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

NCT04414787 | Completed Results DMC

• 2 other identifiers: Pro00101745R01AG058915
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care; Critical Illness; Aging; Care Delivery Model; Informal Caregivers; Psychological Distress

Keywords

palliative care; Intensive Care Unit; critical illness; mobile app; care delivery; informal caregiver

Outcome Measures

Primary Outcomes (1)

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

  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).

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

Secondary Outcomes (7)

• Patient Health Questionnaire 9-Item Scale (PHQ-9)

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

• Generalized Anxiety Disorder 7-Item Scale (GAD-7)

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

• Post-Traumatic Stress Symptom (PTSS) Inventory

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

• Number of Participants With Goal Concordant Care

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

• Patient-Perceived Patient-Centeredness (PPPC) Scale

  Time 3 (target ~1 week post-randomization)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

PCplanner intervention during hospitalization

Behavioral: PCplanner

Usual care control

NO INTERVENTION

Usual care

Interventions

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.

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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
• \- Patient dies before T2
• FAMILY MEMBER
• ≥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)
• 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
• \- Low need burden (NEST score \<10) at baseline
• ICU PHYSICIANS
• ≥18 years of age

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Cox CE, Jones DM, Reagan W, Key MD, Chow V, McFarlin J, Casarett D, Creutzfeldt CJ, Docherty SL. Palliative Care Planner: A Pilot Study to Evaluate Acceptability and Usability of an Electronic Health Records System-integrated, Needs-targeted App Platform. Ann Am Thorac Soc. 2018 Jan;15(1):59-68. doi: 10.1513/AnnalsATS.201706-500OC.

  PMID: 29121480 BACKGROUND

• Cox CE, Olsen MK, Casarett D, Haines K, Al-Hegelan M, Bartz RR, Katz JN, Naglee C, Ashana D, Gilstrap D, Gu J, Parish A, Frear A, Krishnamaneni D, Corcoran A, Docherty SL. Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial. Contemp Clin Trials. 2020 Nov;98:106163. doi: 10.1016/j.cct.2020.106163. Epub 2020 Sep 29.

  PMID: 33007442 BACKGROUND

• Cox CE, Ashana DC, Dempsey K, Olsen MK, Parish A, Casarett D, Johnson KS, Haines KL, Naglee C, Katz JN, Al-Hegelan M, Riley IL, Docherty SL. Mobile App-Facilitated Collaborative Palliative Care Intervention for Critically Ill Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):173-183. doi: 10.1001/jamainternmed.2024.6838.

  PMID: 39680398 DERIVED

Related Links

• general trial information

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Deaths reported reflect patient, not family member, events.

Results Point of Contact

• Title: Christopher Cox
• Organization: Duke University

christopher.cox@duke.edu

919-681-7232

Study Officials

• Christopher Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All masking done via differential user accesses allowed by a mobile app platform.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial comparing intervention to usual care control.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: February 22, 2021
• Primary Completion: September 26, 2023
• Study Completion: December 17, 2023
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2025
• Access Criteria: review by study team

Locations

US (1)