ICUconnect for Palliative Care in Older Adults

(ICUconnect 2 Trial)

Recruiting at3 trial locations

Overseen by Christopher Cox, MD, MHA, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher Cox, MD, MHA, MPH

Principal Investigator

Duke

Eligibility Criteria

This trial is for older adults with critical illnesses in ICUs and their caregivers. Participants must have high levels of unmet palliative care needs. The study excludes those who don't meet the specific inclusion criteria set by the researchers.

Inclusion Criteria

I am the main support person for a patient, and I am 18 or older.

ICU team expects patient to require ICU care for ≥3 more days

I am an ICU clinician, 18 or older, caring for the patient on the day their family gives consent.

Exclusion Criteria

I have been in the ICU for more than 4 days this visit.

I am being followed by a palliative care team during my hospital stay.

Patients with expected death or full comfort care plan within 24 hours

Treatment Details

Interventions

• ICUconnect (Behavioral Intervention)

Trial Overview The trial tests ICUconnect, a mobile app designed to improve palliative care by helping patients and families communicate their needs to ICU clinicians, against usual care without this technology.

Participant Groups

Group I: Usual care control Experimental Treatment 1 Intervention

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.

Group II: ICUconnect intervention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School