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.

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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You Only Die Once

The palliative care community has been rallying to defend itself this past week in the aftermath of a scathing attack in the New England Journal of Medicine.  A short article written by Scott Halpern, a specialist in intensive care medicine, asserts that none of the approaches used by palliative care clinicians, and he singles out advance care planning tools such as physician orders for life-sustaining treatment (POLST) and videos depicting CPR, have been proven to work. He implies that the only way to know whether they are effective is to use the same criteria as those employed by the FDA in approving a new drug: typically, large, multi-center, randomized clinical trials. Superficially, this seems advisable—or even, to use the language that Medicare invokes in determining what it will cover—reasonable and necessary. It is, after all, a plea for evidence-based medicine, and surely all right-thinking physicians are in favor of using scientifically supported treatment. But to propose that we can learn all we need to know about how to provide excellent palliative care from randomized, double blind, placebo-controlled trials, studies in which two groups are compared that are identical in all respects except for the intervention being tested, is sadly naïve and hopelessly reductionist.

Advance directives are promoted to enable patients to shape their own destiny by choosing, with input from their doctors, how they will be treated when they are seriously ill. Advance care planning seeks to protect patients by safeguarding their autonomy in the event of incapacity; it also aspires to help all patients prepare for the future, even those who retain their cognitive capacity. It’s difficult for anyone to think clearly in the throes of serious illness; prior consideration of the goals of care can provide a useful framework for decision-making under stress. But if the point of advance care planning is to encourage patients to think about their goals and preferences and to allow them to have a say in their care, then readily measurable outcomes—things like how much pain patients experience at the end of life or how many procedures they have or how long they live or what their care costs—are the wrong endpoints.

A randomized trial doesn’t make any sense in this setting: we cannot compare patients who participate in advance care planning (cases) with those who do not (controls) and measure whether the planners are more likely than the non-planners to get the kinds of treatment they want. Such a comparison presupposes that everyone actually knows whether he or she wants attempted CPR or a ventilator or third line chemotherapy in much the same way that people know whether they prefer vanilla or chocolate ice cream.  But choosing between vanilla and chocolate requires that people have already tasted both and arrived at a conclusion about which they like more. With end of life medical treatment, patients seldom have any prior experience on which to base a decision. They need help in imagining what they will go through with the various alternatives. And they can’t sample the different possibilities and then decide (though a limited trial is sometimes possible): they will only die once. Nor is it accurate to believe that all patients have well-formed preferences, based on their religious beliefs or values, and that advance care planning simply informs the medical profession of those preferences. In many cases, patients don’t have clear preferences. The essence of good advance care planning is that it elicits preferences—it helps patients figure out what makes sense for them, given the realities of their medical condition.

I’m not suggesting that all formal study of advance care planning is meaningless. Demonstrating that patients who go through a planning process are satisfied with their experience is important. So is comparing different approaches to figure out which one is best received (or perhaps which patients like which strategy). Assessing whether patients who engage in advance care planning are more knowledgeable about their options than those who do not is also useful. So are studies of the implementation of the advance care planning process: finding out whether advance directives (written documentation of the planning process) are available to physicians at the time when decisions need to be made and measuring the concordance between those requests made in advance and what actually happens. All these sorts of studies have been done and collectively make the case that advance care planning is effective.

Although Dr. Halpern longs for a large, randomized controlled study to definitively determine whether advance care planning “works,” he seems to be aware of the inaptness of his FDA analogy. He therefore proposes analyzing electronic medical records using natural language processing as a way to draw conclusions about the efficacy of various palliative care interventions, including advance care planning. Nice idea, but I’m skeptical. It’s not that I’m hostile to natural language processing or totally ignorant of its power: my son has a doctorate in computer science with a specialty in natural language processing and does remarkable work studying how machines can determine the meaning of text. My husband is the co-founder of a tech start up that makes extensive use of natural language processing. It’s a promising technique with many as yet undetermined applications. Maybe it will even prove useful in evaluating advance care planning. But surely we don’t know that. In fact, there are strong a priori reasons for thinking that mining chart notes for words that describe a patient’s experience won’t do anything other than measure how likely a physician is to ask patients about their feelings and to record their answers.   

You might think, reading the New England Journal article, that all of medicine, apart from palliative care, has been subjected to the standards demanded by the FDA. You would be mistaken. A great many of the tests and treatments used regularly by physicians have not been tested with any kind of rigor. But even more to the point, physicians still use their judgment in deciding whether to use a given drug in a given patient, even when that drug has been shown in a carefully conducted randomized clinical trials to be superior to the alternatives. Randomized clinical trials are typically carried out in patients who have nothing wrong with them except the condition being studied. Those patients are rarely over age 65. That vaunted FDA-approved pharmaceutical is then used in 85-year-old patients with multiple chronic illnesses. Maybe it will work just as well. But maybe it won’t work at all or will even cause serious side-effects. It might hasten death. Does Dr. Halpern only use treatments in his ICU that have been demonstrated in a randomized trial to be effective—and to be effective in a patient with exactly the combination of heart failure and diabetes and dementia that the patient before him has?

Of course we need to evaluate the tests and treatments that we use in patients. But we should use whatever method is most appropriate for the situation we are studying. Sometimes it will be a randomized clinical trial. Often it will be a combination of other kinds of studies, some of which may be qualitative. Whether we conclude that the test or treatment should be used will depend on the preponderance of the evidence. Only rarely will we know, beyond a reasonable doubt, that we are doing the right thing.