18 and older, any sex, with Chronic Disease or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Depression Symptoms, Family (HADS-D)Primary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3.
For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 7 items measuring depression, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
6.4
± 4.4
Facilitator-Based INTERVENTION: Family
6.5
± 4.3
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
6.3
± 4.3
Facilitator-Based INTERVENTION: Family
5.9
± 4.1
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
5.9
± 4.1
Facilitator-Based INTERVENTION: Family
5.9
± 4.5
Anxiety Symptoms, Family (HADS-A)Secondary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 7 items measuring anxiety, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher valu
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
8.2
± 4.5
Facilitator-Based INTERVENTION: Family
8.4
± 4.3
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
8.4
± 4.8
Facilitator-Based INTERVENTION: Family
8.2
± 4.4
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
8.1
± 4.8
Facilitator-Based INTERVENTION: Family
7.9
± 4.6
Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam)Secondary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Measure of family experience of patients with serious illness. The QUAL-E (Fam) is a validated 17-item companion instrument to the patient QUAL-E measure of quality of life at the end of life, with four subscales and two general items. This study is using 11 items from three subscales: Relationship with Health Care Provider, Completion, and Preparation subscales. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #5, 6, 7, and 8. The mean could range from 1 to 5, with higher values indicating highe
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
3.94
± 0.85
Facilitator-Based INTERVENTION: Family
4.10
± 0.77
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
3.51
± 1.16
Facilitator-Based INTERVENTION: Family
3.87
± 0.97
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
3.54
± 1.13
Facilitator-Based INTERVENTION: Family
3.64
± 1.11
Quality of Family Experience - Sense of Completion (QUAL-E Fam)Secondary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Measure of family experience of patients with serious illness. The QUAL-E (Fam) is a validated 17-item companion instrument to the patient QUAL-E measure of quality of life at the end of life, with four subscales and two general items. This study is using 11 items from three subscales: Relationship with Health Care Provider, Completion, and Preparation subscales. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the mean of the valid responses to QUAL-E (Fam) items #9, 10, and 11. The mean could range from 1 to 5, with higher values indicating higher
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
3.68
± 1.16
Facilitator-Based INTERVENTION: Family
3.75
± 1.02
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
3.98
± 0.98
Facilitator-Based INTERVENTION: Family
3.94
± 1.03
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
4.05
± 0.93
Facilitator-Based INTERVENTION: Family
4.01
± 1.00
Quality of Family Experience - Preparation Issues (QUAL-E Fam)Secondary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Measure of family experience of patients with serious illness. The QUAL-E (Fam) is a validated 17-item companion instrument to the patient QUAL-E measure of quality of life at the end of life, with four subscales and two general items. This study is using 11 items from three subscales: Relationship with Health Care Provider, Completion, and Preparation subscales. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of valid responses to QUAL-E (Fam) items #12, 13, 14, and 15, weighted for the number of items with valid responses. The sum could r
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
13.5
± 3.2
Facilitator-Based INTERVENTION: Family
13.9
± 3.2
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
13.3
± 3.2
Facilitator-Based INTERVENTION: Family
14.0
± 3.2
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
13.6
± 3.4
Facilitator-Based INTERVENTION: Family
14.0
± 3.2
Goal-Concordant Care, Family AssessmentSecondary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value
Concordance between the care patients want and the care they receive is measured with two questions from the SUPPORT study. The first defines preference (care focused on extending life even with more pain and discomfort vs. care focused on relieving pain and discomfort even with not living as long.) The second assesses perception of current treatment using the same options. The outcome is a dichotomous variable of whether preference matches care received. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was coded 1 if the respondent's perception of the
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
0.57
± 0.497
Facilitator-Based INTERVENTION: Family
0.63
± 0.484
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
0.57
± 0.497
Facilitator-Based INTERVENTION: Family
0.65
± 0.479
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
0.59
± 0.495
Facilitator-Based INTERVENTION: Family
0.64
± 0.481
Impact of Event, Family Assessment (IES-6)Secondary· 1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome
The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses six self-report items to assess subjective distress caused by a traumatic event. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 6 items measuring the traumatic impact of events, weighted for the number of items with valid responses. The sum could range from 0 to 24, with higher values indicating greater traumatic impact (i.e., worse outcome)
at 1-month
Group
Value
95% CI
Usual Care/CONTROL: Family
11
± 6
Facilitator-Based INTERVENTION: Family
9.4
± 5.9
at 3-months
Group
Value
95% CI
Usual Care/CONTROL: Family
9
± 6
Facilitator-Based INTERVENTION: Family
8.9
± 6.4
at 6-months
Group
Value
95% CI
Usual Care/CONTROL: Family
9
± 6
Facilitator-Based INTERVENTION: Family
8.1
± 6.0
Healthcare Utilization: Hospital Readmission - PatientSecondary· within 30 days after discharge from the index hospitalization
Documentation in the patient's electronic health record of hospital readmission within 30 days after discharge from the index hospitalization: 0=no readmission, 1=one or more readmissions; missing if index hospitalization still ongoing at the end of the 183-day follow-up period, patient death during index hospitalization, or randomization occurred after index hospitalization discharge. Valid outcomes could be either 0 or 1, with higher value indicating a worse outcome.
Group
Value
95% CI
Usual Care/CONTROL: Patient
0.10
± 0.31
Facilitator-Based INTERVENTION: Patient
0.19
± 0.39
Healthcare Utilization: Hospital Free Days, 30 Days - PatientSecondary· 30 days after randomization
Number of full days on which the patient was alive and not in the hospital between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Group
Value
95% CI
Usual Care/CONTROL: Patient
5.65
± 8.45
Facilitator-Based INTERVENTION: Patient
6.78
± 8.74
Healthcare Utilization: Hospital Free Days, 91 Days - PatientSecondary· 91 days after randomization
Number of full days on which the patient was alive and not in the hospital between the randomization date and 90 days after the randomization date. Values could range from 0 to 91, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Group
Value
95% CI
Usual Care/CONTROL: Patient
39.63
± 32.95
Facilitator-Based INTERVENTION: Patient
41.43
± 33.29
Healthcare Utilization: Hospital Free Days, 183 Days - PatientSecondary· 183 days after randomization
Number of full days on which the patient was alive and not in the hospital between the randomization date and 182 days after the randomization date. Values could range from 0 to 183, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Group
Value
95% CI
Usual Care/CONTROL: Patient
93.66
± 74.03
Facilitator-Based INTERVENTION: Patient
98.13
± 72.55
Healthcare Utilization: ICU Free Days, 30 Days - PatientSecondary· 30 days after randomization
Number of full days on which the patient was alive and not in an ICU between the randomization date and 29 days after the randomization date. Values could range from 0 to 30, with higher value indicating a better outcome; missing if randomization occurred after index hospitalization discharge.
Group
Value
95% CI
Usual Care/CONTROL: Patient
18.54
± 11.90
Facilitator-Based INTERVENTION: Patient
19.62
± 10.59
Sponsor's own description
This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 7 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03721952.