The Surrogate Project (Surrogate Storytelling)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | June 2013 |
| Contact: | Amber Barnato, MD, MPH, MS |
| Email: | barnae@upmc.edu |
| Phone: | 412-692-4875 |
Surrogate Project - Aim 2: Pilot Randomized Controlled Trial
Research Protocol Abstract:
This is a phase II randomized 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
randomized to "storytelling" (a facilitated elicitation of the experience 2-4 weeks after
bereavement) or no treatment with follow up "monitoring of well-being". All randomized
subjects will receive print bereavement brochures at 1 week, and undergo telephone symptom
assessment at 2-weeks, 3-months, and 6-months after bereavement.
This is a phase II randomized 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
randomized to "storytelling" (a facilitated elicitation of the experience 2-4 weeks after
bereavement) or no treatment with follow up "monitoring of well-being". All randomized
subjects will receive print bereavement brochures at 1 week, and undergo telephone symptom
assessment at 2-weeks, 3-months, and 6-months after bereavement.
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 Randomization 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
- live greater than ~50miles from the University of Pittsburgh
- For Randomization 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
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