ICUconnect for Palliative Care in Older Adults

(ICUconnect 2 Trial)

Recruiting at 3 trial locations

Overseen By Christopher Cox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Death expected, Palliative care, Long ICU stay, Imprisoned, Low need, Suicidal ideation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What data supports the effectiveness of the treatment ICUconnect for palliative care in older adults?

Research on integrated palliative care (IPC) suggests that it can improve the quality of care for patients and support caregivers, which may indicate potential benefits for treatments like ICUconnect. Additionally, using palliative care assessment tools has been shown to enhance communication and care planning, which could be relevant to ICUconnect's effectiveness. ^{1 2 3 4 5}

How is the ICUconnect treatment unique for palliative care in older adults?

ICUconnect is unique because it uses digital health technologies, like web-based videoconferencing, to provide palliative care consultations remotely, making it easier for elderly patients, especially in rural or underserved areas, to access specialized care without needing to travel. ^{6 7 8 9 10}

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

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

I am 60 or older and was in ICU for at least 48 hours due to a serious heart or lung condition.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants use the ICUconnect app for palliative care needs assessment and communication over a 7- to 10-day period

1-2 weeks

Digital interactions via app

Follow-up

Participants are monitored for outcomes such as anxiety, depression, and PTSD symptoms

3 months

Surveys at 1 week and 3 months post-randomization

Treatment Details

Interventions

• ICUconnect

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+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The use of interactive communication via the Internet can significantly improve access to palliative care for patients in underserved areas, enhancing the quality of care for those with advanced diseases.

A collaborative consultation model demonstrated between a rural palliative care nurse practitioner and an urban physician shows that online expert consultations can empower healthcare providers with up-to-date information, leading to better clinical decision-making and timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive collaborative consultation model in end-of-life care. Kuebler, KK., Bruera, E.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Building a taxonomy of integrated palliative care initiatives: results from a focus group. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Impact of electronic palliative care coordination systems (EPaCCS) on care at the end of life across multiple care sectors, in one clinical commissioning group area, in England: a realist evaluation protocol. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using palliative care assessment tools to influence and enhance clinical practice. [2015]

4. Australia pubmed.ncbi.nlm.nih.gov

The Australian Palliative Care Outcomes Collaboration (PCOC)--measuring the quality and outcomes of palliative care on a routine basis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

First referral to an integrated onco-palliative care program: a retrospective analysis of its timing. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Web-based videoconferencing for rural palliative care consultation with elderly patients at home. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Interactive collaborative consultation model in end-of-life care. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

mPalliative Care Link: Examination of a Mobile Solution to Palliative Care Coordination Among Tanzanian Patients With Cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Keep in touch (KIT): perspectives on introducing internet-based communication and information technologies in palliative care. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Virtual models of care for people with palliative care needs living in their own home: A systematic meta-review and narrative synthesis. [2022]