At the Intersection of Health, Health Care and Policy Cite this article as: Ann Hendrich, Christine Kocot McCoy, Jane Gale, Lora Sparkman and Palmira Santos Ascension Health's Demonstration Of Full Disclosure Protocol For Unexpected Events During Labor And Delivery Shows Promise Health Affairs, 33, no.1 (2014):39-45 doi: 10.1377/hlthaff.2013.1009

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Communicating About Errors By Ann Hendrich, Christine Kocot McCoy, Jane Gale, Lora Sparkman, and Palmira Santos 10.1377/hlthaff.2013.1009 HEALTH AFFAIRS 33, NO. 1 (2014): 39–45 ©2014 Project HOPE— The People-to-People Health Foundation, Inc.

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Ascension Health’s Demonstration Of Full Disclosure Protocol For Unexpected Events During Labor And Delivery Shows Promise Communicating openly and honestly with patients and families about unexpected medical events—a policy known as full disclosure— improves outcomes for patients and providers. Although many certification and licensing organizations have declared full disclosure to be imperative, the adoption of and adherence to a full disclosure protocol is not common practice in most clinical settings. We conducted a case study of Ascension Health’s implementation of a full disclosure protocol at five labor and delivery demonstration sites. Twenty-seven months after implementation, the rate of full disclosure had increased by 221 percent. Practitioners saw insurers’ acceptance of the full disclosure protocol, consistent and ongoing leadership by local practitioners and hospitals, the establishment of a well-trained local investigation and disclosure team, and disclosure training for practitioners as key catalysts for change. Lessons learned from this multisite initiative can inform liability insurers and guide providers who are committed to ensuring that full disclosure becomes the only response to unexpected medical events. ABSTRACT

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here is abundant evidence that establishing and implementing a full disclosure protocol, in which practitioners and hospitals communicate honestly and openly with patients and families when unexpected medical events occur, decreases malpractice costs.1 The Joint Commission and many professional societies, including the American Medical Association, have declared the ethical necessity of fully disclosing to the patient or his or her family any unexpected medical event in the hospital or during care provided by the physician.2,3 However, most providers do not fully disclose such events, even though doing so has been shown to lead to positive outcomes for everyone involved— including the patient, family, and providers themselves.4–6 The barriers to establishing a full disclosure protocol include providers’ uneasiness in discussing unexpected events with patients and

Ann Hendrich (AHendrich@ ascensionhealth.org) is senior vice president, Quality and Safety, Patient Safety Organization, at Ascension Health, in St. Louis, Missouri. Christine Kocot McCoy is the senior vice president for legal services and general counsel for Ascension Health. Jane Gale is director of risk management at Ascension Health. Lora Sparkman is a director in clinical excellence at Ascension Health. Palmira Santos is a senior research and policy analyst at the Heller School for Social Policy and Management, Brandeis University, in Waltham, Massachusetts.

families; providers’ fear of being sued, with subsequent increases in malpractice premiums or the termination of malpractice insurance coverage;7,8 and an institutional culture of blame,9 in which faultfinding outweighs the recognition of the complexities of the health care environment. Placing blame on an individual practitioner makes open communication less likely and impedes efforts both to uncover the details of what happened and to devise an appropriate process to prevent a recurrence of the unexpected event that takes human factors into account.10,11 Ascension Health is the largest Catholic and nonprofit health system in the United States.12 In 2006 it introduced a claims management program that promotes the early identification and reporting of unexpected medical events; prompt investigation to determine if the care provided was reasonable; disclosure of the event, with an apology when appropriate; and early resolution in cases of clear liability. J a n u a ry 201 4

