Status:
RECRUITING
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Grief
Trauma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 (PTS...
Detailed Description
Intensive Care Units (ICUs) are stressful places fraught with grief for family members who witness dying loved ones, often in pain, struggling to breathe and/or maintain consciousness. Compounding the...
Eligibility Criteria
Inclusion Criteria:
- Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified "surprise question" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months.
- Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay.
- Surrogate decision-makers are 18 years or older.
- Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate.
- Surrogate decision-makers must speak English.
- Surrogate decision-makers must report "syndromal" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23).
- Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations.
- Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet.
- Surrogate decision-makers who are able and willing to provide an emergency contact.
Exclusion Criteria:
- Patients and surrogate decision-makers who do not meet the eligibility criteria.
- Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent.
- Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.
- Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 11 2027
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05587517
Start Date
October 11 2022
End Date
December 11 2027
Last Update
October 29 2025
Active Locations (3)
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1
University of Miami
Miami, Florida, United States, 33136
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
3
NewYork-Presbyterian Weill Cornell Medicine
New York, New York, United States, 10065