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Recruiting NCT06588556

Improving Needs Among Older Adults

Trial Parameters

Condition Critical Illness
Sponsor Duke University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-16
Completion 2028-08-31
Interventions
ICUconnectUsual care

Brief 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.

Eligibility Criteria

Inclusion Criteria: Patients (who are not interviewed but whose characteristics prompt enrollment of family members) 1. Adult aged ≥18 years 2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU 3. Serious acute illness associated with a need for invasive mechanical ventilation 4. ICU team expect patient to require mechanical ventilation for 2 or more days Family members 1. Adult aged ≥18 years 2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017) ICU clinicians 1. Adult aged ≥18 years 2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent Exclusion Criteria: Patients 1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable in

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