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NCT06588556 · ClinicalTrials.gov registry record · NA
Improving Needs Among Older Adults
A NA study of Critical Illness and Older Adults, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 4
- Study locations
NCT06588556: Recruiting NA study of Critical Illness and Older Adults, sponsored by Duke University.
NCT06588556 is a NA study of Critical Illness and Older Adults that is actively recruiting participants, run by Duke University. The registered enrollment target is 350 participants, below the 3,135-participant average among 91 other Critical Illness trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06588556, a NA study of Critical Illness and Older Adults, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 4
- Study locations
Study Summary
Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia). The specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.
Primary Outcome
A palliative care needs instrument capturing all 8 domains of palliative care quality. Scores range from 0 (no needs) to 130 (higher needs).
Conditions Studied
Interventions
- BEHAVIORAL ICUconnect
- OTHER Usual care
Study Locations (4)
Alabama
- University of Alabama-Birmingham - Birmingham
New York
- Columbia University - New York
North Carolina
- Duke University Medical Center - Durham
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
What NCT06588556 shows while recruiting
NCT06588556 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 3,135-participant average among 91 other Critical Illness trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which ICUconnect is the first listed.
NCT06588556 reports a single indexed study location in Alabama, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06588556 about?
NCT06588556 is a clinical study titled "Improving Needs Among Older Adults". Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, th...
What is the current status of trial NCT06588556?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2025-09-16. Estimated completion is 2028-12-31.
What conditions does trial NCT06588556 study?
This clinical trial studies the following conditions: Critical Illness, Older Adults, Palliative Care, Informal Caregivers, Care Delivery Model.
What interventions are being tested in trial NCT06588556?
The interventions under investigation include: ICUconnect (BEHAVIORAL), Usual care (OTHER).
Who is sponsoring clinical trial NCT06588556?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06588556 being conducted?
This trial has 4 study locations across Alabama, New York, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06588556's enrollment target sits among peer trials
350 37th of 91 higher than 55 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.
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