The Surrogate Project (Surrogate Storytelling) (NCT01902784) | Clinical Trial Compass
CompletedPhase 1/2
The Surrogate Project (Surrogate Storytelling)
United States115 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ma…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute referral to mental health services
Timeframe: 2-6 weeks after patient death (during or after participation in study intervention interview)