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Completed

NCT Number: NCT04414787

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

PATIENTS

Inclusion criteria

  • ≥50 years of age
  • Receive care in a study ICU for ≥24 hours
  • Meets ≥1 of 9 high risk phenotypes a. Dementia (e.g., Alzheimer's, multi-infarct, other dementia etiology) b. Declining health status defined by EITHER: i. ≥2 hospital admissions in 3 months preceding current admission OR ii. >1 ICU admission in 3 months preceding current admission c. Poor functional status defined by EITHER: i. admit from Skilled Nursing Facility (SNF) or Long-Term Acute Care (LTAC) facility OR ii. ≥3 activities of daily living (ADL) limitations at admission d. Severe acute illness defined by EITHER: i. cardiac arrest OR ii. multisystem organ failure (≥3 of: lung, kidney, hematological, brain, cardiac, liver) that has worsened over 48 hours (i.e., Sequential Organ Failure Assessment [SOFA] score increase) e. Severe acute stroke (e.g., acute intracranial hemorrhage, ischemic stroke, or traumatic brain injury) f. Acute respiratory failure (ventilation or high oxygen support for ≥24 hours) g. Acute renal failure (new hemodialysis or continuous venovenous hemodiafiltration for ≥1 hour) h. Advanced cancer (Advanced / metastatic cancer diagnosis) i. Shock (use of vasopressor or inotrope for ≥4 hours)

Exclusion criteria

(pre-consent):

  • Palliative care consultation performed during the hospitalization before eligibility determination
  • Current admission to ICU at the index hospital ≥8 days
  • Imprisoned
  • No known family or surrogate decision maker
  • Death expected within 24 hours

Exclusion criteria

(post-consent):

  • Patient dies before T2

FAMILY MEMBER

Inclusion criteria

  • ≥18 years of age
  • Self-described as the individual (related or unrelated) who provides the most support and with whom the patient has a significant relationship (per definition of 'family' described in the Society of Critical Care Medicine 2016 Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU)

Exclusion criteria

(pre-consent):

  • Lack a knowledge of English such that the potential participant is not confident that they could complete study tasks (app viewing, surveys)
  • Imprisoned
  • Unable to complete surveys for any reason

Exclusion criteria

(post-consent):

  • Low need burden (NEST score <10) at baseline

ICU PHYSICIANS

Inclusion criteria

  • ≥18 years of age
  • Attending or fellow physician in a study ICU

Exclusion criteria

  • None

Treatment and study plan

PCplanner

Behavioral

PCplanner-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.

Primary outcomes

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

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

    The NEST is a palliative care needs instrument capturing all 8 domains of palliative care quality from patients' family members. Scores range from 0 (no needs) to 130 (higher needs). Reported here is scores at Time 3 (~1 week post-randomization).

Secondary outcomes

  1. Patient Health Questionnaire 9-Item Scale (PHQ-9)

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

    A depression symptoms instrument used by patients' family members. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms). Reported here is the scores at Time 4 (3 months post-randomization).

  2. Generalized Anxiety Disorder 7-Item Scale (GAD-7)

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

    An anxiety symptoms instrument used by patients' family members. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms). Reported here is the scores at Time 4 (3 months post-randomization).

  3. Post-Traumatic Stress Symptom (PTSS) Inventory

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

    A post-traumatic stress disorder symptom instrument used by patients' family members. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms). Reported here is the scores at Time 4 (3 months post-randomization).

  4. Number of Participants With Goal Concordant Care

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

    A metric of goal concordance as reported by patients' family members.

  5. Patient-Perceived Patient-Centeredness (PPPC) Scale

    Time frame: Time 3 (target ~1 week post-randomization)

    A measure of patient-centeredness used by patients' family members with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness).

  6. Post-randomization Intensive Care Unit Length of Stay

    Time frame: from randomization until intensive care unit discharge

    A measure of intensive care unit days after randomization for patients of whom participants are family members/caregivers.

  7. Post-randomization Hospital Length of Stay

    Time frame: from randomization until hospital discharge

    A measure of hospital days after randomization for PATIENTS for each patient member of the patient-family member dyad

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: PCplanner

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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