Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 5:19 PM
Study NCT ID:
NCT04283994
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2020-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ekross@uw.edu', 'phone': '206-744-4649', 'title': 'Dr. Erin Kross', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'within 120 days of enrollment/randomization', 'eventGroups': [{'id': 'EG000', 'title': 'Survey-based Bi-directional Jumpstart [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'deathsNumAffected': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EHR-based Clinician-facing Jumpstart [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 0, 'seriousNumAtRisk': 205, 'deathsNumAffected': 38, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 0, 'seriousNumAtRisk': 209, 'deathsNumAffected': 30, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Survey-based Bi-directional Jumpstart [Family]', 'description': 'Surrogate participants completing follow-up assessments', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'EHR-based Clinician-facing Jumpstart [Family]', 'description': 'Surrogate participants completing follow-up assessments', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Usual Care [Family]', 'description': 'Surrogate participants completing follow-up assessments', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Clinicians', 'description': 'Interview subjects only \\[T1/T2\\]', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'EHR Documentation of Goals of Care Discussions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.271', 'groupId': 'OG000'}, {'value': '0.317', 'groupId': 'OG001'}, {'value': '0.206', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.114', 'ciLowerLimit': '0.030', 'ciUpperLimit': '0.197', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.294', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.068', 'ciLowerLimit': '-0.013', 'ciUpperLimit': '0.150', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bidirectional intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.952', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.045', 'ciLowerLimit': '-0.134', 'ciUpperLimit': '0.044', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bidirectional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'NUMBER', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the electronic medical record (EHR) in the period between randomization and 30 days following randomization. The proportion is the number of patients with goals-of-care (GOC) documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our natural language processing/machine learning (NLP/ML) methods.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: ICU Admissions (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0887', 'spread': '0.302', 'groupId': 'OG000'}, {'value': '0.0634', 'spread': '0.282', 'groupId': 'OG001'}, {'value': '0.0622', 'spread': '0.279', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'Any new ICU admissions or readmissions collected from the EHR.', 'unitOfMeasure': 'Count of admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: ICU Admissions (90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.118', 'spread': '0.367', 'groupId': 'OG000'}, {'value': '0.117', 'spread': '0.391', 'groupId': 'OG001'}, {'value': '0.0957', 'spread': '0.354', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from randomization to 90 days post randomization', 'description': 'Any new ICU admissions or readmissions collected from the EHR.', 'unitOfMeasure': 'Count of admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: ICU Admissions (Post-discharge, 7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'spread': '0.121', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.099', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7-days post-discharge', 'description': 'Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.', 'unitOfMeasure': 'Count of admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: ICU Admissions (Post-discharge, 30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.030', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '0.034', 'spread': '0.207', 'groupId': 'OG001'}, {'value': '0.024', 'spread': '0.153', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-days post-discharge', 'description': 'Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.', 'unitOfMeasure': 'Count of admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: Hospital Readmissions (7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0394', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.0732', 'spread': '0.261', 'groupId': 'OG001'}, {'value': '0.0766', 'spread': '0.267', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'readmissions in 7 days following discharge', 'description': 'Any hospital readmissions in 7 days following discharge; collected from the EHR. Censored at 90 days post-randomization.', 'unitOfMeasure': 'Count of admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: Hospital Readmissions (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.128', 'spread': '0.335', 'groupId': 'OG000'}, {'value': '0.176', 'spread': '0.463', 'groupId': 'OG001'}, {'value': '0.230', 'spread': '0.475', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'readmissions in 30 days following discharge', 'description': 'Any hospital readmissions in 30 days following discharge collected from the EHR. Censored at 90 days post-randomization.', 'unitOfMeasure': 'Count of admissions per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: ICU Free Days (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '27.9', 'spread': '6.17', 'groupId': 'OG001'}, {'value': '28.5', 'spread': '4.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.650', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.7', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis'}, {'pValue': '0.985', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.5', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.4', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'Number of days alive and out of the ICU within 30 days from randomization, collected from the EHR.', 'unitOfMeasure': 'Number of days per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: ICU Free Days (90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '79.9', 'spread': '24.3', 'groupId': 'OG001'}, {'value': '83.1', 'spread': '19.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '2.169', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '4.4', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis,'}, {'pValue': '0.391', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '1.0', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '8.2', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': 'from randomization to 90 days post randomization', 'description': 'Number of days alive and out of the ICU within 90 days from randomization, collected from the EHR.', 'unitOfMeasure': 'Number of days per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: Hospital Free Days (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '9.16', 'groupId': 'OG001'}, {'value': '20.8', 'spread': '8.