When words and actions matter most: The Case for CANDOR

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January 20, 2017 When words and actions matter most: The Case for CANDOR Timothy B McDonald, MD Director, Center for Open and Honest Communication in Healthcare MedStar Health, Institute for Quality and Safety, Washington DC Professor, Loyola University School of Law, Chicago Beazley Institute for Health Law and Policy 1

No conflicts January 20, 2017 2

Objectives By the end of the presentation the participants will be able to: 1. List the benefits of a comprehensive response to patient harm that includes open and honest communication. 2. Describe the importance of a proactive "care for the caregiver" program in maintaining staff engagement and wellness. 3. Understand the benefits that accrue from a Just Culture and Human Factors based approach to unexpected patient harm events. January 20, 2017 3

Goals of a Communication and Optimal Resolution [CANDOR] Process Reduce harm thru transparency and learning Reduce legal involvement through early, effective communication with all parties Resolve inappropriate care cases early, efficiently Support patient and family engagement Support care professionals following harm events

Malizzo Family Video 5

The path from 1982 to the Malizzo family January 20, 2017 6

Overview of Patient Safety April 22, 1982 ABC 20/20 show: The Deep Sleep 6,000 will die or suffer brain damage from carelessness

Overview of Patient Safety April 22, 1982 ABC 20/20 show: The Deep Sleep 6,000 will die or suffer brain damage from carelessness

Overview of Patient Safety and Anesthesiology April, 1982 ABC 20/20 show: The Deep Sleep 6,000 will die or suffer brain damage from carelessness 1983 ASA Committee on Patient Safety and Risk Management created closed claims analysis 1984 Anesthesia Patient Safety Foundation

Overview of Patient Safety and Anesthesiology Following the Human Factors Analysis of Harm Events along with closed-claims analysis and the redesign of care delivery 1982 to the present:

Overview of Patient Safety and Anesthesiology Following the Human Factors Analysis of Harm Events 1986 New Monitoring Standards Initiated Anesthesia Mortality Risk 1982-1:2000 2012 1:400,000 Substantial reduction in patients and families seeking legal action

Overview of Patient Safety and Anesthesiology Following the Human Factors Analysis of Harm Events 1986 New Monitoring Standards Initiated Anesthesia Mortality Risk 1982-1:2000 2012 1:400,000 Substantial reduction in patients and families seeking legal action Why?

Institute of Medicine: 1999 report that started the patient safety movement

The Problem: restated Makary and Daniel BMJ 2016; 352:i2139

Making matters worse

Part of the patient safety problem February 2012, Volume 31, Issue 2

Legal community perception of Health Affairs article

Until 2003 we had a sturdy wall of silence COO of sister hospital Came to the University for plastic surgery Abnormal WBC count missed January 20, 2017 19

Until 2003 we had a sturdy wall of silence COO of sister hospital Came to the University for plastic surgery Abnormal WBC count missed She dies 6 weeks after surgery from leukemia We said nothing to fiance or other family members January 20, 2017 20

Until 2003 we had a sturdy wall of silence COO of sister hospital Came to the University for plastic surgery Abnormal WBC count missed She dies 6 weeks after surgery from leukemia We said nothing to fiance or other family members We litigated for years, paid millions, learned little January 20, 2017 21

What about Candor, Professionalism and Safe Culture? Barriers Benefits

What about CANDOR Barriers Lack of skill Loss of job Reputation Shame and blame Loss of control Loss of license, deportation Fear of lawyers, legal system Non standard process Money Benefits Maintain trust Learn from mistakes Improve patient safety Employee morale Psychological well-being Accountability Money Less legal involvement

So, how did we shatter the wall of silence?

2005 Leaders at the University approved: Comprehensive communication- resolution program to prevent and respond to harm a CANDOR process Created urgency Comprehensive with leadership and stakeholder buy-in Integrate safety, risk, quality, credentialing, claims and the Office of Business and Finance Linking transparency to learning: patient safety education plan Agreement to shift the paradigm for response to harm Started small Celebrated wins Continuous Rapid Process Improvement

Changes needed to our response to harm in 1999 26

Paradigm Shift Traditional Response Communication and Optimal Resolution (CANDOR ) Process Incident reporting by clinicians Communication with patient, family Event analysis Delayed, often absent Deny/defend Physician, nurse are root cause Immediate Transparent, ongoing Focus on Just Culture, system, human factors Quality improvement Provider training Drive value through system solutions, disseminated learning Financial resolution Only if family prevails on a malpractice claim Proactively address patient/family needs Care for the caregivers None Offered immediately Patient, family involvement Little to none Extensive and ongoing Introduction 6

When words and actions matter most pillar 3 - communication January 20, 2017 29

When words and actions matter most step three communication with patients and families AND with clinicians involved in event January 20, 2017 30

Empathic communication

Care for the caregiver January 20, 2017 32

When words and actions matter most step five - learning and improving January 20, 2017 33

Need for CFC program MP Steigler, JAMA, 2015;313(4): 361 62. The well being of physicians is directly tied to the well being of their patients 34 Communication

Care for the caregiver West CP, Hushchka MM, Novotny, PJ et al. Association of Perceived Medical Errors With Resident Distress and Empathy. A Prospective Longitudinal Study. JAMA. 2006; 296:1071-1078; January 20, 2017 35

Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study Self-perceived medical errors are common among internal medicine residents and are associated with substantial personal distress. Personal distress and decreased empathy are associated with increased odds of future errors reciprocal cycle.

Safety Attitudes The single greatest impediment to error prevention in the medical industry is that we punish people for making mistakes. --Dr. Lucian Leape, Professor, Harvard School of Public Health Testimony to congress Fallibility is part of the human condition. We cannot change the human condition. But we can change the conditions under which people work 37 --James Reason, Ph.D. Communication

When words and actions matter most final step - resolution January 20, 2017

Resolution beyond money

Process improvements following Michelle s case Immediate change in anesthesia coverage from complex sedation cases. Instituted use of capnography for all applicable sedation cases. Worked with the American Society of Anesthesiologists to establish capnography as a new standard for sedation cases. Worked with Accreditation organizations such as The Joint Commission to build capnography into the accreditation standards.

13 years of data

Proof of concept 42

Premiums over time 45

Balance in self-insurance fund 46

Other critical data Statistically significant reduction in tests associated with defensive medicine Time to resolution reduced more than 60% Care for caregiver impact is significant 47

AHRQ Research Grants

AHRQ Research Grants Agency for Healthcare Research and Quality Task Order to create a CANDOR Toolkit Toolkit released, May, 2016 Organizational assessment tools Event reporting Event analysis HF and process redesign Communication training Care for the Caregiver program implementation guide Optimal Resolution tools Patient and Family Partnership and Engagement

The Communication and Optimal Resolution: CANDOR Process The CANDOR Process consists of five major bundles of activity that proceed in sequence and at times simultaneously. Introduction 7

Work with Kettering Communication workshop Jan 18,19 Event analysis, cognitive interviewing, PI Feb Resolution March Putting it all together - April January 20, 2017 51

Questions 52