PHYSICIANS FIND THEMselves

Transcription

1 COMMENTARY Disclosing Harmful Medical Errors to Patients A Time for Professional Action PHYSICIANS FIND THEMselves in an increasingly untenable bind when deciding whether and how to disclose harmful medical errors to patients. Error disclosure is desired by patients and advocated by safety experts and ethicists and is now included in many hospital policies, state laws, and accreditation standards Yet, as the malpractice crisis deepens, calls to fully disclose errors to patients can strike physicians as naive, simplistic, and unacceptably risky As a result, many patients receive little information about errors in their care. Recently, only 30% of physicians who experienced an error in their own health care said that they were told about the error, a disclosure rate consistent with prior studies Improving the disclosure process could enhance patients satisfaction and their trust in physicians integrity Furthermore, as error disclosure becomes better integrated with patient safety activities, such disclosure could promote higher quality of care. Yet, physicians may feel that the medical malpractice climate poses an insurmountable barrier to disclosing errors more fully to patients. We propose important, feasible steps that physicians, health care institutions, medical societies, specialty organizations, and certifying bodies can take, even in the current litigious environment, to improve the disclosure of harmful errors to patients. THE DISCLOSURE DILEMMA Patients strongly endorse error disclosure and desire a deceptively simple set of information about harmful errors: (1) an explicit statement that an error occurred; (2) what the error was; (3) why the error happened; (4) how recurrences will be prevented; and (5) an apology. 19,27-30 Patients especially value knowing why an error happened and how recurrences will be prevented, information that demonstrates that a lesson has been learned from the error. 31 Patients desire disclosure even when errors cause only minor harm. 29 Yet, for physicians, the risks of disclosing errors to patients, especially the legal risks, are becoming increasingly worrisome. 32 Faced with skyrocketing malpractice premiums, the potential loss of insurability following a single claim, and rising jury awards, physicians are justifiably reluctant to do anything that might precipitate a lawsuit. 33 Also, many patients appear to endorse punitive responses to errors. In one survey, 39% of patients said that following a hypothetical medical error, I would want the doctor to be punished (eg, to be put on probation or to have their license suspended or revoked). 31 In another survey, 69% said that the physician should be sued for malpractice in a case involving a fatal medication error. 20 Such research findings provide little reassurance for physicians who are anxious about the legal risks of disclosure. Even if physicians decide to disclose an error to a patient, they may be unsure exactly what to say. While basic disclosure guidelines have been promulgated, such guidelines are typically based on clear-cut harmful errors, such as wrong-site surgery Yet, in reality, most medical errors are highly complex, and a given event can involve multiple active and latent errors at both the system and the individual provider levels, errors whose relative contribution to the patient s bad outcome is unclear. 37,38 Complicating matters further is the absence of evidence that recommended disclosure strategies are effective. Many institutional disclosure policies heighten such confusion by sending clinicians mixed messages, such as advocating error disclosure but admonishing providers not to admit liability Also, few physicians have had training in error disclosure and may worry about the shame and embarrassment of disclosing an error. 16,42 This disclosure dilemma is especially acute for private practitioners. Many disclosure guidelines were crafted in large, self-insured health care institutions, in which malpractice insurance availability and premiums are of much less concern than in community settings. 43 Furthermore, some private malpractice contracts suggest that disclosing an error to a patient in a way that admits legal liability could constitute noncooperation in the physician s defense, voiding the coverage. 44 While there is no published evidence that such noncooperation clauses have actually been invoked by insurers, the possibility of losing liability coverage in the face of a claim could be a powerful deterrent to disclosure. Private physicians may also have limited access to error analysis resources, hampering efforts to understand and tell patients about an error s cause and prevention. 27 Faced with such pressures, even private physicians who generally favor disclosure may feel that actually disclosing an error poses unacceptable risks. ENHANCING ERROR DISCLOSURE: THE NEXT STEPS Failing to communicate effectively with patients about errors threatens public confidence in medicine and ultimately undermines the qual- 1819