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '2.4', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.923', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.7', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '2.5', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'Number of days alive and out of the hospital within 30 days from randomization; collected from the EHR.', 'unitOfMeasure': 'Number of days per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Intensity of Care: Hospital Free Days (90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '71.6', 'spread': '24.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.384', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '7.9', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.923', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '3.7', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '9.4', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': 'from randomization to 90 days post randomization', 'description': 'Number of days alive and out of the hospital within 90 days from randomization; collected from the EHR.', 'unitOfMeasure': 'Number of days per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Patient or Surrogate/Family-reported Discussion of Goals (3-5 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.160', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.00', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.652', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.04', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-5 days after randomization', 'description': 'Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of participants reporting a goals-of-care discussion over the number of patients in each study arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (potentially by a proxy) to this survey question. One response excluded as it was recorded as having occurred on day of randomization.'}, {'type': 'SECONDARY', 'title': 'Patient or Surrogate/Family-reported Discussion of Goals (4-6 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.192', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.16', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.698', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.12', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.477', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.16', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-6 weeks after randomization', 'description': 'Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of subjects reporting a goals-of-care discussion over the number of patients in each study arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (potentially by a proxy) to this survey question. Includes instances of proxies reporting on the measure after the death of a participant'}, {'type': 'SECONDARY', 'title': 'Quality of Communication (QOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '18.7', 'spread': '14.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '2.293', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-4.30', 'ciUpperLimit': '3.16', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.381', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-4.11', 'ciUpperLimit': '3.14', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-3.86', 'ciUpperLimit': '3.69', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '3-5 days after randomization', 'description': 'Quality of goals-of-care communication is assessed with the end-of-life communication scale (QOC\\_eol) of the Quality of Communication (QOC) survey. The QOC\\_eol subscale is based on 4 items, with item scores ranging from 0 (worst) to 10 (best). Responses of "My doctor has not done this" are converted into a rating of 0. Scores from the 4 items are summed together, resulting in a total score that ranges from 0 (worst) to 40 (best).', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (potentially by a proxy) which is numeric or can be converted to numeric for each of the 4 component questions. One response excluded as it was recorded as having occurred on day of randomization.'}, {'type': 'SECONDARY', 'title': 'SUPPORT Questions (3-5 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '2.829', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.12', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.188', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.24', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.190', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.01', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-5 days after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured with two questions from the SUPPORT study. The first defines patients\' preferences: "If you/patient had to make a choice at this time, would you/they prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would you/they want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. Responses of "unsure" are included in the sample and not counted as missing. The outcome is a dichotomous variable of whether the preference matches the report of care received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (potentially by a proxy) to both component questions. One response excluded as it was recorded as having occurred on day of randomization.'}, {'type': 'SECONDARY', 'title': 'SUPPORT Questions (4-6 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.994', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.14', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.771', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.19', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis. "Unsure" responses counted as non-events.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-6 weeks after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured with two questions from the SUPPORT study. The first defines patients\' preferences: "If you/patient had to make a choice at this time, would you/they prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would you/they want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. Responses of "unsure" are included in the sample and not counted as missing. The outcome is a dichotomous variable of whether the preference matches the report of care received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (potentially by a proxy) to both component questions.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intensity of Care: Palliative Care Consults Completed (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0493', 'spread': '0.217', 'groupId': 'OG000'}, {'value': '0.0829', 'spread': '0.279', 'groupId': 'OG001'}, {'value': '0.0574', 'spread': '0.271', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-days post randomization', 'description': 'Any palliative care consults within 30-days post randomization', 'unitOfMeasure': 'Count of consults per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intensity of Care: Palliative Care Consults Completed (90 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0640', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '0.107', 'spread': '0.340', 'groupId': 'OG001'}, {'value': '0.0670', 'spread': '0.286', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90-days post randomization', 'description': 'Any palliative care consults within 90-days post randomization', 'unitOfMeasure': 'Count of consults per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All-cause Mortality at 30 Days (Safety Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.836', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.058', 'ciUpperLimit': '0.034', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.250', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.021', 'ciLowerLimit': '-0.030', 'ciUpperLimit': '0.073', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.033', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '0.017', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after randomization', 'description': 'From the electronic medical record and Washington State death certificates.