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NCT05019261 · ClinicalTrials.gov registry record · NA
Multi-component Family Support Tool Intervention (FST)
A NA study of Critical Illness, sponsored by University of Pittsburgh.
- Active
- Registry status
- NA
- Development phase
- 1,163
- Enrollment target
- 7
- Study locations
NCT05019261 is a NA study of Critical Illness that is active but no longer recruiting, run by University of Pittsburgh. The registered enrollment target is 1,163 participants, below the 3,126-participant average among 91 other Critical Illness trials with a reported enrollment target (63% lower). The trial reports 7 study locations across 5 states.
The verdict
NCT05019261, a NA study of Critical Illness, is active but no longer recruiting, sponsored by University of Pittsburgh.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,163 participants
- Enrollment target
- 7
- Study locations
Study Summary
The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that. Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.
Conditions Studied
Interventions
- OTHER Multi-component Family Support Intervention
Study Locations (7)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University - Durham
Pennsylvania
- University of Pittsburgh - Pittsburgh
- Pittsburgh VA Medical Center - Pittsburgh
Massachusetts
- Baystate Medical Center - Springfield
New York
- NYC Health + Hospitals/Lincoln Hospital - New York
Oregon
- Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,163 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05019261
The ClinicalTrials.gov registry entry for NCT05019261 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,163 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,126-participant average among 91 other Critical Illness trials with a reported enrollment target (63% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which Multi-component Family Support Intervention is the first listed.
NCT05019261 reports 7 study locations spanning 5 distinct geographic areas - top geographies include North Carolina, Pennsylvania, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05019261 about?
NCT05019261 is a clinical study titled "Multi-component Family Support Tool Intervention (FST)". The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressin...
What is the current status of trial NCT05019261?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,163 participants. The study started on 2021-11-11. Estimated completion is 2026-04-30.
What conditions does trial NCT05019261 study?
This clinical trial studies the following conditions: Critical Illness.
What interventions are being tested in trial NCT05019261?
The interventions under investigation include: Multi-component Family Support Intervention (OTHER).
Who is sponsoring clinical trial NCT05019261?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05019261 being conducted?
This trial has 7 study locations across Massachusetts, New York, North Carolina, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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