At the Intersection of Health, Health Care and Policy Cite this article as: Jason M. Etchegaray, Madelene J. Ottosen, Landrus Burress, William M. Sage, Sigall K. Bell, Thomas H. Gallagher and Eric J. Thomas Structuring Patient And Family Involvement In Medical Error Event Disclosure And Analysis Health Affairs, 33, no.1 (2014):46-52 doi: 10.1377/hlthaff.2013.0831
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Health Affairs is published monthly by Project HOPE at 7500 Old Georgetown Road, Suite 600, Bethesda, MD 20814-6133. Copyright © 2014 by Project HOPE - The People-to-People Health Foundation. As provided by United States copyright law (Title 17, U.S. Code), no part of Health Affairs may be reproduced, displayed, or transmitted in any form or by any means, electronic or mechanical, including photocopying or by information storage or retrieval systems, without prior written permission from the Publisher. All rights reserved.
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Communicating About Errors
10.1377/hlthaff.2013.0831 HEALTH AFFAIRS 33, NO. 1 (2014): 46–52 ©2014 Project HOPE— The People-to-People Health Foundation, Inc.
doi:
By Jason M. Etchegaray, Madelene J. Ottosen, Landrus Burress, William M. Sage, Sigall K. Bell, Thomas H. Gallagher, and Eric J. Thomas
Structuring Patient And Family Involvement In Medical Error Event Disclosure And Analysis
Jason M. Etchegaray (jason [email protected]) is an assistant professor of internal medicine at the University of Texas Medical School at Houston and a member of the University of Texas at Houston—Memorial Hermann Center for Healthcare Quality and Safety.
The study of adverse event disclosure has typically focused on the words that are said to the patient and family members after an event. But there is also growing interest in determining how patients and their families can be involved in the analysis of the adverse events that harmed them. We conducted a two-phase study to understand whether patients and families who have experienced an adverse event should be involved in the postevent analysis following the disclosure of a medical error. We first conducted twenty-eight interviews with patients, family members, clinicians, and administrators to determine the extent to which patients and family members are included in event analysis processes and to learn how their experiences might be improved. Then we reviewed our interview findings with patients and health care experts at a one-day national conference in October 2011. After evaluating the findings, conference participants concluded that increasing the involvement of patients and their families in the event analysis process was desirable but needed to be structured in a patient-centered way to be successful. We conclude by describing when and how information from patients might be incorporated into the event analysis process and by offering recommendations on how this might be accomplished. ABSTRACT
Madelene J. Ottosen is a program manager for research at the University of Texas Medical School at Houston and a member of the Memorial Hermann Center for Healthcare Quality and Safety. Landrus Burress is a research associate at the University of Texas Medical School at Houston and a member of the Memorial Hermann Center for Healthcare Quality and Safety. William M. Sage is the James R. Dougherty Chair for Faculty Excellence, University of Texas School of Law, in Austin. Sigall K. Bell is an assistant professor of medicine in the Division of General Medicine and Primary Care, Harvard Medical School, in Boston, Massachusetts. Thomas H. Gallagher is a professor in the Departments of Medicine and of Bioethics and Humanities, University of Washington School of Medicine, in Seattle. Eric J. Thomas (eric.thomas@ uth.tmc.edu) is a professor of internal medicine and associate dean for health care quality at the University of Texas Medical School at Houston and director of the Memorial Hermann Center for Healthcare Quality and Safety.
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nvolving patients as active participants in their health care has been shown to improve patient satisfaction, health care quality, and patient safety.1 Patients and families who have experienced an unexpected adverse event that resulted in harm or required further treatment could play an integral role in improving future patient safety,2,3 specifically by being active participants in a disclosure process, the event analysis process, or both. For example, patients and families might have information about an error that is unknown to the hospital and that could be useful in analyzing the event and preventing similar events in the future.4 For more than a decade, experts have recognized the potential benefits of involving patients in patient safety.5 However, many questions remain about how best to involve them.
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Research shows that patients and family members can accurately identify errors and provide information not often found in medical records because they may have been present during the event, have witnessed the whole continuum of care, or be able to provide a unique viewpoint on what happened.2,6–8 Yet with few exceptions,9 patients and family members are not typically asked to provide information or to interpret an adverse event. In addition, they may not have access to any type of reporting system through which they could provide details about the event.2 Of course, some patients do not have any information to share about an event. However, they should be asked about what happened as an indication of respect. Traditionally, health care institutions such as
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hospitals and health care systems aspire to communicate with patients and families transparently after an adverse event (in other words, to have full disclosure), while investigating what happened in a parallel but separate process (the event analysis). One way that hospitals could involve patients in patient safety efforts is to include them in an event analysis process, such as a root cause analysis. Root cause analyses are typically conducted by an investigative team to identify the underlying reasons for an error and to determine what can be done to prevent similar errors in the future.10 Involving patients and family members in this analysis could help their healing process.11,12 Other potential benefits include reducing the patient’s isolation, reducing the patient’s and clinician’s sense of blame, helping reestablish trust between the patient and the provider, and giving the provider information that only the patient and his or her family can provide.12–14 However, involving patients and family members in a root cause analysis could have unintended negative consequences. For example, the patient could experience psychological harm: feeling intimidated, having the grieving process intensified, and developing a heightened awareness of the possibility of future errors. In addition, providers could incur legal risks, staff members could experience discomfort, and the root cause analysis could be hindered because staff members were unwilling to share important information in the presence of the patient.12–14 Little is known about how a patient going through the disclosure process might participate in an event analysis. Effective disclosure is a multistep process that involves several discussions with the patient and that should go beyond mere words: It should also include actions taken by hospitals to prevent similar errors.15 Hospitals have a duty to learn about what happened from multiple perspectives, including those of patients and families. Because patients typically want to understand the event, receive an apology, hear an acknowledgment of responsibility, and know that the hospital is making changes based on what it learned from the event, there is an opportunity to explore the potential links between the disclosure and event analysis processes. In 2010 we received a grant from the Agency for Healthcare Research and Quality to determine how to make disclosure a process that will not only serve the needs of individual patients, but will also take greater advantage of patients’ experiences to help hospitals change their systems and improve safety. We conducted a twophase project to better understand whether and
how to involve in the event analysis process patients and family members who were going through disclosure. In the first phase we conducted interviews with key informants to determine how patients and family members were already included in the event analysis process and to obtain insights into how to improve their experience. In the second phase we convened a national conference of key stakeholders to determine how best to involve patients and family members as partners in the event analysis process.