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All-cause Mortality at 120 Days (Safety Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.692', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.039', 'ciLowerLimit': '-0.102', 'ciUpperLimit': '0.025', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.887', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.038', 'ciLowerLimit': '-0.033', 'ciUpperLimit': '0.109', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.077', 'ciLowerLimit': '-0.145', 'ciUpperLimit': '-0.009', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days after randomization', 'description': 'From the electronic medical record and Washington State death certificates.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Goals-of Care Discussions: Time to First Goals of Care Discussion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0120', 'groupId': 'OG000'}, {'value': '0.0147', 'groupId': 'OG001'}, {'value': '0.0082', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.293', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.9', 'ciUpperLimit': '2.1', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Hazard ratio = bi-directional intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.', 'groupDescription': 'Censoring by death.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.027', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.1', 'ciUpperLimit': '2.5', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Hazard ratio = clinician-facing intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.', 'groupDescription': 'Censoring by death.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test adjusting for hospital site and dementia diagnosis'}, {'pValue': '1.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.2', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Hazard ratio = bi-directional intervention / clinician-facing intervention. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.', 'groupDescription': 'Censoring by death.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'NUMBER', 'timeFrame': '30-days post randomization', 'description': 'Time to first goals of care discussion reported per person-day; collected from electronic health record. All participants contribute person-days until their death, the goals or care discussion, or 30 days post-randomization.', 'unitOfMeasure': 'Incidence rate (per person-day)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants contribute person-days until their death, the goals or care discussion, or 30 days post-randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety (HADS Subscale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '5.79', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '5.59', 'spread': '4.25', 'groupId': 'OG001'}, {'value': '6.20', 'spread': '4.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.366', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.70', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.978', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '0.58', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '1.30', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks after randomization', 'description': 'Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. Higher scores reflect more symptoms of anxiety or depression.', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (all HADS questions asked about the person taking the survey, so no proxies could answer) which are numeric scores for each of the component questions.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression (HADS Subscale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '5.94', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '3.90', 'groupId': 'OG001'}, {'value': '5.48', 'spread': '3.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.125', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '1.51', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '0.258', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '1.94', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.63', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks after randomization', 'description': 'Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. Higher scores reflect more symptoms of anxiety or depression.', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (all HADS questions asked about the person taking the survey, so no proxies could answer) which are numeric scores for each of the component questions.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EuroQol 5 Dimensions 5 Level (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '7.20', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '7.11', 'spread': '4.65', 'groupId': 'OG001'}, {'value': '6.85', 'spread': '4.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.594', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '1.32', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.803', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '1.36', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.851', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '1.07', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks after randomization', 'description': 'The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions ask about problems with these domains, with response options on a 4-point Likert scale ranging from 1 (slight) to 4 (unable). Scores from the 5 questions are summed together, resulting in a total score ranging from 5 to 20. Higher scores reflect lower quality of life.', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a response (potentially by a proxy) which is numeric for each of the 5 component questions.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CollaboRATE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '8.14', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '8.16', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '8.44', 'spread': '2.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.243', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '0.40', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.032', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.35', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.742', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.78', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '3-5 days after randomization', 'description': 'The CollaboRATE is patient- or proxy-reported measure of shared decision-making. This 3-question measure asks questions about how much effort was made by doctors and members of the healthcare team to help you understand your/their health issues, listen to what matters most to you/them about your/their health issues, and include what matters most to you/them in choosing what to do next. Answers range from 0 (no effort) to 4 (every effort). Scores from the 3 questions are summed together, resulting in a total score ranging from 0 (no effort) to 12 (highest effort). Higher scores reflect more engagement in shared decision-making.', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a numeric