Time-limited trials offer I.C.U. patients and their families a sense of empowerment in the face of low odds.
In 2019, Dr. Richard Leiter, a palliative care specialist, met a patient and the man’s wife in the intensive care unit at Brigham and Women’s Hospital in Boston. The patient, in his 70s, had heart disease and kidney problems. But he had been living at home and doing reasonably well until sepsis, a life-threatening bloodstream infection, sent him to an emergency room.
He had already spent several days on a ventilator, requiring drugs to keep his blood pressure from plummeting. Now, “his kidneys were no longer working and he wasn’t waking up at all,” Dr. Leiter recalled, adding, “We were very worried that he wasn’t going to survive.”
When the kidney palliative care team — including a nurse-practitioner and a social worker, as well as a consulting nephrologist — met with the man’s wife to discuss treatment, it proposed what is known as a time-limited trial, in which life-sustaining treatment continues for an agreed-on period to see how the patient responds.
Dr. Leiter explained that the team could try continuous dialysis, which might do what the man’s kidneys no longer could: clear toxins and fluid from his body so that he could regain consciousness. But “we weren’t sure dialysis would help,” Dr. Leiter recalled telling her. The team was not optimistic.
Moreover, continuous dialysis involves implanting a large catheter in the neck — an invasive procedure, in addition to the uncomfortable measures the patient was already enduring. His wife reported that he valued his independence and mental awareness. If the man were dying, dialysis might simply prolong his suffering; if he survived, he might be severely impaired.
She understood the risks, Dr. Leiter recalled: “She said, ‘I share your worry, but I need to know I tried.’”
She agreed to round-the-clock dialysis for three days. If her husband’s blood pressure stabilized and he awakened, the team would continue treatment.
But if he remained unconscious, Dr. Leiter explained to the wife, that indicated her husband probably was unlikely to awaken. In that case, the team would keep the patient comfortable as it weaned him off life-sustaining devices and drugs.
Although there is scant data on how commonly critical care doctors suggest a time-limited trial, “it is gaining traction as a way to engage with patients and families in I.C.U.s,” said Dr. Douglas White, who directs the Program on Ethics and Decision Making in Critical Illness at the University of Pittsburgh School of Medicine.
The approach may get a boost from a study undertaken at three large hospitals in Los Angeles and recently published in JAMA Internal Medicine.
The researchers trained I.C.U. staff members, including some 50 doctors, to use time-limited trials when they met with family members who made decisions for patients who were too ill to direct their own care.
“The typical situation is, the medical team is pessimistic,” said Dr. James A. Tulsky, a palliative care doctor at Dana Farber Cancer Institute in Boston and co-author of an editorial accompanying the study.
“The patients are very ill, and the team worries that the odds of survival, with any kind of quality of life acceptable to the patient, are very low,” he said. “Yet the family is holding out hope that something will change. There can be a lot of conflict around this.”
A time-limited trial — whether or not the I.C.U. staff uses that precise term — incorporates several key elements. The medical team asks family members about what matters to the patient, including what medical efforts he or she would accept or decline.
If the clinicians propose a treatment, like a ventilator to help a patient breathe or a device to support a faltering heart, they explain not only the possible benefits but also the downsides.
“These interventions are potentially painful, they lack dignity, they’re tremendously burdensome,” Dr. Tulsky said. Often, I.C.U. patients must be sedated to keep them from trying to pull out uncomfortable breathing tubes and catheters.
The team and the family agree to a specific amount of time to try the treatment; that could be 24 to 48 hours or a few days, depending on the therapy and the patient’s condition.
The staff then maps out the particular markers that would show whether the patient is improving. Perhaps she will be able to breathe with less ventilator support, or receive encouraging blood test results, or regain consciousness. Then, she may be able to leave the I.C.U. for standard hospital care.
“We want to be able to say we’ve given it enough time to see how they’re going to do,” said Dr. Dong Chang, a critical care specialist at Harbor-U.C.L.A. Medical Center and lead author of the study.
“The one thing we don’t want is to carry on indefinitely,” he said. When patients don’t meet the specified goals, he added, “that is often a sign that they won’t get better — they’ll pass away or wind up in a state they would not want.” In that case, the family may opt for less aggressive treatment or comfort care.
The Los Angeles study, involving about 200 I.C.U. patients with an average age of 64, demonstrated how much difference this approach can make. Half the participants were treated before the hospitals adopted time-limited trials; the researchers compared their outcomes with those of patients treated after such trials became standard practice.
At first, formal family meetings to weigh decisions took place for 60 percent of patients. After the hospitals introduced time-limited trials, nearly 96 percent of families had formal meetings — and they happened much earlier, a day after the patient’s admission, instead of five days. The sessions were far more likely to include discussions of the patient’s values and preferences and of treatment risks and benefits.
The average length of stay decreased by a day, a significant change. More important, the proportion of patients who lingered for weeks in the I.C.U. dropped sharply, perhaps because fewer received invasive treatments and more had do-not-resuscitate orders.
Yet the mortality rate was about the same — and high, at nearly 60 percent — for both groups. “It reassured us that we weren’t pushing family members into uncomfortable situations, pushing them to de-escalate treatments for someone who would have survived,” Dr. Chang said.
Treatment trials accord with what many patients tell their doctors, Dr. White said: “They say things like, ‘If you can get me through this quickly, by all means. But don’t keep me on machines long term.’”
Trials can also help families who are faced with crushing decisions, and who often suffer guilt and doubt after their loved ones’ stays in an I.C.U. “People are very human in the way they react to shocking bad news,” Dr. White said. “It can take time to come to terms with it.”
Treatment trials provide that time, and they offer a third option — a middle ground between authorizing every possible aggressive procedure or discontinuing life-sustaining measures.
For families, Dr. Chang said, “being involved in these conversations, seeing the treatment unfold before you, it can be empowering: ‘Now, I see what the doctors are seeing. I understand why they think it’s not going well.’”
In an I.C.U. where no one suggests such a strategy, family members themselves can ask: Can we do a time-limited trial, if there’s something you think might help? “The staff would understand what that means, and I think they’d respond positively,” Dr. Leiter said.
His patient at Brigham and Women’s Hospital, even with continuous dialysis, never awakened, Dr. Leiter recalled: “When three days were up, his wife said: ‘Enough. Let’s do what we can to allow him to die peacefully.’”
She and their children assembled as the team provided pain medication and withdrew the tubes and machinery. As they kept their vigil, the man died in a matter of hours.
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