Study Data And Methods The Interviewees We conducted interviews with twenty-eight parties: five patients and four family members who reported that they or a loved one had experienced an adverse event while in a hospital, six clinicians who had been involved in an adverse event, and thirteen hospital administrators who had responsibility for patient safety and quality. The clinicians included practicing physicians, nurse practitioners, and nurses; the administrators included chief medical officers, risk managers, and directors of quality and patient safety. No two subjects had been involved in the same event. Patients and family members were identified through Consumers Union, which has a database of patients who have experienced adverse events. Clinicians and administrators were identified and recruited by risk managers at six hospitals owned by or affiliated with the University of Texas. All participants provided informed consent.We obtained approval from the Institutional Review Board of the University of Texas Health Science Center at Houston before we conducted the interviews. The Interview Process A qualitative methods expert helped our research team create two sets of interview questions, one for patients and family members and the second for clinicians and administrators. The interviews were conducted from September 2010 to October 2011 at six University of Texas institutions16 by graduate students who received training in conducting interviews. The interviews were conducted either face-to-face or via telephone. All interviews were recorded and transcribed. Four research team members reviewed the interviews, focusing on the following questions: What is the current event analysis process used in hospitals, and what would the ideal process be? And what is the best way to incorporate patients and family members into the process? The four team members individually identified themes based on these questions and reached consensus about which themes to retain. J A N U A RY 2 0 1 4
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Communicating About Errors Limitations This study has several limitations. One is the relatively small number of people and institutions involved, with most people being affiliated with a single academic institution—the University of Texas System. As a result, our findings may have limited generalizability. Another limitation is that the patients we interviewed had not experienced errors at the same hospitals where the interviewed administrators and clinicians worked. Thus, we were not able to determine whether the experiences of patients, providers, and administrators from the same hospital were consistent or not.
Study Results We report key findings from the interview transcripts based on type of interviewee (administrators/clinicians versus patients/family members) and two main questions we sought to answer: What is the current and ideal event analysis process used in hospitals, and what is the best way to incorporate patients and family members in the event analysis process? Current And Ideal Event Analysis Processes The administrators and clinicians we interviewed supported the current best practices for analyzing events. For example, they agreed that analyses should include the clinicians involved in the event and that the analysis process should begin soon after the event occurred. In addition, they endorsed the goals of improving the transparency of the event analysis process and the safety culture of the hospital. They also noted that patients and family members are typically not included in investigations or analyses of events at their institutions. The patients and family members we interviewed had not been involved in the analysis of the event they had experienced. However, they believed that patients and families should be included in such analyses. They recommended conducting the event analysis soon after the event had occurred. And they believed that hospitals should give patients and families information about what changes will be implemented to prevent similar errors from happening in the future. Including Patients And Families In Event Analyses Although the administrators and clinicians said that patients and families were not typically included in the event analysis process, many thought it would be a good idea to include them. The administrators and clinicians suggested listening to comments or suggestions about processes from patients and families and asking them to write a narrative of the event they experienced. The administrators and clinicians also supported involving patients as members of 48
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Despite general support for including patients and family members, administrators and clinicians were not sure how best to do so.
the health care team, specifically by having them act as safety advocates to help prevent events like the ones they experienced from occurring in the future. As one interviewee put it, “[Patients] know our systems probably better than we know our systems because they have been through them so much.” Said another, “I think the whole investigation process is incomplete when you don’t involve [patients].” Despite general support for including patients and family members in the event analysis process, administrators and clinicians were not sure how best to do so. Some thought that patients and family members could suggest needed changes. However, a few thought that patients and family members might not be able to provide useful information because of their lack of familiarity with hospital processes or technical terms. Patients and family members thought that administrators and clinicians should ask for their input because they might have unique information about the patient’s history, normal behavior, or usual condition or they might have observed something about the event that clinicians missed. Key Stakeholder Conference: Participants And Objective We shared the information we had obtained from these key informant interviews at a conference attended by twentyfive participants—five risk managers or hospital administrators; three nurse clinicians; three patient safety experts; three patients; one frontline clinician; and ten members of the multidisciplinary research team, who collectively had expertise in patient safety, legal issues, error disclosure, nursing, statistics or psychometrics, and qualitative analysis. The conference was held in October 2011 in Houston, Texas.
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Participants felt that patients and families could offer a unique perspective on norms and quality of care that would otherwise be lost.