response (potentially by a proxy) for each of the 3 component questions. One response excluded as it was recorded as having occurred on day of randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Goal Concordance (3-5 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.881', 'groupId': 'OG001'}, {'value': '3.06', 'spread': '0.935', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '2.658', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.22', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.523', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '1.381', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.15', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '3-5 days after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured by an investigator-developed question: "Do you think that your current medical care is in line with your goals?" Scale ranges from 0 (Not at all) to 4 (Completely). Higher scores reflect better goal-concordance.', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a numeric response (potentially by a proxy) for this survey question. One response excluded as it was recorded as having occurred on day of randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Goal Concordance (4-6 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Survey Based Bi-directional Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG001', 'title': 'EHR Based Clinician-facing Jumpstart Guide Intervention', 'description': 'Patient-or-LNOK-Proxy'}, {'id': 'OG002', 'title': 'Usual Care: No Intervention', 'description': 'Patient-or-LNOK-Proxy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '0.870', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.977', 'groupId': 'OG001'}, {'value': '3.03', 'spread': '0.961', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '2.191', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.25', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.138', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.27', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}, {'pValue': '2.879', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '022', 'pValueComment': 'P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.', 'groupDescription': 'Complete case analysis.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.'}], 'paramType': 'MEAN', 'timeFrame': '4-6 weeks after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured by an investigator-developed question: "Do you think that your current medical care is in line with your goals?" Scale ranges from 0 (Not at all) to 4 (Completely). Higher scores reflect better goal-concordance.', 'unitOfMeasure': 'Points on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants for which there is a numeric response (potentially by a proxy) for this survey question. Includes instances of proxies reporting on the measure after the death of a participant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Survey-based Bi-directional Jumpstart [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments'}, {'id': 'FG001', 'title': 'EHR-based Clinician-facing Jumpstart [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments'}, {'id': 'FG002', 'title': 'Usual Care [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments'}, {'id': 'FG003', 'title': 'Survey-based Bi-directional Jumpstart [Family]', 'description': 'Surrogate participants completing follow-up assessments'}, {'id': 'FG004', 'title': 'EHR-based Clinician-facing Jumpstart [Family]', 'description': 'Surrogate participants completing follow-up assessments'}, {'id': 'FG005', 'title': 'Usual Care [Family]', 'description': 'Surrogate participants completing follow-up assessments'}, {'id': 'FG006', 'title': 'Clinicians', 'description': 'Interview subjects only \\[T1/T2\\]'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '209'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '40'}, {'groupId': 'FG006', 'numSubjects': '30'}]}, {'type': 'Completed T2Q Survey [3-5 Days Post]', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '28'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Completed After-death (ADQ) Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Completed T3Q Survey [4-6 Weeks Post]', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '124'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Completed Qualitative Interview', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '181'}, {'groupId': 'FG002', 'numSubjects': '192'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '39'}, {'groupId': 'FG006', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients and family/friend surrogates were screened and recruited from July 2021 to October 2023. Potential subjects were approached in the hospital by a research coordinator to assess interest and eligibility. Enrollees completed baseline surveys and were randomized. Patients and family were approached for interviews between December 2021 and May 2023. Clinicians were recruited for interviews in October 2020 (from Trial 1) and from January 2022 to May 2023 (from Trial 2).', 'preAssignmentDetails': '9262 patients were screened for eligibility, 6575 were excluded. 2687 patients/surrogates were approached for recruitment, 1563 were excluded as ineligible, 451 declined participation. Eligibility window expired for another 56 patient/surrogates. 617 subjects were enrolled and randomized for the primary outcome.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Survey-based Bi-directional Jumpstart [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments'}, {'id': 'BG001', 'title': 'EHR-based Clinician-facing Jumpstart [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments'}, {'id': 'BG002', 'title': 'Usual Care [Patient]', 'description': 'Patients: Randomized \\& completing follow-up assessments'}, {'id': 'BG003', 'title': 'Survey-based Bi-directional Jumpstart [Family]', 'description': 'Surrogate participants completing follow-up assessments'}, {'id': 'BG004', 'title': 'EHR-based Clinician-facing Jumpstart [Family]', 'description': 'Surrogate participants completing follow-up assessments'}, {'id': 'BG005', 'title': 'Usual Care [Family]', 'description': 'Surrogate participants completing follow-up assessments'}, {'id': 'BG006', 'title': 'Clinicians', 'description': 'Interview subjects only \\[T1/T2\\]'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '287', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '469', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '64.5', 'upperLimit': '82'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '63', 'upperLimit': '80'}, {'value': '71', 'groupId': 'BG002', 'lowerLimit': '64', 'upperLimit': '80'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '57', 'upperLimit': '75'}, {'value': '61.5', 'groupId': 'BG004', 'lowerLimit': '53.5', 'upperLimit': '70'}, {'value': '62', 'groupId': 'BG005', 'lowerLimit': '55.75', 'upperLimit': '67'}, {'value': '38', 'groupId': 'BG006', 'lowerLimit': '34.25', 'upperLimit': '46'}, {'value': '70', 'groupId': 'BG007', 'lowerLimit': '62', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '355', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '401', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '719', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '49', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '630', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '756', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnoses', 