Can We Talk?

This week revealed the long-awaited results of a trial of the “Serious Illness Program,” the meticulously designed and carefully studied project of researchers in palliative care at Dana Farber Cancer Institute and at the Boston think tank, Ariadne Labs. Initially conceived of as a “checklist” by checklist enthusiast and founding director of Ariadne, Atul Gawande, the program has evolved into an educational program for clinicians. Specifically, it involves teaching physicians to use the “Serious Illness Conversation Guide” to structure discussions with patients about end of life preferences and values. In this study, carried out at 41 “clusters” comprised of 91 physicians, nurse practitioners, and physician assistants working within the Dana Farber orbit, palliative care physicians did the teaching and provided follow up coaching. Ultimately, only 35 clusters providing care to 209 eligible patients had evaluable data. What the results showed is that despite all the effort spread over a four-year period, the Serious Illness Conversation Guide failed to achieve any of its primary outcomes.

The researchers hypothesized that if physicians were trained to use the researchers’ communications tool, patients would be more likely to have “goal-concordant care;” that is, the treatment they received would be aligned with their wishes. In addition, it was hoped, they would be more likely to experience a peaceful end of life. Neither effect was observed. There was less anxiety and depression among patients whose physicians had been trained to use the Serious Illness Conversation Guide, though perhaps a less-labor intensive or qualitatively different approach would have achieved the same effect.

What should we conclude from the failure of this communications guide to achieve its goals? The authors blame it on the small sample size and low patient accrual rate. They point out that their conclusions are of limited generalizability, given that the patient population was predominantly white, affluent, and college-educated. The more fundamental question, however, is whether the intervention itself is valuable. Despite its being well-received by physicians, perhaps the tool is just not an effective approach to educating physicians in communication skills. 

An even deeper assumption of this study is that the major problem with end of life care is poor communication by physicians. A very different perspective formed the basis of the Robert Wood Johnson’s program, Promoting Excellence at the End of Life, which focused principally on educating and empowering patients. This program, despite an enormous financial commitment and extensive evaluation, also failed, as evidenced by the 1995 SUPPORT study, “The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.” The reality, I suspect, is that we need to simultaneously affect both physicians and patients if end of life care is to change. 

One more possibility to consider is that despite what patients say when given theoretical options such as "would you rather die at home or in the hospital?" or "when you are at the end of life, would you prefer comfort care?" in fact, when faced with the reality of a life-limiting illness, patients want all possible efforts at life-prolongation, whatever the personal cost, and they expect their physicians to provide them. Maybe they don't want to discuss options with their physicians. The language of obituaries, "he passed away after a long battle" or after a "heroic struggle" very likely reflects contemporary culture. We need to study what patients want when they are faced with an actual illness, not with an abstract possibility.

Us or Them?

Nearly 30 years have passed since Congress passed the Patient Self-Determination Act, enthroning advance care planning as an important part of care in the last phase of life. While the frequency with which patients designate someone to serve as their proxy in the event of incapacity has increased dramatically and the use of various planning instruments such as living wills and instructional directives has also risen, in most settings no more than one-third of patients with serious illness actually have conversations with their physicians about their preferences. 

Assuming that it’s a good idea for patients with serious illnesses to speak with their physicians about their goals of care, whose responsibility is it to raise the question? Does it make more sense to concentrate on educating physicians to communicate well about goals or to focus on empowering patients? 

Over the years, different initiatives have targeted one population or the other. The Robert Wood Johnson’s “Project on Death in America,” a multi-hundred-million-dollar project launched in 1994, focused to a large extent on prospective patients. The AMA’s program, “Education on Palliative and End-of-Life Care” (EPEC), also introduced in the 1990s, is targeted entirely to physicians (in fact, the “P” in the title used to refer to physicians: when first launched, the program was called “Educating Physicians on End-of-Life Care”.) More recently, a series of videos by Angelo Volandes of ACP Decisions aims to show patients and their families what various medical treatments entail, while the “Serious Illness Conversation Guide” from Susan Block, Atul Gawande and others at Ariadne Labs offers a checklist of questions to help physicians structure their discussions.