The primary objective of the conference was to describe the potential benefits and risks of involving patients and families in the event analysis process after disclosing an adverse event to them. The conference began with an overview of published information about involving patients and families in learning from hospital errors after an event.We also presented common themes and issues identified from the interviews that offered similar considerations. We divided participants into four breakout groups, with a balanced mix of stakeholder roles in each group. A facilitator and a transcriber (both members of the research team) were assigned to each group to encourage discussion and capture recommendations. Then the groups reconvened, and members of each group presented a synopsis of the salient points made in their discussion and possible approaches for including patients and families in learning after an event. Content analysis was conducted on these data to identify common themes and recommendations for including patients and families in postevent learning. Findings From The Conference Three main themes emerged from the conference: defining stakeholder needs, contextual factors, and considerations about involving patients and families in the event analysis process. These themes are depicted in Appendix Exhibit 1.17 Conference participants emphasized that establishing the needs of two central groups of stakeholders—patients and clinicians—in the postevent period is an important first step in defining workable ways to learn from events. Patients’ needs were identified as including time with family members to process the event; time to heal, while communicating openly with clinicians; the ability to talk freely about their concerns and fears with an objective listener; the ability to ask questions about the event and re-
ceive answers in nontechnical language; and an apology. The clinicians’ needs that were identified included a safe environment away from the patient, where the event could be discussed without blame or fear of litigation; the time, confidence, and skills to effectively communicate with patients and families after an event; and emotional support to help them process their feelings about the event. Participants emphasized how important it is for the hospital to have ongoing communication with and support for both patients and clinicians, especially if the patient continues to receive care at the hospital after an event. Conference participants identified several contextual factors that might affect the inclusion of patients and families in event analyses. These factors were strong organizational leadership that supported involving patients and families, sensitivity about involving them based on the event’s severity (for example, whether it was a close call or death), and culture change emphasizing increased transparency and partnership with patients. Participants viewed patients’ lack of comprehensive understanding of workflow processes (such as those in the operating room or pharmacy) and possible lack of awareness of the event as potential limitations to involving patients and families in event analyses. Nonetheless, participants felt that patients and families could offer a unique perspective on norms and quality of care that would otherwise be lost during an analysis. Conference participants recommended that patients and family members be interviewed by a member of the hospital staff to determine what knowledge they have about the event. Participants also viewed fear of legal action as a barrier to involving patients and families in event analyses. They underscored the need to examine laws relevant to quality improvement privilege—that is, the ability of a hospital to claim such privilege when investigating an event so that it cannot be used in a court of law—and legal protections before considering how to best involve patients and families following an unanticipated adverse event. Conference participants also suggested the need to clearly define the role of the patient and family member in the event analysis process. They framed participation by patients and families in this process as a partnership in learning, with no sense of pressure or responsibility to provide missing information. They also advocated sharing with patients and family members the results from the process once they are available. Participants wrestled with the question of whether inclusion in the event analysis was the best way to involve patients and families in postJ A N U A RY 201 4
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Communicating About Errors event learning. Some patients might not be comfortable with the fact that the institution initially does not know why an event occurred; they may want to be included in discussions only when the institution can provide an explanation of the event. Some participants suggested that patients and families might prefer other approaches to inclusion in the event analysis process, such as participating in safety training programs for clinicians at the institution. These participants thought that increased flexibility could be achieved by providing patients and families with an outline of the institution’s process for learning from an event and offering them an opportunity to select which, if any, activities and level of involvement they felt comfortable with. One group at the conference explored the question of whether patients should analyze their own event or another event—perhaps a similar event experienced by another patient, referred to as a “proxy patient.” Several distinct approaches emerged from this discussion.When patients and families are involved in analyzing their own event, they have a voice during the analysis process, and the process becomes transparent to them. However, they and their providers might be uncomfortable speaking up in front of each other. Alternatively, patients and family members could serve on patient safety committees, such as a patient-family advisory council, which could involve both patients who had experienced a medical error and those who had not. If instead of the injured patient, patients and family members from advisory councils were involved in the event analysis process, the participants might be more comfortable communicating with each other. A disadvantage of this approach is that the actual patient is not present to provide his or her perspective on the relevant adverse event. Regardless of the type of involvement, conference attendees recommended a graduated approach, because it takes time to develop and nurture an institutional culture of transparency and openness—including partnering with patients— and to routinely train clinicians about these new ways of interacting with patients and families. Finally, conference participants discussed how the degree of harm in an event might affect the participation of the patient and family in postevent learning. Most participants agreed that events resulting in high levels of harm should be the primary focus of a program for patient and family input. Most also agreed that it would be helpful to involve patients and families in less formal ways when they experience close calls or events that caused no harm or a 50
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Involving patients has great potential to both meet their needs and improve the quality and safety of health care.
low degree of harm. In addition, participants felt that events resulting in fatalities were a unique case that would require particular sensitivity to the family’s grieving process.
Policy Implications We collected a wide range of perspectives on how best to include in the event analysis process patients and family members who are participating in the disclosure process. The interviews revealed that many administrators and clinicians did not ask patients or family members for input about the event or include them in their current practices of event analysis. However, administrators and clinicians generally supported involving patients and family members in analysis processes and offered various suggestions for doing so. The three main themes from the key stakeholder conference were defining stakeholders’ needs, contextual factors, and considerations for involving patients and family members in the event analysis process. Conference participants supported involving patients in event analyses but stressed the importance of considering the needs of patients, family members, and clinicians and the timing and method of involving them. For example, patients might not feel comfortable participating in a formal root cause analysis meeting. If that were the case, their input could be obtained in a less intimidating setting, such as a one-on-one interview. Similarly, some clinicians may need opportunities to discuss the causes of an event without the patient or family members’ being present. Participants also believed that the organizational culture of the hospital, driven by the leadership, needed to be reformed for this degree of transparency. Exhibit 1 presents key issues and our recommendations for involving patients and families in event analysis. Our work is novel in three main ways. First, we
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Exhibit 1 Issues Related To Involving Patients And Families In Adverse Event Analysis And Recommendations For Addressing The Issues Issue
Recommendations
Determining whether patients and families know enough about how hospitals function to provide valuable information about an event
Do not make assumptions about what patients know; interview patients and families to learn about the event
Determining how to include patients and families, given issues related to quality improvement (QI) privilege—that is, the ability of a health care institution to claim such privilege when investigating an event so that it cannot be used in a court of law—and legal protections
The health care institution and its attorneys need to determine whether patient involvement in an analysis voids QI privilege Institutional leaders must encourage patients’ involvement in protected or privileged processes Health care personnel should be educated about the legal protections to encourage open discussions in the appropriate settings Consider the degree of the patient’s or family members’ physical and emotional distress and tailor the timing and content of communications and activities accordingly
Understanding how to balance patient and family input with their distress, given the event’s level of harm Identifying the best way to involve patients and families in postevent learning
Give patients and families an advocate not affiliated with the hospital Understand patients’ and families’ expectations about involvement, including how to keep communication open without fearing legal implications Provide different ways for patients to provide feedback depending upon their preferences (for example, one-on-one interviews, group meetings, and written feedback)
SOURCE Authors’ analysis of results from key stakeholder conference, Houston, Texas, October 2011.
