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Disclosure of Unanticipated Outcomes: Adverse Event Communication and Support

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Unanticipated Outcomes

Despite the best efforts of healthcare professionals, adverse events sometimes happen in healthcare settings. Adverse events can be devastating for patients and healthcare providers who are part of or witness these events. When a patient experiences an unanticipated outcome or a medical error occurs, there is an expectation that the healthcare establishment will deal with the event openly and honestly and that the parties involved will accept responsibility, express empathy, and work to prevent the event from happening in the future.

Disclosure as a Communication Tool

Healthcare providers have a legal, regulatory, and ethical obligation to disclose unanticipated outcomes and medical errors to patients. The American Medical Association Opinion 8.12 states that "It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients." The opinion states that when a patient suffers a significant medical complication that may have resulted from a physician's mistake, then the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what happened. Also, the Joint Commission mandates that accredited organizations inform patients of unanticipated outcomes of care.

While there is an expectation that disclosure will happen, it can be a difficult process. When handled poorly, disclosure can do damage to the patient-provider relationship.

Disclosure should be seen as a part of open communication with patients, families, and hospital staff and not as a separate event that happens after an adverse outcome. From the onset, patients should be informed of the risks, benefits, and alternatives to their care. When providers communicate openly with patients from the beginning, it can ease tensions if or when an unanticipated event occurs. "Effective disclosure/communication begins with informed consent, which is a proactive form of disclosure of an unanticipated or undesired outcome." (ASHRM)

Lack of training on addressing the patient disclosure, lack of professional and administrative support, and fear of a malpractice suit all contribute to the reluctance in communicating with the patient. Disclosure after an unanticipated outcome will not prevent all malpractice claims. However, timely communication with the patient and family, expression of empathy, and factual disclosure of what occurred can minimize a patient's anger, desire for retribution and maintain the patient-physician relationship.

Disclosure is Not a Cost-savings Tool

According to the American Society for Healthcare Risk Management, disclosure is not intended to be a risk management technique that an organization uses to prevent people from filing malpractice claims or requesting compensation. Organizations should not view disclosure as a cost-savings tool. It should be viewed as the single pathway to obtain, maintain, or regain patient and family trust.

Concerns about Discoverability

Organizations should develop their disclosure policy in conjunction with their state statutes around an apology. In addition, risk managers should also be familiar with their malpractice insurance carrier's position on apology and promises of compensation on behalf of the carrier. While it is clear that patients have a right to be informed of adverse events related to their care, challenges continue to surround how the information is delivered, who should deliver it, and how they are trained.

Develop a Policy

The organization should develop policies and procedures to guide staff in the disclosure process. Please see our template for the policy.

Models for Managing the Disclosure Process

An organization's model for managing the disclosure process will depend on its size, complexity, and staff members' strengths. Several models exist, and organizations should review models and determine which model or combination of models best fits their organization's needs. ASHRM's Monograph, Disclosure of Unanticipated Events: The Next Step in Better Communications, identifies four models that have emerged.

These are:

• One-Person Model: One person, frequently the risk manager, coordinates all disclosure discussions. This model might be a good fit for a small organization and can ensure consistency in the process. However, the model might place a tremendous amount of responsibility on one individual for coaching clinicians, and it might be difficult when only one person has the necessary skills to conduct the disclosure process.
• Team Model: In this approach, organizations choose members who are identified as effective communicators and have highly developed interpersonal skills. This group receives intense training in effective disclosure skills and communication policies of the organization, with the expectation that members of the group will coach clinicians and accompany them to disclosure discussions. A downside to this model is that members of the team may be burdened when their disclosure duties take them away from their other duties.
• Train-the-Trainer Model: This model would work best for medium- to large-size organizations. In this model, a large group of physicians and other staff receive comprehensive training with an expectation that they train a certain number of other staff members each year. This approach spreads skills and responsibilities throughout the organization. Quality control and division of labor might be an issue with the approach.
• Just-in-Time Coaching Model: In this model, providers present at the time of the event and disclose what is known to the patient at the time. The individuals receive just-in-time coaching from an individual, oftentimes the risk manager, prior to the disclosure discussion. This model is direct and easy, but efficacy depends largely on the communication skills of the care provider.

Whichever model or combination of models an organization chooses to follow, physician presence during the disclosure discussion is important from the patient's perspective and should be considered.

Steps in the Process

• Preparation: Preparation for the disclosure is essential but sometimes an overlooked element of the process. In preparing for the discussion, the facts of the event should be reviewed. What are known facts, as opposed to speculation about what happened? What caused the adverse event? How will this event affect the future care of the patient? When will more information become available? Who should be involved in the disclosure? Where should the disclosure take place?
• Starting the conversation: The start of the disclosure conversation can set the tone for the entire discussion. Begin the process by ensuring that participants know HIPAA privacy concerns and that the patient is comfortable with the discussion going forward with the parties present. Be aware of the patient's and family's health literacy and their ability to understand the information presented to them. Avoid medical jargon and be prepared to explain medical conditions and treatments in terms that the patient or family will understand. Remember that even highly educated individuals can have difficulty understanding medical terms while they are in a state of shock and grief over an untoward event.
• Presenting the facts: Avoid speculation and theories; describe what is known at the current time for the patient and family. Let them know that as more information is available, there will be further discussions. Finally, describe the next steps that will be taken. Such as:
  • Additional treatment the patient will receive.
  • What the organization is doing to determine what happened and, if appropriate, what steps will be taken to prevent the event from occurring in the future.

