 /yr Clinical Excellence Commission (2007) Analysis of first year of IIMS Data: Annual Report 2005–2006. Sydney, NSW Health.

9. Incidents per year ± 2800 /yr Clinical Excellence Commission (2009). Incident Management in the NSW Public Health System - January to June 2008. Sydney: Clinical Excellence Commission.

10. Incident reporting: behind the scenes • ‘A nurse mentions that she has been “blacklisted” on a ward after making an IIMS report about an incident. A doctor later explains to me that the patient involved was not really harmed in any way, but would have been inconvenienced. During the discussion with the other clinicians, the nurse clarifies that, from her perspective, the incident reflected a lack of vigilance on the part of nurses on duty. When I asked what she meant by being blacklisted, she explains that the staff on the other ward “weren’t very happy that I reported it”, and that they did not believe that the incident should have been reported. When I asked about the senior nurse’s perspective, the nurse said, “She wasn’t very supportive, no. [But] you look after your staff, which is fine.”’ Hor, S., Iedema, R., Williams, K., White, L., Day, A., & Kennedy, P. (forthcoming). Electronic Incident Reporting: A study of formal and informal accountabilities. Qualitative Health Research.

11. “Estimates of the incidence of adverse events in hospitals vary widely and measurement is difficult” Department of Health and Human Services - Office of Inspector General. (2008). Adverse event s in hospitals: overview of key issues. Dallas: Department of Health and Human Services. [http://oig.hhs.gov/oei/reports/oei-06-07-00470.pdf]

13. [2] Incident disclosure ‘Open Disclosure’ policy aims to: “promote a clear and consistent approach by hospitals (and other organisations where appropriate) to open communication with patients and their nominated support person following an adverse event.” Australian Council for Safety and Quality in Health Care (2003). Open Disclosure Standard: a national standard for open communication in public and private hospitals following an adverse event in health care. Canberra: Commonwealth of Australia.

14. Four elements of Open Disclosure “1. an expression of regret, 2. a factual explanation of what happened, 3. the potential consequences, and 4. the steps being taken to manage the event and prevent recurrence.” Australian Council for Safety and Quality in Health Care (2003). Open Disclosure Standard: a national standard for open communication in public and private hospitals following an adverse event in health care. Canberra: Commonwealth of Australia.

15. Disclose incidents – why?

16. Disclosing adverse events: drivers • Publication of health care failures and errors • Medical practice studies (cf. Institute of Medicine 1999, 2001, 2003) • ‘Scandals’ (Bristol, King Edward, Cam/Cam, RNSH) • Cost of litigation (Vines 2005) • Health services, insurance companies and indemnity organisations seeking to minimise the (financial) impact of litigation • Positive outcomes • Montreal/VA Lexington’s ‘experiment’ – ‘tell the patient/family the truth’ (Kraman & Hamm 1999) • Univ Michigan Open Disclosure (Boothman et al 2009) • COPIC • Pressure mounted by consumer groups [e.g.]

17. Open Disclosure impact (USA) • Univ Michigan full OD – since ‘99 • claims fell from 136 to 61 • litigation costs fell from $3 million to $1 million • Time to closure from 20 to 9.5 months • COPIC • $30,000 ex gratia cap • ‘00-’05 drop in malpractice claims = 50% • settlement costs drop 25% Boothman, R., Blackwell, A. C., Campbell, D. A., Commiskey, E., & Anderson, S. (2009). A better approach to medical malpractice claims? The University of Michigan Experience. Journal of Health and Life Sciences Law, 2(2), 125-159.

18. Open DisclosureDevelopments in Australia 2003 publication of the Australian Open Disclosure Standard 2006-2007 Australian Open Disclosure Pilot in 41 sites 2007-2008 Evaluation of the Aust. Open Disclosure Pilot May 2008 - Australian Health Ministers Conference formally endorses Open Disclosure charges ACSQHC with furthering research into consumers’ expectations with regard to Open Disclosure (‘100 patient stories project’)

19. How many incidents are disclosed? Garling, P. (2008). Final report of the Commission of Inquiry: Acute Care Services in NSW Public Hospitals. Sydney: State of NSW. (Vol II, p 559, section 15.214) “There is obviously a tension between open disclosure and the desire of clinicians and hospitals to protect themselves from criticism, disciplinary action or litigation. The evidence I heard suggested open disclosure is observed about half of the time”.

20. NSW Open Disclosure performance data (CEC)

21. NSW Open Disclosure performance data (CEC) cont’d

22. Would you disclose this incident? Insulin overdose scenario You have admitted a diabetic patient to the hospital for a COPD exacerbation. You handwrite an order for the patient to receive “10 U” of insulin. The “U” in your order looks like a zero. The following morning the patient is given 100 units of insulin, ten times the patient’s normal dose, and is later found unresponsive with a blood sugar level of 35. The patient is resuscitated and transferred to the intensive care unit. You expect the patient to make a full recovery. Gallagher, T. H. (2009). Disclosing Harmful Errors to Patients: Recent Developments and Future Directions. Open Disclosure Seminar. University of Technology Sydney.

