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.

Shocking News

Much has been written lately about over-treatment of older patients. Only rarely does anyone suggest that older patients are getting too little treatment, but a new study in JAMA does just that. The reality isn't quite so clear.

The treatment is the implantable cardioverter defibrillator (ICD) and the patients are people over the age of 65 who have had a heart attack and are found afterwards to have a weak heart (defined as an ejection fraction less or equal to 35%). These patients are at risk of sudden death, of an irregular heart rhythm such as ventricular tachycardia, and the ICD is designed to deliver an electric shock if that happens, effectively bringing the patients back from death. By looking at the National Cardiovascular Data Registry, which keeps track of heart attack patients, the authors of the article found that only 8.1% of “eligible” patients actually received an ICD. As a result, they claim, the 92% of patients who didn’t get an ICD were more likely to die than their counterparts who did.

This is a surprising finding in light of the persuasive and cogent argument made by Sharon Kaufman in her recent book, Ordinary Medicine: Extraordinary Treatments, Longer Lives, and Where To Draw The Line. Kaufman makes the case that many high tech treatments come to be seen by physicians and patients as normal and necessary once Medicare agrees to pay for them. The end result for many marginally beneficial, burdensome, and expensive treatments, including the ICD, is that patients just can’t say no. If that's true, why are so few older people getting an ICD? 

Now it wouldn't be the first time that ageism or misinformation prevented older people from getting beneficial treatment. Many years ago, patients who were over a certain age were precluded from receiving clot-busting drugs (thrombolytic therapy) because it was widely assumed that in older age groups, the risks outweighed the benefits. It turned out that clot-busting drugs were actually more beneficial in older patients, basically because their heart disease tended to be severe which meant they stood to gain a great deal from treatment. Elevated systolic blood pressure was likewise once assumed to be normal in the geriatric population, or even desirable in order to improve blood flow to the brain. Studies eventually showed that elevated systolic blood pressure, even in older patients, predisposed to stroke and other unfortunate outcomes, and warranted treatment—though the recommendations about just how much blood pressure should be lowered have evolved over time. Is the ICD implantation rate just another case of bias or ignorance at work?

Dr. Robert Hauser of the Minnesota Heart Institute, writing an editorial published alongside this article, blames our fragmented health care system. He speculates that primary care physicians may not realize that their patients were supposed to get an ICD. The fact that there's supposed to be a 40-day waiting period between the onset of the heart attack and implantation of the ICD contributes to the problem. Hauser suggests that the primary care physician is so frazzled and overburdened that he is apt to neglect to send his patient to a cardiologist. Is this the explanation?

It can’t be the whole story. While patients who saw a cardiologist after hospital discharge were more likely to wind up with an ICD than patients who didn’t, only 30% of the patients who saw a cardiologist had an ICD implanted. Recall that 100% of them were, technically speaking, “candidates” for an ICD. So what else is going on?

Hauser hints at another explanation: “It is possible that some older patients may refuse ICD treatment for personal reasons or because comorbidities such as endstage kidney disease or advanced frailty were considered in the decision regarding ICD implantation.” He doesn't accept this explanation as sufficient, rightly recognizing that patients are very likely to accept whatever technological intervention their physician recommends and that shared decision-making, if it takes place at all, is apt to reflect the physician’s preferences as well as the patient’s. So the problem, if it is a problem, must lie with doctors, too. Physicians are not systematically and emphatically recommending ICD implantation to their older patients. Even the most technologically sophisticated academic medical centers only implanted ICDs in 16% of their eligible older patients. But is this a problem that needs fixing, like under-treatment of heart attacks with clot busters and inadequate treatment of high blood pressure in the past?

Dr.  Hauser believes it is, saying “even though the use of ICD for primary prevention may not seem to make as much sense for an 80 year old patient as it does for a patient in his 50s or 60s, an older patient at risk for sudden cardiac death should have the same opportunity to choose potentially lifesaving therapy.” But the benefits of ICD in those over 80 are far from clear. The studies include very few people in this age group. What data there is indicates that there is little if any survival benefit. Moreover, ICDs implanted in older people fire erroneously half the time. That means they deliver a very unpleasant electric shock to the hapless patient. In addition, if the ICD does work as intended, what that means is the abolition of sudden death. 

Maybe, just maybe, the low rate of ICD implantation in older people is a refreshing instance of massive civil disobedience—of both patients and doctors refusing to abide by prevailing clinical guidelines. We all have to die of something. An ICD virtually guarantees that the something will involve a protracted period of decline and suffering. If you had to choose between cancer, Alzheimer’s disease, and sudden death, which would you pick?