So, who needs more attention, the doctors or the patients? A new study in Health Affairs may offer some clues. I should point out at the outset that the Health Affairs article does not seek to weigh in on the question of whether to concentrate on physicians or on patients when designing interventions to promote advance care planning. The aim of the study, as indicated by its ponderous title, “Factors Contributing to Geographic Variation in End-of-Life Expenditures for Cancer Patients,” is to understand why some regions of the US spend so much more on care near the end of life than other reasons, with no discernible difference in outcomes. 

There are methodological problems with this study, as with all studies that start with death and work backwards—it is possible that although the people who died had similar outcomes (perhaps not surprising, as they all died), other people who weren’t considered in the study because they didn’t die were more likely to do well if more money was spent on them. Nonetheless, we have two groups of people with advanced lung or colorectal cancer on whom very different amounts of money were spent—in the lowest quintile, the average outlay was $10,131 and in the highest quintile, the average expenditure was $19,318). Was the decision to spend more coming from patient pressure or was it something that physicians were pushing for?

What the authors found was that in the high spending areas, physicians were less knowledgeable about treating dying patients (by their self-report), less comfortable providing care to patients near the end of life, and had less favorable attitudes toward hospice than their counterparts in the low spending areas. The high spending areas also tended to have more specialty physicians but fewer primary care physicians, as well as fewer hospices (per capita) than elsewhere. But—and here’s the key—patients’ beliefs about what they wanted were no different in high and low-spending areas.

All the statistically significant findings were in the domain of physicians, not patients:

Now, this finding does not directly translate into the question of who drives decision-making near the end of life in general and advance care planning discussions in particular. But it strongly suggests that physicians play an outsized role in shaping what happens to patients. Many patients don’t have pre-determined preferences; their values do not unambiguously determine what kind of medical treatment they should get. Or, if they do have some idea of what would be best for them, they are nonetheless strongly influenced by the views of their physicians. If “shared decision-making” is to work, both partners need to be informed and on board—and the physicians are particularly in need of some attention.

Much Ado About CPR

Two short essays in this week’s New England Journal of Medicine present differing perspectives on how to treat a desperately ill woman w in the ICU of an American hospital, a woman who is unable to make her own decisions and has no advance directive. One author responded that the right course of action was to “institute a DNR order” and the other that it was to “continue full resuscitative measures,” setting up a quasi-debate. I say a quasi-debate because the two authors, as per the editor’s instructions, simply laid out their own arguments without responding to the other’s point of view. I know, because I am one of the two.

I asserted that the physician should declare the patient DNR—a woman with no written advance directive and no designated health care surrogate who was dying of multiple organ failure triggered by sepsis and unresponsive to maximal medical therapy. Attempted CPR in this setting, I argued, was as close to futile as medical treatment ever is; moreover, the patient had clearly stated to a friend and neighbor that she would not want aggressive measures when facing overwhelming odds. I stand by my arguments, which I won’t repeat here, but I regret that the discussion focused on the wrong question.

The wrong question is whether the patient should have a DNR status; the right question asks about the general treatment strategy rather than a specific medical intervention and about the process for deciding, not just the outcome of the process. It moves the discussion beyond considerations of futility—a debated that raged in the 1980s and ultimately led to the recognition that futility is meaningless without reference to what treatment is intended to accomplish. Maintaining a patient who is in a persistent vegetative state on artificial nutrition is futile if the goal is to restore her to full functioning as a thinking human being. But it’s entirely appropriate if the goal is to sustain life in the sense of a heart that beats and lungs that respire. Discussing how to make medical decisions for patients who have lost capacity and how to think about treatment for those who are dying allows us to discuss much more important decisions than whether or not to attempt CPR.

Ever since 1984, when a New York hospital was found guilty of putting purple dots on patients’ charts signaling that they were not to be resuscitated—without their knowledge or input or that of their next of kin—we’ve been obsessed with DNR orders. I suspect that more ink has been spilled on whether, when and why to write a DNR order than on any other medical decision. The reason, presumably, is that it seems irreversible: if a patient sustains a cardiac arrest and CPR isn’t performed, the patient will surely die. Other seemingly momentous decisions often prove not quite so momentous—even Karen Ann Quinlan, the first patient to bring the possibility of not intervening medically to public attention, lingered for nine years after her “life-sustaining” ventilator had been disconnected. A choice not to resuscitate is far more unambiguous—although CPR, it should be pointed out, is hardly a guarantee of life.