2 Table. Next Steps for Medical Profession to Enhance Disclosure Group Individual physicians Hospitals and other health care organizations Local medical societies and voluntary specialty organizations Certifying boards Medical educators Accrediting bodies Health services researchers ity of health care. 45 Therefore, we propose a variety of strategies that medical professionals and health care organizations should consider implementing as important next steps in improving the disclosure of harmful errors (Table).. DISCLOSURE AND MALPRACTICE A critical next step in improving disclosure is clarifying the relationship of error disclosure to medical malpractice. The experience of being sued can be devastating for physicians, regardless of the claim s outcome. 15,46,47 Therefore, it is understandable that disclosure s potential for precipitating a lawsuit presents a major obstacle to informing patients about errors. 16,42 Some scholars believe that disclosure could indeed heighten liability, noting that only 3% to 5% of the patients who are injured by negligent care actually sue. 14,32 This low rate of lawsuits may partly be due to patients being unaware that medical errors Primary Next Steps Reconsider relationship between malpractice and disclosure Seek opportunities to practice disclosure skills Incorporate patients into quality improvement efforts Enhance disclosure policies, addressing disclosure content and timing Train clinicians in disclosure Integrate disclosure and quality improvement activities Provide emotional support for health care workers involved in errors Educate physicians about malpractice Develop evidence-based guidelines for disclosure Create, disseminate disclosure training Lobby for broader apology bills and against malpractice contracts that inhibit disclosure Provide error analysis resources for private practice physicians Include patient safety and disclosure in continuous professional development Test disclosure skills on certification examinations Include disclosure education and skills training in required curriculum Clarify current standards regarding disclosure of unanticipated outcomes to address disclosure of medical errors Explore variation in patients disclosure preferences Study relationship of disclosure to malpractice Prospectively evaluate impact of different disclosure strategies on real-world outcomes (eg, trust, satisfaction, and intent to sue) were responsible for an adverse outcome. 48 Therefore, disclosure could alert an unsuspecting patient that a harmful error has happened, generating more lawsuits. 14 Yet, there is accumulating evidence of a potentially beneficial effect of disclosure on the likelihood and outcomes of malpractice suits, information that medical societies and specialty organizations should communicate more clearly to physicians. Patients who believe that they are receiving incomplete information about an error often litigate simply to learn what happened and to prevent error recurrences Multiple survey studies have shown that error disclosure reduces patients intention to file a lawsuit. 29,31,54 A robust body of legal and psychological research also suggests that apologies may help deter legal action and promote more effective settlements of lawsuits that have been filed. 55 Furthermore, mock jury studies have shown that damage awards are often higher if errors have not been disclosed. 56 The failure to disclose errors can itself create legal liability related to fraud. 57 Finally, some case series from settings where malpractice concern is lower, such as in Veterans Affairs Hospitals and in Canada and Australia, suggest that more open disclosure does not substantially increase legal liability The University of Michigan Health System recently reported that since a policy of encouraging physicians to disclose errors and to apologize has been adopted, annual attorney fees and legal actions have been reduced by more than 50%. 61 A campaign to educate physicians about disclosure and malpractice could also reduce litigaphobia by correcting physicians malpractice misperceptions, such as their overestimates of the likelihood of litigation Historically, the medical profession s primary objective related to malpractice has been to promote tort reform. Fundamental changes to the tort system, such as no-fault or enterprise liability approaches, could ease physicians concerns about disclosure. However, such reforms appear unlikely to succeed in the current political climate. 14 Other proposed responses to the malpractice crisis, such as capping nonpunitive damages, may limit premium growth but are unlikely to reduce physicians perception of the legal risk of disclosure. Many states have adopted apology laws that exempt expressions of regret from being considered an admission of liability. 65 Still, it is unclear how much protection apology laws actually provide, as statements concerning culpable conduct are generally still admissible. 66 In contrast, Colorado s apology law protects the entire disclosure statement, a model that the profession should urge other states to adopt. 67 Medical societies and specialty organizations should also lobby insurers to remove language in malpractice policies that inhibits disclosure. Some malpractice insurers themselves are adopting more progressive approaches to disclosure, a development that is of particular value to private practice physicians. For example, COPIC, a large Colorado malpractice insurer of academic and community physicians, provides its 1820

