A Conspiracy of Silence: Disclosure , Apology , and Restitution

Abstract

When patients are harmed by their treatment, they want three things from their doctor: they want the doctor to tell them what happened, say they are sorry, and tell them what will be done to keep it from happening to someone else. “What happened” is an acknowledgment that something went wrong, followed by an explanation of why it happened, and some guidance on what the future holds. If they have additional medical expenses or a disability, they also want compensation. Sadly, none of this happens most of the time [1].

When patients are harmed by their treatment, they want three things from their doctor: they want the doctor to tell them what happened, say they are sorry, and tell them what will be done to keep it from happening to someone else. “What happened” is an acknowledgment that something went wrong, followed by an explanation of why it happened, and some guidance on what the future holds. If they have additional medical expenses or a disability, they also want compensation . Sadly, none of this happens most of the time [1].

The psychological harm following injury can be devastating. Feelings of fear, betrayal, anxiety about the future, and anger are common. Yet this aspect of patient safety was scarcely mentioned in the medical literature or in discussions prior to the patient safety movement. An exception was the work of Charles Vincent , who wrote in 1994 about why patients sue doctors. He described the mix of feelings of fear, loss of trust, and not knowing what happened [2]. In fact, for the patient the psychological trauma often exceeds the physical. It is those feelings, not pain or a long convalescence, that they remember years later.

In 2003, Gallagher conducted focus groups of patients to learn about their experiences and opinions about disclosure . They corroborated Vincent’s findings. He found that becoming aware of an error in their care made patients “sad, anxious, depressed, or traumatized.” Patients feared additional errors , were angry that their recovery had been prolonged, and were frustrated that the error was preventable [3]. Patients said they would be less upset if the doctor disclosed the error compassionately and apologized.

(a) Charles Vincent and (b) Tom Gallagher. All rights reserved

While medicine seemed to pay little attention to patients’ feelings, there was a continuing thread in the medical literature over the years about the effects that errors had on the physician. Perhaps the most powerful was by David Hilfiker , who in 1984 wrote a poignant piece in the New England Journal of Medicine, “Facing Our Mistakes,” that described his personal anguish dealing with his patients and his own feelings after harming a patient by his error [4]. In 1985 and in 1988, Vincent reported on the devastating effect that making an error has on physicians [5]. In 1991, Albert Wu wrote of the problems house officers had in talking about mistakes and coined the term “second victim, “ [6] and in 1992, Christensen wrote of the profound effects of their errors on physicians [7].

The second victim ’s emotional state is potentially harmful to the patient as well. It clouds the physician’s judgment, increasing the risk of committing a second error . It makes empathetic communication difficult at just the time when it is most important.

But neither of these powerful forces—the devastating effects of unexpected harm on patients and on their physicians—was much in the discussion about communicating with patients after an error , either before or after the IOM report. Instead, the arguments tended to be framed in terms of duty: honest disclosure is the “right thing to do,” it is the “ethical” thing to do, “we have a professional obligation to be honest with our patients,” etc.

Not that it is the kind thing to do, the healing thing to do, the human thing to do. Nor that effective and empathetic communication is the necessary thing to do, that it is the appropriate medical treatment—effective and science-based—for this second injury we had caused.

And, although principles were declared and practices for disclosure were recommended by elite medical organizations, including the AMA and the Joint Commission , they lacked force; open and honest communication following medical harm remained the exception, not the rule.

As noted previously, the most powerful—and most remembered—event at the very first patient safety meeting, the 1996 Annenberg Conference , was the presentation of the case of Ben Kolb , a boy who died from a medication mix-up in the operating room. What was memorable to the audience was that the hospital was open and transparent about it from the beginning, admitting error and apologizing. It was memorable because it was so rare. Few medical people in the audience thought such a case would be handled that way in their institution.

The very word used to describe these conversations, disclosure , tells much about the problem. It clearly implies ownership and choice. Information about the details of what happened and possible wrongdoing is deemed to belong to the physician, not the patient; it is the physician’s choice whether, and how much of, this secret information should be disclosed to the patient. The high-flown rhetoric about honesty, honor, and professionalism and the duty to disclose reinforce the concept that the information belongs to the physician.

Not surprisingly, this idea is totally rejected by patient advocate groups, who reasonably ask, “Whose body is it anyway?”

Important as these concerns are, they have traditionally had little bearing on what actually happens. Rationality, empathy, logic, duty, and, sadly, even ethics play a distant second fiddle to the real reasons that doctors are not open and honest with their patients: shame and fear. Shame silences doctors, but fear drives the debate: the fear of being sued for malpractice .

