The Surrogate Project (Surrogate Storytelling)

Surrogate Project - Aim 2: Pilot Randomized Controlled Trial

Research Protocol Abstract:

This is a phase II controlled trial (RCT) of a "storytelling" intervention compared to no treatment among surrogates who have participated in a decision to limit life-sustaining treatment in the ICU for an incapacitated loved one. Subjects will be sequentially assigned to "storytelling" (a facilitated elicitation of the experience 2-4 weeks after bereavement) or no treatment with follow up "monitoring of well-being". Subjects will receive print bereavement brochures at 1 week, and undergo telephone symptom assessment at 2-weeks, 3-months, and 6-months after bereavement.

Inclusion Criteria:

Screening/Re-contact (1st phase)

• Eligible patients will:

  • lack decision-making capacity
  • have a surrogate decision maker (family member or friend)

Eligible surrogates will:

• be 18 years of age or older

• self-identify as having primary decision-making authority for the patient

• live within approximately 50miles or less of the University of Pittsburgh

• be able to conduct a 1hr interview in English

  • Court-appointed power of attorney will be excluded, as they are not expected to experience the same emotional distress as a family member or friend of a critically ill patient.

For Assignment to Intervention/Control (2nd phase)

• Eligible surrogates will:

  • have previously given consent for study staff to follow their loved one's course in the hospital and to be re-contacted
  • have participated in decision making about limitation of life-sustaining treatments (LST) for their loved one (ICU patient)
  • have had their loved one (ICU patient) die in the hospital

Exclusion Criteria:

Screening/Re-contact

• Ineligible patients will:

  • be less than 18 years old
  • prisoners
  • be of other legal concern, such as malpractice

• Ineligible surrogates will:

  • be less than 18 years old
  • be unable to complete a 1-hour interview and questionnaires in English

• For Assignment to Intervention/Control

Ineligible patients will:

• have fully and permanently regained decision-making capacity and therefore no longer require a surrogate to make treatment decisions
• be discharged from hospital alive