Better ICU palliative support for older adults and their families

Improving Needs Among Older Adults: the ICUconnect 2 Primary Palliative Care RCT

This trial will test whether a mobile app called ICUconnect helps older adults in the ICU and their family caregivers get the palliative care support they need compared with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (other)
• Locations: 4 sites (Birmingham, Alabama and 3 other locations)
• Trial ID: NCT06588556 on ClinicalTrials.gov

What this trial studies

ICUconnect is a mobile app that lets families and patients report palliative care needs across core domains and gives ICU clinicians a scalable digital platform to coordinate targeted care and role-specific informational supports. In this randomized controlled trial, 350 patient–family member dyads with elevated unmet palliative needs will be enrolled across multiple sites and randomized to ICUconnect or usual care. Eligible patients are adults in medical, cardiac, trauma, surgical, or neurological ICUs who are expected to require invasive mechanical ventilation for two or more days, and enrollment centers on the adult family member who provides the most support. The trial expands on a prior single-center cluster RCT that showed improvements in unmet needs and goal concordance and includes linguistic and cultural adaptation for Latin American Spanish.

Who should consider this trial

Good fit: Adults in medical, cardiac, trauma, surgical, or neurological ICUs expected to need invasive mechanical ventilation for two or more days, together with an adult family member who provides the most support, are the intended participants.

Not a fit: Patients expected to die or transition to full comfort-only care within 24 hours, those not expected to require prolonged mechanical ventilation, or those without an identifiable supporting family member are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, ICUconnect could help ICU teams respond more quickly and consistently to patient and family palliative needs, improving symptom relief and goal-concordant care.

How similar studies have performed: A prior single-center cluster RCT of ICUconnect with 111 patient–family dyads (42% Black) showed significant improvements in unmet needs and goal concordance, so this multicenter RCT builds on promising earlier results.

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 \<15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST).
2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions.

   Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish.
3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection.

   Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control).
4. Patient regains decisional capacity after informed consent but before the first family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians.
5. The ICU clinician changes from a consented clinician to a non-consented clinician before the first family meeting. Rationale: in this circumstance the intervention cannot be fully deployed.

ICU clinicians None

Where this trial is running

Birmingham, Alabama and 3 other locations

• University of Alabama-Birmingham — Birmingham, Alabama, United States (RECRUITING)
• Columbia University — New York, New York, United States (RECRUITING)
• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Christopher Cox — Duke
• Study coordinator: Christopher Cox

Conditions: Critical Illness, Palliative Care, Older Adults, Informal Caregivers, Care Delivery Model