Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
Study NCT ID:
NCT01751061
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2012-12-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christopher.cox@duke.edu', 'phone': '9196817232', 'title': 'Dr. Christopher Cox', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Collected on surrogates.', 'eventGroups': [{'id': 'EG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions', 'otherNumAtRisk': 210, 'deathsNumAtRisk': 210, 'otherNumAffected': 0, 'seriousNumAtRisk': 210, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 0, 'seriousNumAtRisk': 206, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Clinician-surrogate Concordance Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'title': 'Change score', 'categories': [{'measurements': [{'value': '-6.6', 'groupId': 'OG000', 'lowerLimit': '-11.5', 'upperLimit': '-1.6'}, {'value': '-4.8', 'groupId': 'OG001', 'lowerLimit': '-9.1', 'upperLimit': '-0.6'}]}]}, {'title': 'Interview 1 CSCS score', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '29.3', 'upperLimit': '38.0'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '38.8'}]}]}, {'title': 'Interview 2 CSCS score', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '31.4'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': '33.9'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.', 'groupDescription': '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.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'To test the primary 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.'}], 'paramType': 'MEAN', 'timeFrame': '~2-7 days post-randomization', 'description': '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.\n\nWe report pre-intervention to post-intervention difference in the CSCS.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '-2.3'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-5.1', 'upperLimit': '-2.8'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated.', 'groupDescription': 'Generalized linear model.', 'statisticalMethod': 'generalized linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-randomization (study day 1) and 180 days post-randomization', 'description': 'We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary).\n\nHADS scores can range from 0 to 42 points; higher scores=more distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary surrogate decision makers only. There is some dropout at 6 months due to patient death.'}, {'type': 'SECONDARY', 'title': 'Post-traumatic Stress Syndrome Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '0.4'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '0.6'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated.', 'statisticalMethod': 'generalized linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-randomization (study day 1) and 180 days post-randomization', 'description': 'Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers.\n\nPTSS scores can range from 10-70, with greater scores=more distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.'}, {'type': 'SECONDARY', 'title': 'Patient-centeredness of Care Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '44.1'}, {'value': '41.8', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '43.2'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated.', 'statisticalMethod': 'generalized linear models', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 and 180 days post-randomization', 'description': '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.\n\nScores can range from 12-48 points, with higher scores=greater patient-centeredness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.'}, {'type': 'SECONDARY', 'title': 'Medical Comprehension Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.8'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated.', 'statisticalMethod': 'generalized linear models', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 (pre-randomization), ~2-7', 'description': 'Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.\n\nScores can range from 0-8, with greater scores=better comprehension.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Quality of Communication Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '6.8'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated.', 'statisticalMethod': 'generalized linear models', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 (pre-randomization), ~2-7', 'description': 'Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.\n\nScores range from 0-110, with higher scores=better quality of communication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Change in Clinical-surrogate Concordance Scale Score (Nurse)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '0.3'}, {'value': '-6.2', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '-1.7'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P values were calculated.', 'groupDescription': '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.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '~2-7 days post-randomization', 'description': '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.\n\nWe report pre-intervention to post-intervention difference in the CSCS.\n\nThe 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'nurses and primary surrogate decision makers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'patient death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'patient regained decisional capacity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'These numbers reflect primary and secondary surrogate decision makers, not patients, because surrogates were the focus of the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Decision Aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker\n\nDecision aid: A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'usual care in an intensive care unit setting\n\nUsual care: usual ICU care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'primary surrogate decision makers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '52.6', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '12.6', 'groupId': 'BG002'}]}]}, {'title': 'secondary surrogate decision makers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '41.2', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '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.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'primary and secondary surrogate decision makers'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2012-12-13', 'resultsFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-05', 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Clinician-surrogate Concordance Scale Score', 'timeFrame': '~2-7 days post-randomization', 'description': '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.\n\nWe report pre-intervention to post-intervention difference in the CSCS.\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS) Total Score', 'timeFrame': 'Pre-randomization (study day 1) and 180 days post-randomization', 'description': 'We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary).\n\nHADS scores can range from 0 to 42 points; higher scores=more distress.'}, {'measure': 'Post-traumatic Stress Syndrome Inventory', 'timeFrame': 'Pre-randomization (study day 1) and 180 days post-randomization', 'description': 'Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers.\n\nPTSS scores can range from 10-70, with greater scores=more distress.'}, {'measure': 'Patient-centeredness of Care Scale', 'timeFrame': 'Study day 1 and 180 days post-randomization', 'description': '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.\n\nScores can range from 12-48 points, with higher scores=greater patient-centeredness.'}, {'measure': 'Medical Comprehension Scale Score', 'timeFrame': 'Study day 1 (pre-randomization), ~2-7', 'description': 'Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.\n\nScores can range from 0-8, with greater scores=better comprehension.'}, {'measure': 'Quality of Communication Scale Score', 'timeFrame': 'Study day 1 (pre-randomization), ~2-7', 'description': 'Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.\n\nScores range from 0-110, with higher scores=better quality of communication.'}, {'measure': 'Change in Clinical-surrogate Concordance Scale Score (Nurse)', 'timeFrame': '~2-7 days post-randomization', 'description': '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.\n\nWe report pre-intervention to post-intervention difference in the CSCS.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prolonged mechanical ventilation', 'chronic critical illness', 'decision making', 'decision aid', 'decisional support', 'critical illness', 'intensive care unit'], 'conditions': ['Surrogate Decision Makers', 'Prolonged Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '22635048', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30690645', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Patient characteristics required for surrogate inclusion)\n\n* age ≥18\n* ≥10 days of mechanical ventilation interrupted by \\<96 continuous hours of unassisted breathing (including invasive and non-invasive ventilation)\n* no anticipation of imminent (24 hours) death or extubation by the attending.\n\nExclusion Criteria (Patient characteristics that will exclude surrogates from study enrollment):\n\n* possession of decisional capacity\n* no identifiable surrogate, surrogate is unavailable for study procedures such as interviews\n* imminent organ transplantation\n* chronic neuromuscular disease\n* physician refuses permission to approach family and/or patient for consent\n* admission for severe burns\n* admission for high cervical spine injury\n* ventilation for \\>21 days.\n\nInclusion criteria for surrogate decision makers:\n\n* age ≥18\n* self-identified as participating directly in health care decision making for the incapable patient under relevant state law\n\nExclusion criteria for surrogate decision makers:\n\n* do not personally know the patient\n* need translation assistance because of poor English fluency (the decision aid has not been validated in other languages)\n* history of clinically important neurological disorder (e.g., dementia)\n* patient dies after meeting inclusion criteria but before surrogates provide consent\n\nPhysician and nurse inclusion criteria:\n\n* ICU attending or fellow (physicians) at the time of surrogate enrollment\n* bedside ICU nurse present at the time of surrogate enrollment'}, 'identificationModule': {'nctId': 'NCT01751061', 'briefTitle': 'Improving Decision Making for Patients With Prolonged Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving Decision Making for Patients With Prolonged Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'Pro00021965'}, 'secondaryIdInfos': [{'id': 'R01HL109823-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01HL109823-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decision aid', 'description': 'Web-based decision aid (decision support tool) provided to surrogate decision maker', 'interventionNames': ['Behavioral: Decision aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'usual care in an intensive care unit setting', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Decision aid', 'type': 'BEHAVIORAL', 'description': 'A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions', 'armGroupLabels': ['Decision aid']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'usual ICU care', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christopher E Cox, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}