1. Communicating with Patients After a Medical Injury Myths, Realities, and New Horizons Thomas H. Gallagher, MD Professor of Medicine, Bioethics & Humanities Director, UW Medicine Center for Scholarship in Patient Care Quality and Safety University of Washington

2. Background A decade’s emphasis on disclosing unanticipated outcomes to patients has brought limited change Increasingly disclosure programs being coupled with early efforts at resolution Communicating with patients after unanticipated outcome now recognized as: Institutional responsibility Critical part of quality, not solely risk management

3. What is accountability after medical injury? Healthcare institutions and providers: Recognize that event has occurred Disclose it effectively to the patient Proactively make the patient whole Learn from what happened Discuss the event across colleagues, institutions in a healthcare delivery environment that: Prospectively monitors quality of care Identifies unsafe providers and employs effective remediation Spreads learning across institutions

4. Disclosure and Resolution Program Pioneers Early Settlement Programs University of Michigan UIC Stanford Reimbursement Programs COPIC Coverys West Virginia Mutual Lexington VA

5. Myth “Disclosing unanticipated outcomes to patients, especially those due to error, will cause a malpractice claims Armageddon”

6. Reality University of Michigan (Early settlement model) Since implementing disclosure-with-offer program Claims half as likely, lawsuits 1/3 as likely Time to resolution cut nearly in half Reduced liability costs COPIC (Reimbursement model) 5800 physicians participating 4354 cases opened to date 2678 cases closed with payment

7. Myth “We generally do a good job of disclosing unanticipated outcomes to patients.”

8. There’s no easy way I can tell you this – so I’m sending you to somebody who can…

9. Quality of Actual Disclosures COPIC 3Rs program for disclosure and compensation, 2007-2009 837 Events 445 patient surveys (55% response rate) 705 physician surveys (84% response rate)

10. Patient Assessment Physician Assessment Extremely serious (I might have died) 31%7% Very Serious (permanent injury)25% Somewhat serious (injury that resolved) 28%61% Not at all serious3%6% Event Severity

11. Quality of Disclosure

12. SkillAgree The physician provided a sincere apology to me for this event66% The physician had good listening skills64% The physician was truthful when explaining the event to me63% The physician explained the event using terms I could understand62% I trust this physician’s clinical competence59% The physician told me as much information as I wanted to know about the event 54% The physician told me why the event happened50% The physician told me whether or not the event was preventable, i.e., known complication 44% The physician assured me that steps would be taken to prevent similar events from happening again 37% Patient Rating of Disclosure Skills

13. More Myths: Real and Imagined Barriers to Disclosure Imagined Fear of litigation Misunderstanding of patient preferences Does not know/Would not want to know It would harm patient to know Real Shame/embarrassment/rationalizations Low confidence in communication skills Mixed messages from institution Specialty-specific challenges Radiology, pathology, birth injury, delayed dx

14. Just Culture Principles Errors are inevitable. Errors are opportunities for learning and system improvement. Non punitive reporting of errors is essential for learning. All staff are accountable for their behaviors. Most errors are caused by system problems. Organizational leadership is accountable for developing systems that reduce risk. We are all accountable for correcting system flaws that raise the probability that error will occur.

16. Physicians Insurance A Mutual Company16

17. What is the DRP? Be candid and transparent about unanticipated care outcomes Conduct a rapid investigation, offer a full explanation, and apologize as appropriate Where appropriate, provide for the family’s financial needs without requiring recourse to litigation Build systematic patient safety analysis and improvement into risk management

18. HealthPact DRP Demonstration Motivating question: Can DRP work as well… … outside a closed system? … when multiple insurers are involved? Our Project: Collaboration between PI and 6 Partner organizations on: Event investigation Disclosure to patient Incident resolution, including compensation offer when appropriate 18

19. Goals of the DRP Facilitate communication about unanticipated care outcomes (disclosure and reporting) Attend to the emotional needs of patients, families, and providers Create mechanisms for providers, insurers, and others to collaborate around communication, event analysis, and resolution

20. DRP Partners Physicians Insurance A Mutual Company Providence Sacred Heart Medical Center and Children’s Hospital Providence Regional Medical Center, Everett Providence St. Mary Medical Center The Everett Clinic The PolyClinic The Vancouver Clinic

21. AHRQ Grants with DRP Component StatePI Core DRP componentRelated activities Demonstration Projects ILMcDonald“Seven Pillars” approach at 10 Illinois Hospitals Patient compensation card NYKluger/ Cohn CRP in place at 5 NYC hospitalsEnhance culture, AE reporting Judge-directed negotiation TXThomasDRP in place at 6 UT health campuses Patient engagement in event analysis, resolution Ascension Health HendrichCORE program in place at 6 hospitalsMajor focus on OB safety WAGallagherDRP at 6 institutions, Physicians Insurance A Mutual Company HealthPact-transforming healthcare communication Planning Grants MASandsCreate MA collaborative for DRP implementation Implementation underway using alternate funding. UTGuentherExploring DRP options in UtahCollaborative with Utah stakeholders underway WAGarciaAccelerated Compensation Events

