Disclosing harmful medical errors

Walter F. Baile1 and Daniel Epner2

1 Departments of Behavioral Science, Psychiatry and Faculty and Academic Development, The University of Texas MD Anderson Cancer Center, Houston, USA

2 Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA KEY POINTS

• Serious medical errors occur commonly but are under-reported.

• The climate for error disclosure has moved from secrecy to telling patients.

• Prompt disclosure of errors is the ethical thing to do.

• Disclosure of errors can reduce litigation by patients and families.

• In disclosing errors clinicians should adopt a model of "giving bad news."

• Patients should be given clear information as to what happened, why it happened, and what is going to be done to prevent similar occurrences.

• In addition to helping patients and families cope with errors, attention should be given to the practitioner(s) involved in the error whose emotions and reactions require support and occasionally professional help.

Case Study 7.1

Mrs. Grant is a 72-year-old Afro-American female who has been acutely hospitalized in the intensive care unit for severe hypotension, intractable nausea and vomiting, and dehydration one day after receiving chemotherapy for metastatic breast cancer. During her workup it was discovered that she received the wrong dose of chemotherapy, exposing her to acute toxicity. The attending oncologist has discovered this error and scheduled a meeting to inform the son.

At one time medical errors were hidden from all but a tight circle around the personnel who had committed the error. Now it is recognized that the disclosure of medical errors is not only obligatory from an ethical standpoint but has significant benefits from the risk management point of view and also can serve to preserve the clinician-patient-family relationship at a time when there may be a crisis of trust, strong emotions such as anger and disbelief, and when families may be in crisis as a result of the consequences of the errors made.

Why this is important?

1 Medical errors are common: It is estimated that in the USA medical error results in anywhere from 44 000-98 000 unnecessary deaths each year and 1 000 000 excess injuries. [1] A recent study estimates that among hospitalized Medicare beneficiaries, 13.5% experienced adverse events during their hospital stays. [2]

2 Patients expect medical errors to be disclosed: In a study by Blendon [3] published in the NEJM in 2002, 89% of individuals surveyed in a national study believed that physicians should be required to disclose. Other studies have supported this finding. [4]

3 It is the right thing to do: Most professional societies regard error disclosure as a professional responsibility. [5] In a study published by Gallagher in 2006, 98%

[6] of physicians studied believed that all serious errors should be disclosed.

4 Error disclosure can lead to enhanced safety through corrective action: An important reason for error disclosure is that corrective action may be taken to remedy the cause of the error and also result in practice change. This was seen in a study by Wu [7] of 254 internal medicine residents who undertook disclosure of a medical error. He found that many had reported changes in their practice, such as paying more attention to detail and personally confirming medical data, 62% were more inclined to seek advice about aspects of their medical care, and 52% changed how they organized medical data.

5 Disclosing an error can clear the air of secrecy and blame: Focusing on patient safety and performance improvement as a consequence of medical errors can diminish the culture of blame and shift the emphasis on to the support of the physician. [8]

6 Error disclosure and apology can preserve the relationship with the patient and family: Non-disclosure can increase the likelihood of changing physicians, reduce satisfaction and trust, and increase seeking legal advice. [9, 10]

7 Just compensation for errors may avoid expensive litigation: A number of studies have been published which indicate that medical error disclosure can reduce expensive litigation. [11]

Although the climate is changing, medical errors have been shrouded in a culture of blame where they have often been seen as a moral failure of a single individual. [8] In this culture, physicians were often left to fend off feelings of shame where they often questioned their competence, played the event over and over again in their mind, and felt dread over expected punishment and litigation. In the past when error disclosure was not routinely practiced, practitioners were also left to think over and over whether the patient and family noticed the error.

On the other hand, many medical errors are due to systems and procedural failures and not to physician negligence. [12] These failures include: (i) lack of appropriate communication among medical providers; (ii) incorrect record keeping; (iii) lack of check-points in care; and (iv) errors in prescribing or transcribing. Thus making medical errors a "safety" issue moves the task of disclosure from "deny and defend," as well as blame, to system improvement.

Why doctors don't disclose errors Over the past 15 years the call to disclose medical errors has been vocal. Not only is error disclosure desired by patients, but it is advocated by safety experts and ethicists and included in many hospital practices, state laws, and accreditation standards. [13]

However, the data indicates that only a modest number of errors are actually disclosed. Factors responsible indicate shame and fear on the part of the practitioner, worry and uncertainty about how to disclose, lack of clarity about responsibility for the error, and absence of evidence that recommended disclosure strategies are effective as well as denial of the error on the part of the clinician.