'classes': [{'title': 'dementia, confirmed via manual screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG007'}]}]}, {'title': 'non-hematologic cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG007'}]}]}, {'title': 'hematologic cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG007'}]}]}, {'title': 'chronic obstructive pulmonary disease (COPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG007'}]}]}, {'title': 'other chronic pulmonary disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG007'}]}]}, {'title': 'coronary artery disease (CAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG007'}]}]}, {'title': 'congestive heart failure (CHF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG007'}]}]}, {'title': 'peripheral vascular disease (PVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG007'}]}]}, {'title': 'liver disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG007'}]}]}, {'title': 'diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG007'}]}]}, {'title': 'renal disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '617', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Collected from the patients' EHR. Eligibility diagnoses documented within the 2 years prior to randomization. Counts are not mutually exclusive and participants may have more than one categorical diagnosis.", 'unitOfMeasure': 'Participants', 'populationDescription': 'Diagnoses were only collected for the 617 patient subjects.'}, {'title': 'Hospital Site', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '647', 'groupId': 'BG007'}]}], 'categories': [{'title': 'County [HMC]', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG006'}, {'value': '150', 'groupId': 'BG007'}]}, {'title': 'University [UW-ML]', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG006'}, {'value': '251', 'groupId': 'BG007'}]}, {'title': 'Community [UW-NW]', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG006'}, {'value': '233', 'groupId': 'BG007'}]}, {'title': 'More than one location', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Unknown/Not recorded', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Collected from the electronic health record and institutional data.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.'}, {'title': 'Relationship to patient', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '109', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Spouse/partner', 'measurements': [{'value': '12', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG007'}]}, {'title': 'Adult child', 'measurements': [{'value': '11', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG007'}]}, {'title': 'Sibling', 'measurements': [{'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG007'}]}, {'title': 'Parent', 'measurements': [{'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Other relative', 'measurements': [{'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Friend', 'measurements': [{'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Relationship of the participating family member/friend to the patient subject, collected via self-report from Surrogate Survey Respondents', 'unitOfMeasure': 'Participants', 'populationDescription': 'Relationship to patient was only relevant for the family/friend surrogates of the patients.'}], 'populationDescription': 'Patient data from medical records; family/friend surrogate data from self-report surveys. Clinician data from self-report at the time of interview.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-15', 'size': 1573943, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-15T17:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 756}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2020-02-19', 'resultsFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-01', 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intensity of Care: Palliative Care Consults Completed (30 Days)', 'timeFrame': '30-days post randomization', 'description': 'Any palliative care consults within 30-days post randomization'}, {'measure': 'Intensity of Care: Palliative Care Consults Completed (90 Days)', 'timeFrame': '90-days post randomization', 'description': 'Any palliative care consults within 90-days post randomization'}, {'measure': 'All-cause Mortality at 30 Days (Safety Outcome)', 'timeFrame': '30 days after randomization', 'description': 'From the electronic medical record and Washington State death certificates.'}, {'measure': 'All-cause Mortality at 120 Days (Safety Outcome)', 'timeFrame': '120 days after randomization', 'description': 'From the electronic medical record and Washington State death certificates.'}, {'measure': 'Goals-of Care Discussions: Time to First Goals of Care Discussion', 'timeFrame': '30-days post randomization', 'description': 'Time to first goals of care discussion reported per person-day; collected from electronic health record. All participants contribute person-days until their death, the goals or care discussion, or 30 days post-randomization.'}, {'measure': 'Anxiety (HADS Subscale)', 'timeFrame': '4-6 weeks after randomization', 'description': 'Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. Higher scores reflect more symptoms of anxiety or depression.'}, {'measure': 'Depression (HADS Subscale)', 'timeFrame': '4-6 weeks after randomization', 'description': 'Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. Higher scores reflect more symptoms of anxiety or depression.'}, {'measure': 'EuroQol 5 Dimensions 5 Level (EQ-5D-5L)', 'timeFrame': '4-6 weeks after randomization', 'description': 'The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions ask about problems with these domains, with response options on a 4-point Likert scale ranging from 1 (slight) to 4 (unable). Scores from the 5 questions are summed together, resulting in a total score ranging from 5 to 20. Higher scores reflect lower quality of life.'}, {'measure': 'CollaboRATE', 'timeFrame': '3-5 days after randomization', 'description': 'The CollaboRATE is patient- or proxy-reported measure of shared decision-making. This 3-question measure asks questions about how much effort was made by doctors and members of the healthcare team to help you understand your/their health issues, listen to what matters most to you/them about your/their health issues, and include what matters most to you/them in choosing what to do next. Answers range from 0 (no effort) to 4 (every effort). Scores from the 3 questions are summed together, resulting in a total score ranging from 0 (no effort) to 12 (highest effort). Higher scores reflect more engagement in shared decision-making.'}, {'measure': 'Goal Concordance (3-5 Days)', 'timeFrame': '3-5 days after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured by an investigator-developed question: "Do you think that your current medical care is in line with your goals?" Scale ranges from 0 (Not at all) to 4 (Completely). Higher scores reflect better goal-concordance.'}, {'measure': 'Goal Concordance (4-6 Weeks)', 'timeFrame': '4-6 weeks after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured by an investigator-developed question: "Do you think that your current medical care is in line with your goals?" Scale ranges from 0 (Not at all) to 4 (Completely). Higher scores reflect better goal-concordance.'