A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Recruiting now · Phase 2

Conditions studied: Grief, Trauma, Psychotherapy, Critical Care

In brief

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.

Key facts

Study ID

NCT05587517

Run by

Weill Medical College of Cornell University

People needed

172

Starts

2022-10-11

Expected to finish

2027-12-11

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• NewYork-Presbyterian Weill Cornell Medicine — New York, New York, United States (enrolling)
• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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