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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Florida
University of Miami
NOT_YET_RECRUITING
Miami
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NewYork-Presbyterian Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Holly Prigerson, PhD
hgp2001@med.cornell.edu
212-746-1374
Backup
Hillary Winoker, B.A.
hiw4002@med.cornell.edu
646-962-7143
Time Frame
Start Date: 2022-10-11
Estimated Completion Date: 2027-12-11
Participants
Target number of participants: 172
Treatments
Experimental: EMPOWER arm
The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone.~Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.
Placebo_comparator: Supportive Conversation arm
The Supportive Conversation (SC) arm includes a supportive, empathic encounter without specific skill-building for approximately the same amount of time as EMPOWER.~Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after SC within 3 months conducted in person and by phone.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR)
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov