Trial Outcomes & Findings for Addressing Palliative Care Needs Among Intensive Care Unit Family Members (NCT NCT03506438)
NCT ID: NCT03506438
Last Updated: 2023-11-13
Results Overview
A palliative care needs instrument that assesses palliative care needs across all 8 domains of palliative care quality. Scores on this 13-item instrument can range from 0 (no needs) to 130 (higher needs)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Results posted on
2023-11-13
Participant Flow
This was a cluster randomized trial with randomization at the level of the ICU physician. Cluster size was 4 family member-patient dyads (2 Black and 2 White family members). Patients were used to determine family member eligibility.
Family members were excluded post-enrollment if their baseline NEST score was \<15, representing low needs.
Participant milestones
| Measure |
Family Members in ICU Attending Physician Mobile App Group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in ICU Attending Physician Usual Care Group
Usual ICU care
Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal
|
Patients in ICU Attending Mobile App Group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Patients in the ICU Attending Usual Care Group
Usual ICU care
Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal
|
ICU Attendings in the ICU Attending Mobile App Group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
ICU Attendings in the ICU Attending Usual Care Group
Usual ICU care
Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
55
|
56
|
19
|
18
|
|
Overall Study
COMPLETED
|
47
|
49
|
47
|
49
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
8
|
7
|
0
|
0
|
Reasons for withdrawal
| Measure |
Family Members in ICU Attending Physician Mobile App Group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in ICU Attending Physician Usual Care Group
Usual ICU care
Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal
|
Patients in ICU Attending Mobile App Group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Patients in the ICU Attending Usual Care Group
Usual ICU care
Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal
|
ICU Attendings in the ICU Attending Mobile App Group
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
ICU Attendings in the ICU Attending Usual Care Group
Usual ICU care
Usual care: Usual ICU care is usual care from an ICU attending physician in an ICU setting, as per normal
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
8
|
7
|
0
|
0
|
Baseline Characteristics
Age was not collected for ICU attending physicians.
Baseline characteristics by cohort
| Measure |
Family Members in ICU Attending Physician Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in ICU Attending Physician Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care is standard care from an ICU attending in an ICU setting per the standards of the care area without a mobile app
|
Patients in ICU Attending Physician Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Patients in ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care is standard care from an ICU attending in an ICU setting per the standards of the care area without a mobile app
|
ICU Attendings in the ICU Attending Mobile App Group
n=19 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
ICU Attendings in the ICU Attending Usual Care Group
n=18 Participants
Usual ICU care
Usual care: Usual ICU care is standard care from an ICU attending in an ICU setting per the standards of the care area without a mobile app
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
n=55 Participants • Age was not collected for ICU attending physicians.
|
54 years
n=56 Participants • Age was not collected for ICU attending physicians.
|
55.7 years
n=55 Participants • Age was not collected for ICU attending physicians.
|
57.9 years
n=56 Participants • Age was not collected for ICU attending physicians.
|
—
|
—
|
54.7 years
n=222 Participants • Age was not collected for ICU attending physicians.
|
|
Sex/Gender, Customized
Gender self-described as man
|
12 Participants
n=55 Participants
|
7 Participants
n=56 Participants
|
28 Participants
n=55 Participants
|
38 Participants
n=56 Participants
|
12 Participants
n=19 Participants
|
11 Participants
n=18 Participants
|
108 Participants
n=259 Participants
|
|
Sex/Gender, Customized
Gender self-described as woman
|
43 Participants
n=55 Participants
|
49 Participants
n=56 Participants
|
27 Participants
n=55 Participants
|
18 Participants
n=56 Participants
|
7 Participants
n=19 Participants
|
7 Participants
n=18 Participants
|
151 Participants
n=259 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=259 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
55 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
18 Participants
n=19 Participants
|
16 Participants
n=18 Participants
|
256 Participants
n=259 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=259 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=259 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
5 Participants
n=259 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=259 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=55 Participants
|
28 Participants
n=56 Participants
|
18 Participants
n=55 Participants
|
27 Participants
n=56 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
92 Participants
n=259 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=55 Participants
|
28 Participants
n=56 Participants
|
36 Participants
n=55 Participants
|
29 Participants
n=56 Participants
|
15 Participants
n=19 Participants
|
16 Participants
n=18 Participants
|
160 Participants
n=259 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=259 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=259 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
56 participants
n=56 Participants
|
55 participants
n=55 Participants
|
56 participants
n=56 Participants
|
19 participants
n=19 Participants
|
18 participants
n=18 Participants
|
259 participants
n=259 Participants
|
|
Needs; existential concerns; symptoms; and therapeutic interaction (NEST) scale
|
36.9 units on a scale
STANDARD_DEVIATION 19.0 • n=55 Participants • Note that the NEST was completed by family members only in this study (i.e., NOT by patients and NOT by ICU physicians). For this reason, these sections are blank.
|
36.3 units on a scale
STANDARD_DEVIATION 17.4 • n=56 Participants • Note that the NEST was completed by family members only in this study (i.e., NOT by patients and NOT by ICU physicians). For this reason, these sections are blank.