Malpractice

It is not an irrational fear. The conventional wisdom for decades was that you made mistakes because you weren’t careful enough. It was your fault, doctor. This thinking was reinforced by the lawyers and the courts, who took the position that an error is by definition a failure to meet the standard of care; failure to meet the standard of care in turn is the definition of negligence , of malpractice .

This is not true, of course. Making a mistake is not negligence , it is part of normal human behavior. That is the point of the patient safety movement. But the lawyers didn’t believe that. They would have us believe that if you admit to making a mistake, or even if you acknowledge that something went wrong, you are asking to be sued for malpractice .

Defense lawyers—those who worked for hospitals and doctors—saw their responsibility as protecting the doctor or hospital from being sued regardless of whether there was negligence . The way they sought to do that was to get the doctors to “stonewall” from the beginning: tell the patient nothing, don’t admit error , and, by all means, never apologize. Liability insurers, anxious to minimize losses, reinforced this message. Many even told physicians that if they admitted error, their insurance would not cover them.

Doctors went along. Admitting error , especially an error that has hurt your patient who trusted you, is painfully difficult. Being told by an authority not to admit anything gave them cover for not doing something they really didn’t want to do. If the lawyers recommended it, then perhaps it was all right, even though it did violate their code of professionalism and even though deep down they knew it was wrong.

A word about malpractice suits. When a claim is filed, a protracted period of several years or more follows during which the physician must go back over the case in minute detail in multiple interviews with lawyers and depositions from the opposing side, while constantly dreading the trial itself. Often, the physician does not believe he did anything wrong. In fact, he may not even have made a mistake, or if he did, it was no worse than anyone else’s, and he certainly didn’t intend harm . But intent has nothing to do with it in tort law. (If the injury were intended, it would be criminal assault.)

Nor does the fact that we now know that almost all errors result from multiple systemic factors. In addition, in the USA, the focus of medical liability has long been on the physician, so that is who insurance policies cover. That is where the money is, so that is who the malpractice lawyer goes after. Medical negligence is about the individual not meeting the standard of care , defined as “what a reasonably prudent specialist should do under the same or similar circumstances.”

Although safety experts hold that in most cases it is the hospital that should be held liable since it is responsible for the systems that fail and cause harm , that is a relatively new concept and still not widely accepted. Moreover, most hospitals were, until recently, charitable organizations for which states have traditionally provided immunity or very limited liability.

In a malpractice trial, the plaintiff’s lawyer’s task is to convince the jury not only that the doctor’s action harmed the patient, but that the physician was careless, even reckless. The trial is an exercise in public humiliation, drawn out over a week or more: not only did the doctor do a bad thing, he or she is a bad person. No wonder doctors dread it and do whatever they can to avoid it.

Medicine is the only profession consistently subjected to this type of humiliation. Not just a few, but most physicians are sued at least once in their professional career, and some, especially those in the high-risk specialties such as vascular surgery and neurosurgery, are sued multiple times. The average neurosurgeon is said to spend 25% of their time in malpractice litigation.

In addition to fear of being sued for malpractice , doctors had other reasons to perpetuate a “conspiracy of silence.” Admitting a mistake, most believed, would undermine their patient’s trust of the physician. Colleagues would think less of them. Both their professional and their public reputations would be tarnished, perhaps irrevocably damaged. Referring relationships might be diminished and their income suffer.

But the most powerful deterrent to open communication is shame . The roots are deep within the physician’s psyche, the product of the high-achieving personalities that are attracted to medicine. It is enhanced by an educational system that sets perfect performance as the standard and of a cultural environment that reinforces it. Admitting—to yourself or to others—that you have made a serious error is admitting that you have failed to live up to your own standard of perfect performance to prevent harm to your patient.

For the physician, making a serious error is not just a practice failure, it is a character failure. The shame can be overwhelming. With their self-esteem so at risk, it is not surprising that physicians develop defense mechanisms, such as denial that an error occurred or displacement of blame to an underling. Failing that, they desperately want to keep it a secret.

When I first began to comprehend the power of approaching medical errors as systems failures in the early 1990s, it seemed to me that a systems approach would not only reduce harm to patients, it would immensely benefit physicians. If doctors bought into the concept that errors are caused by systems failures, not personal failures, the burden of shame and guilt would be lifted from their shoulders, enabling them to be open and honest with their patients. While this is attractive in theory, in practice it has yet to happen on any significant scale.

Not only have malpractice concerns totally dominated the thinking about disclosure , some have argued that full disclosure would significantly increase the number of liability suits and total costs. Their reasoning held that if all patients were informed about an error, a significant number of patients who otherwise would not have known would be added to the pool of patients who might sue [8].

