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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG058915 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | PCplanner intervention during hospitalization |
|
| Usual care control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Time 1 (baseline), Time 3 (~1 week post-randomization), and Time 4 (3 months post-randomization) |
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PATIENTS
Inclusion Criteria:
Exclusion Criteria (pre-consent):
Exclusion Criteria (post-consent):
- Patient dies before T2
FAMILY MEMBER
Inclusion Criteria:
Exclusion Criteria (pre-consent):
Exclusion Criteria (post-consent):
- Low need burden (NEST score <10) at baseline
ICU PHYSICIANS
Inclusion Criteria:
Exclusion Criteria:
- None
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cox, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29121480 | Background | 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. | |
| 33007442 | 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. |
| Label | URL |
|---|---|
| general trial information | View source |
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Per NIH and Duke University policies after trial and analyses completed.
2025
review by study team
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1. Physicians and patients were not considered enrolled for study measure purposes as NEITHER completed surveys or other self-reported outcomes. 2. Physicians were not randomized to a group and therefore cannot be sensibly included in a RCT data table. 3. Note in the flow table these are also the numbers of patient-family members dyads. ONLY FAMILY MEMBERS completed surveys in this trial. They are not represented in separate flow diagrams because it would be too confusing for the reader.
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| ID | Title | Description |
|---|---|---|
| FG000 | PCplanner Intervention Dyad - Family Member | PCplanner intervention during hospitalization PCplanner: 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. |
| FG001 | PCplanner Intervention Dyad - Patient | PCplanner intervention during hospitalization PCplanner: 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. |
| FG002 | Usual Care Control Dyad - Family Member | Usual care includes standard ICU care |
| FG003 | Usual Care Control Dyad - Patient | Usual care includes standard ICU care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ONLY FAMILY MEMBERS have survey outcomes reported (i.e., NEST). Physicians and patients DID NOT complete surveys.
The ONLY patient-level data reported are for demographics, length of stay, and AEs.
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| ID | Title | Description |
|---|---|---|
| BG000 | PCplanner Intervention Family Members | PCplanner intervention during hospitalization PCplanner: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants with data collected at Time 3 (~1 week post-randomization). | Posted | Mean | Standard Deviation | score on a scale | Time 1 (baseline), Time 2 (~3 days post-randomization), and Time 3 (~1 week post-randomization) |
|
3 months
Adverse event reporting by family members and patients are as follows. Numbers reported for PHQ-9 item 9 (suicidality) reflect FAMILY MEMBERS. Numbers reported for deaths reflect PATIENTS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCplanner Intervention Family Members | PCplanner intervention during hospitalization PCplanner: 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. Adverse event reporting by family members and patients are as follows. Numbers reported for PHQ-9 item 9 (suicidality) reflect FAMILY MEMBERS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Family member reporting a value other than 1 for PHQ-9 item 9 (suicidality) | Psychiatric disorders | Systematic Assessment | Note PI called both participant immediately to ensure safety and confirm there was no active suicidality. |
Deaths reported reflect patient, not family member, events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cox | Duke University | 919-681-7232 | christopher.cox@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2022 | Jul 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2022 | Oct 27, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized clinical trial comparing intervention to usual care control.
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All masking done via differential user accesses allowed by a mobile app platform.
|
| 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). | 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). | 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. | 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). | 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. | 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 | from randomization until hospital discharge |
| 39680398 | Derived | 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. |
| Patient Hospitalization |
|
| Lost to Follow-up |
|
| Residence in post-acute care facility |
|
| BG001 |
| Usual Care Control Family Members |
Usual care is standard ICU care |
| BG002 | PCplanner Intervention Patients | PCplanner intervention during hospitalization PCplanner: 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. |
| BG003 | Usual Care Control Patients | Usual care is standard ICU care |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| NEST score | The NEST (Needs; Existential Concerns; Symptoms; and Therapeutic Interaction) is a palliative care needs instrument capturing all 8 domains of palliative care quality. Scores range from 0 (no needs) to 130 (higher needs). Note that NEST data were not captured from patients. On family members completed the NEST. | NEST surveys were not collected from patients. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care Control Family Members | Usual care is standard ICU care |
|
|
|
| Secondary | 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). | Participants with data collected at Time 4 (3 months post-randomization). | Posted | Mean | Standard Deviation | score on a scale | Time 1 (baseline), Time 3 (~1 week post-randomization), and Time 4 (3 months post-randomization) |
|
|
|
|
| Secondary | 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). | Participants with data collected at Time 4 (3 months post-randomization). | Posted | Mean | Standard Deviation | score on a scale | Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization) |
|
|
|
|
| Secondary | 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). | Participants with data collected at Time 4 (3 months post-randomization). | Posted | Mean | Standard Deviation | score on a scale | Time 1 (baseline) and Time 4 (3 months post-randomization) |
|
|
|
|
| Secondary | Number of Participants With Goal Concordant Care | A metric of goal concordance as reported by patients' family members. | Participants with data collected at Time 3 (~1 week post-randomization). | Posted | Count of Participants | Participants | Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization) |
|
|
|
|
| Secondary | 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). | Participants with data collected at Time 3 (~1 week post-randomization). | Posted | Mean | Standard Deviation | score on a scale | Time 3 (target ~1 week post-randomization) |
|
|
|
|
| Secondary | 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. | Patients of whom participants are family members/caregivers. | Posted | Median | Inter-Quartile Range | days | from randomization until intensive care unit discharge |
|
|
|
|
| Secondary | 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 | Patients of whom participants are family members/caregivers. | Posted | Median | Inter-Quartile Range | days | from randomization until hospital discharge |
|
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 1 |
| 76 |
| EG001 | Usual Care Control Family Members | Usual care is standard ICU care Adverse event reporting by family members and patients are as follows. Numbers reported for PHQ-9 item 9 (suicidality) reflect FAMILY MEMBERS. | 0 | 75 | 0 | 75 | 1 | 75 |
| EG002 | PCplanner Intervention Patients | PCplanner intervention during hospitalization PCplanner: 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. Adverse event reporting by family members and patients are as follows. Numbers reported for deaths reflect PATIENTS. | 18 | 76 | 0 | 76 | 0 | 76 |
| EG003 | Usual Care Control Patients | Usual care is standard ICU care Adverse event reporting by family members and patients are as follows. Numbers reported for deaths reflect PATIENTS. | 15 | 75 | 0 | 75 | 0 | 75 |
|
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|