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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL109823-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| University of Pittsburgh | OTHER |
| University of Washington | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision aid | Experimental | Web-based decision aid (decision support tool) provided to surrogate decision maker |
|
| Usual care | Active Comparator | usual care in an intensive care unit setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision aid | Behavioral | A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ~2-7 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-randomization (study day 1) and 180 days post-randomization |
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Inclusion Criteria (Patient characteristics required for surrogate inclusion)
Exclusion Criteria (Patient characteristics that will exclude surrogates from study enrollment):
Inclusion criteria for surrogate decision makers:
Exclusion criteria for surrogate decision makers:
Physician and nurse inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E Cox, MD MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22635048 | Background | Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63. | |
| 30690645 | Derived | Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29. |
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These numbers reflect primary and secondary surrogate decision makers, not patients, because surrogates were the focus of the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care | usual care in an intensive care unit setting Usual care: usual ICU care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
primary and secondary surrogate decision makers
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | ~2-7 days post-randomization |
6 months
Collected on surrogates.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Cox | Duke University | 9196817232 | Christopher.cox@duke.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| NIH |
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| Usual care | Other | usual ICU care |
|
| 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. | Pre-randomization (study day 1) and 180 days post-randomization |
| 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. | Study day 1 and 180 days post-randomization |
| 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. | Study day 1 (pre-randomization), ~2-7 |
| 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. | Study day 1 (pre-randomization), ~2-7 |
| 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. | ~2-7 days post-randomization |
| Durham |
| North Carolina |
| 27710 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Lost to Follow-up |
|
| patient regained decisional capacity |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
usual care in an intensive care unit setting Usual care: usual ICU care |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | 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 |
| OG001 | Usual Care | usual care in an intensive care unit setting Usual care: usual ICU care |
|
|
|
| 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. | Primary surrogate decision makers only. There is some dropout at 6 months due to patient death. | Posted | Mean | 95% Confidence Interval | units on a scale | Pre-randomization (study day 1) and 180 days post-randomization |
|
|
|
|
| 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. | Primary surrogate decision makers only; there is some dropout at 6 months due to patient death. | Posted | Mean | 95% Confidence Interval | units on a scale | Pre-randomization (study day 1) and 180 days post-randomization |
|
|
|
|
| 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. | Primary surrogate decision makers only; there is some dropout at 6 months due to patient death. | Posted | Mean | 95% Confidence Interval | units on a scale | Study day 1 and 180 days post-randomization |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Study day 1 (pre-randomization), ~2-7 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Study day 1 (pre-randomization), ~2-7 |
|
|
|
|
| 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. | nurses and primary surrogate decision makers | Posted | Mean | 95% Confidence Interval | units on a scale | ~2-7 days post-randomization |
|
|
|
|
| 0 |
| 210 |
| 0 |
| 210 |
| 0 |
| 210 |
| EG001 | Usual Care | usual care in an intensive care unit setting Usual care: usual ICU care | 0 | 206 | 0 | 206 | 0 | 206 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|