obtained the perspectives of various stakeholders, including patients and family members, about the disclosure process through in-depth interviews. Second, previous literature on involving patients in adverse event analysis represents mostly informed opinion,13 but the recommendations in our study stem from data we collected from key stakeholders, including patients. Third, experts at a conference reviewed the data from our interviews to formulate issues and recommendations for involving patients in the event analysis process (Exhibit 1). Two key findings are that there is unlikely to be a “one size fits all” approach and that understanding patients’ preferences will require much additional work. Appendix Exhibit 217 illustrates steps involved in the event analysis process and the disclosure process. Although this exhibit simplifies the nuances in both processes, we include it as a starting point to illustrate how information from these two processes can lead to synergistic effects. Several opportunities exist for using information from the disclosure process to inform the event analysis process and vice versa. The first opportunity for patients and families to inform the event analysis is during or soon after the initial disclosure conversation. If patients are asked for their input this early, it is likely that they will still recall details of the event and that their input can be used to guide the initial data gathering for the event analysis. However, at this
time the patient and family members may be too physically or emotionally harmed to participate, and other issues such as further medical care may be more important. Organizations that want to engage patients at this early stage should consider using a patient advocate to facilitate the conversations with patients. The second opportunity is during a follow-up disclosure conversation. This may coincide with a later phase of event analysis, such as a formal root cause analysis meeting. At this time the organization has more information to share with patients, patients may be more physically and emotionally prepared to share their perspectives, and they may be better informed after talking with family members who know about the event. Patients’ input at this stage could still be included in the event analysis before conclusions are made. However, it is possible that early conclusions about the cause of the event have been reached, and it may be hard to change them even with new information from the patient. Also, at this time a hospital’s assessment of legal risk may lead its administrators to avoid involving the patient or family members. The third opportunity for patients’ experiences to inform an event analysis is after conclusions have been reached about the causes of the event and while changes are being made. At this time the hospital can provide the patient and family members with a clear understanding of what happened and what changes will be made and can ask for feedback about the adequacy of JANUARY 2014
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Communicating About Errors the proposed changes. However, it may be too late at this stage for patient input to be used to change care processes, and patients and families may resent being asked for input so late in the process. Finally, during all stages, caregivers, administrators, and quality improvement professionals should offer choices about when patients and families can provide input and how—for example, through interviews, surveys, or meetings.
Conclusion
involve in an event analysis process patients and families who are going through a disclosure process after an adverse event. We encourage hospitals to build on our results by involving patients in their analyses while making disclosure a meaningful process that provides the information that patients seek. Many questions remain unanswered about the best approach for hospitals to use. However, it is clear that involving patients has great potential to both meet their needs and improve the quality and safety of health care. ▪
Our findings provide insights into how best to This project was funded by an R18 award from the Agency for Healthcare Research and Quality (R18-HS01956101). Sigall Bell is a consultant for the CRICO/Risk Management Foundation of the Harvard Medical Institutions. The authors acknowledge the assistance of Michal Tamuz, State University of New
York Downstate School of Public Health, in creating interview questions and training interviewers. The authors also acknowledge the participation in the key stakeholder conference of Monique Allen, Geri Amori, James Battles, Scott Baumann, Pamela Berens, Dan Ford, Steve Hartranft, Jeffrey Katz, Mark
Kirschbaum, Kathy Masters, Kathleen Mazor, Armando Nahum, Renee Reimer, Susan Ridgely, Rebecca Shaw, Debora Simmons, Crystal Stafford, Karla Stuebing, Catherine Thompson, and Dori Upton.
NOTES 1 Sage WM. Putting the patient in patient safety: linking patient complaints and malpractice risk. JAMA. 2002;287(22):3003–5. 2 Millman EA, Pronovost PJ, Makary MA, Wu AW. Patient-assisted incident reporting: including the patient in patient safety. J Patient Saf. 2011; 7(2):106–8. 3 Weingart SN, Pagovich O, Sands DZ, Li JM, Aronson MD, Davis RB, et al. What can hospitalized patients tell us about adverse events? Learning from patient-reported incidents. J Gen Intern Med. 2005;20(9):830–6. 4 Iedema R, Allen S, Britton K, Gallagher TH. What do patients and relatives know about problems and failures in care? BMJ Qual Saf. 2012;21(3):198–205. 5 Vincent CA, Coulter A. Patient safety: what about the patient? Qual Saf Health Care. 2002;11(1):76–80. 6 Zhu J, Stuver SO, Epstein AM, Schneider EC, Weissman JS, Weingart SN. Can we rely on patients’ reports of adverse events? Med Care. 2011;49(10):948–55. 7 Weissman JS, Schneider EC, Weingart SN, Epstein AM, DavidKasdan J, Feibelmann S, et al. Comparing patient-reported hospital
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adverse events with medical record review: do patients know something that hospitals do not? Ann Intern Med. 2008;149(2):100–8. Surbone AS, Rowe M, Gallagher TH. Confronting medical errors in oncology and disclosing them to cancer patients. J Clin Oncol. 2007;25(12): 1463–7. McDonald TB, Helmchen LA, Smith KM, Centomani N, Gunderson A, Mayer D, et al. Responding to patient safety incidents: the “seven pillars.” Qual Saf Health Care. 2010;19(6):e11. Lyons M. Should patients have a role in patient safety? A safety engineering view. Qual Saf Health Care. 2007;16(2):140–2. Ghinassi F. Root cause analysis [Internet]. Pittsburgh (PA): University of Pittsburgh; 2009 [cited 2013 Nov 27]. Available from: http://www .nasmhpd.org/docs/publications/ docs/2009/HospitalCEOToolkit/ 8_7.pdf Institute for Safe Medication Practices. Benefits and risks of including patients on RCA teams [Internet]. Horsham (PA): ISMP; 2008 Jun 5 [cited 2013 Nov 19]. Available from: http://www.ismp.org/
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newsletters/acutecare/articles/ 20080605_2.asp Zimmerman TM, Amori G. Including patients in root cause and system failure analysis: legal and psychological implications. J Healthc Risk Manag. 2007;27(2):27–34. Hall J, Peat M, Birks Y, Golder S, PIPS Group, Entwistle V, et al. Effectiveness of interventions designed to promote patient involvement to enhance safety: a systematic review. Qual Saf Health Care. 2010;19(5):e10. Mazor KM, Greene SM, Roblin D, Lemay CA, Firneno CL, Calvi J, et al. More than words: patients’ views on apology and disclosure when things go wrong in cancer care. Patient Educ Couns. 2013;90(3):341–6. The institutions were the University of Texas (UT) Health Science Center at Houston Medical School, UT Medical Branch at Galveston, UT Southwestern Medical Center at Dallas, UT School of Medicine at San Antonio, UT M.D. Anderson Cancer Center, and UT Health Science Center at Tyler. To access the Appendix, click on the Appendix link in the box to the right of the article online.