The Contrarians

The first chink in the wall of silence appeared in 1999, about the time To Err Is Human came out. Steve Kraman and Ginny Hamm published the experience from the Veterans Administration Hospital in Lexington, Kentucky, which in 1987 had instituted a policy of full disclosure and compensation following harm from a negligent medical error . A review of 88 cases from 1990 to 1996 revealed total hospital annual payments were less than half the rate in previous years [9].

Unfortunately, although the entire VHA adopted a disclosure policy that patients be informed of unintended outcomes, it did not extend Kraman’s program to the entire system. VHA continued the practice of not explaining why things went wrong and not apologizing.

In Colorado, COPIC , the state’s largest liability insurer, in 2000 developed the “3Rs ” (recognize, respond, resolve) program of “no-fault ” compensation to forestall litigation. It provides patients up to $30,000 for out-of-pocket health-care expenses and lost work time. They do not offer explanations or apologies and make the offer only in cases where the patient has not filed a claim. It is a structured service recovery operation, in effect an expansion of long-standing insurance practices aimed at loss control. It has been effective in reducing litigation, however. In one reported 5-year period, it handled over 3000 cases and reduced payouts and lawsuits dramatically [10, 11].

The real breakthrough came a few years later when Rick Boothman , Chief Risk Officer of University of Michigan Health System, reported their experience with a program he instituted in 2001 of responding to claims by admitting fault and offering compensation if internal investigation revealed “that the injury resulted from care that fell below expectations.” The program was not limited to disclosure but linked to quality and safety efforts and expanded to identify injuries by various means. If an error was found, fault was admitted, and compensation was given for lifelong medical expenses, lost wages, and other costs —all without the patient needing to file a claim.

Analysis of results over a 5-year period following full implementation of the program showed a reduction of suits by 65% and decreases in legal costs and payouts to patients by more than 50% each. Total liability costs per year dropped from $3 million to $1 million [12].

Boothman emphasizes that the more important impact was on the culture . Full disclosure after unplanned clinical outcomes became the leading edge of changing the culture within the organization to increase transparency . Transparency is the key to a learning culture that facilitates internal reporting of adverse events and dealing with disruptive behavior and other performance problems. Full and open case investigations are necessary if we are to learn from our mistakes and advance the systems thinking that safety requires [13]. Boothman observed that in those organizations in which open disclosure failed, leadership did not connect it to their core mission and did not actively support adoption against the skeptics [13].

So, the arguments against full disclosure and apology were wrong: patients weren’t more likely to sue, they were less likely to sue. And the costs went down not up. Trust depends on honesty, so it is not surprising that patients’ trust in their physicians is enhanced, not diminished, by the doctor’s forthright admission of failure and taking responsibility for it. Being honest is not only the morally and ethically right thing to do, it is the smart thing to do.

An interesting sidebar: at a lawyers’ conference on malpractice that I attended about this time, a prominent Houston plaintiff’s lawyer boasted about the number of patients who came to him to sue their doctor and then said, “Ninety percent of them wouldn’t be there if the doctor had just told them what happened and said he was sorry!”

Physicians agreed in principle but had trouble doing it. They were cautious about how much to tell patients and believed that apology would be used as evidence of liability. They chose their words carefully, sometimes acknowledging the harm but not disclosing the error , why it happened, or what would be done to prevent recurrences. They were unlikely to discuss minor errors or near misses [3].

But things were beginning to change. At about this time, Gallagher issued a call for action by physicians, hospitals, certifying boards, accrediting bodies, medical societies, and medical educators to develop policies for disclosure , train physicians in communication, and provide support for patients and doctors [14].

Also in 2005, two senators, Hillary Clinton and Barack Obama, introduced the National Medical Error Disclosure and Compensation (MEDiC) Act that emphasized open disclosure , apology , early compensation , and analysis of the event. It was offered as a means of addressing both patient safety and the problems with the liability system. Although it never passed, it put the issue on the national agenda [15].

Doing It Right

Responding appropriately after a serious harmful event is not as simple as it may seem to those who have never had to do it. It is a highly emotionally charged moment for the patient and the physician. The patient is frightened, and if the harm resulted from an error the physician may be overwhelmed with feelings of shame and guilt. It is not a situation conducive to thoughtful supportive communication. The patient needs immediate reassurance from their doctor, primarily that they will be all right, and an explanation of what happened, but the initial talk is not the time to speculate on causes or details of what happened. They need to know what happened, not yet why it happened.

The physician should be honest and transparent, acknowledge that something has gone wrong, and explain what happened and what is being done to counter its effects. They should express regret—“I’m sorry this happened to you”—but avoid commenting on the cause of the event or apologizing, because investigation may reveal information that contradicts the initial assumptions of culpability. The patient should be told that an investigation will be carried out and the results will be given to them as soon as it is completed.

If investigation reveals that the injury was caused by an error , the physician needs to apologize. As the person responsible for the patient’s care, the doctor in charge is the one to apologize, even if the error was made by a resident, a nurse, the pathologist, or someone else. The patient looks to their personal physician to make sure care is safe. The other person should accompany the physician if appropriate.

The CEO or other high-ranking administrator should also be there to apologize for the failure of the hospital’s systems to prevent the injury. Although the patient understandably holds the person who made the error responsible, since errors result from systems failures , it is important for the patient to hear that from someone other than the physician, from whom it would seem self-serving.

A meaningful apology must include three elements: remorse, accountability , and amends. The physician must communicate their genuine deep feelings of sorrow, “I feel terrible about what happened.” They must also take responsibility, “We let you down, it should not have occurred.” The exact words are not critical, but it must come from the heart. Mere words, however “correct,” will not do.

Meaningful apology also includes making every possible effort to make up for the injury. This means financial compensation for all expenses related to the injury, present and future. In addition to medical expenses, these include lost wages, extra household costs , and long-term effects of disability. Without restitution, apology is a gesture.

These are difficult conversations, and they will not occur unless there is serious advance planning. Physicians need to be trained in disclosure —which is not easy since it is so painful for them—and they need support in the moment. They need help in apologizing. Fortunately, for most physicians these conversations occur rarely, but that means they need coaching and support when they do.

This is where the hospital comes in. Ideally, the risk management department has shifted its focus from limiting liability to limiting (emotional) harm to both the patient and the doctor and is integrated with the quality and safety programs and nursing and physician administration. If not, a team needs to be developed in the quality and safety group. A training program is essential for teaching physicians how to communicate in this difficult situation, and it should be required for all physicians, who will find it difficult and painful.

Hospitals must also have support systems for both the patient and the doctor, as well as the nurse and support staff. Open, honest disclosure diminishes the patient’s fears and anxiety, but it doesn’t take it away. The patient needs comforting and understanding. So does the doctor. Even if they succeed at communicating with the patient after a serious event as a result of their training and excellent coaching, the shame and guilt don’t go away. A colleague’s arm around the shoulder and a reassuring word can go a long way, but more is needed. A system is needed to make sure both patients and doctors get emotional support in these first traumatic days.

Some years ago, a seriously injured patient in Boston, Linda Kenney , began to create that system. From her own experience, Linda recognized that the best support would come from a peer – someone who had been through a similar experience. With Rick VanPelt , the anesthesiologist involved in her episode, she founded Medically Induced Trauma Support Services (MITSS) to help hospitals develop peer support systems both for patients and families and for clinicians and staff. Thousands of people have been trained by this program, which is now a division of the Betsy Lehman Center for Patient Safety [16] .

(a) Rick Boothman and (b) Linda Kenney. All rights reserved

Truly effective support requires changing the institution’s culture away from punishment to learning—the basic challenge of the safety movement. Away from the hushed comment and pointed fingers, from “Isn’t it too bad about Charlie” or “We all make mistakes” to a culture that really does look at an adverse event as a “treasure,” an opportunity to learn how the system failed—and fixes it. A culture that recognizes that, with rare exceptions, the physician is not the cause of the error but the victim of it.

When Things Go Wrong —The Disclosure Project

Gallagher’s work and Kraman’s and Boothman’s experiences changed the discussion in the patient safety world but seemed to have little impact on the practice in hospitals. Most of the principle players: hospitals, doctors, defense lawyers, and liability insurers were skeptical. The VA and Michigan were “different.” Too risky to take a chance—although, of course, it was “the right thing to do.”

Harvard hospitals were no exception. The ones that I was close to were not changing their policies or practices. CRICO , the Harvard hospitals’ umbrella liability insurance company that funded our early error research, was proud of its record defending doctors and saw no need to change. Despite my entreaties and those of others, they and the hospitals were loath to take a chance. They gave lip service to full disclosure but did little to facilitate it. I stewed about this for some time. I would teach my students about the importance of honesty, communication, and apology , but I knew it wasn’t happening.

How to get it moving? Perhaps if it were possible to get the leadership of all of the Harvard hospitals to agree on a uniform policy of full disclosure , apology , and restitution, it would stimulate their staff to actually do it. And if Harvard hospitals had success, perhaps that might persuade others that it was feasible and safe.

To see if this idea had any traction, I ran it by some of my frontline colleagues and friends: the safety leaders at the five major Harvard teaching hospitals. I asked them whether they were interested in exploring the issues about disclosure and apology . All responded enthusiastically.