The Deciders

Shared decision-making has become something of a sacred cow in medicine, even though few physicians actually practice it. There is certainly evidence that patient participation in discussions about their health care and patient engagement in self-care lead to better outcomes, as well as to greater patient satisfaction. Promoting patient autonomy requires that patients play a role in shaping their fate. So some kind of patient involvement is decidedly a good thing. But shared decision-making, I argue in an article just published in the Journal of Medical Ethics, needs to be re-engineered for it to work in practice.

To be sure, not everyone means exactly the same thing by shared decision-making. But most of the definitions look like this one, offered by a leading proponent and expounder of the model: shared decision-making is an approach in which the patient receives information about available treatment options (including their risks and benefits), the clinician and the patient consider each one in light of the patient’s situation, goals, and preferences, and the two parties jointly select the best option.

The focus of all this deliberation is the selection of a treatment. Which treatment to provide is what the doctor needs to know. And the reason for involving patients in the decision-making is that, unlike in selecting which antibiotic to use in the treatment of pneumonia, which is strictly a technical decision, deciding whether to use chemotherapy or radiation for the treatment of cancer, or whether to use fourth line chemotherapy or hospice for treatment of cancer when it progresses to a very advanced stage, depends on the patient’s values. But what I suggest in my essay is that respecting patient autonomy requires eliciting those values. Once the doctor understands the patient’s goals, once he or she knows what is most important to the patient, that information constitutes data that goes into the decision about treatment along with other data involving outcomes, side effects, and probabilities. To ask the patient to draw conclusions about which treatment is best, rather than to have the doctor make a recommendation based on a whole raft of information that includes the patient’s input about goals and values, makes no more sense than providing a patient with data about antibiotics and then expecting a patient to select which antibiotic he should take for his pneumonia.

I argue that despite several decades of work seeking to overcome the barriers to shared decision-making—barriers such as cognitive biases, innumeracy, and health illiteracy—and despite evidence that sophisticated decision aids can help patients, most doctors and patients don’t like the conventional approach to shared decision-making and don’t use it. Even medical ethicists who believe strongly in honoring patient autonomy and who have traditionally advocated shared decision-making balk when they themselves or their family members develop cancer and the physician tries to implement shared decision-making. 

The approach I advocate doesn't go back to the older paternalistic model in which physicians decree and patients obey; rather, it reformulates the way shared decision-making takes place by suggesting that what needs to be shared is the process of determining the patient’s goals of care, not the process of deciding how to translate those goals, along with other highly technical information, into a treatment decision.

Getting to Yes?

Last fall, the prestigious Institute of Medicine released a “discussion paper” supporting the use of shared decision to improve outcomes in medicine. It specifically advocated greater use of decision aids, formal algorithms (written, oral, or video) to facilitate the process. Shared decision-making is not a new concept: the term itself was used and the practice recommended in 1982 when the President’s Ethics Commission (the full name is the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research) issued a lengthy report on decision-making in medicine. What's fascinating is that the New England Journal of Medicine could feature an article called “Enduring and Emerging Challenges of Informed Consent” that makes only a passing reference to shared decision-making. How is informed consent related to shared decision-making (SDM)?

Both shared decision-making and informed consent are supposed to be prerequisites to any decision about medical treatment. In the SDM approach, clinicians share information with patients about the potential risks and benefits of possible treatment options (or testing or screening); patients explore with clinicians their preferences; and through a process of deliberation, they reach a mutual decision. In the informed consent approach, clinicians recommend a particular treatment, summarize its risks and benefits in the context of available alternatives, and patients either accept or reject the clinician’s proposal.

The two models overlap a great deal—both involve presenting information and both hinge on patients’ understanding their options and making an un-coerced choice. But there are also stark differences. Informed consent is all about “getting to yes;” the clinician has decided what’s best for the patient (perhaps but not necessarily based on a prior conversation), though the patient is free to decline. It is a very legalistic process, whose centerpiece is a form in which a patient officially agrees to the treatment, sometimes signing away all liability on the part of the clinician. Shared decision-making is all about enabling patients to choose their own healthcare.

What’s striking is how separate the literature on these two subjects is today, as the IOM report and the NEJM article attest. The topics are like descendants of a common ancestor that diverged in their development 50 years ago. Lawyers and surgeons focus more on informed consent; ethicists and internists on shared decision-making. But there is little justification for two separate processes. 

