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NCT01902784 · ClinicalTrials.gov registry record · Phase 1
The Surrogate Project (Surrogate Storytelling)
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
NCT01902784: Completed Phase 1 study, sponsored by University of Pittsburgh.
NCT01902784 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01902784, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
Study 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.
Primary Outcome
We will assess acute risk of self-harm (or harm to others) and subsequent required referrals to mental health crisis services in participants throughout the intervention interview. Trained clinicians conducting interviews will refer when needed and record the number of participants requiring this service. Less than 5% of participants requiring an acute mental health crisis referral will be considered acceptable and an indicator of study safety.
Interventions
- BEHAVIORAL Storytelling Interview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01902784 record still lists
NCT01902784 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 1 intervention - of which Storytelling Interview is the first listed.
NCT01902784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01902784 about?
NCT01902784 is a clinical study titled "The Surrogate Project (Surrogate Storytelling)". 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 t...
What is the current status of trial NCT01902784?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2013-06. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01902784?
The interventions under investigation include: Storytelling Interview (BEHAVIORAL).
Who is sponsoring clinical trial NCT01902784?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01902784's enrollment target sits among peer trials
115 504th of 2000 higher than 1,494 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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