The online version of this article, along with updated information and services, is available at: http://content.healthaffairs.org/content/33/1/46.full.html
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Health Affairs is published monthly by Project HOPE at 7500 Old Georgetown Road, Suite 600, Bethesda, MD 20814-6133. Copyright © 2014 by Project HOPE - The People-to-People Health Foundation. As provided by United States copyright law (Title 17, U.S. Code), no part of Health Affairs may be reproduced, displayed, or transmitted in any form or by any means, electronic or mechanical, including photocopying or by information storage or retrieval systems, without prior written permission from the Publisher. All rights reserved.
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Communicating About Errors
10.1377/hlthaff.2013.0831 HEALTH AFFAIRS 33, NO. 1 (2014): 46–52 ©2014 Project HOPE— The People-to-People Health Foundation, Inc.
doi:
By Jason M. Etchegaray, Madelene J. Ottosen, Landrus Burress, William M. Sage, Sigall K. Bell, Thomas H. Gallagher, and Eric J. Thomas
Structuring Patient And Family Involvement In Medical Error Event Disclosure And Analysis
Jason M. Etchegaray (jason [email protected]) is an assistant professor of internal medicine at the University of Texas Medical School at Houston and a member of the University of Texas at Houston—Memorial Hermann Center for Healthcare Quality and Safety.
The study of adverse event disclosure has typically focused on the words that are said to the patient and family members after an event. But there is also growing interest in determining how patients and their families can be involved in the analysis of the adverse events that harmed them. We conducted a two-phase study to understand whether patients and families who have experienced an adverse event should be involved in the postevent analysis following the disclosure of a medical error. We first conducted twenty-eight interviews with patients, family members, clinicians, and administrators to determine the extent to which patients and family members are included in event analysis processes and to learn how their experiences might be improved. Then we reviewed our interview findings with patients and health care experts at a one-day national conference in October 2011. After evaluating the findings, conference participants concluded that increasing the involvement of patients and their families in the event analysis process was desirable but needed to be structured in a patient-centered way to be successful. We conclude by describing when and how information from patients might be incorporated into the event analysis process and by offering recommendations on how this might be accomplished. ABSTRACT
Madelene J. Ottosen is a program manager for research at the University of Texas Medical School at Houston and a member of the Memorial Hermann Center for Healthcare Quality and Safety. Landrus Burress is a research associate at the University of Texas Medical School at Houston and a member of the Memorial Hermann Center for Healthcare Quality and Safety. William M. Sage is the James R. Dougherty Chair for Faculty Excellence, University of Texas School of Law, in Austin. Sigall K. Bell is an assistant professor of medicine in the Division of General Medicine and Primary Care, Harvard Medical School, in Boston, Massachusetts. Thomas H. Gallagher is a professor in the Departments of Medicine and of Bioethics and Humanities, University of Washington School of Medicine, in Seattle. Eric J. Thomas (eric.thomas@ uth.tmc.edu) is a professor of internal medicine and associate dean for health care quality at the University of Texas Medical School at Houston and director of the Memorial Hermann Center for Healthcare Quality and Safety.
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nvolving patients as active participants in their health care has been shown to improve patient satisfaction, health care quality, and patient safety.1 Patients and families who have experienced an unexpected adverse event that resulted in harm or required further treatment could play an integral role in improving future patient safety,2,3 specifically by being active participants in a disclosure process, the event analysis process, or both. For example, patients and families might have information about an error that is unknown to the hospital and that could be useful in analyzing the event and preventing similar events in the future.4 For more than a decade, experts have recognized the potential benefits of involving patients in patient safety.5 However, many questions remain about how best to involve them.
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Research shows that patients and family members can accurately identify errors and provide information not often found in medical records because they may have been present during the event, have witnessed the whole continuum of care, or be able to provide a unique viewpoint on what happened.2,6–8 Yet with few exceptions,9 patients and family members are not typically asked to provide information or to interpret an adverse event. In addition, they may not have access to any type of reporting system through which they could provide details about the event.2 Of course, some patients do not have any information to share about an event. However, they should be asked about what happened as an indication of respect. Traditionally, health care institutions such as
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hospitals and health care systems aspire to communicate with patients and families transparently after an adverse event (in other words, to have full disclosure), while investigating what happened in a parallel but separate process (the event analysis). One way that hospitals could involve patients in patient safety efforts is to include them in an event analysis process, such as a root cause analysis. Root cause analyses are typically conducted by an investigative team to identify the underlying reasons for an error and to determine what can be done to prevent similar errors in the future.10 Involving patients and family members in this analysis could help their healing process.11,12 Other potential benefits include reducing the patient’s isolation, reducing the patient’s and clinician’s sense of blame, helping reestablish trust between the patient and the provider, and giving the provider information that only the patient and his or her family can provide.12–14 However, involving patients and family members in a root cause analysis could have unintended negative consequences. For example, the patient could experience psychological harm: feeling intimidated, having the grieving process intensified, and developing a heightened awareness of the possibility of future errors. In addition, providers could incur legal risks, staff members could experience discomfort, and the root cause analysis could be hindered because staff members were unwilling to share important information in the presence of the patient.12–14 Little is known about how a patient going through the disclosure process might participate in an event analysis. Effective disclosure is a multistep process that involves several discussions with the patient and that should go beyond mere words: It should also include actions taken by hospitals to prevent similar errors.15 Hospitals have a duty to learn about what happened from multiple perspectives, including those of patients and families. Because patients typically want to understand the event, receive an apology, hear an acknowledgment of responsibility, and know that the hospital is making changes based on what it learned from the event, there is an opportunity to explore the potential links between the disclosure and event analysis processes. In 2010 we received a grant from the Agency for Healthcare Research and Quality to determine how to make disclosure a process that will not only serve the needs of individual patients, but will also take greater advantage of patients’ experiences to help hospitals change their systems and improve safety. We conducted a twophase project to better understand whether and
how to involve in the event analysis process patients and family members who were going through disclosure. In the first phase we conducted interviews with key informants to determine how patients and family members were already included in the event analysis process and to obtain insights into how to improve their experience. In the second phase we convened a national conference of key stakeholders to determine how best to involve patients and family members as partners in the event analysis process.
