Time-Limited Trials Near the End of Life

CLINICIANS, PATIENTS, AND FAMILIES FREQUENTLY face scenarios in which they must make decisions near the end of life about whether to initiate major interventions in circumstances in which the outcome is uncertain. They do not want to prematurely forgo treatments that might help, but they also may not want to risk indefinite exposure to burdensome treatments. The possibility of a time-limited trial (TLT) of treatment may provide a way forward. A TLT is an agreement between clinicians and a patient/ family to use certain medical therapies over a defined period to see if the patient improves or deteriorates according to agreed-on clinical outcomes. If the patient improves, diseasedirected therapy continues. If the patient deteriorates, the therapies involved in the trial are withdrawn, and goals frequently shift more purely to palliation. If significant clinical uncertainty remains, another TLT might be renegotiated. A TLT begins with an assessment of the patient’s current clinical status, preferences, and prognosis with or without the treatment in question. In addition to disease-related factors, the patient’s cognitive and functional status is generally relevant. If the patient is unable to participate in decision making, surrogates should use “substituted judgment” to keep the patient’s voice alive. The benefits and burdens of initiating or forgoing the intervention, and whether knowledge about its efficacy for the patient can be ascertained within a specified time frame, should be carefully weighed. Clinical uncertainty impacts these decisions. For some patients, a 5% chance of surviving in any functional state will be enough to go forward, whereas for others any significant prospect of functional deterioration would preclude any trial of treatment. Some patients, as they get sicker, will accept treatments more aggressive than they thought they would when healthy. Physicians contribute to uncertainty as well, tending to err systematically in either optimistic and pessimistic directions when presenting poor prognostic information. Although patients and families generally want honesty with compassion when discussing prognosis, their desire to be told the truth may waver as prognosis gets worse. Many patients and families prefer their physicians to assist and often make challenging medical decisions on their behalf. Moreover, some patients are too ill to make these decisions themselves, so the burden of decision making falls on family members who may be hesitant about limiting any treatment. A strategy for discussing TLTs is outlined in the BOX. TLTs have 5 key sequential elements: 1. Define clinical problem and prognosis. All treating clinicians should agree about the patient’s medical status and treatment options. If some invasive life-sustaining therapies have already been started, are others likely to be needed in the future? How long will it take for a clear prognosis to emerge? Are some invasive treatments (eg, cardiopulmonary resuscitation) so unlikely to benefit the patient that some limits should be recommended from the outset? 2. Clarify the patient’s goals and priorities. Can the patient understand his or her clinical circumstances? If the paBox. Strategy for Discussing a Time-Limited Trial (TLT)