Surrogate Project - Aim 2: Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Acute referral to mental health services
Study Overview
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-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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 make treatment decisions
- •be discharged from hospital alive
Arms & Interventions
Storytelling Interview
Participants assigned to receive the intervention will participate in an interview with a trained interventionist who will facilitate the telling of their 'story' - the personal experience they went through as a surrogate decision-maker for a loved one in the intensive care unit (ICU), who subsequently died after decisions were made to limit life-sustaining treatments (LST).
These participants will be evaluated with questionnaires at baseline, 3 months, and 6 months after the death of their loved one (ICU patient).
Intervention: Storytelling Interview (Behavioral)
Monitoring of well-being
Participants assigned to the Monitoring of well-being group will receive follow up phone calls from study staff and be evaluated with questionnaires at baseline, 3 months, and 6 months after the death of their loved one (ICU patient).
Outcomes
Primary Outcomes
Acute referral to mental health services
Time Frame: 2-6 weeks after patient death (during or after participation in study intervention interview)
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.
Secondary Outcomes
- Burdensomeness of participation(6 months (end of study participation))
- Research approach rates (participant interest)(start of recruitment - 6 months)
- Participation regret(6 months (end of study participation))
- enrollment rate(start of recruitment - end of study)
- follow up questionnaire completion(6 months +/- 18 days)
- completion of intervention session(2 - 6 weeks after patient death)
- Randomization(2- 6 weeks after patient death)
- Experience of participation(6 months (end of study participation))
- follow up questionnaire completion(3 months +/- 9 days)
Investigators
Amber Barnato, MD, MPH, MS
Associate Professor of Medicine
University of Pittsburgh