Study Data And Methods The Interviewees We conducted interviews with twenty-eight parties: five patients and four family members who reported that they or a loved one had experienced an adverse event while in a hospital, six clinicians who had been involved in an adverse event, and thirteen hospital administrators who had responsibility for patient safety and quality. The clinicians included practicing physicians, nurse practitioners, and nurses; the administrators included chief medical officers, risk managers, and directors of quality and patient safety. No two subjects had been involved in the same event. Patients and family members were identified through Consumers Union, which has a database of patients who have experienced adverse events. Clinicians and administrators were identified and recruited by risk managers at six hospitals owned by or affiliated with the University of Texas. All participants provided informed consent.We obtained approval from the Institutional Review Board of the University of Texas Health Science Center at Houston before we conducted the interviews. The Interview Process A qualitative methods expert helped our research team create two sets of interview questions, one for patients and family members and the second for clinicians and administrators. The interviews were conducted from September 2010 to October 2011 at six University of Texas institutions16 by graduate students who received training in conducting interviews. The interviews were conducted either face-to-face or via telephone. All interviews were recorded and transcribed. Four research team members reviewed the interviews, focusing on the following questions: What is the current event analysis process used in hospitals, and what would the ideal process be? And what is the best way to incorporate patients and family members into the process? The four team members individually identified themes based on these questions and reached consensus about which themes to retain. J A N U A RY 2 0 1 4
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Communicating About Errors Limitations This study has several limitations. One is the relatively small number of people and institutions involved, with most people being affiliated with a single academic institution—the University of Texas System. As a result, our findings may have limited generalizability. Another limitation is that the patients we interviewed had not experienced errors at the same hospitals where the interviewed administrators and clinicians worked. Thus, we were not able to determine whether the experiences of patients, providers, and administrators from the same hospital were consistent or not.
Study Results We report key findings from the interview transcripts based on type of interviewee (administrators/clinicians versus patients/family members) and two main questions we sought to answer: What is the current and ideal event analysis process used in hospitals, and what is the best way to incorporate patients and family members in the event analysis process? Current And Ideal Event Analysis Processes The administrators and clinicians we interviewed supported the current best practices for analyzing events. For example, they agreed that analyses should include the clinicians involved in the event and that the analysis process should begin soon after the event occurred. In addition, they endorsed the goals of improving the transparency of the event analysis process and the safety culture of the hospital. They also noted that patients and family members are typically not included in investigations or analyses of events at their institutions. The patients and family members we interviewed had not been involved in the analysis of the event they had experienced. However, they believed that patients and families should be included in such analyses. They recommended conducting the event analysis soon after the event had occurred. And they believed that hospitals should give patients and families information about what changes will be implemented to prevent similar errors from happening in the future. Including Patients And Families In Event Analyses Although the administrators and clinicians said that patients and families were not typically included in the event analysis process, many thought it would be a good idea to include them. The administrators and clinicians suggested listening to comments or suggestions about processes from patients and families and asking them to write a narrative of the event they experienced. The administrators and clinicians also supported involving patients as members of 48
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Despite general support for including patients and family members, administrators and clinicians were not sure how best to do so.
the health care team, specifically by having them act as safety advocates to help prevent events like the ones they experienced from occurring in the future. As one interviewee put it, “[Patients] know our systems probably better than we know our systems because they have been through them so much.” Said another, “I think the whole investigation process is incomplete when you don’t involve [patients].” Despite general support for including patients and family members in the event analysis process, administrators and clinicians were not sure how best to do so. Some thought that patients and family members could suggest needed changes. However, a few thought that patients and family members might not be able to provide useful information because of their lack of familiarity with hospital processes or technical terms. Patients and family members thought that administrators and clinicians should ask for their input because they might have unique information about the patient’s history, normal behavior, or usual condition or they might have observed something about the event that clinicians missed. Key Stakeholder Conference: Participants And Objective We shared the information we had obtained from these key informant interviews at a conference attended by twentyfive participants—five risk managers or hospital administrators; three nurse clinicians; three patient safety experts; three patients; one frontline clinician; and ten members of the multidisciplinary research team, who collectively had expertise in patient safety, legal issues, error disclosure, nursing, statistics or psychometrics, and qualitative analysis. The conference was held in October 2011 in Houston, Texas.
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Participants felt that patients and families could offer a unique perspective on norms and quality of care that would otherwise be lost.
