← Back to all trials
Recruiting
NCT06588556
Improving Needs Among Older Adults
Conditions: Critical Illness, Palliative Care, Older Adults, Informal Caregivers, Care Delivery Model
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 350
Sponsor: Duke University
Location: University of Alabama-Birmingham Birmingham Alabama
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 intervention effect unlikely
2. Palliative care consultative team and/or palliative care specialists are currently involved in the patient's care.
Rationale: this would dilute the intervention's effect.
3. ICU length of stay \>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization.
6\. Imprisoned person. Rationale: this is a vulnerable population.
Family members
1. Low palliative care need burden (i.e., NEST scale score \
Source: ClinicalTrials.gov (NCT06588556). StuddyBuddy aggregates publicly available trial information.