Time-Limited Trials Can Help

Time-Limited Trials Can Help Patients and Families Shift Focus to Hospice Care

In the care of seriously ill patients who may be nearing the end of life, physicians and families can be faced with the decision of whether or not to initiate disease-directed interventions in clinical circumstances in which the outcome is uncertain. A possible way forward in this challenging situation may be the use of a time-limited trial (TLT), according to an article recently published in the Journal of the American Medical Association.

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,” write the authors. If the patient improves, the therapy can be continued. If the patient deteriorates, the therapy is withdrawn, and goals of care often shift to palliation and hospice care.

Although there is a lack of empirical evidence regarding the risks and benefits of TLTs, framing challenging medical decisions as TLTs can be helpful for both patients/families and the members of the medical team, the authors point out. [See sidebar, below.]

BEFORE BEGINNING A TLT DISCUSSION WITH THE PATIENT/FAMILY:

• Assess the patient’s current prognosis, preferences, and clinical status, factoring in cognitive and functional status.
• Seek consensus among all treating clinicians regarding the patient’s medical status and treatment options.
• Select the main medical spokesperson and identify key clinicians to include.
• Determine whether the patient has done any advance care planning.
• Identify key patient and family decision makers, and encourage surrogates to use “substituted judgment” to represent the voice of an incapacitated loved one.
• Carefully weigh the benefits and burdens of the intervention and whether its effect can be determined within a set time.
• Identify clear clinical markers of improvement or deterioration.

APPROACH TO A TLT FAMILY MEETING

1. Ask each person to identify him- or herself and to state how he or she relates to the patient.
2. Summarize the meeting’s purpose.
3. Ask the family members for their views of the patient’s situation.
4. Reconcile the understanding of the clinical team with the patient’s views.
5. Propose the key elements of the TLT.
6. Explain how progress will be measured and communicated. If possible, try to link clinical markers of improvement or deterioration to signs that would be visible to the patient and family.
7. Suggest a time frame for reevaluation, based on the patient’s clinical condition, the type of intervention, and the needs of the patient and family.
8. Schedule a follow-up meeting. Arrangements should be made to inform the family on a regular basis about the patient’s progress, and potential actions to be taken at the end of the TLT should be defined. “These are not rigidly binding contracts,” write the authors, “but rather ways of structuring challenging decisions and linking them closely with what clinicians and families are observing about the patient’s condition.”

Source: “Time-Limited Trials Near the End of Life,” Journal of the American Medical Association; October 5, 2011; 306(13):1483- 1484. Quill TE, Holloway R; Center for Ethics, Humanities, and Palliative Care, University of Rochester Medical Center, New York.

Framing Challenging Medical Decisions as Time-Limited Trials Can:

• Allow families to learn and observe how physicians are trying to balance the benefits and burdens of medical treatment honestly and compassionately with the patient and the patient's family
• Help treating clinicians reach a consensus and speak with a unified voice
• Lessen potential conflict among medical teams and the patient/family by establishing mutual expectations and a regular, structured dialogue about the patient's progress
• Provide a path to a middle ground between patients/families who want "everything" done and medial professionals who may want to unilaterally limit treatment

-Adapted from Quill and Holloway,
Journal of the American Medical Association