RECRUITING

Improving Needs Among Older Adults

Conditions

Critical Illness Palliative Care Older Adults Informal Caregivers Care Delivery Model

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-16

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06588556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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) 1. Adult aged ≥18 years 2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent	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. 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. 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. 3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection. 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.

Inclusion Criteria

Exclusion Criteria

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
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)
1. Adult aged ≥18 years
2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent

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.
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.
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.
3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection.
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.

Contacts and Locations

Study Contact

Christopher Cox

CONTACT

919-684-8111

christopher.cox@duke.edu

Brittany McDowell

CONTACT

919-684-8111

brittany.mcdowell@duke.edu

Principal Investigator

Christopher Cox

PRINCIPAL_INVESTIGATOR

Duke

Study Locations (Sites)

University of Alabama-Birmingham

Birmingham, Alabama, 35233

United States

Columbia University

New York, New York, 10032

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Medical University of South Carolina

Charleston, South Carolina, 29403

United States

Collaborators and Investigators

Sponsor: Duke University

Christopher Cox, PRINCIPAL_INVESTIGATOR, Duke

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-16

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-09-16

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Critical Illness
Palliative Care
Older Adults
Informal Caregivers
Care Delivery Model