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

Primary Purpose

Palliative Care, Critical Illness, Aging

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PCplanner

About this trial

This is an interventional supportive care trial for Palliative Care focused on measuring palliative care, Intensive Care Unit, critical illness, mobile app, care delivery, informal caregiver

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Usual care control

Arm Description

PCplanner intervention during hospitalization

Usual care

Outcomes

Primary Outcome Measures

Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score

A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)

Secondary Outcome Measures

Patient Health Questionnaire 9-Item scale (PHQ-9)

A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)

Generalized Anxiety Disorder 7-Item scale (GAD-7)

An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)

Post-Traumatic Stress Symptom (PTSS) inventory

A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)

Goal concordant care

A measure of hospital days after randomization

Patient-Perceived Patient-Centeredness (PPPC) scale

A measure of patient-centeredness with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness)

Post-randomization intensive care unit length of stay

A measure of intensive care unit days after randomization

Post-randomization hospital length of stay

A measure of hospital days after randomization

Full Information

NCT ID

NCT04414787

First Posted

June 1, 2020

Last Updated

October 17, 2023

Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04414787

Brief Title

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

Acronym

PCplanner

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 22, 2021 (Actual)

Primary Completion Date

October 1, 2023 (Actual)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial comparing intervention to usual care control.

Masking

ParticipantOutcomes Assessor

Masking Description

All masking done via differential user accesses allowed by a mobile app platform.

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

PCplanner intervention during hospitalization

Arm Title

Usual care control

Arm Type

No Intervention

Arm Description

Usual care

Intervention Type

Behavioral

Intervention Name(s)

PCplanner

Intervention Description

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 Outcome Measure Information:

Title

Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale total score

Description

A palliative care needs instrument. Scores range from 0 (no needs) to 130 (higher needs)

Time Frame

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

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire 9-Item scale (PHQ-9)

Description

A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)

Time Frame

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

Title

Generalized Anxiety Disorder 7-Item scale (GAD-7)

Description

An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)

Time Frame

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

Title

Post-Traumatic Stress Symptom (PTSS) inventory

Description

A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)

Time Frame

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

Title

Goal concordant care

Description

A measure of hospital days after randomization

Time Frame

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

Title

Patient-Perceived Patient-Centeredness (PPPC) scale

Description

A measure of patient-centeredness with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness)

Time Frame

Time 3 (target ~1 week post-randomization)

Title

Post-randomization intensive care unit length of stay

Description

A measure of intensive care unit days after randomization

Time Frame

Across the entire hospitalization after randomization (approximately 2 weeks)

Title

Post-randomization hospital length of stay

Description

A measure of hospital days after randomization

Time Frame

Across the entire hospitalization after randomization (approximately 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Cox, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Per NIH and Duke University policies after trial and analyses completed.

Citations:

PubMed Identifier

29121480

Citation

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.

Results Reference

background

PubMed Identifier

33007442

Citation

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.

Results Reference

background

Links:

URL

http://pcplanner.duke.edu

Description

general trial information

Learn more about this trial

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

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