}], 'primaryOutcomes': [{'measure': 'EHR Documentation of Goals of Care Discussions', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the electronic medical record (EHR) in the period between randomization and 30 days following randomization. The proportion is the number of patients with goals-of-care (GOC) documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our natural language processing/machine learning (NLP/ML) methods.'}], 'secondaryOutcomes': [{'measure': 'Intensity of Care: ICU Admissions (30 Days)', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'Any new ICU admissions or readmissions collected from the EHR.'}, {'measure': 'Intensity of Care: ICU Admissions (90 Days)', 'timeFrame': 'from randomization to 90 days post randomization', 'description': 'Any new ICU admissions or readmissions collected from the EHR.'}, {'measure': 'Intensity of Care: ICU Admissions (Post-discharge, 7 Days)', 'timeFrame': '7-days post-discharge', 'description': 'Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.'}, {'measure': 'Intensity of Care: ICU Admissions (Post-discharge, 30 Days)', 'timeFrame': '30-days post-discharge', 'description': 'Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.'}, {'measure': 'Intensity of Care: Hospital Readmissions (7 Days)', 'timeFrame': 'readmissions in 7 days following discharge', 'description': 'Any hospital readmissions in 7 days following discharge; collected from the EHR. Censored at 90 days post-randomization.'}, {'measure': 'Intensity of Care: Hospital Readmissions (30 Days)', 'timeFrame': 'readmissions in 30 days following discharge', 'description': 'Any hospital readmissions in 30 days following discharge collected from the EHR. Censored at 90 days post-randomization.'}, {'measure': 'Intensity of Care: ICU Free Days (30 Days)', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'Number of days alive and out of the ICU within 30 days from randomization, collected from the EHR.'}, {'measure': 'Intensity of Care: ICU Free Days (90 Days)', 'timeFrame': 'from randomization to 90 days post randomization', 'description': 'Number of days alive and out of the ICU within 90 days from randomization, collected from the EHR.'}, {'measure': 'Intensity of Care: Hospital Free Days (30 Days)', 'timeFrame': 'from randomization to 30 days post randomization', 'description': 'Number of days alive and out of the hospital within 30 days from randomization; collected from the EHR.'}, {'measure': 'Intensity of Care: Hospital Free Days (90 Days)', 'timeFrame': 'from randomization to 90 days post randomization', 'description': 'Number of days alive and out of the hospital within 90 days from randomization; collected from the EHR.'}, {'measure': 'Patient or Surrogate/Family-reported Discussion of Goals (3-5 Days)', 'timeFrame': '3-5 days after randomization', 'description': 'Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of participants reporting a goals-of-care discussion over the number of patients in each study arm.'}, {'measure': 'Patient or Surrogate/Family-reported Discussion of Goals (4-6 Weeks)', 'timeFrame': '4-6 weeks after randomization', 'description': 'Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of subjects reporting a goals-of-care discussion over the number of patients in each study arm.'}, {'measure': 'Quality of Communication (QOC)', 'timeFrame': '3-5 days after randomization', 'description': 'Quality of goals-of-care communication is assessed with the end-of-life communication scale (QOC\\_eol) of the Quality of Communication (QOC) survey. The QOC\\_eol subscale is based on 4 items, with item scores ranging from 0 (worst) to 10 (best). Responses of "My doctor has not done this" are converted into a rating of 0. Scores from the 4 items are summed together, resulting in a total score that ranges from 0 (worst) to 40 (best).'}, {'measure': 'SUPPORT Questions (3-5 Days)', 'timeFrame': '3-5 days after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured with two questions from the SUPPORT study. The first defines patients\' preferences: "If you/patient had to make a choice at this time, would you/they prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would you/they want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. Responses of "unsure" are included in the sample and not counted as missing. The outcome is a dichotomous variable of whether the preference matches the report of care received.'}, {'measure': 'SUPPORT Questions (4-6 Weeks)', 'timeFrame': '4-6 weeks after randomization', 'description': 'Concordance between the care patients want and the care they are receiving is measured with two questions from the SUPPORT study. The first defines patients\' preferences: "If you/patient had to make a choice at this time, would you/they prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would you/they want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. Responses of "unsure" are included in the sample and not counted as missing. The outcome is a dichotomous variable of whether the preference matches the report of care received.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient care', 'Inpatients', 'Health Communication', 'Patient Care Planning', 'Quality of Life', 'Health care quality, access, and evaluation', 'Palliative care'], 'conditions': ['Dementia', 'Chronic Disease', 'Neoplasm Metastasis', 'Lung Neoplasms', 'Pulmonary Disease, Chronic Obstructive', 'Heart Failure, Congestive', 'Liver Cirrhosis', 'Kidney Failure, Chronic', 'Lung Diseases, Interstitial', 'Peripheral Vascular Disease', 'Diabetes With End Organ Injury']}, 'descriptionModule': {'briefSummary': "The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses.\n\nThe specific aims are:\n\n1. To evaluate the efficacy of the EHR-based clinician-facing Jumpstart, drawn from the electronic medical record (EHR), the survey-based bi-directional Jumpstart, drawn from patient or family completed surveys, and usual care for improving quality of care provided to patients with chronic illness experiencing a hospitalization. The primary outcome is EHR documentation of a goals-of-care discussion, assessed from randomization through 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital free days, hospital readmissions, costs of hospital care); and b) patient- and family-reported outcomes assessed by surveys at 3-5 days and 4-6 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life.\n2. To conduct a mixed-methods evaluation of the implementation of the interventions, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative evaluation of the interventions' reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.", 'detailedDescription': 'OVERVIEW: Jumpstart is a communication-priming intervention for clinicians, patients and their families that focuses on hospitalized patients\' goals of care. In this comparative effectiveness trial, the investigators examine the effectiveness of two approaches designed to promote goals-of-care discussions for older, seriously ill, hospitalized patients recruited from three UW Medicine hospitals. The two approaches include a survey-based bi-directional intervention and an EHR-based clinician-facing intervention. Both of these interventions provide clinicians with Jumpstart Guides that include data selected from the EHR on advance care planning as well as tips designed to improve communication about patients\' goals of care and care preferences. Additionally, the survey-based bi-directional Jumpstart includes not only the EHR-based care planning information but also communication tips that are based on specific information from patients\' (or surrogates) self-reported surveys. These bi-directional Jumpstarts are shared not only with clinicians but also with participating patients and families. The Jumpstart Guide is provided by email and in-person. This trial tests the comparative effectiveness of the survey-based bi-directional Jumpstart, the EHR-based clinician-facing Jumpstart and usual care. Unique to this trial is the use of the EHR to identify eligible participants, provide data for the intervention, and be the mechanism for delivering the intervention.