Far more reasonable would be a single process that begins with physicians describing to patients their general health status and the likely course of any new condition that warrants treatment; the process would then move to patients indicating their goals of care; next, physicians would explain how to translate those goals into a treatment, describing the risks of pursuing the proposed strategy. Based on this give and take, physicians recommend a treatment, patients accept or reject the treatment, and then both parties sign a document indicating their conclusion and briefly describing the process by which they reached that decision. For some kinds of treatment, for instance those well-established therapies for which there are no viable alternatives (eg surgery for a mobile patient with a hip fracture), the first few steps would go very quickly. For other kinds of treatment, for example those with multiple alternatives (eg chemotherapy, radiation, or hospice for a patient with advanced cancer), all steps of the process would be followed and documented.

Only a standardized, consistent approach to decision-making can achieve the aims of both SDM and informed consent: knowledgeable, thoughtful patients participating meaningfully in their own healthcare.

Goals, Goals, and then What?

Last week’s New England Journal of Medicine asked readers to weigh in on who should initiate a conversation about goals of care with the patient described in a clinical vignette, a 59 year old woman with very advanced breast cancer. Should it be the primary care physician? The oncologist?  Or should it be a palliative care specialist? Three short pieces make the case for each perspective. But the reality is that it’s not who initiates the conversation about the goals of care that’s important; it’s what’s done with the information.

The primary care doctor might be the best person to start talking to the patient about “what is most important to her” if that physician has a longstanding relationship with her. The oncologist might be the best person to “elicit... values and goals” if he or she has the requisite communication skills. The palliative care physician might be the optimal choice if there are other issues to address, such as symptoms or social supports. Ideally, any of the three candidates could discuss with the patient what matters to her, given the realities of her disease and its likely trajectory.

What the three respondents leave out is the next crucial step: going from goals to decisions about treatment. The primary care advocate says that the physician should help the patient “match future care and treatment to her goals” but is principally concerned with recommending use of the POLST form (physician order for life sustaining treatment) as a means of documenting her wishes. She doesn't explain how wishes, expressed in terms of goals, are to be translated into actual medical orders. The palliative care advocate argues that the patient needs “help understanding what to expect and how to manage it” along with symptom control and emotional support, and is chiefly concerned with touting the importance of palliative care as a specialty. She says nothing about who or how anyone will infer from goals what the treatment should involve. The oncologist argues that the physician should provide information about prognosis and elicit the patient’s values and is mainly interested in assuring that the specialist physician not abdicate this responsibility. He alludes to the physician’s “judgment and advice,” but then states that the doctor's role is to to help the patient "understand her prognosis and options, articulate her values, and match her medical decisions to those values." Evidently the patient is supposed to make the leap from goals to treatment, though with the physician's advice.

What should the process of moving from goals to a plan of action look like? Figuring out what treatment plan is most consistent with a patient’s goals of care requires technical understanding of the treatment and its alternatives. Suppose the patient decides that focusing on comfort is most important to her; it is the physician (most plausibly the oncologist, in this scenario) who is in the best position to explain whether oral opioids, an infusion pump, or radiation therapy are most conducive to achieving that goal. Suppose the patient chooses to focus on life-prolongation. It is the physician who is best able to determine which, if any of the available chemotherapeutic regiments, is likely to prolong life. Or suppose the patient concludes that remaining as mobile, independent, and clear-headed as possible is her primary concern. It is the physician who is able to say, based on knowledge of the benefits as well as the burdens of each alternative, how best to accomplish this goal.

Shared decision-making, the gold standard of care today, involves the active participation of both clinicians and patients. It is a dynamic process that requires give and take by both parties. It demands skill, rests on trust, and takes time. But it’s important to realize that the physician and the patient bring different kinds of knowledge and expertise to the dialogue. A division of labor between patients and doctors is perfectly consistent with respect for both parties. Just as patients have a unique understanding of what matters to them, physicians have a special understanding of what it is like to go through a course of treatment. Physicians can help patients articulate their goals but then it is up to physicians to conclude what those goals imply for treatment. Patients may reject the conclusions drawn by physicians—usually because they realize, when faced with the implication of their stated goals, that their description of what was important to them was not quite accurate. 

The translation of goals of care into actual therapy should be the physician’s prerogative--with the patient maintaining veto power. What matters isn’t so much who starts the ball rolling as how to shepherd it into the end zone.