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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying ways to support family members who make medical decisions for critically ill patients in intensive care units (ICUs). The research is focused on a specific program called the EMPOWER intervention, which aims to help these family surrogates cope with feelings of grief and symptoms of Post Traumatic Stress Disorder (PTSD) that can arise during this challenging time. By comparing this program to regular supportive conversations, the trial hopes to show that EMPOWER can reduce grief and PTSD symptoms, as well as improve the quality of care for patients.

To participate in this trial, you must be a family member (age 18 or older) who is responsible for making health decisions for a patient in the ICU. You also need to speak English and experience significant grief or distress. Participants will engage in discussions and receive support through videoconferencing, which means you’ll need access to a computer, tablet, or phone with internet. The trial is currently recruiting, and while it offers a chance for valuable support, it is important to note that not everyone will qualify, especially if there are concerns about cognitive impairment or suicidal thoughts.

Gender

ALL

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.