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NCT03276559 · ClinicalTrials.gov registry record · NA
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
A NA study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT03276559: Completed NA study, sponsored by Weill Medical College of Cornell University.
NCT03276559 is a NA study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03276559, a NA study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls. Thus, interventions to improve the quality of life and care of ICU patients are needed. EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life through enhancing value-directed end-of-life care while also empowering surrogates to cope with a loved one's potential impending death and adjust following the patient's ICU death or discharge. Specifically, investigators aim to: * 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in the ICU. Key informants, including bereaved ICU patient caregivers and clinicians, will be asked to evaluate the EMPOWER intervention manual to increase its potential tolerability, acceptability and efficacy. * 2: Determine feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on surrogate mental health. * 3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU admission. Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower levels of peritraumatic distress when compared to usual care condition at post intervention assessment (T2). Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care, better quality of life, and better quality of death. EMPOWER was first evaluated though a single site open trial (n=10). All 10 p
Primary Outcome
Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Interventions
- OTHER Enhanced Usual Care
- BEHAVIORAL EMPOWER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2023-05-22 |
| Phase | NA |
What the finished NCT03276559 record still lists
NCT03276559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT03276559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03276559 about?
NCT03276559 is a clinical study titled "Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients". Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls...
What is the current status of trial NCT03276559?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2017-07-12. Estimated completion is 2023-05-22.
What interventions are being tested in trial NCT03276559?
The interventions under investigation include: Enhanced Usual Care (OTHER), EMPOWER (BEHAVIORAL).
Who is sponsoring clinical trial NCT03276559?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03276559's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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