The primary objective of the conference was to describe the potential benefits and risks of involving patients and families in the event analysis process after disclosing an adverse event to them. The conference began with an overview of published information about involving patients and families in learning from hospital errors after an event.We also presented common themes and issues identified from the interviews that offered similar considerations. We divided participants into four breakout groups, with a balanced mix of stakeholder roles in each group. A facilitator and a transcriber (both members of the research team) were assigned to each group to encourage discussion and capture recommendations. Then the groups reconvened, and members of each group presented a synopsis of the salient points made in their discussion and possible approaches for including patients and families in learning after an event. Content analysis was conducted on these data to identify common themes and recommendations for including patients and families in postevent learning. Findings From The Conference Three main themes emerged from the conference: defining stakeholder needs, contextual factors, and considerations about involving patients and families in the event analysis process. These themes are depicted in Appendix Exhibit 1.17 Conference participants emphasized that establishing the needs of two central groups of stakeholders—patients and clinicians—in the postevent period is an important first step in defining workable ways to learn from events. Patients’ needs were identified as including time with family members to process the event; time to heal, while communicating openly with clinicians; the ability to talk freely about their concerns and fears with an objective listener; the ability to ask questions about the event and re-
ceive answers in nontechnical language; and an apology. The clinicians’ needs that were identified included a safe environment away from the patient, where the event could be discussed without blame or fear of litigation; the time, confidence, and skills to effectively communicate with patients and families after an event; and emotional support to help them process their feelings about the event. Participants emphasized how important it is for the hospital to have ongoing communication with and support for both patients and clinicians, especially if the patient continues to receive care at the hospital after an event. Conference participants identified several contextual factors that might affect the inclusion of patients and families in event analyses. These factors were strong organizational leadership that supported involving patients and families, sensitivity about involving them based on the event’s severity (for example, whether it was a close call or death), and culture change emphasizing increased transparency and partnership with patients. Participants viewed patients’ lack of comprehensive understanding of workflow processes (such as those in the operating room or pharmacy) and possible lack of awareness of the event as potential limitations to involving patients and families in event analyses. Nonetheless, participants felt that patients and families could offer a unique perspective on norms and quality of care that would otherwise be lost during an analysis. Conference participants recommended that patients and family members be interviewed by a member of the hospital staff to determine what knowledge they have about the event. Participants also viewed fear of legal action as a barrier to involving patients and families in event analyses. They underscored the need to examine laws relevant to quality improvement privilege—that is, the ability of a hospital to claim such privilege when investigating an event so that it cannot be used in a court of law—and legal protections before considering how to best involve patients and families following an unanticipated adverse event. Conference participants also suggested the need to clearly define the role of the patient and family member in the event analysis process. They framed participation by patients and families in this process as a partnership in learning, with no sense of pressure or responsibility to provide missing information. They also advocated sharing with patients and family members the results from the process once they are available. Participants wrestled with the question of whether inclusion in the event analysis was the best way to involve patients and families in postJ A N U A RY 201 4
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Communicating About Errors event learning. Some patients might not be comfortable with the fact that the institution initially does not know why an event occurred; they may want to be included in discussions only when the institution can provide an explanation of the event. Some participants suggested that patients and families might prefer other approaches to inclusion in the event analysis process, such as participating in safety training programs for clinicians at the institution. These participants thought that increased flexibility could be achieved by providing patients and families with an outline of the institution’s process for learning from an event and offering them an opportunity to select which, if any, activities and level of involvement they felt comfortable with. One group at the conference explored the question of whether patients should analyze their own event or another event—perhaps a similar event experienced by another patient, referred to as a “proxy patient.” Several distinct approaches emerged from this discussion.When patients and families are involved in analyzing their own event, they have a voice during the analysis process, and the process becomes transparent to them. However, they and their providers might be uncomfortable speaking up in front of each other. Alternatively, patients and family members could serve on patient safety committees, such as a patient-family advisory council, which could involve both patients who had experienced a medical error and those who had not. If instead of the injured patient, patients and family members from advisory councils were involved in the event analysis process, the participants might be more comfortable communicating with each other. A disadvantage of this approach is that the actual patient is not present to provide his or her perspective on the relevant adverse event. Regardless of the type of involvement, conference attendees recommended a graduated approach, because it takes time to develop and nurture an institutional culture of transparency and openness—including partnering with patients— and to routinely train clinicians about these new ways of interacting with patients and families. Finally, conference participants discussed how the degree of harm in an event might affect the participation of the patient and family in postevent learning. Most participants agreed that events resulting in high levels of harm should be the primary focus of a program for patient and family input. Most also agreed that it would be helpful to involve patients and families in less formal ways when they experience close calls or events that caused no harm or a 50
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Involving patients has great potential to both meet their needs and improve the quality and safety of health care.
low degree of harm. In addition, participants felt that events resulting in fatalities were a unique case that would require particular sensitivity to the family’s grieving process.
Policy Implications We collected a wide range of perspectives on how best to include in the event analysis process patients and family members who are participating in the disclosure process. The interviews revealed that many administrators and clinicians did not ask patients or family members for input about the event or include them in their current practices of event analysis. However, administrators and clinicians generally supported involving patients and family members in analysis processes and offered various suggestions for doing so. The three main themes from the key stakeholder conference were defining stakeholders’ needs, contextual factors, and considerations for involving patients and family members in the event analysis process. Conference participants supported involving patients in event analyses but stressed the importance of considering the needs of patients, family members, and clinicians and the timing and method of involving them. For example, patients might not feel comfortable participating in a formal root cause analysis meeting. If that were the case, their input could be obtained in a less intimidating setting, such as a one-on-one interview. Similarly, some clinicians may need opportunities to discuss the causes of an event without the patient or family members’ being present. Participants also believed that the organizational culture of the hospital, driven by the leadership, needed to be reformed for this degree of transparency. Exhibit 1 presents key issues and our recommendations for involving patients and families in event analysis. Our work is novel in three main ways. First, we
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Exhibit 1 Issues Related To Involving Patients And Families In Adverse Event Analysis And Recommendations For Addressing The Issues Issue
Recommendations
Determining whether patients and families know enough about how hospitals function to provide valuable information about an event
Do not make assumptions about what patients know; interview patients and families to learn about the event
Determining how to include patients and families, given issues related to quality improvement (QI) privilege—that is, the ability of a health care institution to claim such privilege when investigating an event so that it cannot be used in a court of law—and legal protections
The health care institution and its attorneys need to determine whether patient involvement in an analysis voids QI privilege Institutional leaders must encourage patients’ involvement in protected or privileged processes Health care personnel should be educated about the legal protections to encourage open discussions in the appropriate settings Consider the degree of the patient’s or family members’ physical and emotional distress and tailor the timing and content of communications and activities accordingly
Understanding how to balance patient and family input with their distress, given the event’s level of harm Identifying the best way to involve patients and families in postevent learning
Give patients and families an advocate not affiliated with the hospital Understand patients’ and families’ expectations about involvement, including how to keep communication open without fearing legal implications Provide different ways for patients to provide feedback depending upon their preferences (for example, one-on-one interviews, group meetings, and written feedback)
SOURCE Authors’ analysis of results from key stakeholder conference, Houston, Texas, October 2011.