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Communicating About Errors The program was implemented across the Ascension Health system in 2007. However, it was not accompanied by standardized systemwide education or the establishment of a formal process to ensure that disclosure occurred in a consistent manner. As a result, the disclosure protocol was not widely adopted, and the system’s culture did not incorporate the recognition that fully disclosing unexpected medical events was required of hospital teams and physicians. Disclosure documentation was rare; the best estimate of the rate of full disclosure systemwide was 10 percent—far below the goal of 100 percent. Ascension Health received a demonstration grant from the Agency for Healthcare Research and Quality in 2010 to test a common disclosure protocol. The specialty of obstetrics—in particular, labor and delivery—is a field with a high risk of medical liability.13 As a result, five hospitals in the Ascension Health system that had labor and delivery units were selected as demonstration sites. During the initial assessment phase we identified a wide variation among the hospitals’ responses to unexpected medical events. Four of the hospitals had disclosure policies in place, and the fifth included a discussion of disclosure in its written patient safety plan. The policies ranged from a brief 129-word statement to a six-page document with a separate two-page appendix. Most followed the language found in the Joint Commission’s accreditation standards but lacked details about how to communicate effectively with patients and families. At three sites, the Risk Management Department provided optional education about disclosure and offered “just in time” coaching for physicians and nurses who were preparing to disclose an unexpected event. Each site had a policy regarding the investigation and management of such events, but responsibility for the initial investigation differed: At two sites the Quality Department led the investigation, while at the other three sites it was the Risk Management Department, sometimes in collaboration with the nursing, physician, and risk management leader, that examined the circumstances leading to an event. Organizationally, Ascension Health follows a “distributive leadership” model, meaning that individual hospitals have independent boards of directors and clinical leadership. This gives them autonomous decision-making authority within the purview of the system’s mission and vision. Variations in policy, protocol, and practice were therefore common. However, the degree of variation across hospitals and the lack of documented outcomes required the development of standard guidelines 40

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for responses to and disclosures of unexpected medical events. These guidelines had to account for the differences across facilities and to ensure that the key elements of an effective full disclosure protocol would be incorporated into day-today operations and become part of the mind-set of all practitioners. This article presents a case study concerning challenges, including physician resistance, to the establishment of a common full disclosure protocol at five labor and delivery demonstration sites. The lessons learned can inform liability insurers and guide providers who are committed to ensuring that full disclosure becomes the primary response to unexpected medical events.

Study Data And Methods The case study captured the experience and perspectives of labor and delivery physicians, midwives, and nurses concerning the full disclosure of unexpected events to patients and their families, and the changes in the documented disclosure rate over time. Five labor and delivery sites in different states and parts of the country began the implementation of a full disclosure protocol on April 1, 2011. These sites were selected based on their geographic diversity, claims history, use of employed or nonemployed physicians, and differences in case-mix. Data were gathered from labor and delivery physicians, midwives, nurses, and risk managers. Of the targeted participants, 873 (96 percent) had implemented the new disclosure protocol at the five demonstration sites during the first three months of the study period, when we first contacted them. We also contacted the participants fifteen and twenty-seven months after implementation. We collected information about participants’ experiences in communicating and documenting unexpected events through interviews and observations. We then measured the rate of disclosing unexpected events to determine if any changes in disclosure practice had occurred after implementation of the new protocol.

The Disclosure Protocol To create the full disclosure protocol, the labor and delivery providers and risk managers at the five demonstration sites first reviewed malpractice claims trend data and then reached consensus on which types of events to report, investigate, and disclose. As part of this effort, a list of unexpected events during labor and delivery (Exhibit 1), called trigger events, was developed to indicate occurrences that had the highest likelihood of malpractice risk.

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Exhibit 1 Labor And Delivery Trigger Events Trigger event Apgar score of 3 or less at 5 minutes Any Apgar score recorded at 10 minutes Cord blood gas pH less than 7.0 Shoulder dystocia with injury (Erb’s palsy) present at discharge Intrauterine fetal demise at 32 weeks or more gestation when the mother was evaluated and discharged within the previous 24 hours Unexpected death of an infant at more than 24 weeks gestation, without anomalies, within 48 hours of birth (if there is doubt about the presence of anomalies, report the death) Unplanned transfer to neonatal intensive care unit for meconium aspiration, full body cooling, seizure, Group B streptococcal septicemia Any other unexpected neurological injury to an infant at birth Infant abduction

SOURCE Ascension Health Event and Disclosure Protocol 2010.

