Palliative CarePCplannerNCT04414787
A Needs-focused Palliative Care Intervention for Older Adults in ICUs
A study testing PCplanner in people with Palliative Care and Critical Illness, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Palliative Care, Critical Illness, Aging
- What is being tested?
- PCplanner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 17 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
- ≥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)
- ≥18 years of age
- Attending or fellow physician in a study ICU
Who cannot join
- 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
Show all 13Show fewer
- FAMILY MEMBER
- 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
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Operationalizing PCplanner, a Needs-focused Palliative Care for Older Adults in Intensive Care Units: a Randomized Clinical Trial
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.
Read the 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
- Palliative Care, Critical Illness, Aging, Care Delivery Model, Informal Caregivers, Psychological Distress
- Being tested
- PCplanner
- Keywords
- palliative care, Intensive Care Unit, critical illness, mobile app, care delivery, informal caregiver
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCplannerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | PCplanner intervention during hospitalization Receives: Behavioral: PCplanner |
| Usual care control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: Time 1 (baseline), Time 3 (~1 week post-randomization), and Time 4 (3 months post-randomization)
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
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).
Measured: Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)
Post-Traumatic Stress Symptom (PTSS) Inventory
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).
Measured: Time 1 (baseline) and Time 4 (3 months post-randomization)
Number of Participants With Goal Concordant Care
A metric of goal concordance as reported by patients' family members.
Measured: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Patient-Perceived Patient-Centeredness (PPPC) Scale
A measure of patient-centeredness used by patients' family members with scores that range from 12 (higher patient-centeredness) to 48 (lower patient-centeredness).
Measured: Time 3 (target ~1 week post-randomization)
Post-randomization Intensive Care Unit Length of Stay
A measure of intensive care unit days after randomization for patients of whom participants are family members/caregivers.
Measured: from randomization until intensive care unit discharge
Post-randomization Hospital Length of Stay
A measure of hospital days after randomization for PATIENTS for each patient member of the patient-family member dyad
Measured: from randomization until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start22 Feb 2021
- Primary completion26 Sep 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial comparing intervention to usual care control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Christopher Cox, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414787
- Sponsor's protocol ID
- Pro00101745
- Other IDs
- R01AG058915
- Acronym
- PCplanner
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2020
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIH and Duke University policies after trial and analyses completed.
Publications
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.
PubMed 29121480Cox 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.
PubMed 33007442Cox 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.
PubMed 39680398
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operationalizing PCplanner, a Needs-focused Palliative Care for Older Adults in Intensive Care Units: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04414787
- Acronym / sponsor ID
- PCplanner / Pro00101745
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial comparing intervention to usual care control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: PCplannerPCplanner intervention during hospitalization |
| Usual care control | No intervention | –Usual care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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)
- ≥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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCplannerPCplanner-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. | Behavioural | Intervention |
Primary outcome
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).
7 secondary outcomes
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)
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)
Post-Traumatic Stress Symptom (PTSS) Inventory
Time frame: Time 1 (baseline) and Time 4 (3 months post-randomization)
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)
Patient-Perceived Patient-Centeredness (PPPC) Scale
Time frame: Time 3 (target ~1 week post-randomization)
Post-randomization Intensive Care Unit Length of Stay
Time frame: from randomization until intensive care unit discharge
Post-randomization Hospital Length of Stay
Time frame: from randomization until hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29121480Cox 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.
- Background: PubMed 33007442Cox 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.
- Derived from this study: PubMed 39680398Cox 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.
- general trial informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Per NIH and Duke University policies after trial and analyses completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Cox, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCplanner in people with Palliative Care and Critical Illness, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414787, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.