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NCT03099746 · ClinicalTrials.gov registry record · NA
Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 281
- Enrollment target
NCT03099746: Completed NA study, sponsored by Case Western Reserve University.
NCT03099746 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 281 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03099746, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 281 participants
- Enrollment target
Study Summary
Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have transient or persistent cognitive impairment that precludes them from making their own healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a family member. SDMs for the critically ill often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role. The purpose of this study is to test the effectiveness of two decision support interventions for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format.
Primary Outcome
ANOVA Model (F-Statistic)
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Informational Support
- BEHAVIORAL INVOLVE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-06 |
| Phase | NA |
What the finished NCT03099746 record still lists
NCT03099746 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Usual Care is the first listed.
NCT03099746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03099746 about?
NCT03099746 is a clinical study titled "Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)". Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%...
What is the current status of trial NCT03099746?
This trial is currently completed. It is a NA study. The enrollment target is 281 participants. The study started on 2015-09. Estimated completion is 2020-06.
What interventions are being tested in trial NCT03099746?
The interventions under investigation include: Usual Care (BEHAVIORAL), Informational Support (BEHAVIORAL), INVOLVE (BEHAVIORAL).
Who is sponsoring clinical trial NCT03099746?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03099746's enrollment target sits among peer trials
281 380th of 2000 higher than 1,621 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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