3 physicians with training and support in error disclosure. 68 COPIC s innovative program, called 3Rs (recognize, respond, and resolve), assists patients who have experienced an unanticipated adverse outcome, including reimbursement for economic losses. Since December 2001, there have been 453 qualifying incidents, resulting in 153 patient reimbursements, totaling almost $ To date, none of these cases has gone to litigation, and such payments do not trigger reporting to the National Practitioner Databank. The medical profession should encourage the expansion of such pioneering programs. Physicians should recognize that no approach to error disclosure is without legal risks and that uncertainty about disclosure s effect on malpractice will continue for the foreseeable future. 69 While the possibility that error disclosure could precipitate (or fail to prevent) a lawsuit cannot be ignored, 70 there is no published evidence to suggest that more open disclosure of errors dramatically increases liability. Fortunately, the vast majority of patients who are injured by medical errors never sue. 48 Thus, we believe that physicians can presume that disclosure will lead to an overall reduction in the likelihood of a successful lawsuit. ESTABLISHING AND DISSEMINATING EVIDENCE-BASED GUIDELINES FOR ERROR DISCLOSURE Once physicians have decided to disclose an error, additional challenges arise regarding how much information to share with the patient. Deciding what disclosure content best conveys accountability to patients is especially difficult, as is determining whether disclosing why an error happened is akin to admitting legal liability. 71 Physicians further wonder about disclosure language, eg, whether to say such words as error, mistake, orharm or to apologize. However, currently, no guidelines exist regarding the minimal information that should be disclosed to patients following harmful errors. The medical profession, particularly physicians with expertise in communication, should create evidence-based guidelines for disclosure of harmful errors. Such guidelines should be fundamentally patient centered. However, if they are based purely on patients preferences for disclosure ( tell me everything ), without incorporating the perspectives of physicians, health care institutions, and risk managers regarding what information is reasonable to share with patients, such standards are unlikely to be effective. Disclosure guidelines should also provide detailed information regarding what errors need to be disclosed and address not only clear-cut harmful errors but also more common and complex situations, such as adverse events that are not clearly errors or errors that cause minimal harm. Such guidelines can draw on existing strategies for delivering bad news to patients. 72,73 Physicians should recognize, however, that error disclosure is often more complicated than simply sharing bad news, given that the physicians may be partly responsible for the adverse event. Filling gaps in the existing research could help create such evidence-based disclosure guidelines. 22 Most prior studies of patients disclosure preferences have been performed outside the acute care setting and have used hypothetical vignettes. It is not known whether these disclosure preferences change when patients are ill or have actually experienced an error. From physicians perspectives, the most noteworthy gap is the absence of prospective evidence about whether recommended disclosure strategies improve patient satisfaction and the intent to sue. Health services researchers should seek to fill these research gaps, thereby helping to validate and refine disclosure guidelines. Once these guidelines have been developed and tested, the profession should create, disseminate, and assess educational programs to enhance physicians disclosure skills. While it is important that basic concepts related to patient safety and error disclosure be introduced at the earliest stages of medical education, the most urgent need at present is providing disclosure training at the graduate and continuing medical education levels. The topic of error disclosure represents an ideal opportunity for residency programs to integrate many of the core competencies identified by the Accreditation Council for Graduate Medical Education, including patient care, practicebased learning and improvement, interprofessional and communication skills, and professionalism. 74 As with any communication skill, training in disclosure should include both didactic instruction and the opportunity to practice and receive feedback, such as by disclosing hypothetical errors to standardized patients. Emphasizing the positive impact that disclosure training could have on quality improvement and risk management activities may help educators garner institutional support for disclosure education. INTEGRATING ERROR DISCLOSURE AND QUALITY IMPROVEMENT While physicians are acutely aware of the risks of disclosure, all members of the medical profession should increase their understanding of the potential positive benefits of disclosure, such as enhancing quality improvement Physicians and health care institutions may underestimate patients desire for information about why an error happened and how recurrences will be prevented, information that currently is shared with patients only in vague terms, if at all. 16,78 For example, the American Society for Healthcare Risk Management advises that the disclosure of investigation outcomes should be factual and broad...possible approaches include saying In our investigation we learned we have an area in our pharmacy process that could be improved in order to prevent this type of error from happening again. We have instituted some of these changes already. 36 Such a general statement may actually create more questions in patients minds than it answers, especially if the institution fails to disclose exactly what the pharmacy problem was and what 1821

