Improving Needs Among Older Adults

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.

Conditions

• Critical Illness
• Palliative Care
• Older Adults
• Informal Caregivers
• Care Delivery Model

Interventions

BEHAVIORAL

ICUconnect

ICUconnect is essentially digital infrastructure for facilitating consistent person-centered communication. It is a web app platform that works on any digital device (smartphone, computer, tablet) and uses a series of automated and timed text messages and emails to direct family members and clinicians to perform timeline-driven tasks (e.g., surveys, content review, coaching features, family meetings) across the 7- to 10-day intervention period.

OTHER

Usual care

Control family participants will receive standard ICU care that includes the study team's suggestion to clinicians to conduct regular family meetings. While control participants will also report needs, all family meetings that occur, and other outcomes via texted or emailed links to surveys within the app platform, control group needs will not be visible to clinicians and ICUconnect content will not be visible to family members. However, basic study information and staff contacts will be available on a control group-specific website accessible via links sent by the platform at the time of each data collection.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Christopher Cox · Duke

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-16

Primary Completion

2028-08-31

Completion

2028-12-31

Countries

• United States

Study Locations