Status:
COMPLETED
The Surrogate Project (Surrogate Storytelling)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Surrogate Decision Maker, After Death of Patient
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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-sust...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01902784
Start Date
June 1 2013
End Date
November 1 2014
Last Update
June 15 2017
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213