Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06588556

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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