    It is vital that healthcare providers sincerely acknowledge the patient/family's grief and suffering.

  • Be honest, empathetic, and compassionate.
  • Encourage the patient to express his feelings, thoughts, fears, or anger about an adverse event.
  • Listen and be responsive to the patient's concerns.
  • Respond to questions with honest answers.
  • Ask open-ended questions, "Is there something you would like to ask?"
• Concluding the discussion: Summarize for the family the facts of the conversation and ensure their understanding. If necessary, repeat any questions raised by the patient or family. Be sure that the patient or family knows who will follow up with them after the discussion. Address any actions that the patient or family needs to take. Provide them with contact information to know whom to call if they have further questions or need clarification.
• Documentation: Documentation of the disclosure conversation should reflect the conversation's content, all plans discussed, the follow-up responsibilities of the participants, and the patient's contact person. Additionally, document the patient's understanding of the process. Questions on the location of this documentation should be directed to legal counsel, risk management, and the hospital's professional liability insurer.
  • Do not alter the record. Most attorneys would agree that this is the most self-destructive thing a provider can do.
  • Avoid remarks regarding liability insurance coverage.
  • Avoid jousting remarks about the hospital or other physicians.
  • Avoid discussion regarding peer review and quality improvement review. Peer review and quality analyses may lose their statutory protection if discussions are documented in medical records or shared outside the committee setting.

See MMIC's Documentation of the Discussions following an Unanticipated Outcome for more details on documentation.

Legal Protection around Apology

Some states have passed legislation, and others are drafting legislation prohibiting physicians' apologies or benevolent gestures from being used as evidence in malpractice suits while admissions of fault are not protected. An apology is meaningful. It is a powerful tool in maintaining the physician-patient relationship, and it can be instrumental in avoiding lawsuits. Expressions of sympathy with concern for the patient are encouraged without a specific admission of fault. See citation for Maine, New Hampshire, Vermont, and Massachusetts apology statutes.

Maintaining the Physician-Patient Relationship

Ongoing rapport is key to maintaining a patient-physician relationship. Inattention to your patient's concerns and expectations can damage this rapport. Both parties must make a mutual commitment to work through the issues to support the relationship. Elicit the patient's goals and values and collaborate when making treatment decisions.

• Express your commitment to the patient and be their advocate.
• Be available to the patient and family.
• Show concern and involvement in the ongoing care of the patient. Reinforce that you will continue to provide care and assistance.
• Inform the family when you will meet with them at a later time for a follow-up discussion.
• Promptly respond to telephone calls.

However, avoid direct contact with a patient who leaves your care or is represented by an attorney. At this point, the discussion should only occur with your liability insurance claims professional.

Risk Prevention

Adverse outcomes may be related to a systems deficit or a human factor such as fatigue. Analyzing the cause of the adverse outcome is a step to prevent a reoccurrence.

• Identify a problem and address it with a solution.
• Anticipate adverse outcomes by analyzing systems.
• Perform the analysis to find the cause, correct it, and/or prevent a similar outcome from reoccurring.
• Identify contributing factors that result in an adverse event.

Adverse outcomes may be avoided by reviewing literature, case studies, and learning from other past events.

Caring for the Provider

Often, providers involved in an adverse event have feelings of shame, guilt, and overwhelming sadness over the event. Some physicians and other providers have reported that they have found little support within their organizations. When providers are blamed and ostracized after an event, it creates a culture of blame and shame, where others are reluctant to admit to errors or work towards solutions.

Efforts have been made in recent years to recognize and support the providers involved in medical errors. Organizations such as the Agency for Healthcare Research and Quality and the University of Missouri Health Care have resources available to help with developing programs to support providers.

References

American Society of Healthcare Risk Management, Monographs: www.ashrm.org

• Disclosure of Unanticipated Events: The Next Step in Better Communication
• Disclosure of Unanticipated Events: Creating an Effective Communication Policy
• Disclosure: What Works Now and What Can Work Even Better

ECRI Institute. Disclosure of unanticipated outcomes. Health System Risk Management, 2018 May 7. https://www.ecri.org/search-results/member-preview/hrc/pages/increp5 (login required)

Thomas, M. O., Quinn, C. J., & Donohue, G. M. (2009). Practicing medicine in difficult times: protecting physicians from malpractice litigation. Sudbury, Mass.: Jones and Bartlett Publishers.

Risk Management Reporter, ECRI Institute, Let the Healing Begin: Caring for the "Second Victim" February 2013 Vol. 32, No. 1

State Apology Statutes

Maine:
https://legislature.maine.gov/statutes/24/title24sec2907-2.html

Vermont:
http://legislature.vermont.gov/statutes/section/12/081/01912

New Hampshire:
http://www.gencourt.state.nh.us/rsa/html/LII/507-E/507-E-mrg.htm

Massachusetts:
https://malegislature.gov/Laws/GeneralLaws/PartIII/TitleII/Chapter233/Section79L