[14] An excellent review of the sociodynamic and interpersonal issues involved in error disclosure may be found in the article by Petronio. [15]

Although most physicians believe in error disclosure, in many instances it does not occur. In a studyby Gallagher in 2003 [16] only21% of physicians who admitted making a medical error stated that they had disclosed it. Reasons given by these physicians included: (i) believing that the patient would not want to know or could not comprehend; (ii) the patient did not know about the error; (iii) fear of a lawsuit; (iv) fear of patient anger; and (v) didn't know the patient well.

The establishment of a culture of prevention and quality improvement has gone a long way to change practitioner behavior with regard to errors. Hospitals have established rapid response teams for serious adverse events. Often all billing is stopped. Guidelines for physicians on how to disclose have emerged. Error reduction campaigns are now common in hospitals. There has been the establishment of root-cause analysis immediately after a medical error. A no fault compensation system helps to dispel fears of a lawsuit.

What do patients want when medical errors occur?

It has been recognized that error disclosure is only one piece of the program to promote safety. Several studies have recommended that disclosure itself draw on existing guidelines for giving bad news. [11] Also a number of studies have identified key patient attitudes which can guide the error disclosure process. They can be summarized as follows and indicate that most patients want:

1 An explicit statement that an error has occurred.

2 What the error was.

3 Why the error happened.

4 How re-occurrences can be prevented.

5 An apology.

Based on the above, we can identify some guidelines for error disclosure. Some thoughts and considerations:

1 Disclosure guidelines should detail what errors should be disclosed and the method of communication. Disclosure should be made promptly even if data as to the cause of the error is unknown. Several studies have shown that the major sources of dissatisfaction among patients to whom errors are disclosed are lack of information, the unsympathetic way it is presented, and the lack of opportunity to ask questions. [17] Thus sufficient time should be set aside to inform and answer questions.

2 You can't make an error sound like a routine event. Trying to "sell" an error as something that "happens frequently in hospitals" will sound lame and self-serving to patients and families. One should realize that honesty is the best policy. Patients and families have placed their trust in the medical care system often at a time of crisis in their lives and an error breaches that trust.

3 Many disclosures will need to occur before an investigation of the cause is completed. Patients and families should be reassured that the occurrence is being investigated.

4 Disclosure should be accompanied by an expression of regret. Stating "we sincerely regret that this has happened" does not acknowledge personal responsibility for the error but acknowledges that something wrong happened which had adverse consequences for the patient.

5 Dealing with strong emotions is a central part of the disclosure and should be expected, especially if the error resulted in catastrophic results for the patient.

6 The support of junior colleagues who were involved in the error is important since they are likely to be the most vulnerable. Remember that the culture of medicine is one of perfectionism and often an exaggerated sense of responsibility and guilt, and also that "do no harm" is a long-standing medical credo. [18]

7 Although an error may be made by any member of the treatment team, it is usually the attending physician's responsibility to disclose, since they are likely not only to be the most experienced person on the team but also are legally responsible for the patient.

8 A patient liaison or advocate should be present during the disclosure and be available to work with the patient and family and keep them informed of the investigations.

9 Support for the physician disclosing the error, especially if he or she was involved in the error, should be a prime consideration. This is especially true because even when told with compassion, patients may be angry, blaming, and otherwise upset. This is superimposed on a practitioner who is already experiencing shame, guilt, and anxiety. Loss of confidence, sleep difficulties, reduced job satisfaction, and harm to reputation may occur following error disclosure [19] and it should be clear to clinicians where they can obtain emotional support. [16]

One guideline for disclosing "bad news" is the SPIKES protocol (Setting, Perception, Invitation, Knowledge, Emotions, Strategy and Summary). [20] It has been adapted for error disclosure as CONES (Context, Opening shot, Narrative, Emotions, Strategy and summary) (see Table 7.1) to emphasize the key elements of preparation (the planning may involve many members of the treatment team as well as risk management) and the fact that the "strategy" or plan may be incomplete due to ongoing investigations which will require additional disclosure.

Here is what an error disclosure might look like.

C= Context Prepare for what you are going to say ahead of time and get a disclosure coach if you are not sure what to say. [21] Get the facts of what happened right and know as much as you can about the patient's condition. Rehearse to yourself if you need to. Get the setting right. Make sure you leave enough time. Decide who should be in the room. Have someone with you for support if necessary. Turn off your pager and put your cellphone on silent.

