Improving Needs Among Older Adults

NCT06588556 | Recruiting DMC

• 2 other identifiers: Pro00116128R01AG084572
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score

  A palliative care needs instrument capturing all 8 domains of palliative care quality. Scores range from 0 (no needs) to 130 (higher needs).

  Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)

Secondary Outcomes (6)

• Patient Health Questionnaire 9-Item scale (PHQ-9)

  Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)

• Generalized Anxiety Disorder 7-Item scale (GAD-7)

  Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)

• Post-Traumatic Stress Symptom (PTSS) inventory

  Time 1 (baseline) and Time 4 (3 months post-randomization)

• Goal concordant care

  Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)

• Patient-Perceived Patient-Centeredness (PPPC) scale

  Time 3 (target ~1 week post-randomization)

Other Outcomes (2)

• Intensive Care Unit Length of Stay

  From randomization to discharge from the ICU, up to approximately 10 days

• Post-randomization Hospital Length of Stay

  From randomization to discharge from the ICU, up to approximately 10 days

Study Arms (2)

ICUconnect intervention

EXPERIMENTAL

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.

Behavioral: ICUconnect

Usual care control

OTHER

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.

Other: Usual care

Interventions

ICUconnect BEHAVIORAL

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.

ICUconnect intervention

Usual care OTHER

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.

Usual care control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (who are not interviewed but whose characteristics prompt enrollment of family members)
• Adult aged ≥18 years
• Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU
• Serious acute illness associated with a need for invasive mechanical ventilation
• ICU team expect patient to require mechanical ventilation for 2 or more days
• Family members
• Adult aged ≥18 years
• 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
• Adult aged ≥18 years
• ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent

You may not qualify if:

• Patients
• Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely
• 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.
• 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.
• \. Imprisoned person. Rationale: this is a vulnerable population.
• Family members
• 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).
• 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.
• 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).
• 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.
• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (4)

University of Alabama-Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

Related Publications (1)

• Cox CE, Ashana DC, Riley IL, Olsen MK, Casarett D, Haines KL, O'Keefe YA, Al-Hegelan M, Harrison RW, Naglee C, Katz JN, Yang H, Pratt EH, Gu J, Dempsey K, Docherty SL, Johnson KS. Mobile Application-Based Communication Facilitation Platform for Family Members of Critically Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2349666. doi: 10.1001/jamanetworkopen.2023.49666.

  PMID: 38175648 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Cox

  Duke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Cox

CONTACT

919-684-8111; christopher.cox@duke.edu

Kristy Johnson

CONTACT

kristy.johnson@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcomes are self-reported by participants directly via the intervention apps and so not seen by the study team. The site PIs are blinded to study group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Per NIH regulations
• Access Criteria: To be determined

Locations

US (4)