Prolonged Mechanical Ventilation, Surrogate Decision Makers
Conditions
Keywords
prolonged mechanical ventilation, chronic critical illness, decision making, decision aid, decisional support, critical illness, intensive care unit
Brief summary
Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).
Detailed description
The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.
Interventions
BEHAVIORALDecision aid
A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
OTHERUsual care
usual ICU care
Sponsors
University of North Carolina, Chapel Hill
University of Pittsburgh
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Patient characteristics required for surrogate inclusion) * age ≥18 * ≥10 days of mechanical ventilation interrupted by \<96 continuous hours of unassisted breathing (including invasive and non-invasive ventilation) * no anticipation of imminent (24 hours) death or extubation by the attending.
Exclusion criteria
(Patient characteristics that will exclude surrogates from study enrollment): * possession of decisional capacity * no identifiable surrogate, surrogate is unavailable for study procedures such as interviews * imminent organ transplantation * chronic neuromuscular disease * physician refuses permission to approach family and/or patient for consent * admission for severe burns * admission for high cervical spine injury * ventilation for \>21 days. Inclusion criteria for surrogate decision makers: * age ≥18 * self-identified as participating directly in health care decision making for the incapable patient under relevant state law
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-surrogate Concordance Scale Score | ~2-7 days post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Stress Syndrome Inventory | Pre-randomization (study day 1) and 180 days post-randomization | 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. |
| Patient-centeredness of Care Scale | Study day 1 and 180 days post-randomization | 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. |
| Hospital Anxiety and Depression Scale (HADS) Total Score | Pre-randomization (study day 1) and 180 days post-randomization | 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. |
| Quality of Communication Scale Score | Study day 1 (pre-randomization), ~2-7 | 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. |
| Change in Clinical-surrogate Concordance Scale Score (Nurse) | ~2-7 days post-randomization | 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. |
| Medical Comprehension Scale Score | Study day 1 (pre-randomization), ~2-7 | 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. |
Countries
United States
Participant flow
Pre-assignment details
These numbers reflect primary and secondary surrogate decision makers, not patients, because surrogates were the focus of the trial.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 210 |
| Usual Care usual care in an intensive care unit setting
Usual care: usual ICU care | 206 |
| Total | 416 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 40 | 25 |
| Overall Study | patient death | 5 | 0 |
| Overall Study | patient regained decisional capacity | 4 | 8 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Decision Aid | Usual Care | Total |
|---|---|---|---|
| Age, Continuous primary surrogate decision makers | 49.9 years STANDARD_DEVIATION 13.5 | 52.6 years STANDARD_DEVIATION 11.6 | 51.2 years STANDARD_DEVIATION 12.6 |
| Age, Continuous secondary surrogate decision makers | 46.7 years STANDARD_DEVIATION 14 | 41.2 years STANDARD_DEVIATION 15.4 | 44.1 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 10 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 198 Participants | 196 Participants | 394 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 25 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) White | 151 Participants | 166 Participants | 317 Participants |
| Region of Enrollment United States | 210 Participants | 206 Participants | 416 Participants |
| Sex: Female, Male Female | 147 Participants | 150 Participants | 297 Participants |
| Sex: Female, Male Male | 63 Participants | 56 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 206 |
| other Total, other adverse events | 0 / 210 | 0 / 206 |
| serious Total, serious adverse events | 0 / 210 | 0 / 206 |
Outcome results
Primary
Change in Clinician-surrogate Concordance Scale Score
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.
Time frame: ~2-7 days post-randomization
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Decision Aid | Change in Clinician-surrogate Concordance Scale Score | Change score | -6.6 score on a scale |
| Decision Aid | Change in Clinician-surrogate Concordance Scale Score | Interview 1 CSCS score | 33.6 score on a scale |
| Decision Aid | Change in Clinician-surrogate Concordance Scale Score | Interview 2 CSCS score | 27.1 score on a scale |
| Usual Care | Change in Clinician-surrogate Concordance Scale Score | Change score | -4.8 score on a scale |
| Usual Care | Change in Clinician-surrogate Concordance Scale Score | Interview 1 CSCS score | 34.3 score on a scale |
| Usual Care | Change in Clinician-surrogate Concordance Scale Score | Interview 2 CSCS score | 29.5 score on a scale |
Comparison: We estimated that 210 patients (315 surrogates, assuming \~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.p-value: <0.05GEE
Secondary
Change in Clinical-surrogate Concordance Scale Score (Nurse)
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.
Time frame: ~2-7 days post-randomization
Population: nurses and primary surrogate decision makers
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Change in Clinical-surrogate Concordance Scale Score (Nurse) | -5.4 units on a scale |
| Usual Care | Change in Clinical-surrogate Concordance Scale Score (Nurse) | -6.2 units on a scale |
Comparison: To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.p-value: <0.05GEE
Secondary
Hospital Anxiety and Depression Scale (HADS) Total Score
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.
Time frame: Pre-randomization (study day 1) and 180 days post-randomization
Population: Primary surrogate decision makers only. There is some dropout at 6 months due to patient death.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Hospital Anxiety and Depression Scale (HADS) Total Score | -3.8 units on a scale |
| Usual Care | Hospital Anxiety and Depression Scale (HADS) Total Score | -4.0 units on a scale |
Comparison: Generalized linear model.p-value: <0.05generalized linear model
Secondary
Medical Comprehension Scale Score
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.
Time frame: Study day 1 (pre-randomization), ~2-7
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Medical Comprehension Scale Score | 0.8 units on a scale |
| Usual Care | Medical Comprehension Scale Score | 0.5 units on a scale |
p-value: <0.05generalized linear models
Secondary
Patient-centeredness of Care Scale
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.
Time frame: Study day 1 and 180 days post-randomization
Population: Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Patient-centeredness of Care Scale | 42.7 units on a scale |
| Usual Care | Patient-centeredness of Care Scale | 41.8 units on a scale |
p-value: <0.05generalized linear models
Secondary
Post-traumatic Stress Syndrome Inventory
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.
Time frame: Pre-randomization (study day 1) and 180 days post-randomization
Population: Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Post-traumatic Stress Syndrome Inventory | -1.7 units on a scale |
| Usual Care | Post-traumatic Stress Syndrome Inventory | -1.4 units on a scale |
p-value: <0.05generalized linear model
Secondary
Quality of Communication Scale Score
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.
Time frame: Study day 1 (pre-randomization), ~2-7
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decision Aid | Quality of Communication Scale Score | 4 units on a scale |
| Usual Care | Quality of Communication Scale Score | 7.0 units on a scale |
p-value: <0.05generalized linear models