Clinical Trials Directory

Trials / Completed

CompletedNCT04414787

A Needs-focused Palliative Care Intervention for Older Adults in ICUs

Operationalizing PCplanner, a Needs-focused Palliative Care for Older Adults in Intensive Care Units: a Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
151 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

The quality of intensive care unit (ICU)-based palliative care is highly variable, particularly for the 2 million older adults admitted annually to ICUs. To address these care delivery barriers among older ICU patients, a mobile app platform called PCplanner (Palliative Care planner) was developed. PCplanner automates the identification of high-risk patients (e.g., dementia, declining health status, poor functioning) by directly capturing data from electronic health record (EHR) systems, cultivates family engagement with supportive information and a digital system for self-report of actual needs, and facilitates the delivery of care to those with a high burden of need by coordinating collaboration between ICU teams and palliative care specialists. 150 patients, 150 family caregivers, and 75 physicians from academic and community settings will be enrolled in a RCT designed to test the efficacy of PCplanner-augmented collaborative palliative care vs usual care. Family caregiver and clinician experiences will be explored using mixed methods to understand intervention mechanisms as well as implementation barriers within diverse case contexts. The key hypothesis is that compared to usual care, PCplanner will reduce family caregivers' unmet needs and psychological distress, increase the frequency of goal concordant treatment among older adult patients, and reduce hospital length of stay.

Detailed description

The quality of intensive care unit (ICU)-based palliative care is highly variable, particularly for the 2 million older adults admitted annually to ICUs. However, improving care quality on a broad scale with the efficient delivery of patient-centered, need-targeted palliative care is challenging because of logistical and technological barriers. To address these care delivery barriers among older ICU patients, a mobile app platform called PCplanner (Palliative Care planner) was developed. PCplanner automates the identification of high-risk patients (e.g., dementia, declining health status, poor functioning) by directly capturing data from electronic health record (EHR) systems, cultivates family engagement with supportive information and a digital system for self-report of actual needs, and facilitates the delivery of care to those with a high burden of need by coordinating collaboration between ICU teams and palliative care specialists. In pilot comparison to a standard palliative care control, the intervention reduced unmet needs, psychological distress, and length of stay and increased goal concordant care, communication, and hospice utilization. While these data are compelling, an efficacy evaluation of PCplanner is needed. Therefore, we plan to enroll approximately 150 patients, 150 family caregivers, and 75 physicians will be enrolled from academic and community settings in a project with 2 key aims: (1) Test the efficacy of PCplanner-augmented collaborative palliative care vs usual care in a randomized clinical trial (RCT) with 3-month follow up, and (2) Explore family caregiver and clinician experiences using mixed methods to understand intervention mechanisms as well as implementation barriers within diverse case contexts. The key hypothesis is that compared to usual care, PCplanner will reduce family caregivers' unmet needs and psychological distress, increase the frequency of goal concordant treatment among older adult patients, and reduce hospital length of stay.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPCplannerPCplanner-augmented care. The PCplanner mobile app will allow patients / family members to report their needs in a platform viewable by ICU physicians. Should the needs not improve over time, the palliative care team will be activated to contribute to care.

Timeline

Start date
2021-02-22
Primary completion
2023-09-26
Completion
2023-12-17
First posted
2020-06-04
Last updated
2025-07-18
Results posted
2025-07-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04414787. Inclusion in this directory is not an endorsement.