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

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.

Agenda Topic Speaker Time Introduction, session overview Transparency, safety, and quality: conceptual considerations Gallagher 15 min Transparency and safety culture Thomas Promoting transparency at the institutional level McDonald What now? Innovations to promote transparency at the institutional and national level Boothman Discussion All 30 min

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

(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.

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.

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

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

How transparent are we? Event reporting Disclosure to patient 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

Comparing Patient and Physician Ratings of Disclosure Quality

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

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

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

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? Interprofessional implications 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?

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

Transparency and Safety Culture

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.

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:

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.

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.

Teamwork Climate and BSIs Across Michigan ICUs: “No BSI” is > 5 consecutive months without BSI.   No BSI 21% No BSI 31% No BSI 44% % 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

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

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

Transparency and Safety Culture

Promoting Transparency at the Institutional Level

Condition Predicate to “Transparency”

Condition Predicate to “Transparency” Courage…… and Leadership

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

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

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

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

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

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

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

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

Resident Reporting Must report 5 unsafe conditions or “near misses per year”

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 Catastrophes Gazoni et al. Anesth Analg.2008; 107: 591-600 Hold bills

Power of engaging families in the aftermath of a tragic event

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.

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

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

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

What do patients want? What do patients deserve?

Truthful Explanation

Accountability

Apology and Compensation when warranted

What do caregivers want? What do caregivers deserve?

Truthful Explanation

Reasonable Benchmark against which you judge their actions

Support

What do hospitals want? What do hospitals deserve?

Truthful Explanation

Opportunity to be Accountable

Opportunity to Improve

The very best risk management is to make no medical mistakes The next best is not to make the same mistake again “Deny and defend” and learning from mistakes are mutually exclusive

Institutional Patient Safety Concept Collection Institutional Patient Safety Concept Triage Intervention, Investigation, Stabilization Referral for Action Measurement to Gauge Improvement Educate with Lessons Learned, Facilitate Improvements in Patient Safety, QI

Define “Disclosure” Communicating with patients/families/caregivers Following unanticipated medical outcome And telling them the truth (or as close to it as we can come after the fact)

When an explanation is needed, every day that passes further cements mistaken beliefs When an apology is truly owed, every day that passes results in a new injury

University of Michigan’s Claims Management Principles We will compensate quickly and fairly when inappropriate medical care causes injury. We will defend appropriate care vigorously. We will reduce patient injuries (and claims) by learning from mistakes.

Key Questions: Was the care at issue “reasonable”? Did the care adversely impact the patient’s outcome?

U of M Claims Management Model Assessment and Direction Investigation and Analysis of Risk and Value Medical Committee (3 months after notice) ← Pre Suit → Legal Office Assign to Counsel Litigate Agree to Disagree Engage Patient and Share Information Litigation No Dialogue Settlement Mistake/Injury Claims Committee Settle or Trial? Agree no Claim

Pre Suit Investigation Assessment and Direction Investigation and Analysis of Risk and Value Medical Committee (3 months after notice) Clinical Quality Improvement Peer Review Educational Opportunities

Biggest Barrier: Fear

The University of Michigan has two important advantages: Caregivers are employees of health system/medical school Alignment of culture, ethics, financial consequences Caregivers are insulated from personal financial ruin Still accountable, but freedom from imminent, catastrophic financial consequences enables transparency, adherence to principles, wider and longer view of patient safety imperatives

Fear leads to: Provider/hospital’s abdication of responsibility to ask threshold question: what should my/our response be to this patient’s unanticipated outcome? Fight or flight rules, cedes control over this critical issue to lawyers/courtroom And freezes efforts to improve in deference to the legal system

Ten years from now . . . Information and honesty prevail Incentives and penalties aligned to favor just response to patient and improve patient safety Social safety net for patients so financial ruin is not main impetus for litigation Protection for caregivers so financial ruin is not reason for deny and defend Accountability (peer review), reasonable consequences based on “just culture” algorithm Robust, widespread, compulsory data collection, sharing best practices, lessons learned and measurement of improvement

Litigation must change Last resort (cooling off period, mediation, other ADR) Elimination of opportunistic exploitation of weaknesses (runaway verdicts/caps, early evaluation of merit, affidavits of merit, junk science limits) Favor full disclosure (federal civil procedure trend) Experts are key (Australia’s “hot tubbing”, use of “masters”, elimination of charlatans) Consideration of “health courts”

The truth will set you free. But first, it will piss you off. Gloria Steinem