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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: Active NA study of Critical Illness, sponsored by University of Pittsburgh.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.

Conditions Studied

Critical Illness

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

FieldValue
Enrollment Target 1,163 participants
Start Date 2021-11-11
Est. Completion 2026-04-30
Phase NA
University of Pittsburgh

1,238 total trials

What the registry record for NCT05019261 still lists

NCT05019261 is an interventional study that assigns participants to a tested intervention. Its 1,163 participants enrollment target places it among the larger protocols in the corpus, below the 3,126-participant average among 91 other Critical Illness trials with a reported enrollment target (63% lower).

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 lists 7 locations in 5 states (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.

Learn More About Clinical Trials

Similar trials for Critical Illness

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05019261's enrollment target sits among peer trials

1,163 19th of 91 higher than 73 of 91 other Critical Illness trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Critical Illness 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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Related registry views

Source: ClinicalTrials.gov NCT05019261, the US trial registry maintained by the National Library of Medicine. NCT05019261 (large enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.