Trial Outcomes & Findings for Improving Decision Making for Patients With Prolonged Mechanical Ventilation (NCT NCT01751061)
NCT ID: NCT01751061
Last Updated: 2019-05-02
Results Overview
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, "What percent chance do you think \[the patient/your loved one\] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
COMPLETED
NA
416 participants
~2-7 days post-randomization
2019-05-02
Participant Flow
These numbers reflect primary and secondary surrogate decision makers, not patients, because surrogates were the focus of the trial.
Participant milestones
| Measure |
Decision Aid
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Overall Study
STARTED
|
210
|
206
|
|
Overall Study
COMPLETED
|
154
|
172
|
|
Overall Study
NOT COMPLETED
|
56
|
34
|
Reasons for withdrawal
| Measure |
Decision Aid
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
patient death
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
40
|
25
|
|
Overall Study
patient regained decisional capacity
|
4
|
8
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
Baseline characteristics by cohort
| Measure |
Decision Aid
n=210 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=206 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
primary surrogate decision makers
|
49.9 years
STANDARD_DEVIATION 13.5 • n=137 Participants • Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
|
52.6 years
STANDARD_DEVIATION 11.6 • n=138 Participants • Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
|
51.2 years
STANDARD_DEVIATION 12.6 • n=275 Participants • Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
|
|
Age, Continuous
secondary surrogate decision makers
|
46.7 years
STANDARD_DEVIATION 14.0 • n=73 Participants • Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
|
41.2 years
STANDARD_DEVIATION 15.4 • n=68 Participants • Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
|
44.1 years
STANDARD_DEVIATION 14.9 • n=141 Participants • Note that we have broken the population down into primary and secondary surrogate decision makers. However, the two groups sum to the total for intervention and control.
|
|
Sex: Female, Male
Female
|
147 Participants
n=210 Participants
|
150 Participants
n=206 Participants
|
297 Participants
n=416 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=210 Participants
|
56 Participants
n=206 Participants
|
119 Participants
n=416 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=210 Participants
|
10 Participants
n=206 Participants
|
22 Participants
n=416 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
198 Participants
n=210 Participants
|
196 Participants
n=206 Participants
|
394 Participants
n=416 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=416 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=210 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=416 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=210 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=416 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=210 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=416 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=210 Participants
|
25 Participants
n=206 Participants
|
69 Participants
n=416 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=210 Participants
|
166 Participants
n=206 Participants
|
317 Participants
n=416 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=210 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=416 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=210 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=416 Participants
|
|
Region of Enrollment
United States
|
210 Participants
n=210 Participants
|
206 Participants
n=206 Participants
|
416 Participants
n=416 Participants
|
PRIMARY outcome
Timeframe: ~2-7 days post-randomizationPopulation: Note that the discrepancy between the number of surrogates in these analyses (122 and 127) differs from those enrolled (137 and 138). This is because the CSCS requires complete data at both Interview 1 and Interview 2. Some patients died or regained decisional capacity before Interview 2, leading to loss of surrogates' data.
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, "What percent chance do you think \[the patient/your loved one\] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
Outcome measures
| Measure |
Decision Aid
n=122 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=127 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Change in Clinician-surrogate Concordance Scale Score
Change score
|
-6.6 score on a scale
Interval -11.5 to -1.6
|
-4.8 score on a scale
Interval -9.1 to -0.6
|
|
Change in Clinician-surrogate Concordance Scale Score
Interview 1 CSCS score
|
33.6 score on a scale
Interval 29.3 to 38.0
|
34.3 score on a scale
Interval 29.9 to 38.8
|
|
Change in Clinician-surrogate Concordance Scale Score
Interview 2 CSCS score
|
27.1 score on a scale
Interval 22.8 to 31.4
|
29.5 score on a scale
Interval 25.1 to 33.9
|
SECONDARY outcome
Timeframe: Pre-randomization (study day 1) and 180 days post-randomizationPopulation: Primary surrogate decision makers only. There is some dropout at 6 months due to patient death.
We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary). HADS scores can range from 0 to 42 points; higher scores=more distress.
Outcome measures
| Measure |
Decision Aid
n=101 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=117 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Total Score
|
-3.8 units on a scale
Interval -5.3 to -2.3
|
-4.0 units on a scale
Interval -5.1 to -2.8
|
SECONDARY outcome
Timeframe: Pre-randomization (study day 1) and 180 days post-randomizationPopulation: Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.
Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers. PTSS scores can range from 10-70, with greater scores=more distress.
Outcome measures
| Measure |
Decision Aid
n=101 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=117 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Post-traumatic Stress Syndrome Inventory
|
-1.7 units on a scale
Interval -3.9 to 0.4
|
-1.4 units on a scale
Interval -3.4 to 0.6
|
SECONDARY outcome
Timeframe: Study day 1 and 180 days post-randomizationPopulation: Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.
Here we report change in patient-centeredness score between Study day 1 (Interview 1) and 180 days post-randomization (Interview 4) for primary (not secondary) surrogate decision makers. Scores can range from 12-48 points, with higher scores=greater patient-centeredness.
Outcome measures
| Measure |
Decision Aid
n=101 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=117 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Patient-centeredness of Care Scale
|
42.7 units on a scale
Interval 41.3 to 44.1
|
41.8 units on a scale
Interval 40.3 to 43.2
|
SECONDARY outcome
Timeframe: Study day 1 (pre-randomization), ~2-7Population: Note that the discrepancy between the number of surrogates in these analyses (122 and 127) differs from those enrolled (137 and 138). This is because the MCS requires complete data at both Interview 1 and Interview 2. Some patients died or regained decisional capacity before Interview 2, leading to loss of surrogates' data.
Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers. Scores can range from 0-8, with greater scores=better comprehension.
Outcome measures
| Measure |
Decision Aid
n=122 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=127 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Medical Comprehension Scale Score
|
0.8 units on a scale
Interval 0.5 to 1.1
|
0.5 units on a scale
Interval 0.2 to 0.8
|
SECONDARY outcome
Timeframe: Study day 1 (pre-randomization), ~2-7Population: Note that the discrepancy between the number of surrogates in these analyses (122 and 127) differs from those enrolled (137 and 138). This is because the QOC requires complete data at both Interview 1 and Interview 2. Some patients died or regained decisional capacity before Interview 2, leading to loss of surrogates' data.
Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers. Scores range from 0-110, with higher scores=better quality of communication.
Outcome measures
| Measure |
Decision Aid
n=122 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=127 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Quality of Communication Scale Score
|
4 units on a scale
Interval 1.3 to 6.8
|
7.0 units on a scale
Interval 4.1 to 9.8
|
SECONDARY outcome
Timeframe: ~2-7 days post-randomizationPopulation: nurses and primary surrogate decision makers
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the primary surrogate decision maker and the IUC nurse, and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of the nurse to the question, "What percent chance do you think \[the patient/your loved one\] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
Outcome measures
| Measure |
Decision Aid
n=94 Participants
Web-based decision aid (decision support tool) provided to surrogate decision maker
Decision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
|
Usual Care
n=101 Participants
usual care in an intensive care unit setting
Usual care: usual ICU care
|
|---|---|---|
|
Change in Clinical-surrogate Concordance Scale Score (Nurse)
|
-5.4 units on a scale
Interval -11.2 to 0.3
|
-6.2 units on a scale
Interval -10.6 to -1.7
|
Adverse Events
Decision Aid
Usual Care
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