Actively Recruiting
Improving Needs Among Older Adults
Led by Duke University · Updated on 2026-03-06
350
Participants Needed
4
Research Sites
171 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Needs Among Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Patients managed in an adult medical, cardiac, trauma, surgical, or neurological ICU
- Patients with serious acute illness needing invasive mechanical ventilation
- Anticipated need for mechanical ventilation for 2 or more days
- Adult family members aged 18 years or older providing most support to the patient
- Adult ICU clinicians aged 18 years or older caring for the patient on the day of family member consent
You will not qualify if you...
- Patients expected to die or receive full comfort care within 24 hours
- Patients currently receiving care from palliative care specialists
- Patients with ICU stay longer than 4 days during current admission
- Patients who are imprisoned
- Family members with low palliative care need (NEST score below 15) at baseline
- Family members who do not speak English or Spanish fluently
- Family members endorsing suicidal thoughts at baseline
- Patients who regain decision-making capacity after consent but before first family meeting
- Cases where the ICU clinician changes to a non-consented clinician before first family meeting
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Columbia University
New York, New York, United States, 10032
Actively Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Actively Recruiting
Research Team
C
Christopher Cox
CONTACT
K
Kristy Johnson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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