4 process changes have been implemented. By advocating for the importance of providing patients with specific information about an error s cause and prevention, the medical profession can, over time, promote an important paradigm shift from disclosure as damage control to disclosure as an integral component of patient safety. Integrating disclosure and quality improvement could enhance both activities. Appreciating patients desire to know about an error s cause and prevention could encourage physicians and safety programs to examine errors more closely and to develop more effective prevention plans. Applying quality improvement approaches to the disclosure process could also help identify common disclosure breakdowns and test strategies for improving disclosure. Also, physicians willingness to disclose errors to patients will likely increase once they witness the disclosure process stimulating implementation of error prevention plans and reducing future errors. 16 Achieving disclosure s quality improvement potential will require institutions to strengthen the typically tenuous and blame-oriented connections among their patient safety, quality improvement, and risk management programs as well as between these programs and frontline clinicians. ADDITIONAL STEPS TO ENHANCE DISCLOSURE Health care institutions can take a number of additional steps to enhance disclosure. They can strengthen their error disclosure policies, providing clinicians with guidance about the content of disclosure, when to explicitly state that an adverse event was due to an error, and how to apologize. Disclosure policies should consider the optimal timing of disclosure, avoiding both hasty and ill-considered declarations or inadvertently creating the impression of stonewalling and obfuscation. Furthermore, many clinicians have had limited personal experience in disclosing harmful errors. Therefore, hospitals and large medical groups should provide physicians with ready access to disclosure assistance, using innovative resources such as justin-time disclosure coaching or mediation. 7,79 Also, health care workers who are involved in harmful medical errors often have considerable unmet emotional needs Enhanced emotional support for health care workers after errors have occurred would help them communicate more effectively with the patient who experienced an error. Providing such disclosure assistance and emotional support could reduce common mistakes in error disclosure, such as hypodisclosure (disclosing insufficient information), hyperdisclosure (disclosing excessive information), and misdisclosure (disclosing information later found to be incorrect). Clinicians should be especially wary of misdisclosure, the correction of which often involves the challenging task of trying to convince a patient that what on first glance appeared to be a harmful medical error was actually not preventable. Determining whether an error has occurred or whether the error caused harm frequently requires formal analyses by patient safety experts. Integrating error disclosure and quality improvement as described above would help ensure that patients receive accurate information about errors. Certifying bodies, specialty boards, and medical societies can also take additional steps to enhance disclosure, especially in private practice. Private physicians rarely have access to safety programs to analyze outpatient errors, making it difficult for physicians to inform patients about an error s cause and prevention. Medical societies and specialty organizations could facilitate access to such error analysis resources. Also, as the board certification process evolves from periodic examinations to continuous learning and quality improvement, specialty boards could spur physicians in both private and academic settings to learn and practice new error disclosure skills. 85 Accrediting bodies, such as the Joint Commission on Accreditation of Healthcare Organizations, should expand existing disclosure standards, which currently require the disclosure of unanticipated outcomes to patients but provide little guidance regarding the content of disclosure or the need to state explicitly if an unanticipated outcome was the result of an error. 86 CONCLUSIONS The risk that disclosing an error to a patient could prompt a lawsuit cannot be disregarded. However, the medical profession cannot continue to ignore its failure to communicate effectively with patients who have been harmed by medical errors. Our patients unequivocally want and certainly deserve full disclosure of harmful medical errors. Rather than remaining paralyzed by the litigious health care environment, we must start taking the necessary steps to achieve this goal. Thomas H. Gallagher, MD Wendy Levinson, MD Correspondence: Dr Gallagher, University of Washington School of Medicine, th Ave NE, Suite 230, Campus Box , Seattle, WA ([email protected]). Financial Disclosure: None. Funding/Support: This work was supported in part by the Greenwall Foundation Faculty Scholars Program, New York, NY, and by grants 1U18HS and 1K08HS from the Agency for Healthcare Research and Quality, Rockville, Md. Acknowledgment: We thank Eric Larson, MD, MPH, for his insightful contributions to the manuscript for this article, Alison Ebers and Mary Lucas, RN, MA, for their assistance with manuscript preparation, and Victoria Fraser, MD, and the Washington University Patient Safety Project for their support. REFERENCES 1. Banja J. Moral courage in medicine disclosing medical error. Bioethics Forum. 2001;17: Bosk CL. 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