NCT05587517 A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
| NCT ID | NCT05587517 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Grief |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2022-10-11 |
| Primary Completion | 2027-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 172 participants in total. It began in 2022-10-11 with a primary completion date of 2027-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
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.
Contact & Investigator
Holly Prigerson, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05587517 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Grief. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05587517 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05587517 currently recruiting?
Yes, NCT05587517 is actively recruiting participants. Contact the research team at hgp2001@med.cornell.edu for enrollment information.
Where is the NCT05587517 trial being conducted?
This trial is being conducted at Miami, United States, New York, United States, New York, United States.
Who is sponsoring the NCT05587517 clinical trial?
NCT05587517 is sponsored by Weill Medical College of Cornell University. The principal investigator is Holly Prigerson, PhD at Weill Medical College of Cornell University. The trial plans to enroll 172 participants.