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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 is a NA study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 63 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03276559
The ClinicalTrials.gov registry entry for NCT03276559 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT03276559 reports 0 study locations.
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.
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