Table 7.1 CONES for error disclosure.

CONTEXT - prepare for the encounter by reflecting on the task at hand. Getting the right information to disclose:

what happened why it happened where things are at what are you doing to investigate and prevent Make sure the right people are present Rehearse if necessary Take time OPENING SHOT - warn that bad news is coming ... ”I have something important to talk to you about. I'm afraid there has been an error in your loved one's treatment.”

NARRATIVE APPROACH - summarize the medical history up to the event, then disclose the error "You recall that we were treating your husband with ....”

Make an apology.

EMOTIONS - address them with validating and empathic responses such as "I know that this is shocking for you.”

STRATEGY AND SUMMARY - state clearly where things are at now and what is happening with treatment. Emphasize that an investigation is taking place. Assign an advocate to the family O= Opening shot It is a good idea to begin the conversation by exploring what the family already knows or has been told. This allows you to start the disclosure at an appropriate point. Many recommend sending a message that you have something serious to talk to the patient or family about.

N= Narrative In unfolding the conversation about a medical error it is useful to start "from the beginning." That is to provide a summary of the treatment up until the time that an error had occurred and then link the event to the time-line of treatment. This allows the patient and or family to see the "big picture." Be sure and make a very clear statement that an error has occurred, what it was, and why it happened. Making an apology is also an essential part of the disclosure process. Assure those involved that steps are being taken to investigate and if appropriate to prevent the error from occurring. When disclosing errors it is important to refrain from "blaming the system" because this will be seen as ducking responsibility.

E= Emotions Emotions can run quite high both in the person disclosing the error and in the recipients of this bad news. In order for effective disclosure to take place the clinician disclosing the error must deal not only with the other parties' emotions but also his or her own. Feelings of guilt, helplessness, and shame may consciously or unconsciously be felt by the clinician. When one's own emotions come to color the error disclosure dialogue it is referred to as "limbic lobe hijacking." [22] This may thwart effective disclosure if it results in information being withheld or premature reassurance that things will be fine or ineffective apology. Mindfulness about not speaking from one's own emotional brain has been called by Larson [23] "emotional labor" and it requires an "in the moment," conscious and deliberate awareness of how one is communicating. Of course preparation for error disclosure can not only include some rehearsal but also raising consciousness of the effort needed to keep one's own feelings from sabotaging a discussion.

A crucial part of error disclosure is addressing the emotions of the other persons involved. Disclosing errors is likely to result in a number of emotions on the part of the recipient. These can include disbelief, anger, blaming, and even threats of litigation. Addressing emotions with validating and empathic responses while avoiding becoming defensive is a chore that those making error disclosure would benefit from learning. Handling emotions empathically can transmit the feeling that you really care. Coupled with an apology it can feel supportive to the patient and family and reduce the probability of conflict and confrontation.

S= Strategy and summary When emotions are addressed patients and families will want to know "what happens next." If significant physical harm has occurred because of the Address emotions before giving facts about anything. Otherwise the other person might not process the information you are giving.

Watch for emotions that may be subtle, such as changes in facial expression, sighing or shaking one's head.

Use empathic responses such as:

"I know that this is awful news for you.”

"This is a real shock of course.” and validating responses such as

"It's perfectly normal to feel that way.”

"Most people in your situation would be very upset also.”

Avoid saying

"I know how you feel.” (you really can't)

"I'm sure things are going to get better.” (they may not)

"These things happen.” (they should not to anyone's loved one)

"The system broke down.” (sounds like shirking responsibility)

"It doesn't help getting too upset about it.” (only likely to escalate conflict)

error, loved ones will want to know what is being done and what the potential outcome could be. Supporting the family through assignment of a patient advocate and keeping the family up to date are crucial steps. In many medical settings now hospital billing is immediately suspended and discussions of compensation to the family are begun.

Despite intention to disclose, mistakes in error disclosure often occur [15, 16, 24] (see Table 7.2). A video illustrating the use of CONES applied to the case of Mrs. Barnes can be seen on our I*CARE (Interpersonal Communication and Relationship Enhancement) website: http://www.mda nderson.org/education-and-research/resources-for-professionals/professional-educational-resources/i-care/complete-library-of-communication-videos/man aging-difficult-communications-error.html.

Training in error disclosure Communication is a skill and is best learned experientially. [25] High stakes conversations such as error disclosure are best mastered through simulation with standardized patients or using role plays and observation of training effects during the trainee-patient encounter. [26] Role plays allow appropriate coaching to occur and for learners to practice the skills necessary to have an effective conversation around error disclosure. In role plays the "action" can be stopped and reviewed. When learners get "stuck" they can explore and reflect on the obstacles Partial Disclosure - e.g. leaving out a link between the error and the consequences of the error. "Your mom has taken a turn for the worse. It could be she got too much chemo or it's her underlying disease.”

Misleading Disclosures - e.g. implying that the clinical occurrence was a consequence of the underlying disease "Your mom was pretty sick anyway and had a limited life expectancy.”

Deferring Disclosure - e.g. implying that further investigation was needed when the source of the error was known.

Blocking avenues to questions - e.g. "it doesn't really matter who was responsible we just need to ... ”

Overloading the patient/family with information - e.g. launching on a prolonged monolog with jargon without leaving space for questions.

Blaming the system - e.g. "if we had had more staff this dosage mistake not have happened.”

Blaming the family - "you know if you had gotten her here sooner, we might not have had to put her in the ICU.”

Billing the patient or family when it is clear an error has occurred.

Responding to emotions with facts or being condescending.

"It doesn't help to get upset.”

"I know how you feel.”

that prevented them from going forward with a dialog and try again. Done in a small group setting, learners can get feedback and support from peers and from standardized patients who can be trained to communicate the impact of the disclosure on themselves. In this way learners can calibrate their communication skills and learn higher-order skills, such as reflecting on their own emotions.

Wayman and colleagues [27] used standardized patients and a six-step Relational Communication Model to instruct oncology nurses in error disclosure and found increased self-efficacy in disclosing errors. Sukalich and colleagues

[28] showed that using standardized patients in an error disclosure role-play can enhance PGY 1 residents' self-efficacy in disclosing errors. Stroud and colleagues introduced a very useful rating scale for assessing trainee competency in disclosing medical errors. [29] Recently we have introduced advanced role play techniques borrowed from psychodrama and sociodrama into training for difficult conversations such as giving bad news. These techniques enhance role play by promoting reflection on the feelings of the person disclosing. Since dealing with these emotions is as essential a component of error disclosure as dealing with the emotions of the patient and family, they make explicit that which would otherwise be unspoken. [25]

In training clinicians to address the issue of patient emotions we introduce the concept of both amygdala hijacking (explained above) and the emotional jug

[30] because we believe that dealing with emotions is the most challenging aspect of bad news disclosure and is inadequately taught. Teaching specific empathie responses (see Table 7.3) has been found helpful by clinicians who often struggle to find the right words. Helping clinicians recognize that blame, denial, and anger may come from feelings of helplessness, guilt, and fear provide a framework for when to use empathic statements. Using techniques such as "doubling" and "role-reversal" can help clinicians "get into the shoes" of the patient and family to guide their own communications. Having learners role play their own error disclosure can provide support for their disclosure efforts, reinforce skills, calibrate communication, and normalize the experience for the learner.

In summary, error disclosure is a challenging communication skill. In order to become effective one must have a "cognitive road map" such as CONES to tell a learner "what to do" as well as a methodology for teaching "how to do it." Moreover, learning how to disclose errors is not a "one-shot" event but must be reinforced through repeated practice, revisited through simulation of encounters that have already occurred with learners taking on the role of patients and families, and reviewed as strategies and protocols for error disclosure evolve.

References

1 Weingart SN, Wilson RM, Gibberd RW, Harrison B. Epidemiology of medical error. BMJ 2000 Mar 18; 320(7237):774-777.

2 Levinson DR. Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; November 2010. Report No. 0EI-06-09-00090.

3 Blendon RJ, DesRoches CM, Brodie M, et al. Views of practicing physicians and the public on medical errors. NEnglJMed 2002 Dec 12;347(24):1933-1940.

4 Robinson AR, Hohmann KB, Rifkin JI, et al. Physician and public opinions on quality of health care and the problem of medical errors. Arch Intern Med 2002 Oct 28;162(19):2186-2190.

5 Gallagher TH, Studdert D, Levinson W. Disclosing harmful medical errors to patients. N Engl JMed 2007 Jun 28;356(26):2713-2719.

