Aging, Care Delivery Model, Critical Illness, Informal Caregivers, Palliative Care, Psychological Distress
Conditions
Keywords
palliative care, Intensive Care Unit, critical illness, mobile app, care delivery, informal caregiver
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, 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.
Interventions
BEHAVIORALPCplanner
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.
Sponsors
National Institute on Aging (NIA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All masking done via differential user accesses allowed by a mobile app platform.
Intervention model description
Randomized clinical trial comparing intervention to usual care control.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 9-Item Scale (PHQ-9) | 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). |
| 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) | 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). |
| Post-Traumatic Stress Symptom (PTSS) Inventory | 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). |
| 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) | A metric of goal concordance as reported by patients' family members. |
| Patient-Perceived Patient-Centeredness (PPPC) Scale | 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). |
| Post-randomization Intensive Care Unit Length of Stay | 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. |
| Post-randomization Hospital Length of Stay | from randomization until hospital discharge | A measure of hospital days after randomization for PATIENTS for each patient member of the patient-family member dyad |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| Usual Care Control Family Members Usual care is standard ICU care | 75 |
| 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. | 76 |
| Usual Care Control Patients Usual care is standard ICU care | 75 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 7 | 5 | 5 |
| Overall Study | Patient Death | 18 | 18 | 15 | 15 |
| Overall Study | Patient Hospitalization | 1 | 1 | 2 | 2 |
| Overall Study | Residence in post-acute care facility | 3 | 3 | 5 | 5 |
Baseline characteristics
| Characteristic | Usual Care Control Family Members | PCplanner Intervention Family Members | PCplanner Intervention Patients | Usual Care Control Patients | Total |
|---|---|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 13 | 57.3 years STANDARD_DEVIATION 12.9 | 69.2 years STANDARD_DEVIATION 9.8 | 70.5 years STANDARD_DEVIATION 9.6 | 57.4 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 74 Participants | 75 Participants | 73 Participants | 296 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| NEST score | 32.6 units on a scale STANDARD_DEVIATION 17.9 | 31.8 units on a scale STANDARD_DEVIATION 18.4 | — | — | 32.2 units on a scale STANDARD_DEVIATION 18.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 23 Participants | 23 Participants | 14 Participants | 74 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 56 Participants | 50 Participants | 52 Participants | 58 Participants | 216 Participants |
| Region of Enrollment United States | 75 Participants | 76 Participants | 76 Participants | 75 Participants | 302 Participants |
| Sex: Female, Male Female | 57 Participants | 53 Participants | 34 Participants | 31 Participants | 175 Participants |
| Sex: Female, Male Male | 18 Participants | 23 Participants | 42 Participants | 44 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 75 | 18 / 76 | 15 / 75 |
| other Total, other adverse events | 1 / 76 | 1 / 75 | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 75 | 0 / 76 | 0 / 75 |
Outcome results
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).
Time frame: Time 1 (baseline), Time 2 (~3 days post-randomization), and Time 3 (~1 week post-randomization)
Population: Participants with data collected at Time 3 (\~1 week post-randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCplanner Intervention Family Members | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | 28.5 score on a scale | Standard Deviation 19.4 |
| Usual Care Control Family Members | Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score | 29.3 score on a scale | Standard Deviation 21.4 |
Comparison: Difference between Time 1 (baseline) and Time 3 (\~1 week post-randomization)p-value: 195% CI: [-6.21, 6.21]Mixed Models Analysis
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).
Time frame: Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization)
Population: Participants with data collected at Time 4 (3 months post-randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCplanner Intervention Family Members | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | 4.9 score on a scale | Standard Deviation 5.2 |
| Usual Care Control Family Members | Generalized Anxiety Disorder 7-Item Scale (GAD-7) | 4.8 score on a scale | Standard Deviation 3.9 |
Comparison: Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)p-value: 0.7295% CI: [-1.28, 1.86]Mixed Models Analysis
Secondary
Number of Participants With Goal Concordant Care
A metric of goal concordance as reported by patients' family members.
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Population: Participants with data collected at Time 3 (\~1 week post-randomization).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCplanner Intervention Family Members | Number of Participants With Goal Concordant Care | 49 Participants |
| Usual Care Control Family Members | Number of Participants With Goal Concordant Care | 45 Participants |
Comparison: Difference between Time 1 (baseline) and Time 3 (target \~1 week post-randomization)p-value: 0.1295% CI: [0.2, 1.2]Mixed Models Analysis
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).
Time frame: Time 1 (baseline), Time 3 (~1 week post-randomization), and Time 4 (3 months post-randomization)
Population: Participants with data collected at Time 4 (3 months post-randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCplanner Intervention Family Members | Patient Health Questionnaire 9-Item Scale (PHQ-9) | 6.0 score on a scale | Standard Deviation 4.6 |
| Usual Care Control Family Members | Patient Health Questionnaire 9-Item Scale (PHQ-9) | 6.3 score on a scale | Standard Deviation 5.3 |
Comparison: Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)p-value: 0.9595% CI: [-1.83, 1.72]Mixed Models Analysis
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).
Time frame: Time 3 (target ~1 week post-randomization)
Population: Participants with data collected at Time 3 (\~1 week post-randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCplanner Intervention Family Members | Patient-Perceived Patient-Centeredness (PPPC) Scale | 20.2 score on a scale | Standard Deviation 7 |
| Usual Care Control Family Members | Patient-Perceived Patient-Centeredness (PPPC) Scale | 21.4 score on a scale | Standard Deviation 8.4 |
p-value: 0.58Wilcoxon (Mann-Whitney)
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
Time frame: from randomization until hospital discharge
Population: Patients of whom participants are family members/caregivers.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PCplanner Intervention Family Members | Post-randomization Hospital Length of Stay | 19.0 days |
| Usual Care Control Family Members | Post-randomization Hospital Length of Stay | 20.0 days |
p-value: 0.79Wilcoxon (Mann-Whitney)
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.
Time frame: from randomization until intensive care unit discharge
Population: Patients of whom participants are family members/caregivers.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PCplanner Intervention Family Members | Post-randomization Intensive Care Unit Length of Stay | 11.5 days |
| Usual Care Control Family Members | Post-randomization Intensive Care Unit Length of Stay | 10.0 days |
p-value: 0.29Wilcoxon (Mann-Whitney)
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).
Time frame: Time 1 (baseline) and Time 4 (3 months post-randomization)
Population: Participants with data collected at Time 4 (3 months post-randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCplanner Intervention Family Members | Post-Traumatic Stress Symptom (PTSS) Inventory | 21.7 score on a scale | Standard Deviation 13.1 |
| Usual Care Control Family Members | Post-Traumatic Stress Symptom (PTSS) Inventory | 21.6 score on a scale | Standard Deviation 11.3 |
Comparison: Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)p-value: 0.4895% CI: [-2.44, 5.14]Mixed Models Analysis