\n\nThis current study is "Trial 2" of the R01 Award funding this trial. Trial 1 was completed prior to the initiation of Trial 2.\n\nSPECIFIC AIM 1: Evaluate the effectiveness of the survey-based bi-directional Jumpstart compared to the EHR-based clinician-facing Jumpstart and usual care for improving quality of care.\n\nTRIAL 2 has four components.\n\nComponent 1- Subject Identification/Recruitment/Randomization: Patients who meet the inclusion criteria are screened and identified using daily screening reports and staff review. The investigators oversample patients with ADRD to include 40% of the sample. Patients are approached by study staff in person during their hospital stay to assess their interest in participating in the study. Recruitment conversations are designed to take place in the patient\'s hospital room. Subjects are asked to complete surveys at three time points: 1) at enrollment; 2) 3-5 days after randomization; and 3) 4-6 weeks after randomization. Follow-up surveys may be completed in-person, by paper, online, or by phone, based on respondents\' preferences.\n\nIf patients are not able to participate themselves (e.g., cognitive impairment, sedated or ventilated), the investigators recruit their legal surrogate decision-maker to participate. This surrogate (under Washington State Law RCW 7.70.065) provides consent on their own behalf and is a research study subject.\n\nEligible patients are assigned to one of the three interventions in a 1:1:1 ratio. Patients are randomized using variable size blocks and stratified for hospital and ADRD vs. no ADRD. Surrogates/families follow the randomization status of the patients whom they are representing.\n\nComponent 2- EHR-based clinician-facing Jumpstart guide: The Jumpstart guide is developed from an automated review of the EHR. It summarizes the presence/absence of POLST, advance directives and DPOA documentation. It provides general recommendations to assist clinicians in initiating goals of care discussions.\n\nComponent 3- Survey-based bi-directional Jumpstart Guide: Survey data, completed by patients or their surrogate/family at enrollment provide assessments of the following: a) preferences for discussions about goals of care; b) most important barrier and facilitator for having such discussions; and c) current goals of care. These elements are contained within the Jumpstart guides and the information is tailored to each recipient (i.e., patient, surrogate/family, or clinician). This version provides survey-response specific recommendations to initiate goals of care discussions.\n\nComponent 4- Delivery of the intervention:\n\nClinician delivery: Guides are delivered within the first few days (1-3) after randomization to the primary clinician team (attending and resident physicians and advanced practice providers) via secure email or in person. Study staff monitor the care team for the patient and ensure that any new providers also receive the Jumpstart guide.\n\nPatient and family delivery: For the survey-based bi-directional Jumpstart arm, study staff provide the patient or surrogate with a version of the Jumpstart guide, tailored to be appropriate for patients or their surrogates (without information on EHR-based advance care planning documents) and following the same timeframe. Jumpstart guides are delivered to the patient or surrogate/family at the hospital.\n\nComparison group: We will compare all 3 arms (survey-based bi-directional Jumpstart, EHR-based clinician-facing Jumpstart, usual care) in three two-way comparisons.\n\nOutcome Assessment: The primary outcome is EHR documentation of a goals-of-care discussion in the 30 days following randomization. All subjects are asked to complete questionnaires at enrollment. The questionnaires may be completed as computer-assisted interviews or on-line depending on the subject\'s preference. The study staff member enrolling the subjects notifies them of their randomization status at this time. Subjects randomized to the survey-based bi-directional Jumpstart arm complete additional questionnaire items used to create the Jumpstart Guide.\n\nThe research staff will contact all subjects in person (or by telephone or email) for the evaluation/post-intervention phase. Patient and surrogate/family subjects will complete surveys at 3-5 days and 4-6 weeks after randomization. Surveys can be completed by telephone, mail, or online; we will contact each patient or family/surrogate at each interval using their preferred modality. Subjects may complete the surveys with study staff in person (if the patient is still in the hospital), over the phone, online using REDCap, or on paper and return via mail. Surrogate/Family subjects will complete the same measures at the same intervals as patients with a few exceptions: families will complete the SF-1 for themselves as well as by proxy for patients.\n\nFollow up contacts for subjects at 3-5 days follow-up will be as follows: If the patient is still hospitalized, in-person contact will be attempted (surrogates, who may not be reachable in person, may be contacted by their preferred mode); otherwise, contact will be attempted via phone, email, or mail per the subject\'s preference. Second and third contact attempts will be made using the subject\'s preferred mode 2 and 4 days later (7 and 14 days later for mail).\n\nFollow-up contacts for subjects at 4-6 weeks follow-up will be as follows: initial contact by subject\'s preferred mode at 4 weeks from enrollment, followed by 4 additional contacts at an interval of every 4-7 days for phone and online, and an interval of every 7-10 days for mail. In all cases, only non-respondents will continue to be contacted.\n\nFor surrogates of patients who have died, after a minimum of 4 weeks following the patient death, an "after death" questionnaire will be sent to the subject using their preferred mode. The after-death questionnaire includes items related to treatment preferences, psychological distress (HADS), and health-related quality of life (SF1). The after-death questionnaire will be sent one time with no additional follow-ups.\n\nAt the end of study participation, study staff will collect additional information from the patient\'s electronic health record including intensity of care outcomes. Data will be abstracted using automated EHR data collection and "gold standard" manual abstraction using standardized methods for training and quality control.\n\nSecondary outcomes also include the following patient- and surrogate/family-reported outcomes assessed by survey at 3-5 days and 4-6 weeks after randomization: occurrence and quality of goals-of-care communication in the hospital, goal concordant care, psychological symptoms, and quality of life.\n\nSPECIFIC AIM 2: Evaluate the factors affecting the Jumpstart intervention implementation and identify barriers and facilitators to future implementation.