The first meeting of what became the Disclosure Working Group was on May 10, 2004. Quality and safety leaders from the five hospitals were joined by two representatives from the Risk Management Foundation (RMF ) of CRICO , and one from the Institute for Healthcare Improvement (IHI) :

• Janet Barnes , nurse and risk manager at Brigham and Women’s Hospital (BWH)

• Maureen Connor , risk manager at Dana-Farber Cancer Institute (DFCI)

• Connie Crowley-Ganser , vice president for quality at Boston Children’s Hospital

• Frank Federico , pharmacist and quality leader at IHI

• Bob Hanscom and Luke Sato from CRICO /RMF

• Cy Hopkins , a quality and safety leader at Massachusetts General Hospital

• Hans Kim, quality specialist at Beth Israel Deaconess Medical Center

Review of their current institutional policies revealed that only three of the five hospitals had a written disclosure policy, and only one had a training program for physicians regarding disclosure . Clearly, we had work to do. Perhaps if we could spell out in detail what was needed and show how to do it, we would get buy-in.

At the second meeting a month later, we were joined by three new members, all physicians, Arnold Freedman , from DFCI , David Roberson from Children’s, and Rick Van Pelt from BWH . John Ryan , the key CRICO /RMF lawyer, would join us at the next meeting. At this meeting, we made an important decision: in keeping with the systems concept, the policy should not focus on errors , but on adverse events .

At the July meeting, we made an even more important decision. Rather than limit our efforts to disclosure policy, we would craft a comprehensive document that addressed all aspects of responding to unanticipated events. No such statement existed; there were major assertions about disclosure (ASHRM, Minnesota Children’s Hospital, etc.), and papers written about supporting patients and physicians, but no statements, policies, or recommendations that embraced all of the issues. Such a statement could have a major educational impact within our institutions at all levels. Much of the information and the rationale behind it would be new for many physicians.

The organizing principle, setting the “tone” of the statement, would be, “What is the right thing to do?” We defined the “right thing” as the institution taking responsibility to make things right by being open, informative, supportive, and restorative. We would try to break the mold of hospitals and doctors thinking about what is in their best interest to what is in the best interest of the patient.

We also agreed that the document needed to start off with the moral/conceptual justification for this work. We are talking about much more than just disclosure or dealing with malpractice or the “business case.” It is about hospitals meeting their obligation to respect patient’s integrity, be sensitive to their needs, and earn their trust . This is the “do the right thing” part. Something like, “We hold these truths to be self-evident, that all patients are entitled to ... ” (though not quite so grand—nor stolen!).

A bit late, but fortunately not too late, we suddenly realized that our group was missing the key stakeholder : the patient! To our great good fortune, Mary Dana Gershanoff and Gary Jernegan, co-chairs of the Dana-Farber Pediatric Patient & Family Advisory Council, were pleased to join us. When I told Tom Delbanco , an old friend and nationally respected physician patient advocate at BIDMC , about what we were doing, he expressed strong interest, so we asked him to join us as well. I was delighted, for his contributions were bound to be significant.

By March, we had a consensus document that we were happy with. We framed it in three parts: The Patient and Family Experience, The Caregiver Experience, and Management of the Event, with chapters on relevant issues. Each topic was organized into three sections: what should be done, why (the reasoning and evidence), and the specific recommendations. Following Tom Delbanco’s recommendation, we titled it When Things Go Wrong [17].

When Things Go Wrong

The Patient and Family Experience

Three issues were addressed: communicating with the patient, support of the patient and family , and follow-up care of the patient and family .

The initial communication should occur promptly, within 24 hours. Patients have a right to be fully and promptly informed of any incident as soon as it is recognized. The physician responsible for the patient’s care should acknowledge the event, take responsibility for it, express regret, and explain what happened. When results of the investigation are available, they should be communicated by the responsible physician and involve the CEO or CMO in serious cases. If an error was found, the physician apologizes.

Support of the patient and family addresses their psychological, social, and financial needs. Patients should be asked about their feelings, provided with psychological support, and given attention to their continuing medical care. Immediate financial assistance should be given if needed. Hospitals should consider paying for all future expenses due to permanent disability and continuing medical treatment.

Follow-up care after discharge from the hospital requires the care team to provide continuing psychological and social support by maintaining communication through scheduled follow-up visits and telephone calls.

The Caregiver Experience

Like patients and families, caregivers are significantly impacted, emotionally and functionally, following an adverse event . They need support to recover and to communicate appropriately with the injured patient. Hospitals need to have training programs in communication with patients when things go wrong, and how to deal with their own feelings. They also need “just in time” coaching when events occur and training in supporting colleagues when in need.

