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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion moved earlier from Dec 11, 2027 to Jan 31, 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 70 of 82 entries
  2. Re-verified, no change to tracked fieldsv10
  3. Eligibility criteria expanded, about 50 wordsv9
  4. Study sites: 2 to 3
    • Primary and study completion dates: Dec 2027 to Dec 11, 2027
    • Eligibility criteria expanded, about 14 words
    v8
  5. Site details revised at 1 of 2 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Collaborators: 2 to 1v6
  2. Study sites: 1 to 2v5
  3. Start date: Oct 20, 2022 to Oct 11, 2022v4
  4. Start date changed from estimate of Oct 2022 to Oct 20, 2022v3
  5. Eligibility criteria shortened, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05587517
Lead Sponsor Weill Medical College of Cornell University
Collaborators: National Institute of Nursing Research (NINR)
Conditions
(from sponsor)		 Grief, Trauma, Psychotherapy, Critical Care
Related terms Wounds and Injuries
Enrollment 172 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov