Trial Outcomes & Findings for A Needs-focused Palliative Care Intervention for Older Adults in ICUs (NCT NCT04414787)
NCT ID: NCT04414787
Last Updated: 2025-07-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
Time 1 (baseline), Time 2 (~3 days post-randomization), and Time 3 (~1 week post-randomization)
Results posted on
2025-07-18
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
Usual Care Control Dyad - Family Member
Usual care includes standard ICU care
|
Usual Care Control Dyad - Patient
Usual care includes standard ICU care
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
75
|
75
|
|
Overall Study
COMPLETED
|
47
|
47
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
29
|
29
|
27
|
27
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Usual Care Control Dyad - Family Member
Usual care includes standard ICU care
|
Usual Care Control Dyad - Patient
Usual care includes standard ICU care
|
|---|---|---|---|---|
|
Overall Study
Patient Death
|
18
|
18
|
15
|
15
|
|
Overall Study
Patient Hospitalization
|
1
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
5
|
5
|
|
Overall Study
Residence in post-acute care facility
|
3
|
3
|
5
|
5
|
Baseline Characteristics
NEST surveys were not collected from patients.
Baseline characteristics by cohort
| Measure |
PCplanner Intervention Family Members
n=76 Participants
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.
|
Usual Care Control Family Members
n=75 Participants
Usual care is standard ICU care
|
PCplanner Intervention Patients
n=76 Participants
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.
|
Usual Care Control Patients
n=75 Participants
Usual care is standard ICU care
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 12.9 • n=76 Participants
|
57.4 years
STANDARD_DEVIATION 13.0 • n=75 Participants
|
69.2 years
STANDARD_DEVIATION 9.8 • n=76 Participants
|
70.5 years
STANDARD_DEVIATION 9.6 • n=75 Participants
|
57.4 years
STANDARD_DEVIATION 12.9 • n=302 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=76 Participants
|
57 Participants
n=75 Participants
|
34 Participants
n=76 Participants
|
31 Participants
n=75 Participants
|
175 Participants
n=302 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=76 Participants
|
18 Participants
n=75 Participants
|
42 Participants
n=76 Participants
|
44 Participants
n=75 Participants
|
127 Participants
n=302 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
4 Participants
n=302 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=76 Participants
|
74 Participants
n=75 Participants
|
75 Participants
n=76 Participants
|
73 Participants
n=75 Participants
|
296 Participants
n=302 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=76 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
2 Participants
n=302 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=75 Participants
|
1 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=76 Participants
|
2 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
2 Participants
n=75 Participants
|
4 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=75 Participants
|
1 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=76 Participants
|
14 Participants
n=75 Participants
|
23 Participants
n=76 Participants
|
14 Participants
n=75 Participants
|
74 Participants
n=302 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=76 Participants
|
56 Participants
n=75 Participants
|
52 Participants
n=76 Participants
|
58 Participants
n=75 Participants
|
216 Participants
n=302 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=75 Participants
|
2 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=76 Participants
|
0 Participants
n=75 Participants
|
1 Participants
n=76 Participants
|
0 Participants
n=75 Participants
|
4 Participants
n=302 Participants
|
|
Region of Enrollment
United States
|
76 Participants
n=76 Participants
|
75 Participants
n=75 Participants
|
76 Participants
n=76 Participants
|
75 Participants
n=75 Participants
|
302 Participants
n=302 Participants
|
|
NEST score
|
31.8 units on a scale
STANDARD_DEVIATION 18.4 • n=76 Participants • NEST surveys were not collected from patients.
|
32.6 units on a scale
STANDARD_DEVIATION 17.9 • n=75 Participants • NEST surveys were not collected from patients.
|
—
|
—
|
32.2 units on a scale
STANDARD_DEVIATION 18.1 • n=151 Participants • NEST surveys were not collected from patients.
|
PRIMARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=61 Participants
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.
|
Usual Care Control Family Members
n=53 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
|
28.5 score on a scale
Standard Deviation 19.4
|
29.3 score on a scale
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=47 Participants
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.
|
Usual Care Control Family Members
n=48 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Patient Health Questionnaire 9-Item Scale (PHQ-9)
|
6.0 score on a scale
Standard Deviation 4.6
|
6.3 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=47 Participants
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.
|
Usual Care Control Family Members
n=48 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
|
4.9 score on a scale
Standard Deviation 5.2
|
4.8 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Time 1 (baseline) and Time 4 (3 months post-randomization)Population: Participants with data collected at 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).
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=47 Participants
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.
|
Usual Care Control Family Members
n=48 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Post-Traumatic Stress Symptom (PTSS) Inventory
|
21.7 score on a scale
Standard Deviation 13.1
|
21.6 score on a scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 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).
A metric of goal concordance as reported by patients' family members.
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=61 Participants
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.
|
Usual Care Control Family Members
n=53 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Number of Participants With Goal Concordant Care
|
49 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Time 3 (target ~1 week post-randomization)Population: Participants with data collected at Time 3 (\~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).
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=61 Participants
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.
|
Usual Care Control Family Members
n=53 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Patient-Perceived Patient-Centeredness (PPPC) Scale
|
20.2 score on a scale
Standard Deviation 7.0
|
21.4 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: from randomization until intensive care unit dischargePopulation: Patients of whom participants are family members/caregivers.
A measure of intensive care unit days after randomization for patients of whom participants are family members/caregivers.
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=76 Participants
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.
|
Usual Care Control Family Members
n=75 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Post-randomization Intensive Care Unit Length of Stay
|
11.5 days
Interval 6.0 to 60.0
|
10.0 days
Interval 7.0 to 23.0
|
SECONDARY outcome
Timeframe: from randomization until hospital dischargePopulation: Patients of whom participants are family members/caregivers.
A measure of hospital days after randomization for PATIENTS for each patient member of the patient-family member dyad
Outcome measures
| Measure |
PCplanner Intervention Family Members
n=76 Participants
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.
|
Usual Care Control Family Members
n=75 Participants
Usual care is standard ICU care
|
|---|---|---|
|
Post-randomization Hospital Length of Stay
|
19.0 days
Interval 12.0 to 31.0
|
20.0 days
Interval 12.0 to 32.0
|
Adverse Events
PCplanner Intervention Family Members
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care Control Family Members
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PCplanner Intervention Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Usual Care Control Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PCplanner Intervention Family Members
n=76 participants at risk
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.
|
Usual Care Control Family Members
n=75 participants at risk
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.
|
PCplanner Intervention Patients
n=76 participants at risk
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.
|
Usual Care Control Patients
n=75 participants at risk
Usual care is standard ICU care
Adverse event reporting by family members and patients are as follows. Numbers reported for deaths reflect PATIENTS.
|
|---|---|---|---|---|
|
Psychiatric disorders
Family member reporting a value other than 1 for PHQ-9 item 9 (suicidality)
|
1.3%
1/76 • Number of events 1 • 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.
|
1.3%
1/75 • Number of events 1 • 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.
|
0.00%
0/76 • 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.
|
0.00%
0/75 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place