Management of the Event

The hospital needs to have an incident policy that sets expectations and provides guidance for the staff to improve patient safety by learning from adverse events and changing systems.

The elements of the policy are a commitment to open and honest communication, provision of just-in-time guidance, education of caregivers in empathetic communicating, provision of emotional support, and systems of documentation and reporting.

The initial response is first to stabilize the patient and eliminate any remaining threat, to secure implicated drugs and equipment, and to provide a substitute provider if needed. The care team must be promptly briefed to ensure consistent communication with the patient and family . The person to communicate with the patient and family is decided upon. An investigation should be done quickly while memories are fresh. The event is reported to the appropriate hospital authority.

Analysis of the event is essential for several reasons: to prevent, if possible, a recurrence in a future patient, to satisfy the patient’s right to know what the causes were and what is being done to remedy them, and to disseminate the learnings to other health-care organizations. Analyses should be multidisciplinary and nonjudgmental. The objective is to uncover the multiple factors that contributed to the event and, where possible, develop systems changes to make it less likely that the event will recur.

Documentation of the event is essential, as is reporting. The reporting policy should define the process for responding, identify who is to be notified, how, and by whom. Reporting must be safe for the caregiver and should lead to investigation and corrective action. When required, file reports with regulators.

We were pleased with our product. Nothing like this had been done before. We hoped it would motivate all of the Harvard hospitals, and others, to make major changes in how they handle patient harms . We made it clear up front that this was a call to action. Now to find out if anyone would respond to the call!

Getting Support

I went on a major selling job. RMF arranged a meeting with the Chief Medical Officers of all 14 Harvard-affiliated hospitals. I asked them to read the draft; discuss it with their local physicians, nurses, administrative leaders, and hospital counsel; and circulate it widely among staff. We asked them to tell us if this was an appropriate approach and to tell us how to make it better—within a month. They did—and we received a deluge of comments from many people in many of the hospitals. We were pleased that all were supportive of the effort, and we got a lot of good advice. This was the first step in building stakeholder support.

John Ryan , our legal representative from RMF , arranged for me to meet with the risk management lawyers from the major hospitals to get their input. At the meeting, I was pleased, and frankly a bit surprised, to find they had no problems with what we had written. That was a good sign!

However, they did have a concern that some doctors might apologize right away for something that was found on investigation to not be due to an error . Coming back to the patient later with a different story would be difficult. We changed the document to emphasize that the initial communication should be an expression of regret about the event. Apologizing would take place later if appropriate.

The committee member from each institution and I then met with all of the hospital CEOs and their key leaders, such as the CMO, CNO, and COO to discuss the paper and ask for their endorsement. We found them overall quite receptive. The CEOs of two of them, BWH and Children’s Hospital sent me letters of support.

In July, an unfortunate thing happened. Liz Kowalczyk , a health reporter for the Boston Globe contacted me. She got wind of our project—hardly a surprise, since by now probably over 100 people had seen the draft—but she had not seen the draft. I told her that we would welcome an article on the final version, after the hospitals had approved it, but because of the sensitivity of the subject, they would have a negative reaction to anything coming out before all issues had been settled. It would make it harder to get them to sign on. I asked her to hold off for now. Despite that, she went ahead and published a substantial article on July 24.

As predicted, there were some strong reactions—particularly the MGH . Their CEO , Peter Slavin , was furious. I met with him and assured him that we had released no information and would not until everyone was signed on.

By September, we had incorporated many suggestions and had the revised, final version of the report. I then sent it to the CEOs with the request that “your institution endorse the principles and concepts in the document and commit to implementing them in your hospital.” Recognizing that this would require approval at various levels, from medical executive committee to the Trustees, we asked for a response by December 1.

By November 15, we had a letter of endorsement signed by all seven of the Partners hospitals’ CMOs! By mid-December, we knew we would get letters from all the rest, so we made plans to publish in the spring.

After getting the endorsement from the hospitals, I went to Harvard Medical School to see if we could also get them to endorse it and be the organization to publish it. I thought the combination would be very powerful—a statement coming from the school and all of its teaching hospitals.

They requested I provide letters from all of the hospital CMOs, which was easily done, and present it to the Academic Council. The meeting went well, there were no difficult questions, and I left thinking they were supportive. In the end, however, they decided not to endorse it. Having “jumped through all the hoops,” I was very disappointed. It was yet another example of how difficult it is to navigate the political aspects of this sensitive subject.

Fortunately, their refusal did not hold us back nor have any long-term impact. Paula Griswold of the Massachusetts Coalition for the Prevention of Medical Errors Coalition was delighted to publish it. RMF agreed to pay for printing and mailing costs .