24. Dialogue US Medicine Canadian Medicine 1% 1% • Your blood sugar went too low and you passed out. Your blood sugar went too low because you received more insulin than you needed. 28% 21% Your blood sugar went too low because an error happened and you received too much insulin. 71% 78% “What would you most likely say about what happened?” From: Gallagher, T. H. (2009). Disclosing Harmful Errors to Patients: Recent Developments and Future Directions. Open Disclosure Symposium. University of Technology Sydney.

25. Dialogue US Medicine Canadian Medicine I would not volunteer that I was sorry or apologize. 3% 3% I am sorry about what happened. 54% 48% I am so sorry that you were harmed by this error. 43% 49% “Would you apologise?” From: Gallagher, T. H. (2009). Disclosing Harmful Errors to Patients: Recent Developments and Future Directions. Open Disclosure Symposium. University of Technology Sydney.

26. [3] How are disclosures experienced? Comparing Patient and Physician Ratings of Disclosure Quality From: Gallagher, T. H. (2009). Disclosing Harmful Errors to Patients: Recent Developments and Future Directions. Open Disclosure Symposium. University of Technology Sydney.

27. The ‘disclosure gap’ Garling, P. (2008). Final report of the Commission of Inquiry: Acute Care Services in NSW Public Hospitals. Sydney: State of NSW. (Vol II, p 560. Section 15.219) There is “a difference between ‘disclosure’ and ‘transparency’. It is one thing to say you made an error. It is another to fully open up and share and get down in the dirt, so to speak, and allow the patients and the families to really see what went on”.

28. How are disclosures experienced?

29. [4] Disclosure and risk The ‘disclosure risk analysis model’: • Severity of the mistake • Degree of responsibility • Intensity of self-blame • Technical culpability • Level of patient’s (family’s) anger • Threat of a lawsuit • Potential job loss • Possible damage to professional reputation Hannawa, A. (2009). Negotiating medical virtues: Toward the development of a physician mistake disclosure model. Health Communication, 24(2009), 391-399.

30. Hannawa, A. (2009). Negotiating medical virtues: Toward the development of a physician mistake disclosure model. Health Communication, 24(2009), 391-399.

31. [4] Disclosureand risk

32. Disclosure and risk (cont’d) Iedema, R., Sorensen, R., & Gallagher, T. H. (in preparation). What prevents the disclosure of clinical incidents? Sydney: Centre for Health Communication, UTS

33. Bridging the disclosure gap • Training • communication / awareness training • Supporting • how can we make staff more comfortable with disclosing incidents? • debriefing / trust: ‘what would you have done?’ • consistency in how individuals & incidents are handled • Taking a moral stance • Reinforcing • cultural change: ‘disclosure is part of what we do’ • legal reform: ‘making apologies less risky’

34. When will risk management encompass disclosure? • The incident is personally, professionally and organisationally acknowledged • The clinician intending to disclose has the support of their colleagues, their management, the health department, and the insurance organisation(s) • The patient is involved in an initial discussion to prepare them for disclosure • The disclosure meetings are appropriately formal, respectful and culturally sensitive • The clinician(s) / organisation are able to offer comprehensive explanations for complex clinical-organisational processes and patient trajectories • The patient is recognised to have family members who may need support too • The organisation is able to offer ex gratia support • The disclosure process reaches closure when the patient/family is ready for closure • The organisation appropriately records disclosure details • The practice improvement process has a place for the patient tobe involved

35. Selected references Iedema, R., Jorm, C., Wakefield, J., Ryan, C., & Dunn, S. (2009). Practising Open Disclosure: Clinical Incident Communication and Systems Improvement. Sociology of Health & Illness, 31(2 (March)), 262-277. Iedema, R., Jorm, C., Wakefield, J., Ryan, C., & Sorensen, R. (2009). A New Structure of Attention? Open Disclosure of adverse events to patients and families. Journal of Language & Social Psychology, 139-157. Iedema, R., Mallock, N., Sorensen, R., Manias, E., Tuckett, A., Williams, A., Perrott, B., Brownhill, S., Piper, D., Hor, S., Hegney, D., Scheeres, H., & Jorm, C. (2008). The National Open Disclosure Pilot: Evaluation of a Policy Implementation Initiative. Medical Journal of Australia, 188(2008), 397-400. Iedema, R., Sorensen, R., Manias, E., Tuckett, A., Piper, D., Mallock, N., Williams, A., & Jorm, C. (2008). Patients’ and family members’ experiences of Open Disclosure following adverse events. International Journal for Quality in Health Care, 20(6), 421-432. Piper, D., Iedema, R., & Sorensen, R. (2008). Open Disclosure and Legal Reform: Legal Issues Raised by Clinicians in the National Open Disclosure Pilot Evaluation. Sydney: University of Technology Sydney, Centre for Health Communication. Sorensen, R., Iedema, R., Piper, D., Manias, E., & Tuckett, A. (2008). Health care professionals’ views of implementing a policy of open disclosure errors. Journal of Health Services Research & Policy. 13(4): 2008: 227–232.

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