22. DRP Events DRP study events: Unanticipated, adverse outcomes of care (from perspective of patient, provider, or institution) Many unanticipated outcomes are not caused by health care Disease progression, unmet expectations Some unanticipated outcomes may be “adverse events” (harm due to health care) Some adverse events may be associated with care that was not reasonable under the circumstances Effective communication with patients important for all unanticipated outcomes

23. Disclosure and Resolution Program Process Study Event (SE) Care team responds to immediate patient needs and provides information then known Involved staff reports SE to Risk Manager

24. Disclosure and Resolution Program Process Action by Facility Risk Manager Study Event (SE) Initiates QI investigation using Just Culture approach Initiates support services for patient/family Initiates disclosure coaching and other support services for healthcare team Contacts other Partners to explain SE and steps taken and initiates collaboration

25. Disclosure and Resolution Program Process Physicians Insurance Facility Insurer Other Insurer Action by Facility Risk Manager Study Event (SE) Partners collaborate on approach to evaluation and resolution

26. Expedited Care Assessment and Review of Event (CARE) Disclosure and Resolution Program Process Physicians Insurance Facility Insurer Other Insurer Action by Facility Risk Manager Study Event (SE) Partners and involved providers decide on effective approach and timeline for CARE, including internal and/or external expert review to determine: Whether care was reasonable Whether system improvements are needed to prevent recurrence Whether other actions are warranted

27. Joint Approach to Resolution Expedited Care Assessment and Review of Event (CARE) Disclosure and Resolution Program Process Physicians Insurance Facility Insurer Other Insurer Action by Facility Risk Manager Study Event (SE) Partners agree on approach to resolution: What are the patient’s/family’s needs? Will monetary compensation or other remedies be offered? What will be disclosed to patient/family? How will identified system improvements be pursued?

28. Patient/Family Communication Joint Approach to Resolution Expedited Care Assessment and Review of Event (CARE) Disclosure and Resolution Program Process Physicians Insurance Facility Insurer Other Insurer Action by Facility Risk Manager Study Event (SE) Patient/family is notified of findings and approach to resolution: Full explanation of what happened Apology as appropriate Offer of compensation and/or other remedies, or explanation of why no offer is being made Information about any safety improvements

29. DRP: Benefits for Physicians Provider support Engagement from beginning in event analysis, disclosure, resolution Disclosure coaching Improved patient safety Possible reduction in likelihood of being sued, outcome if lawsuit is filed

30. What do we hope to learn? Were Partners able to implement the DRP as envisioned? Did clinicians and patients/families find the DRP helpful and fair? How did the DRP affect the volume and costs of claims? How did the DRP affect the environment for patient safety?

31. DRP metrics MetricsMethods Implementation Leader surveys and interviews Case-level data collection User satisfaction Patient surveys Clinician surveys Liability effects Case-level data collection Pre/post comparison of summary- level data Patient safety effects Safety culture survey Case-level data collection Leader surveys and interviews

32. Implementation study Was the DRP fully implemented and consistently applied? How did structures, policies, and procedures change because of the DRP? What implementation challenges arose? How useful do institutional leaders expect the DRP to be at the outset of implementation? How valuable did they find it by project end?

33. Satisfaction study Patients/family/friends: Information received and how it was conveyed Compensation offered Respectfulness, truthfulness, and caring Time to disposition Fairness of decisions Involved clinicians: How well disclosure conversations went How fair and helpful DRP staff were Fairness of how clinician and patient/family were treated Time to disposition Fairness of decisions Usefulness in avoiding a lawsuit

34. Liability effects study Did the DRP improve liability outcomes for the hospital, including the frequency of claims and lawsuits, indemnity and expense costs, and premiums? Did the DRP achieve faster time to case resolution? Detailed, real-time data collection on new cases Pre/post comparison using 4 years of summary-level, pre-implementation data

35. Patient safety effects study Does the DRP result in identifiable patient safety improvements? Is the DRP (along with other project interventions) associated with improved safety culture? Data from culture surveys, leader interviews, prospective case-level data

36. Myths: The DRP is not: A rush to judgment A rush to settlement Mandatory Telling the patient absolutely everything known about an adverse event Paying patients when care was reasonable Business as usual

37. DRP: Implementation Barriers Reaching consensus on what events qualify for DRP Overcoming mistrust Within healthcare stakeholders MD: Is DRP in my best interest? Why be proactive if claim may never materialize? Malpractice insurers: What cases benefit most from DRP? Healthcare institutions: Is DRP “inviting claims”? Outside healthcare: “fox guarding the hen house” Bandwidth challenges for front-line personnel tasked with DRP implementation Concern from defense attorneys

38. DRP: Scientific Barriers Time horizon problems Small numbers problem Uneven implementation across sites

39. Common questions/concerns from physicians Why does this involve reporting of known complications? Why be proactive if a claim may never materialize? What if the partners don’t agree on how to approach the disclosure/resolution? What if I decline to participate?

40. New Horizons Successful collaborations among diverse stakeholders DRP as mechanism to improve response to injury that triggers less concern about “tort reform” Growing interest in expanding DRP model at state, institutional level Recognition of DRPs potential for significant cost savings for payers