Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT05587517

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

Led by Weill Medical College of Cornell University · Updated on 2025-10-29

172

Participants Needed

3

Research Sites

269 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to the ICU who are near end-of-life, as identified by physicians expecting they may not survive the next 12 months
  • Surrogate decision-makers of patients admitted to the ICU or step-down unit during current stay or within 1 month after discharge
  • Surrogate decision-makers aged 18 years or older
  • Surrogates designated as health care proxies by physicians, advance practice providers, medical charts, or self-report
  • Surrogates must speak English
  • Surrogates must report significant pre-loss grief (PG-12 score 6 25) or peritraumatic distress (PDI 6 23)
  • Surrogates must reside in a state where interventionists are licensed or comply with telehealth regulations
  • Surrogates must be willing and able to use a device with internet access
  • Surrogates must be able and willing to provide an emergency contact
Not Eligible

You will not qualify if you...

  • Patients and surrogates not meeting eligibility requirements
  • Surrogates with cognitive impairment or significant psychiatric disturbance preventing participation
  • Surrogates endorsing suicidal ideation in the past month
  • Surrogates unable to access a functional device for videoconferencing and unwilling to use a study loaner device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Miami

Miami, Florida, United States, 33136

Not Yet Recruiting

2

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

Actively Recruiting

3

NewYork-Presbyterian Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

H

Holly Prigerson, PhD

CONTACT

H

Hillary Winoker, B.A.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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