CARe: Resources for clinicians

Likely, your institution has a system in place for responding to adverse events and/or near misses that you should follow. You, your attending (if you are a trainee or student), or a faculty member will most likely notify patient safety or risk management personnel by calling them or filing an event report.

You do not need to decide whether the case is appropriate for CARe before calling for help.

The patient safety or risk management department will be able to offer resources and, ideally, will guide involved clinicians through a number of best practices which may include all or some of the following, depending on the nature of the event:

• Disclosure coaching to guide the clinician about how to communicate about the adverse event with the patient and/or family
• Event analysis to determine what happened and why 
• Peer support for those involved

1. Document the adverse event in the medical record.
2. Make the initial communication to the patient or family member as soon as practicable, ordinarily within 24 hours.
3. Document the initial communication with patients in the medical record detailing who was present and what was discussed.
4. Add the event to your patient safety reporting system. All adverse events, even near misses, should be reported.

Consider disclosure if:

1. You would want to know about the event had it occurred to you or a loved one; or
2. It will result in a change of treatment, now or in the future.

In some cases, clinicians may struggle with deciding whether a disclosure may do more harm than good. Some events clearly meet the threshold for disclosure, but pose unique ethical challenges. One example is if the patient or family member lacks capacity to understand the conversation. Such situations should be viewed as the rare exception to the norm, and decisions to withhold or delay disclosure should be made carefully with input from an ethics advisory group, and documented carefully in the patient record.

Patients want open and honest communication after medical error. Focus group studies show that patients want:

• An explicit statement that an error occurred
• What happened and the implications for their health
• Why the error occurred
• How the mistake will be prevented in the future
• An apology
• Honest, empathic communication

The first step to approaching a disclosure conversation is to get help. No matter how senior or experienced you may be, it is always helpful to talk through and practice what you plan to say with a coach or trusted colleague. Most health care organizations have guidelines for communicating with patients and families after adverse events and medical error.

These types of guidelines can be helpful to prepare for the conversation, conduct the discussion, and debrief and document after meeting with the patient and or family. Most sets of guidelines include details on:

• Getting help
• Explaining what happened (facts as known)
• Describing the implications for the patient's health and treatment plan
• Offering genuine expression of regret and apology
• Discussing the plan for investigation and analysis
• Discussing how recurrences will be prevented
• Establishing contacts and supports so it is clear who patients and families should follow up with as questions arise

Although some clinicians worry that open communication about and apology for error may increase liability, data in Michigan and in Massachusetts suggest that it in fact decreases claims. Studies, such as these published in the New England Journal of Medicine and The Lancet, have shown that patients who pursue litigation often do so because they did not receive clear, empathic, and effective communication after an adverse outcome. They felt they weren’t told the truth and that no one took responsibility. Patients and families want to learn the whole story, receive an apology, and have assurances that steps are being taken to prevent similar incidents from happening to other patients. In addition, mock jury trials suggest that in cases where full disclosure and apology are delivered, juries focus on meeting patients’ financial needs, whereas those cases without full disclosure and apology may prompt juries to consider punitive measures toward the physician or institution.

Additionally, several studies across the country of facilities that have implemented CARe programs demonstrated that claims either remained flat or decreased with CARe programs in place.

Communication after harmful events can be challenging, even for experienced providers. Each patient and family member has distinct needs and reactions. While guidelines can help guide the conversation, disclosure of medical error requires constant flexibility and adaptation. Here are a few common pitfalls and how to avoid them:

• "Your loss is our learning opportunity." Some clinicians will focus too much on quality improvement, and assuring patients that the institution will learn from the mistake. While these are important reassurances, timing is everything. In the wake of an error, focusing on QI to the exclusion of the individual patient’s needs and emotions can backfire.
• "All's well that ends well." In cases where no significant harm persists, clinicians can adopt this mentality, relieved that the patient suffered no permanent harm. Still, the event is understandably concerning and frightening to patients and may require time and space for emotional reactions to what happened.
• "Just the facts ... " Clinicians are encouraged to avoid speculation and focus just on the facts when discussing an adverse event with a patient or family member. However, some clinicians take this to an extreme, feeling nothing can be known for certain, and therefore impart little if any meaningful information to the patient. Patients and families need a plausible explanation of what happened as soon as one is known. Avoiding speculation needs to be balanced with providing patients and families with a fair understanding of the event.

Some organizations offer in-person peer support for clinicians and staff to connect with colleagues who have had a similar experience. The Betsy Lehman Center's Virtual Peer Support Network connects doctors, nurses, and other health care workers with trained peers across Massachusetts.

This will vary considerably based on the organization you work for, the extent of the harm to the patient and many other factors. Likely, members of the patient safety team, patient relations and other departments will be part of these conversations as well. Patients are encouraged to seek legal counsel even if they are involved in a CARe case.

Remember that the benefit of CARe is that all legal and medical issues and concerns from all parties will be aired together in a collaborative environment so that the patient can receive appropriate compensation in a timely manner. Evidence shows that being honest about what occurred has positive implications for patient relationships, emotional well-being, and even financial consequences. During CARe meetings, patients should be told the truth and the information should be no different than what would be revealed in a courtroom. If an error was made, it should be admitted in a CARe meeting.

This determination is a complex process. First, there is an internal institution-led review which informs an insurer review. The insurer will use the hospital's internal review, evaluation of the standard of care and causation of harm, and expert reviews to determine whether there will be any apportionment to the physician. Reviews are very thorough and the insurer will make efforts to ensure that the allocation is understood and accepted by the physician involved.

Yes, but only if the fault was apportioned at least partially to you, and not entirely to the system. However, there is a new way to report cases resolved through CARe with the NPDB, which indicates your willingness to be transparent and honest with the patient in the resolution process. More details can be found here.

Patients are entitled to know the facts of their health care. Caregivers are encouraged to be empathetic and honest about the clinical details of a patient's care, but should be careful to distinguish facts from speculation or premature judgments about the reasonableness of anyone's care. Speculation and premature judgments can often be counterproductive and can even be harmful to patient and caregivers alike regardless of later admissibility determinations. The goal, of course, is to be honest and forthcoming, so admissibility may not play such a crucial role as it once did in claims or suits.

In Massachusetts, any statement of apology, regret, mistake or error is not admissible in court proceedings arising from the mistake or error unless a contradictory or inconsistent statement is made under oath. A best practice is to use statements of regret until all the facts are known about the event. Conversations with the patient and family about the findings of the event review and investigation are admissible, and should be - these discussions are intentionally open and transparent and should be the same as what is stated in a courtroom.