Next, Ascension Health worked with the five demonstration sites to develop a standardized protocol for investigation, analysis, and disclosure communications. The protocol had two central focuses: immediate reporting of unexpected events, investigation and causal analysis, and documentation; and having staff, as a team, fully disclose unexpected events to the patient and his or her family, both when the event occurred and after the investigation. To address the first central focus of the new disclosure protocol, an Obstetrics Event Response Team was created at each site. The response team members were recommended by their peers. The core team included an obstetrician, an obstetrics nurse manager, a risk manager, a neonatologist, and a medical coder. As warranted, other clinicians with specific expertise depending on the nature of the unexpected event were added to the core response team. A one-day workshop was conducted for the response team at each of the five sites on the use of analytic tools to identify the apparent and actual causes of unexpected events. Following the training, the teams became accountable for the following duties: immediate identification and reporting of any event that resulted in patient harm; expedited investigation of the event; prompt, transparent, and ongoing disclosure; early resolution of events involving probable liability; and using lessons learned from the event to improve patient care. To address the second central focus of the disclosure protocol, the obstetrician, obstetrics nurse manager, and risk manager from all five sites were trained to be disclosure coaches by a master trainer from the Institute for Healthcare Communication in an intensive training course lasting a day and a half. The participants learned effective techniques for communicating with pa-

tients and families in the three situations described below, with language appropriate for each situation. In the first situation, the cause of the unexpected event is not yet known. Participants practiced expressing empathy and telling the patient: “We are sorry that this event occurred and want you to know that it is being reviewed carefully to determine the cause. As soon as this assessment is completed, we will meet with you to let you know the findings.” In the second situation, the medical care was determined to be appropriate, and the outcome was not preventable. Participants again practiced expressing empathy and then fully explaining what had occurred and why it was not preventable: “Again, we are very sorry that this event has occurred.We have completed the review, and the event was not preventable for the following reasons.” In the third situation, the care was determined to be inappropriate, and the outcome could have been prevented: Practitioners practiced saying how sorry they were and outlining steps for compensation: “We are very sorry that our actions led to this very disappointing outcome. We would like to explain what happened and what changes we have made so this won’t happen again.We will work with you to try to make you whole and earn back your trust.” In addition, members of the five teams learned how to coach and support practitioners at their facilities when they were faced with completing a disclosure communication in any of the above three categories. All of the labor and delivery clinicians at the five sites were asked to attend a training program offered by the Institute for Healthcare Communication, called Disclosing Unanticipated Medical Outcomes.14 These educational sessions typically January 2014

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Communicating About Errors lasted for one to two hours and introduced the three communication models described above, covering the key elements for each type of communication. Team members completed both the cause analysis and disclosure training programs between January and March 2011. The rollout of the new full disclosure protocol began April 1, 2011.

Placing blame on an individual practitioner makes open communication less likely.

Key Strategies And Challenges Before the protocol rollout, all sites conducted meetings to introduce it, including the role of the new Obstetrics Event Response Teams and the need for fully coordinated disclosure communications with patients and family members when an unexpected event occurred. The meetings included presentations of the evidence that disclosure does not increase malpractice claims and discussions of the benefits of open communication for the patient, family, practitioner, and care team. During this early phase of outlining the benefits and expectations involved in the full disclosure protocol, our interviews with clinicians revealed consistent resistance. Many physicians affiliated with but not employed by Ascension Health believed that their malpractice insurance carriers would not support a model of full disclosure of unexpected events. Even with a strong emphasis on teams working together as the best deterrent of unexpected outcomes, physicians continued to express concerns that they would be the primary targets for blame, especially for preventable occurrences. In fact, physicians at some sites reported that they could not use the protocol because their insurance carriers did not support it. As we learned, this lack of physician participation can be the greatest challenge for health systems attempting to establish a full disclosure protocol.15 It is true that some malpractice insurance companies do not support physicians’ participation in disclosure initiatives. To address this barrier, Ascension Health collaborated with ProAssurance, the fourth-largest writer of medical liability insurance in America. As a result of this collaboration, Ascension and ProAssurance created Certitude, an insurance program for physicians affiliated with Ascension Health hospitals. One strategy of the Certitude program is to align hospitals’ and physicians’ efforts to establish full disclosure initiatives that improve patient outcomes and decrease malpractice liability. Physicians covered under the Certitude program at one of the demonstration sites were eligible for a premium credit for completing the cause analysis and disclosure trainings and three 42

