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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called ICUconnect, designed to improve palliative care for older adults in the ICU. The app enables patients and their families to report care needs and assists ICU staff in delivering consistent, personalized care. The trial compares the effects of using ICUconnect with regular ICU care on outcomes such as reducing stress for patients and families. Suitable participants have family members in the ICU on a ventilator for at least two days and feel their palliative care needs are unmet. As an unphased trial, this study offers a chance to contribute to innovative care solutions that could enhance palliative care experiences for many families.

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 prior data suggests that ICUconnect is safe for use in palliative care for older adults?

Research has shown that the ICUconnect app assists with palliative care needs in Intensive Care Units (ICUs). This digital tool organizes care by sending automated messages and emails.

Regarding safety, specific data on side effects is not available because ICUconnect is not a drug or medical procedure. It functions as a communication tool on devices like smartphones and tablets, eliminating concerns about the usual side effects associated with medications or surgeries.

The app aims to improve communication between families and ICU staff, making care more personalized and consistent. It is generally well-received, as it enhances how care is delivered without altering medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional palliative care in ICUs, which often relies on face-to-face meetings and manual communication, ICUconnect is unique because it uses a web app platform to streamline and automate communication between family members and clinicians. It delivers timed text messages and emails to guide families and medical staff through crucial tasks like surveys and coaching features over a 7- to 10-day period. Researchers are excited about ICUconnect because it promises to enhance person-centered care by ensuring consistent and structured communication, potentially improving the overall experience for families and patients during a critical time.

What evidence suggests that ICUconnect is effective for improving palliative care in older adults?

Studies have shown that ICUconnect, the intervention being tested in this trial, better meets the palliative care needs of older adults in the ICU compared to usual care. This mobile app enhances communication between families and doctors regarding patient needs. It sends timely messages and tasks to keep everyone informed and coordinated. Research indicates that ICUconnect helps ensure patients' palliative care needs are met, reducing stress for families. Overall, this tool is designed to ensure patients receive the right support at the right time in the ICU. ^{2 3 5 6 7}

Who Is on the Research Team?

Christopher Cox, MD, MHA, MPH

Principal Investigator

Duke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. reporter.nih.gov reporter.nih.gov/search/6v4Npa5EGky2za-PKzVw1A/project-details/10975540

Improving needs among older adults The likelihood of success is high because of the team's expertise in clinical trials, critical care, palliative care, geriatrics, health equity, and health ...

2. withpower.com withpower.com/trial/phase-palliative-care-6-2025-eecec

ICUconnect for Palliative Care in Older Adults 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 ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/38/NCT03506438/Prot_000.pdf

Addressing Palliative Care Needs Among Intensive ... The purpose of the study is to test and develop a web application (ICUconnect) that will improve racial disparities and unmet palliative care needs among ICU ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813604

Mobile Application–Based Communication Facilitation ... Compared with usual care, the ICUconnect primary palliative care intervention improved the burden of unmet palliative care needs among family ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686302/

Operationalizing needs-focused palliative care for older ... The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8330133/

Improving racial disparities in unmet palliative care needs ... We developed a mobile app intervention for ICU clinicians and family members called ICUconnect that assists with delivering need-based care.

7. newswise.com newswise.com/articles/icuconnect-app-helped-clinicians-address-unmet-palliative-care-needs-across-course-of-icu-care

ICUconnect App Helped Clinicians Address Unmet ... The primary outcome was patient score on the Needs at the End-of-Life Screening Tool (NEST), completed after a week of ICU care. Developed from ...