The Surrogate Project (Surrogate Storytelling)
NCT01902784 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2017-06-15
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-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.
Conditions
- Surrogate Decision Maker, After Death of Patient
Interventions
- BEHAVIORAL
-
Storytelling Interview
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
collaborator OTHER -
University of Pittsburgh
lead OTHER
Principal Investigators
-
Amber E Barnato, MD MPH MS · University of Pittsburgh
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2014-11-30
- Completion
- 2014-11-30
Countries
- United States
Study Locations
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