When the printed copies arrived, I went for maximum distribution. Copies were sent to the leaders of all of the hospitals, members of the Coalition , CRICO /RMF , IHI , NPSF , BCBS, as well as the head of every national organization with a stake in patient safety (AMA , ANA , AONE , Leapfrog, CAPS, advocacy groups, etc.) and to every person I knew in patient safety anywhere in the world.

It was well received. As we hoped, this comprehensive statement by an authoritative source gave those working in patient safety what they needed to start making disclosure and apology work in their hospitals. We hoped we had kick-started the process. Later feedback and citations in fact did indicate that it was widely disseminated and had significant influence.

National Progress in Communication and Resolution

While we were working to move communication and resolution ahead, the National Quality Forum (NQF ) also had a committee working on it, although none of us were aware of it. Eight months after we published our report, the NQF issued a new Safe Practice on disclosure . The key elements were that the patient should be provided the facts about the event: whether there was an error and the results of event analysis, the physician should express regret and give formal apology if the outcome was caused by error or system failure . Institutions were to integrate disclosure , patient-safety, and risk-management activities and establish a support system with coaching and emotional support for patients and staff [18].

The NQF action changed the ballgame. The NQF cannot require any institution to implement its Safe Practices , but it is the respected source that regulators and overseers, such as the Joint Commission [19], AHRQ , and the Center for Medicare and Medicaid Services look to for establishing standards. Activity picked up.

In 2007, Stanford University Medical Network launched a claims management process called Process for Early Assessment, Resolution and Learning (PEARL) . Although, like COPIC , it was not a full program that included apology and appropriate compensation for all injured patients, it did reduce suits and costs . They reported that in the first 3.5 years after implementation, claim frequency dropped 36%, with a cost savings of $3.2 million per fiscal year.

At the University of Illinois Medical Center at Chicago (UIMCC ) , Tim McDonald and David Mayer developed the “Seven Pillars ” program derived from work done at Michigan to integrate communication with system improvement [20]. Mayer was Associate Dean for Education who had a deep interest in patient safety. In 2005 he started the Academy for Emerging Leaders in Patient Safety, a week-long program on patient safety at Telluride for medical students. There were 20 students. The program has since been expanded to include residents and is now given in four locations to over 150 a year.

In the Seven Pillars program, quality improvement efforts were directed to define or improve systems for all seven stages of the process: reporting, investigation, communication and disclosure , apology and remediation, system improvement, data tracking and analysis, and education and training.

They later reported that from 2002 to 2013, the intervention at UIMCC nearly doubled the number of incident reports, reduced the number of claims by 42%, reduced legal fees and costs by 51%, and reduced the number of lawsuits by 47% [21, 22].

In 2009, at the direction of President Obama, the US Department of Health and Human Services authorized AHRQ to launch a demonstration project on communication and resolution programs under its $23 million Patient Safety and Medical Liability grant. UIMCC and the University of Washington (UW) were among four health systems piloting chosen. UIMCC ’s demonstration project demonstrated that it was possible to package training and tools to disseminate the Seven Pillars approach to DRP to community hospitals settings. The UW intervention trained 1300 health-care providers in teaching skills in disclosure and apology [22].

But the full application of Boothman’s work did not take off until Alan Woodward , an emergency physician and past president of Massachusetts Medical Society who was passionate about medical liability reform, and Kenneth Sands , chief quality officer of Beth Israel Deaconess Medical Center , developed a plan for getting widespread adoption of programs by involving all stakeholders .

They obtained a 1-year planning grant from AHRQ to create a roadmap for implementing a statewide Communication and Resolution Program (CRP ) model. They interviewed dozens of key stakeholders in the medical liability arena and identified 12 significant obstacles to implementation and developed strategies to overcome each. The roadmap provided a guide for action [23].

Woodward then did something quite remarkable to assure success: he brought the lawyers on board . He persuaded the Massachusetts Bar Association and the Massachusetts Academy of Trial attorneys to join the Massachusetts Medical Society to promote CRP programs statewide. Not just to participate but to join in leading the new effort. This was not to be just a doctors’ patient safety project.

(a) David Mayer and (b) Alan Woodward. All rights reserved

Their first task was to create a more supportive legal environment. They developed consensus language for legislation that mandated sharing of all pertinent medical records, a 6 month pre-litigation resolution period, strong apology protections, and the obligation of hospitals to disclose any significant adverse outcome [24]. Given the support of the key parties, the legislature accepted their language without change as part of the 2012 comprehensive medical reform act, setting the stage for moving ahead with the new approach.