Cardiac arrest may have special cachet because it seems to divide the living from the dead. But in fact, for older patients who are critically ill, it is often merely the last step in what is often a relentless progression of markers on the way to death. From the perspective of human suffering and of doing good (and avoiding harm), other steps along the way are often far more significant. After all, a person whose heart has stopped and who is not breathing is no longer able to experience anything, neither the existential angst from awareness of imminent death nor the physical discomfort of aggressive treatment. The nurses and doctors who attempt CPR in a dying patient may feel guilty of assault; they often regard intubation, chest compressions, and electrical shocks as an undignified way to end life, but they are the ones experiencing malaise, not the patient.

Subjecting a patient who is in the final phase of life to dialysis for four hours a day, three times a week, or to major surgery to repair a damaged heart valve, or to ventilator care for advanced lung disease, by contrast, may cause pain and suffering to the person receiving treatment. Both the potential benefit of treatment (longer life) and its potential burdens (ranging from delirium and functional decline to a shorter life) are difficult to assess quantitatively. These decisions, which are difficult to make with a competent patient and correspondingly more fraught with an incapacitated patient, are the ones we should be discussing, not CPR.

Ironically, despite the now 42-year history of DNR orders, there is still confusion about whether DNR indicates that CPR will not be performed in the event of a cardiopulmonary arrest (as it is defined by the American College of Cardiology and other authorities) or something more. Indeed, the opposing piece in the New England Journal of Medicine talks about a time-limited trial of “continued resuscitative measures,” which presumably refers to ongoing ventilator treatment for respiratory failure, dialysis for kidney failure, and fluids and antibiotics for sepsis, rather than for a few minutes of attempted CPR. This uncertainty about what DNR means reflects another problem with the obsession with “getting the DNR order,” and that is the widespread belief that treatment decisions must be all-or-nothing: if you don’t want CPR, then surely you don’t want any potentially life-prolonging medical interventions. The reality is that many people don’t want burdensome treatments that are extremely unlikely to be beneficial, but that doesn’t mean they want to focus exclusively on comfort. 

There’s much more to discuss—I haven’t even touched on the process for making medical decisions. That includes not only who the surrogate should be in the event of decisional incapacity and what standard that surrogate should use for making decisions (substituted judgment is the usual standard, with best interests the back-up if no information about the patient’s preferences is available), but also how the discussion should unfold. Typically, physicians are so eager to reach a decision about what to do that they jump to this step in the process without first clarifying the patient’s underlying health state (in the NEJM vignette, the crucial bit of information is that the patient was dying), as though preferences are independent of any broader context. But for now, let me leave you with the thought that both medical decision-making and advance care planning involve much more than checking off items on a menu, and that if we do engage in intervention-specific planning, CPR should be low on the list of what we discuss.

Can We Talk?

This week, the Massachusetts Coalition for Serious Illness Care released the results of a survey of state residents about advance care planning. The coalition wanted to know whether people were talking about their preferences for care near the end of life and if so, with whom—family? Physicians? The concern was also with whether people who had suffered a serious illness over the preceding year were more likely to have had such conversations and whether factors such as age, ethnicity, or gender influenced behavior. And regardless of whether people had discussed their views, had they designated a health care proxy, a substitute decision-maker in the event of incapacity?

On the assumption that more talk is better, it’s difficult to spin the results as encouraging. Massachusetts residents do not talk much to their doctors about such issues, even if they have had a serious illness and even if they are over age 65—although these two groups do have appreciably higher talk rates than their healthier or younger counterparts. On average, they are not very different from people in the rest of the country and the rates of conversation have not appreciably changed since the last such survey was administered in 2016.

In the population as a whole (the survey sampled adults over the age of 18), only 13 percent had had a conversation with a health care provider about their end of life preferences. Among those with a serious illness or over age 65, this rose to 27 percent.

Those surveyed were more likely to have chosen who would make decisions for them than to talk about what their surrogate should decide, with 63 percent of those over 65 having completed a health care proxy form. 

Perhaps what’s most interesting is that among those who reported they had had a discussion of their wishes, 59 percent said they had initiated the conversation, not the physician or other member of the health care team. Moreover, 34 percent of those surveyed said they did not want to have such a discussion with their doctor—they felt confident that their family members understood their wishes.