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other trainings specific to obstetric emergencies. Certitude was not available at the other four sites. However, ProAssurance offered the obstetricians it insured at one other demonstration site a similar premium credit for completing the required trainings. Commercially insured physicians at the other three sites were encouraged to work with their carriers and apply for any premium credits or discounts offered for certified medical education programs in risk management or ethics. Physicians at two sites received subsequent premium credits and reported that having their malpractice carriers endorse the full disclosure protocol enabled and encouraged them to participate. As implementation of the protocol progressed, physicians, midwives, and nurses identified several key strategies used to overcome their initial resistance. For example, clinical leaders continued to focus on the goal of implementing the full disclosure protocol. The obstetrician, obstetrics nurse manager, and risk manager at each site displayed and shared with their respective departments the percentages of doctors and nurses who had completed each of the training elements. They also shared specific rates of full disclosure, including the number of occurrences requiring full disclosure and the number of fully documented disclosures completed. Personal influence and peer pressure became factors in urging the labor and delivery practitioners to participate in the disclosure training and protocol implementation. In addition, once they had attended the disclosure training or participated in a full disclosure communication, they reported to peers and others that the training helped them find the appropriate words to discuss unexpected events with patients and families. The training did not make it easier to present bad news, especially when an error had occurred, the practitioners noted. But they felt that it offered them a way to integrate their feelings about the occurrence through an honest account to patients and family members. Many practitioners shared with other practi-

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As participants came to embrace the protocol, the rate of documented disclosures increased.

tioners and interviewers for this case study their feelings of relief that they were able to communicate truthfully and that a team was working on a fair and just resolution in cases where the unexpected event had been preventable. The protocol’s framework helped practitioners find words to express empathy and, if an inappropriate variation in practice had occurred, to offer an apology that included specific details about the variation. Another strategy identified by practitioners as useful in reducing their resistance to the protocol was involving a “champion”—a locally respected obstetrician—to provide leadership, support, and encouragement during the process of implementing the protocol. This person could increase the motivation among other physicians to use the protocol and gently erode practitioners’ resistance and fear. The role and style of the Obstetrics Event Response Teams were also recognized as key factors during the implementation. The teams responded immediately to trigger events, offering support and advice to physicians and clinical teams about investigations and cause analyses. They also worked with practitioners to develop a coordinated full disclosure plan and ensure timely documentation of the disclosure discussion. Participants at the demonstration sites reported that physician leadership and an objective, thoughtful, team-based coordinated response to trigger events were the strongest remedies to practitioner resistance to the disclosure protocol. Physicians and midwives also reported that coordinated efforts between hospitals’ and the providers’ professional liability insurers was vital and that this alignment had allowed them to participate in the program. Physicians and midwives who received premium credits were more likely to participate in the disclosure training than those who did not (93 percent versus 73 percent). Practitioners who received premium credits valued this incentive and also identified the local champion and the team approach to disclo-

sure as the greatest influences on their day-today investment in the full disclosure protocol.

