Support for family members of critically ill patients

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

This study tests a new program called EMPOWER to see if it can help family members of critically ill patients in the ICU feel less grief and PTSD compared to regular support conversations.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Weill Medical College of Cornell University (Academic / other)
• Locations: 3 sites (Miami, Florida and 2 other locations)
• Trial ID: NCT05587517 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the EMPOWER intervention aimed at reducing grief and PTSD symptoms in family surrogates of critically ill patients in ICUs. It compares the EMPOWER approach to a Supportive Conversation arm, measuring outcomes such as grief, PTSD, and decision-making quality. The study also seeks qualitative insights to complement quantitative findings and explores the role of experiential avoidance in mediating grief and PTSD symptoms. The trial is particularly relevant in the context of heightened distress due to the COVID-19 pandemic.

Who should consider this trial

Good fit: Ideal candidates include family members of ICU patients who are near end-of-life and exhibit significant pre-loss grief or peritraumatic distress.

Not a fit: Patients who are not currently in the ICU or whose surrogates do not meet the criteria for grief or distress may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health and decision-making capabilities of family surrogates during critical care situations.

How similar studies have performed: While there is ongoing research in this area, the specific EMPOWER intervention represents a novel approach to addressing the needs of family surrogates in critical care settings.

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.

Where this trial is running

Miami, Florida and 2 other locations

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

Study contacts

• Principal investigator: Holly Prigerson, PhD — Weill Medical College of Cornell University
• Study coordinator: Holly Prigerson, PhD

Conditions Grief; Trauma; Psychotherapy; Critical Care