Before we get too carried away by the numbers, we should note that only about 210 of the participants were over age 65 (according to the 2010 Massachusetts census, 14 percent of the population was over 65; there were 1500 people sampled in the survey). That’s not many people on whom to base sweeping conclusions and this is the group for whom advance care planning is most essential.

Which leads me to my conclusion: advance care planning doesn’t make much sense in young people or healthy people. The likelihood that such a plan will have to be implemented is just too remote (Karen Ann Quinlan, Nancy Beth Cruzan, and Terri Schiavo notwithstanding—they are the exceptions, not the rule) and the chance that their perspective on what they would want if they were in an unimaginable future state reflects what they would actually want if such a situation came to pass seems slim. Efforts to think about future wishes make most sense for people who already have the condition that is apt to kill them in the future. Once they have started on a particular path, they are better positioned to think about the next steps on that journey.

Geriatricians learned a long time ago that “targeting” interventions to the appropriate population is crucial if they are to be beneficial (and cost-effective). Proponents of advance care should likewise concentrate their efforts on the people who stand to gain the most from discussions of the goals of care—and who are in a position to imagine their future. Even in this arena, we have a great deal of work to do. But spreading our efforts too thinly won't help.

As Simple as ABCD: A Better Care Directive

Kudos to Barak Gaster, a general internist at the University of Washington, who has developed a dementia-specific advance directive. In this document, he starts out by explaining what dementia is and why patients and families might not want every possible medical treatment throughout the course of this long illness. Then he simply and clearly characterizes each of the three main stages of dementia: mild, moderate, and severe (or early, mid-stage, and late) and asks what the goal of care would be in each instance. 

I like the framework because it's basically what I have used for the past twenty years in articles and books. Gaster uses the same formulation that I propose—prolonging life, maximizing comfort, and something in between that is related to maintaining function and dignity—but adds one more option, life prolonging therapy minus attempted CPR. That’s it. No long list of potential treatments, ranging from ventilators to iv’s as with typical instructional directives (or, indeed, with the POLST, which is an instructional directive turned into a medical order). No complicated list of symptoms for each of the three stages of dementia, a list that leaves people reeling and uncertain about just what stage a given person is actually in.

            

Here are the parts of the document:

    1. What is dementia? Three short paragraphs indicating that Alzheimer’s disease and other dementias are progressive, ultimately fatal diseases. Indicates average time from onset to death (says 8 years, though some of the data I’ve seen indicate 5-7 is more accurate). Highlights features of last stage.

     2. Why is it important to express your wishes? Emphasizes that patients lose capacity and families benefit from receiving guidance.

     3. What kind of guidance can you give? Explains that tests and procedures are more difficult to tolerate as dementia progresses. Also emphasizes that many people would not want life-prolongation as their thinking and ability to derive meaning from life deteriorate.

     4. Stages of dementia:

     

     Stage I (mild): lose ability to remember recent events; 

     routine tasks become difficult (ie cooking); other tasks can

     be more dangerous (ie driving).

     

     Stage II (moderate): lose ability to have conversations and

     to understand what is going on around them. Require full 

     time assistance with dressing (I would quibble over this one;

     people do need some help with their “activities of daily

     living,” one of which is dressing, but I don’t think singling out

    dressing and saying “full time assistance” is needed is quite

    accurate.

    

    Stage III (severe): no longer able to recognize family, may become angry and agitated (one caveat here: agitation often starts in moderate dementia); need round the clock help with all daily activities.

    Even the description of the goals of care are well done: there is some explanation of why a person might choose a particular goal. For example, if the goal of care is “to only receive care in the place where I am living,” the text clarifies that the reason for not wanting to go to an emergency room or be hospitalized is to avoid the “possible risks and trauma that can come from being in the hospital.”

    For people who find images helpful to elucidate the words, I suggest viewing the videos from acpdecisions.org addressing dementia. Angelo Volandes, president of ACPdecisions, has filmed a series of dementia-related videos based on the script I offered: one addresses the stages of dementia, and another details the goals of care across the spectrum of the disease (suggesting that many people favor different goals as the illness becomes more advanced).

    

    The proposed new "advance directive for dementia" is a

    valuable contribution to the tools available to help individuals plan for the future. I hope it will be used widely--and that individuals who are physically frail will also engage in a similar type of advance care planning. It's high time we recognized that thinking about the future is not just for those who have no future.