|
—
|
—
|
—
|
—
|
37.0 units on a scale
STANDARD_DEVIATION 18.0 • n=111 Participants • Note that the NEST was completed by family members only in this study (i.e., NOT by patients and NOT by ICU physicians). For this reason, these sections are blank.
|
PRIMARY outcome
Timeframe: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)A palliative care needs instrument that assesses palliative care needs across all 8 domains of palliative care quality. Scores on this 13-item instrument can range from 0 (no needs) to 130 (higher needs)
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
NEST baseline
|
36.9 score on a scale
Standard Deviation 19.0
|
36.3 score on a scale
Standard Deviation 17.4
|
|
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
NEST day 3
|
26.5 score on a scale
Standard Deviation 19.1
|
32.3 score on a scale
Standard Deviation 22.1
|
|
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
NEST day 7
|
24.9 score on a scale
Standard Deviation 19.5
|
29.6 score on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)Population: Data not collected on the the patient and ICU attendings Arms/Groups.
A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Patient Health Questionnaire 9-Item Scale (PHQ-9)
PHQ-9 baseline
|
8.0 score on a scale
Standard Deviation 3.5
|
7.7 score on a scale
Standard Deviation 3.6
|
|
Patient Health Questionnaire 9-Item Scale (PHQ-9)
PHQ-9 day 3
|
6.9 score on a scale
Standard Deviation 3.7
|
6.4 score on a scale
Standard Deviation 3.1
|
|
Patient Health Questionnaire 9-Item Scale (PHQ-9)
PHQ-9 3 months
|
6.0 score on a scale
Standard Deviation 3.4
|
6.0 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)Population: Data not collected on the the patient and ICU attendings Arms/Groups.
An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
GAD-7 3 days
|
7.9 score on a scale
Standard Deviation 6.1
|
7.4 score on a scale
Standard Deviation 5.4
|
|
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
GAD-7 baseline
|
9.2 score on a scale
Standard Deviation 6.3
|
8.4 score on a scale
Standard Deviation 5.9
|
|
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
GAD-7 month 3
|
6.1 score on a scale
Standard Deviation 5.2
|
5.3 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Time 1 (baseline) and Time 4 (3 months post-randomization)Population: Data not collected on the the patient and ICU attendings Arms/Groups.
A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Post-Traumatic Stress Symptom (PTSS) Inventory
PTSS month 3
|
25.4 score on a scale
Standard Deviation 15.7
|
23.0 score on a scale
Standard Deviation 13.9
|
|
Post-Traumatic Stress Symptom (PTSS) Inventory
PTSS baseline
|
26.2 score on a scale
Standard Deviation 14.8
|
24.5 score on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Time 1 (baseline) and Time 2 (target ~3 days post-randomization)Population: Data not collected on the the patient and ICU attendings Arms/Groups.
A measure of the alignment between patient values and treatments received. This is a dichotomous scale; care is either concordant or discordant.
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Number of Participants With Goal Concordant Care
Day 3
|
47 Participants
|
47 Participants
|
|
Number of Participants With Goal Concordant Care
Baseline
|
37 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Across the entire hospitalization after randomization (approximately 2 months)Population: Data not collected on the the patient and ICU attendings Arms/Groups.
Patient hospital length of stay measured in days post-randomization
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Post-randomization Hospital Length of Stay (Days)
|
37.2 days
Standard Deviation 21.2
|
38.6 days
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Across the entire hospitalization after randomization (approximately 2 months)Population: Data not collected on the the patient and ICU attendings Arms/Groups.
Patient intensive care unit length of stay post-randomization
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Post-randomization Intensive Care Unit Length of Stay (Days)
|
21.2 days
Standard Deviation 16.4
|
21.2 days
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline (at time of randomization) and ~3 days post-randomizationPopulation: Data not collected on the the patient and ICU attendings Arms/Groups.
The IPC-18 is a measure of the interpersonal aspects of care. Interpersonal processes of care are the social-psychological aspects of the patient-physician interaction. These components of quality of care may help explain disparities in health between minority patients and their counterparts. The "elicited concerns, responded" scale within the Communication domain is used here. All items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' A higher score indicates better processes.
Outcome measures
| Measure |
Family Members in the ICU Attending Mobile App Group
n=55 Participants
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Needs-focused mobile app: A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
|
Family Members in the ICU Attending Usual Care Group
n=56 Participants
Usual ICU care
Usual care: Usual ICU care per the standards of the ICU attending
|
|---|---|---|
|
Number of Participants Who Responded "Usually" or "Always" on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain
Day 3
|
49 Participants
|
44 Participants
|
|
Number of Participants Who Responded "Usually" or "Always" on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain
Day 1
|
46 Participants
|
47 Participants
|
Adverse Events
Patients in ICU Attending Physician Mobile App Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
Patients in ICU Attending Physician Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Family Members in ICU Attending Physician Mobile App Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Family Members in ICU Attending Physician Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ICU Attending in the ICU Attending Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ICU Attending in the ICU Attending Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place