\n\nPatient and Surrogate/Family Subject Identification and Recruitment: Included in the patient\'s and surrogate/family member\'s consent form is a provision informing subjects that they may be contacted at the end of their study involvement to take part in a short, semi-structured interview to evaluate their study participation. Subjects will be sampled purposively to represent the following experiences: 1) participants from both intervention arms (EHR-based and survey-based); 2) participants who participated in the intervention fully as well as those who did not to better understand the reasons for less than full participation. "Full" participation is indicated by having completed all of the study materials.\n\nClinician Subject Identification and Recruitment: Study staff will recruit clinicians who were involved with the study to participate in a short interview after the clinician\'s study involvement with the enrolled patient has ended.\n\nAll interview participants will be selected using purposive sampling to ensure a diverse group (e.g., age, race/ethnicity, gender, specialty, year of training) in addition to the characteristics noted above.\n\nInterview: Using an interview guide developed specifically for this project, interviewers will assess respondents\' experience with the intervention and gather suggestions for ways to improve the intervention\'s content, delivery, and implementation, including implementation outcomes (e.g., acceptability, fidelity, penetration, maintenance) that will guide future dissemination of the intervention.\n\nAssessment: Interviews are audio recorded, transcribed, and analyzed using thematic analysis. Validity and reliability are assessed by co-coding approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Eligibility criteria apply to three subject groups: 1) seriously ill adult patients; 2) adult surrogate legal next of kin of the patients; and 3) hospital clinicians.\n\nInclusion Criteria:\n\nPATIENTS. Eligible patients will be those who are: 1) equal to or older than 80 years of age; or 2) equal to or older than 55 years of age with one or more chronic conditions used by the Dartmouth Atlas to study end-of-life care: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease, 3) English-speaking, 4) admitted for minimum of 12 hours/maximum of 96 hours to participating in-patient services at the participating hospitals, and 5) without documentation in the EHR of a goals-of-care discussion during this admission. Patients without decisional capacity (as documented in the EHR or as identified with a brief six-item screening tool) will be represented by a legal surrogate decision maker/legal next of kin (LNOK) in accordance with Washington State Law RCW 7.70.065.\n\nSURROGATE/FAMILY. Eligible surrogate/family subjects will be those who are 18 years of age or older, English-speaking, involved in the patient's medical care or decision-making.\n\nCLINICIANS (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial.\n\nExclusion Criteria:\n\nReasons for exclusion for any patient in include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation); unable to complete informed consent procedures; and without a legal surrogate to participate for them. Patients who are non-English speaking (and therefore unable to complete survey materials) are excluded. Reasons for exclusion for any surrogate/family subject include: non-English speaking (and therefore unable to complete study materials), legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires. Patients under COVID precautions will be excluded."}, 'identificationModule': {'nctId': 'NCT04283994', 'acronym': 'PICSI-H', 'briefTitle': 'Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness', 'orgStudyIdInfo': {'id': 'STUDY00007031-B'}, 'secondaryIdInfos': [{'id': '1R01AG006244', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG006244', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Survey-based Patient/Clinician Jumpstart', 'description': 'The Survey-based Patient/Clinician Jumpstart Guide will be developed with two types of data: 1) EHR data; and 2) Survey data. Using automated methods and NLP/ML algorithms, the presence/absence of POLST, advance directives and DPOA documentation will be identified from both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. The survey data will be completed by patients or their surrogate/family at enrollment and will provide assessments of the following: a) preferences for discussions about goals of care; b) most important barrier and facilitator for having such discussions; and c) current goals of care. These elements are contained within the Jumpstart guides and the information is tailored to each recipient (i.e., patient, surrogate/family, or clinician).', 'interventionNames': ['Behavioral: Survey-based Patient/Clinician Jumpstart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EHR-based Clinician Jumpstart', 'description': 'The EHR-based Clinician Jumpstart Guide will be developed by using automated methods and NLP/ML algorithms to both inpatient and outpatient EHR notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation. It will not include survey-based information.', 'interventionNames': ['Behavioral: EHR-based Clinician Jumpstart']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients in this arm receive usual care; neither subjects nor providers will receive either version of the Jumpstart Guide.'}], 'interventions': [{'name': 'Survey-based Patient/Clinician Jumpstart', 'type': 'BEHAVIORAL', 'otherNames': ['Bidirectional Jumpstart Guide Intervention'], 'description': 'The Jumpstart Guide is a communication-priming intervention for clinicians, patients and their families that addresses hospitalized patients\' goals of care. The intervention\'s goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The Jumpstart takes two forms. One is "EHR-based" and provides information to the clinician about prior advance care planning documentation derived from the EHR. The other is "bi-directional" and patient-specific (Survey-based Patient/Clinician Jumpstart Guide). It provides the same information as the EHR-based Clinician Jumpstart Guide but also includes information about patients\' self-reported preferences for communication and care as well as primary barriers and facilitators to this communication. The Jumpstart Guides include tips to improve this communication for clinicians, patients and families.', 'armGroupLabels': ['Survey-based Patient/Clinician Jumpstart']}, {'name': 'EHR-based Clinician Jumpstart', 'type': 'BEHAVIORAL', 'otherNames': ['Clinician-facing Jumpstart Guide Intervention'], 'description': "The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page EHR-based Clinician Jumpstart Guide provides information to the clinician about prior advance care planning documentation derived from the EHR. The EHR-based Clinician Jumpstart Guide includes tips to improve goals-of-care communication.", 'armGroupLabels': ['EHR-based Clinician Jumpstart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW Medical Center - Northwest', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW Medical Center - Montlake', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Erin K Kross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Pulmonary, Critical Care and Sleep Medicine', 'investigatorFullName': 'Erin Kross', 'investigatorAffiliation': 'University of Washington'}}}}