One of the major mile posts in biomedical ethics was the passage of legislation that today’s medical residents—and I daresay most Americans—have never heard of, the Patient Self-Determination Act of 1990. Certainly all those who inveighed against “death panels” and who balked at the idea that the Affordable Care Act might include provisions allowing Medicare to reimburse for advance planning conversations never heard of it. This act, as its title indicates, was intended to put patients in the driver’s seat, to allow them to weigh in on the approach to medical care they would get at the end of life, even if they were unable to participate in decisions at the time those decisions need to be made. It officially sanctioned advance directives by enshrining them in federal law. 

What the PSDA says is that any health care institution receiving government funds, which is to say virtually all health care institutions, is obligated to ask patients if they have an advance directive, to offer them the opportunity to complete one if they don't, and to prominently display a copy of that directive in the medical record if they do. The PSDA put advance care planning on the map. It also put advance care planning squarely in the legal domain and that, as the authors of a new article in the New England Journal assert, was a big mistake.

What “Delegalizing Advance Directives—Facilitating Advance Care Planning” argues is that a major reason that advance directives haven’t caught on is that they typically have to be signed by two witnesses (or a notary), and in some states (North Carolina, South Carolina Virginia, and Missouri) a notary; some states also require use of a specified form. I agree that these requirements are an impediment to widespread use of advance directives. I agree that the POLST (Physician Orders for Life-Sustaining Treatment) model, which uses a medical order rather than a legal document and just requires the signature of the patient and the physician, puts advance care planning unambiguously within the medical sphere. But I don’t think that simply allowing patients or prospective patients to designate a health care agent, or surrogate decision-maker, without use of a mandated form and without witnesses would solve the problem. 

The real problem is not just that people don’t bother with the forms and that the forms don’t always make it into the hands of clinicians. The real problem, as Charlie Sabatino of the American Bar Association put it in a 2010 article, is that advance directives are based on a transactional view of advance care planning rather than a communications model. And what we now understand is that advance care planning has to be founded on dialogue between a clinician and a patient.

The problem with advance directives is not that they have to be witnessed or written on special forms. If that was the problem, we’d expect to see much higher utilization rates in Idaho, where there are no witness or notary requirements, and somewhat higher utilization rates in Utah, where only one witness is required. The problem is that they reduce advance care planning to completing a form, to checking off boxes on a list. 

In Idaho, for example, individuals have the opportunity to say that if they are ever unable to communicate and “have an incurable or irreversible injury, disease, illness or condition,” and that a medical doctor, based on a physical examination, has concluded that the “injury, disease, illness or condition is terminal” and that “death is imminent” no matter what is done, and that the “application of artificial life-sustaining procedures” would only artificially prolong life, then they would (or would not) want medical treatment and procedures, nutrition and hydration, hydration but not nutrition…

The lawyers who design such forms believe they allow people to indicate with great precision just what they would want and under what circumstances they would want it. But in fact, as many others have observed, it is far from clear what exactly it means for a condition to be terminal. I would argue that dementia is a terminal disease—but with a typical time course of about five years from the time of diagnosis to death. Ah, you might say, but the advance directive forms include the qualifier that death must be imminent. But that's not good enough. How imminent? In a matter of hours? Days? Months? And if we could agree, based on a careful reading of the text of the directive (which I’m not so sure we can), that what is meant is the person has a  disease that in the normal course of things results in death within six months and that the person's disease has progressed to the point where death will occur within at most days; then is it really so useful to specify that in those very limited circumstances we wouldn’t want treatment that won’t make a difference anyway? Is that all the advance care planning is about—stopping futile treatment in the 72 hours of life? And what about “treatment” that is symptomatic, that is intended to ameliorate suffering, rather than to prolong life, though it might, as an unintended consequence, prolong life. Are such “medical treatment[s] and procedures” to be rejected?

Advance care planning, as we have come to understand it over the last several decades, is not about procedures or treatments—or checking boxes. It is about reflecting on what’s important, in the context of a realistic understanding of a person’s medical condition. It's about figuring out what medical treatments are most consistent with achieving whatever it is that the patient deems important in life. 

Making it easier to complete a form will not transform advance directives. Conceptually, advance directives are legal documents, whether or not they must be witnessed or notarized or completed on special paper. What people need is not a better document. It’s a different process, a process that is built on communication and that deals with the purpose of medical treatment, not the technical means of achieving those ends.

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