Implementation Results When we contacted participants twelve months after the full disclosure protocol was implemented, 43 percent expressed full support for the protocol. At twenty-seven months after implementation, 77 percent of all labor and delivery physicians, midwives, and nurses gave the protocol their full support. As participants came to embrace the protocol, the rate of documented disclosures increased. Three months after the protocol’s implementation, the rate was 24 percent. Fifteen months after, it was 41 percent; twenty-seven months after, it was 53 percent. In other words, twenty-seven months after implementing the full disclosure protocol, the rate of documented disclosures had increased by an average of 221 percent across the demonstration sites. It is also worth noting that 86 percent of the documented disclosure communications with a patient and family were initiated by the practitioner who delivered the baby. Only three communications (less than 1 percent) were initiated by the patient or family. Practitioners’ rate of participation in training was clearly influenced by the malpractice premium credit. However, the rate of documented disclosures was not affected by the availability of the credit. In fact, one of the sites where physicians had received premium credits had the lowest rate of improvement in documented disclosures. In contrast, one site that did not offer premium credits achieved an 88 percent disclosure rate twenty-seven months after implementation. This site reported that a newly hired risk manager who was committed to full disclosure continually reminded practitioners of the protocol, addressed their concerns, and coordinated the protocol. This demonstrates the need for an ongoing process that reminds practitioners of the expectations related to full disclosure and helps them meet those expectations. Similarly, twenty-seven months after implementation, practitioners at each site said that another key factor was having local physician and organizational leaders set a clear and consistent expectation of full disclosure. This case study had several limitations. One was that we interviewed only a few patients and their families about their experiences with the full disclosure protocol. All of the people we contacted were very positive about the honesty and resolution process. However, input from more patients and families is required to fully understand their perspective. January 2014

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Communicating About Errors A second limitation is that it is too soon to assess the impact of full disclosure on malpractice insurance rates and legal costs. Although hospitals’ and physicians’ legal expenses did decrease during the twenty-seven-month study period, additional data are needed.

Conclusion Enabling full and honest communication with patients and families when unexpected medical events occur must be central to any considerations of liability insurance reform. Providers face substantial barriers to establishing a full disclosure protocol, even though such a protocol can improve outcomes for both patients and providers. This case study suggests approaches that practitioners and hospitals could use to implement a protocol. It also provides three important lessons. First, the goals of liability insurers and of hospitals and providers may be contradictory. Aligning them would likely encourage and enable providers to participate in full disclosure models. Convincing insurers to support full disclosure was ranked by providers at all five demonstration sites as the best strategy to address practitioners’ resistance. Ascension Health worked closely to reach agreement with liability insurers about the impact of a full disclosure protocol on their insurance contracts with providers. Nonetheless, there were physicians at three of the demonstration sites whose malpractice insurers did not support their using the protocol. The active involvement of all liability insurers would remove this important barrier to making full disclosure the norm instead of the exception. Second, administrative and clinical leaders must adopt an easily understood protocol and make clear their expectation that full disclosure will occur for all unexpected events. Practitioners viewed consistent communication from leaders as necessary for decreasing and eventually eliminating the practice of not communicating fully and honestly with patients and families. In addition to that consistent communication, two infrastructure elements emerged as key to any successful disclosure initiative. Hospitals or health systems implementing a full disclosure protocol should devise a system for rapid reporting of unexpected medical events. They should also establish a trained investigation team that would immediately be notified of a trigger event, initiate an investigation and cause analysis, and coordinate the disclosure plan. These two features were not components of Ascension Health’s earlier efforts. However, because of the experience in the disclosure case study, they 44

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The active involvement of all liability insurers would remove an important barrier to making full disclosure the norm.

are now viewed by Ascension’s leadership as being essential for success. Third, training the Obstetrics Events Response Teams, ensuring that each site has disclosure coaches, and providing brief training sessions for all practitioners are necessary components of implementing a disclosure protocol. Practitioners appreciated having opportunities to practice what to say to patients about unexpected events. They found the brief trainings to be useful and practical. The training of the investigation team members as well as designated people who take the lead for response and disclosure ensured that the protocol was consistently followed and also gave support and guidance to practitioners. These leaders were not included in Ascension’s initial effort in 2007. However, creating their positions and providing brief practitioner trainings allowed clinicians to develop the skills and confidence they needed in their communications with patients and families. Ascension now sees requiring practitioners to receive uniform training in reporting, investigating, and coordinating disclosure as essential to reaching the goal of full disclosure for all unexpected medical events. The literature1–3 supports full disclosure protocols as a central element in improving both patient and provider outcomes when an unexpected event occurs, and an overwhelming majority of certification and licensing organizations demand full disclosure. The consistent use of disclosure enables the analysis and documentation of unexpected events and provides opportunities to develop prevention strategies that ultimately improve patient care. With these strong reasons for change, policy makers, practitioners, and providers must commit to eliminating obstacles to full disclosure. Open and honest communication with patients and their families is essential. ▪

