Actively Recruiting
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
Led by Weill Medical College of Cornell University · Updated on 2025-10-29
172
Participants Needed
3
Research Sites
269 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.
CONDITIONS
Official Title
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the ICU who are near end-of-life, as identified by physicians expecting they may not survive the next 12 months
- Surrogate decision-makers of patients admitted to the ICU or step-down unit during current stay or within 1 month after discharge
- Surrogate decision-makers aged 18 years or older
- Surrogates designated as health care proxies by physicians, advance practice providers, medical charts, or self-report
- Surrogates must speak English
- Surrogates must report significant pre-loss grief (PG-12 score 6 25) or peritraumatic distress (PDI 6 23)
- Surrogates must reside in a state where interventionists are licensed or comply with telehealth regulations
- Surrogates must be willing and able to use a device with internet access
- Surrogates must be able and willing to provide an emergency contact
You will not qualify if you...
- Patients and surrogates not meeting eligibility requirements
- Surrogates with cognitive impairment or significant psychiatric disturbance preventing participation
- Surrogates endorsing suicidal ideation in the past month
- Surrogates unable to access a functional device for videoconferencing and unwilling to use a study loaner device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
3
NewYork-Presbyterian Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
H
Holly Prigerson, PhD
CONTACT
H
Hillary Winoker, B.A.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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