6 Gallagher TH, Waterman AD, Garbutt JM, et al. US and Canadian physicians' attitudes and experiences regarding disclosing errors to patients. Arch Intern Med 2006 Aug 14—28;166(15):1605—1611.

7 Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from their mistakes? Qual Saf Health Care 2003 Jun;12(3):221-226; discussion 227-228.

8 Delbanco T, Bell SK. Guilty, afraid, and alone - struggling with medical error. N Engl J Med 2007 Oct 25;357(17):1682-1683.

9 Mazor KM, Simon SR, Yood RA, et al. Health plan members' views about disclosure of medical errors. Ann Intern Med 2004 Mar 16;140(6):409-418.

10 Mazor KM, Reed GW, Yood RA, et al. Disclosure of medical errors: what factors influence how patients respond? J Gen Intern Med 2006 Jul;21(7):704-710.

11 Christmas C, Ziegelstein RC. The seventh competency. Teach LearnMed 2009 Apr-Jun;21(2): 159-162.

12 Leape LL. Errors in medicine. Clin Chim Acta 2009 Jun;404(1):2-5.

13 Gallagher TH, Levinson W. Disclosing harmful medical errors to patients: a time for professional action. Arch Intern Med 2005 Sep 12;165(16):1819-1824.

14 Leape LL. Full disclosure and apology - an idea whose time has come. Physician Exec 2006 Mar-Apr;32(2):16-18.

15 Petronio S, Torke A, Bosslet G, et al. Disclosing medical mistakes: a communication management plan for physicians. Perm J 2013 Spring;17(2):73-79.

16 Gallagher TH, Waterman AD, Ebers AG, et al. Patients' and physicians' attitudes regarding the disclosure of medical errors. JAMA 2003 Feb 26;289(8):1001-1007.

17 Mazor KM, Simon SR, Gurwitz JH. Communicating with patients about medical errors: a review of the literature. Arch Intern Med 2004 Aug 9-23;164(15):1690-1697.

18 Liang BA. A system of medical error disclosure. Qual Saf Health Care 2002 Mar;11(1):64-68.

19 Waterman AD, Garbutt J, Hazel E, et al. The emotional impact of medical errors on practicing physicians in the United States and Canada. Jt Comm J Qual Patient Saf 2007 Aug;33(8):467-476.

20 Baile WF, Buckman R, Lenzi R, et al. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist2000;5:302-311.

21 WhiteAA, GallagherTH. Medicalerroranddisclosure. HandbClinNeurol 2013;118:107-117.

22 Goleman D. Emotional Intelligence: Why It Can Matter More Than IQ. New York: Bantam Books, 2005.

23 Larson EB, Yao X. Clinical empathy as emotional labor in the patient-physician relationship.

JAMA 2005 Mar 2;293(9):1100-1106.

24 Fein SP, Hilborne LH, Spiritus EM, et al. The many faces of error disclosure: a common set of elements anda definition. JGen InternMed 2007 Jun;22(6):755-761.

25 Baile WF, Blatner A. Teaching communication skills: using action methods to enhance role-play in problem-based learning. Simulation in Healthcare. In press 2014.

26 Rodriguez-Paz JM, Kennedy M, Salas E, et al. Beyond "see one, do one, teach one": toward a different training paradigm. Qual SafHealth Care 2009 Feb;18(1):63-68.

27 Wayman KI, Yaeger KA, Sharek PJ, et al. Simulation-based medical error disclosure training for pediatric healthcare professionals. JHealthc Qual 2007 Jul-Aug;29(4):12-19.

28 Sukalich S, Elliott JO, Ruffner G. Teaching medical error disclosure to residents using patient-centered simulation training. Acad Med 2014 Jan;89(1):136-143.

29 Stroud L, McIlroy J, Levinson W. Skills of internal medicine residents in disclosing medical errors: a study using standardized patients. AcadMed 2009 Dec;84(12):1803-1808.

30 Gordon L, Frandsen, J. Passage to Intimacy. New York: Simon & Schuster, 1993.

31 Loren DJ, Garbutt J, Dunagan WC, et al. Risk managers, physicians, and disclosure of harmful medical errors. Jt Comm J Qual Patient Saf 2010 Mar;36(3):101-108.

CHAPTER 8

Рекомендуем к просомтру

www.kievoncology.com благодарны автору и издательству, которые способствует образованию медицинских работников. При нарушении авторских прав, сообщите нам и мы незамедлительно удалим материалы.