obtained the perspectives of various stakeholders, including patients and family members, about the disclosure process through in-depth interviews. Second, previous literature on involving patients in adverse event analysis represents mostly informed opinion,13 but the recommendations in our study stem from data we collected from key stakeholders, including patients. Third, experts at a conference reviewed the data from our interviews to formulate issues and recommendations for involving patients in the event analysis process (Exhibit 1). Two key findings are that there is unlikely to be a “one size fits all” approach and that understanding patients’ preferences will require much additional work. Appendix Exhibit 217 illustrates steps involved in the event analysis process and the disclosure process. Although this exhibit simplifies the nuances in both processes, we include it as a starting point to illustrate how information from these two processes can lead to synergistic effects. Several opportunities exist for using information from the disclosure process to inform the event analysis process and vice versa. The first opportunity for patients and families to inform the event analysis is during or soon after the initial disclosure conversation. If patients are asked for their input this early, it is likely that they will still recall details of the event and that their input can be used to guide the initial data gathering for the event analysis. However, at this
time the patient and family members may be too physically or emotionally harmed to participate, and other issues such as further medical care may be more important. Organizations that want to engage patients at this early stage should consider using a patient advocate to facilitate the conversations with patients. The second opportunity is during a follow-up disclosure conversation. This may coincide with a later phase of event analysis, such as a formal root cause analysis meeting. At this time the organization has more information to share with patients, patients may be more physically and emotionally prepared to share their perspectives, and they may be better informed after talking with family members who know about the event. Patients’ input at this stage could still be included in the event analysis before conclusions are made. However, it is possible that early conclusions about the cause of the event have been reached, and it may be hard to change them even with new information from the patient. Also, at this time a hospital’s assessment of legal risk may lead its administrators to avoid involving the patient or family members. The third opportunity for patients’ experiences to inform an event analysis is after conclusions have been reached about the causes of the event and while changes are being made. At this time the hospital can provide the patient and family members with a clear understanding of what happened and what changes will be made and can ask for feedback about the adequacy of JANUARY 2014
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Communicating About Errors the proposed changes. However, it may be too late at this stage for patient input to be used to change care processes, and patients and families may resent being asked for input so late in the process. Finally, during all stages, caregivers, administrators, and quality improvement professionals should offer choices about when patients and families can provide input and how—for example, through interviews, surveys, or meetings.
Conclusion
involve in an event analysis process patients and families who are going through a disclosure process after an adverse event. We encourage hospitals to build on our results by involving patients in their analyses while making disclosure a meaningful process that provides the information that patients seek. Many questions remain unanswered about the best approach for hospitals to use. However, it is clear that involving patients has great potential to both meet their needs and improve the quality and safety of health care. ▪
Our findings provide insights into how best to This project was funded by an R18 award from the Agency for Healthcare Research and Quality (R18-HS01956101). Sigall Bell is a consultant for the CRICO/Risk Management Foundation of the Harvard Medical Institutions. The authors acknowledge the assistance of Michal Tamuz, State University of New
York Downstate School of Public Health, in creating interview questions and training interviewers. The authors also acknowledge the participation in the key stakeholder conference of Monique Allen, Geri Amori, James Battles, Scott Baumann, Pamela Berens, Dan Ford, Steve Hartranft, Jeffrey Katz, Mark
Kirschbaum, Kathy Masters, Kathleen Mazor, Armando Nahum, Renee Reimer, Susan Ridgely, Rebecca Shaw, Debora Simmons, Crystal Stafford, Karla Stuebing, Catherine Thompson, and Dori Upton.
NOTES 1 Sage WM. Putting the patient in patient safety: linking patient complaints and malpractice risk. JAMA. 2002;287(22):3003–5. 2 Millman EA, Pronovost PJ, Makary MA, Wu AW. Patient-assisted incident reporting: including the patient in patient safety. J Patient Saf. 2011; 7(2):106–8. 3 Weingart SN, Pagovich O, Sands DZ, Li JM, Aronson MD, Davis RB, et al. What can hospitalized patients tell us about adverse events? Learning from patient-reported incidents. J Gen Intern Med. 2005;20(9):830–6. 4 Iedema R, Allen S, Britton K, Gallagher TH. What do patients and relatives know about problems and failures in care? BMJ Qual Saf. 2012;21(3):198–205. 5 Vincent CA, Coulter A. Patient safety: what about the patient? Qual Saf Health Care. 2002;11(1):76–80. 6 Zhu J, Stuver SO, Epstein AM, Schneider EC, Weissman JS, Weingart SN. Can we rely on patients’ reports of adverse events? Med Care. 2011;49(10):948–55. 7 Weissman JS, Schneider EC, Weingart SN, Epstein AM, DavidKasdan J, Feibelmann S, et al. Comparing patient-reported hospital
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adverse events with medical record review: do patients know something that hospitals do not? Ann Intern Med. 2008;149(2):100–8. Surbone AS, Rowe M, Gallagher TH. Confronting medical errors in oncology and disclosing them to cancer patients. J Clin Oncol. 2007;25(12): 1463–7. McDonald TB, Helmchen LA, Smith KM, Centomani N, Gunderson A, Mayer D, et al. Responding to patient safety incidents: the “seven pillars.” Qual Saf Health Care. 2010;19(6):e11. Lyons M. Should patients have a role in patient safety? A safety engineering view. Qual Saf Health Care. 2007;16(2):140–2. Ghinassi F. Root cause analysis [Internet]. Pittsburgh (PA): University of Pittsburgh; 2009 [cited 2013 Nov 27]. Available from: http://www .nasmhpd.org/docs/publications/ docs/2009/HospitalCEOToolkit/ 8_7.pdf Institute for Safe Medication Practices. Benefits and risks of including patients on RCA teams [Internet]. Horsham (PA): ISMP; 2008 Jun 5 [cited 2013 Nov 19]. Available from: http://www.ismp.org/
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newsletters/acutecare/articles/ 20080605_2.asp Zimmerman TM, Amori G. Including patients in root cause and system failure analysis: legal and psychological implications. J Healthc Risk Manag. 2007;27(2):27–34. Hall J, Peat M, Birks Y, Golder S, PIPS Group, Entwistle V, et al. Effectiveness of interventions designed to promote patient involvement to enhance safety: a systematic review. Qual Saf Health Care. 2010;19(5):e10. Mazor KM, Greene SM, Roblin D, Lemay CA, Firneno CL, Calvi J, et al. More than words: patients’ views on apology and disclosure when things go wrong in cancer care. Patient Educ Couns. 2013;90(3):341–6. The institutions were the University of Texas (UT) Health Science Center at Houston Medical School, UT Medical Branch at Galveston, UT Southwestern Medical Center at Dallas, UT School of Medicine at San Antonio, UT M.D. Anderson Cancer Center, and UT Health Science Center at Tyler. To access the Appendix, click on the Appendix link in the box to the right of the article online.