To implement the roadmap, the group formed the Massachusetts Alliance for Communication and Resolution following Medical Injury (MACRMI ) with representation from statewide organizations with a stake in the medical liability process: physicians, hospitals, patient advocates, insurers, and attorneys.

MACRMI ’s goal was to develop, implement, and pilot a rigorous Communication, Apology, and Resolution Program (which it calls CARe ), collect comprehensive data to assess its impact, and assist its dissemination. Modeled after the University of Michigan Health System’s program, CARe promotes early resolution in cases of avoidable medical injury . When unanticipated adverse outcomes occur, patients and their families are provided full explanation of what happened, what it means for the patient medically, what will be done to prevent the error from happening again, and, where appropriate, a sincere apology and adequate and an offer of fair and timely compensation .

To achieve this goal, MACRMI developed an implementation guide with comprehensive resources, including best practices, algorithms, policies and procedures, teaching materials, and tracking tools (all available free on their website: www.macrmi.info). It then tested CARe and the toolkit in a pilot program in 6 hospitals over 3 years, collecting settlement data on nearly 1000 cases as well as patient experience and provider satisfaction survey information.

Data from the study showed that claims and costs did not increase, and more patients were compensated. The median compensation for these cases was $75,000, a number too low for a typical plaintiff’s attorney to take the case. Of cases that reached the resolution stage, 41% gave rise to a safety measure that was or was likely to be implemented by the hospital. These included new labeling for high-risk medications, color-coded socks for patients at risk for falls, and a multidisciplinary checklist for breech deliveries [25, 26].

As a result of MACRMI ’s efforts, 12 health-care institutions in Massachusetts are now using CARe , and a number of others are moving toward it. In addition, several entities in other states are in the process of implementing programs [27].

But the impact of MACRMI is much greater than the early adoption numbers signify. What we are witnessing is the beginning of a culture change in the way we think about and respond to those we harm . A change in thinking not just in a group of hospitals and a physicians’ group and a carrier, but in the governor’s office, in the legislature, in the plaintiff’s bar, in the defense bar and even in the courts. Patient safety—their welfare—and honesty are what CRP programs are about, not reducing losses in malpractice suits.

From the experience of those in Massachusetts, Michigan, Washington, and others around the country, AHRQ developed the CANDOR (Communication and Optimal Resolution) initiative to proactively engage health-care providers, patients, and their family in preventable harm communications. It combines early event reporting, analysis, prompt, supportive and compassionate ongoing communication to the patient, fast, fair resolution where warranted, and applying lessons learned to change systems [28, 29].

AHRQ developed a CANDOR toolkit with input from those facilities awarded grants and other experts to help hospitals implement CRPs quickly and promoted its adoption. Several large health-care systems, including CentraCare and MedStar Health, have made commitments to its implementation, and the Medical Professional Liability Association and the Doctors Company have given it strong support [30].

Conclusion

The extensive activity on all fronts over the past two decades has dramatically changed the landscape for communication and resolution programs , increasing awareness of the urgency for change and providing an array of mechanisms to help health-care organizations implement new systems and provide the training and support that are needed.

But the challenges are immense. Implementing an effective system of communication, apology , and resolution is the cutting edge of the larger issue of transparency . Openness and honesty in communicating with patients is difficult in an institution that is not transparent in other ways, such as freedom to discuss errors and a willingness to go public with its mistakes. Creating transparency requires strong leadership .

CRP is also about another crucial aspect of a safety culture that is too often overlooked in the emphasis on reducing blame: accountability . The mindset of doctors and hospital leaders has to change to putting accountability ahead of fears of litigation and loss of reputation. To do this, strong leadership is required. CEOs have to stand up to the lawyers and insurers and insist they play their roles in that mission.

Even with strong leadership and a skilled team, teaching physicians to communicate effectively and empathetically after a serious preventable event is difficult. Unfortunately, lip service to CRP often outstrips true implementation. Needing to fulfill oversight demands, some hospitals initiate program improvements that focus selectively on claims resolution rather than on comprehensive programs of full communication, apology, and restitution that prioritize patient support and opportunities for improving quality and safety. While some patients are helped, many are not, and there is little learning or system change . The culture really doesn’t change [31].

For all these reasons, it is not surprising that progress has been slow. From an historical perspective, however, a great deal has happened in a relatively short time. The vice grip of the dishonest and futile legal approach of deny and defend has been broken. Open communication and support are now at least part of the conversation in health-care organizations as the key organizations overseeing their behavior, AHRQ , NQF , TJC , CMS , ABMS , and ACGME, have incorporated it into their standards. The pace has accelerated. A better future is in sight for our patients and their doctors.