The Surrogate Project (Surrogate Storytelling)

Completed · Phase 1/Phase 2

Conditions studied: Surrogate Decision Maker, After Death of Patient

In brief

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.

Key facts

Study ID

NCT01902784

Run by

University of Pittsburgh

People needed

115

Starts

2013-06-01

Expected to finish

2014-11-01

Last updated by the study team

2017-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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