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The Agency for Healthcare Research and Quality (AHRQ) provided grant funding for the demonstration study (Grant No. 1R18 HS19608-01). The content of this article represents the opinion of the authors and does not necessarily represent the opinion of AHRQ.

NOTES 1 Kachalia A, Kaufman SR, Boothman R, Anderson S, Welch K, Saint S, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010;153(4):213–21. 2 Joint Commission. Comprehensive accreditation manual for hospitals: the official handbook. Oakbrook Terrace (IL): Joint Commission; 2010. 3 American Medical Association. Code of medical ethics of the American Medical Association: Council on Ethical and Judicial Affairs current opinions with annotations. 2010– 2011 ed. Chicago (IL): AMA; 2010. Patient information. p. 280–3. 4 Helmchen L, Richards MR, McDonald TB. How does routine disclosure of medical error affect patients’ propensity to sue and their assessment of provider quality? Evidence from survey data. Med Care. 2010;48(11):955–61. 5 López L, Weissman JS, Schneider EC, Weingart SN, Cohen AP, Epstein AM. Disclosure of hospital adverse events and its association with patients’ ratings of the quality of care. Arch Intern Med. 2009;169(20):1888–94. 6 Agency for Healthcare Research and

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Quality. 2012 User Comparative Database Report [Internet]. Rockville (MD): AHRQ; 2012 Jan [cited 2013 Nov 15]. Available from: http:// www.ahrq.gov/professionals/ quality-patient-safety/patientsafety culture/hospital/2012/index.html Gallagher T, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289(8):1001–7. Mazor KM, Simon SR, Gurwitz JH. Communicating with patients about medical errors: a review of the literature. Arch Intern Med. 2004; 164:1690–7. Khatri N, Brown GD, Hicks LL. From a blame culture to a just culture in health care. Health Care Manage Rev. 2009;34(4):312–22. Pettker CM, Funai EF. Getting it right when things go wrong. JAMA. 2010;303(10):977–8. Sammer CE, Lykens K, Singh KP, Mains DA, Lackan NA. What is patient safety culture? A review of the literature. J Nurs Scholarsh. 2010; 42(2):156–65. Ascension Health Alliance. A great hope in common: Ascension Health Alliance annual report 2012 [Inter-

net]. St. Louis (MO): Ascension Health; [cited 2013 Nov 15]. Available from: http://www.ascension health.org/annualreport/pdf/2012_ AHA_AnnualReport.pdf 13 Klagholz J, Strunk AL. Overview of the 2012 ACOG Survey on Professional Liability [Internet]. Washington (DC): American Congress of Obstetricians and Gynecologists; [cited 2013 Nov 15]. Available from: https://www.acog.org/About_ ACOG/ACOG_Districts/District_ II/~/media/Departments/ Professional%20Liability/2012PL SurveyNational.pdf 14 Institute for Healthcare Communication. Disclosing unanticipated medical outcomes [Internet]. New Haven (CT): The Institute; [cited 2013 Nov 18]. Available from: http:// healthcarecomm.org/training/ faculty-courses/disclosingunanticipated-outcomes-andmedical-errors/ 15 Kaldjian LC, Jones EW, Rosenthal GE. Facilitating and impeding factors for physicians’ error disclosure: a structured literature review. Jt Comm J Qual Patient Saf. 2006; 32(4):188–98.

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Ascension health's demonstration of full disclosure protocol for unexpected events during labor and delivery shows promise.

Communicating openly and honestly with patients and families about unexpected medical events-a policy known as full disclosure-improves outcomes for p...
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