Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-30 @ 5:44 AM
Study NCT ID:
NCT04948866
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D000093902', 'term': 'Mixed Dementias'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], '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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kwessell@email.unc.edu', 'phone': '919-966-2939', 'title': 'Kathryn Wessell, MPH', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from when participants entered the study to 60 days post hospital discharge.', 'description': 'Due to the severity of illness present in the study population, adverse events including mortality and caregiver emotional distress were expected but adjudicated as unrelated to study participation.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Condition: ADRD-PC Program (Patients)', 'description': 'Patients randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 0, 'seriousNumAtRisk': 221, 'deathsNumAffected': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention Condition: ADRD-PC Program (Caregivers)', 'description': 'Caregivers randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 24, 'seriousNumAtRisk': 221, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Condition (Patients)', 'description': "Patients randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.", 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 0, 'seriousNumAtRisk': 221, 'deathsNumAffected': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Condition (Caregivers)', 'description': "Caregivers randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care.", 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 40, 'seriousNumAtRisk': 221, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Emotional Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 221, 'numEvents': 52, 'numAffected': 40}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Hospital Transfers (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000'}, {'value': '1.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.522', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post index hospital discharge', 'description': 'Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.', 'unitOfMeasure': 'events per person day at risk', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Treatment (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '8.06', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 days post hospital discharge', 'description': 'Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Control for Physical Symptoms (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '9.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.402', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 days post hospital discharge', 'description': 'Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.'}, {'type': 'SECONDARY', 'title': 'Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '5.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.803', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 days post hospital discharge', 'description': 'Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.'}, {'type': 'SECONDARY', 'title': 'Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 days post hospital discharge', 'description': "Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.'}, {'type': 'SECONDARY', 'title': 'Access to Hospice (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.977', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of people with ADRD who access hospice services.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Access to Community-based Palliative Care (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of people with ADRD who access community-based palliative care services', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transition to Nursing Home Level of Care (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.935', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of people with ADRD who transition to nursing home care', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Documented Discussion of Dementia Prognosis (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients with documented discussion of dementia prognosis in their medical record.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Documented Discussion of Goals of Care (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients with documented discussion of overall goals of care.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Shared Decision-making - Hospitalization (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '25.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.417', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Shared Decision-making - Burdensome Treatment (Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '42.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.531', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Caregiver Distress Score (Caregivers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 days post hospital discharge', 'description': 'Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.'}, {'type': 'SECONDARY', 'title': 'Caregiver Burden (Caregiver)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'classes': [{'categories': [{'measurements': [{'value': '7.52', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '5.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.876', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 days post hospital discharge', 'description': 'Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'FG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '442'}]}, {'type': 'Patients Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '221'}]}, {'type': 'Caregivers Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '221'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '376'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '66'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'BG000'}, {'value': '442', 'groupId': 'BG001'}, {'value': '884', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Condition: ADRD-PC Program', 'description': 'Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.\n\n1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.'}, {'id': 'BG001', 'title': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '8.03', 'groupId': 'BG000'}, {'value': '82.5', 'spread': '7.78', 'groupId': 'BG001'}, {'value': '82.6', 'spread': '7.89', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.2', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are reported separately for Patients and Caregivers.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are reported separately for Patients and Caregivers.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are reported separately for Patients and Caregivers.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are reported separately for Patients and Caregivers.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'BG000'}, {'value': '442', 'groupId': 'BG001'}, {'value': '884', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Patients', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}, {'title': 'Caregivers', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data are reported separately for Patients and Caregivers.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-20', 'size': 651917, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-22T11:45', 'hasProtocol': True}, {'date': '2023-04-05', 'size': 164239, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-04T12:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization allocation to study arms is concealed from all study personnel until the point of randomization assignment.\n\nIn the ADRD-PC Study, the overall PI (Dr. Hanson) and the research staff Clinical Research Coordinators (CRC) collecting data in 30- and 60-day interviews (data source for primary outcome and most secondary outcomes) are masked to study assignment until planned study arm reveal during final analyses. CRCs will conduct 60-day electronic health record (EHR) reviews only after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 884}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2021-06-23', 'resultsFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-01', 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Hospital Transfers (Patients)', 'timeFrame': '60 days post index hospital discharge', 'description': 'Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Symptom Treatment (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment'}, {'measure': 'Symptom Control for Physical Symptoms (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms.'}, {'measure': 'Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control.'}, {'measure': 'Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': "Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress."}, {'measure': 'Access to Hospice (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of people with ADRD who access hospice services.'}, {'measure': 'Access to Community-based Palliative Care (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of people with ADRD who access community-based palliative care services'}, {'measure': 'Transition to Nursing Home Level of Care (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of people with ADRD who transition to nursing home care'}, {'measure': 'Documented Discussion of Dementia Prognosis (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients with documented discussion of dementia prognosis in their medical record.'}, {'measure': 'Documented Discussion of Goals of Care (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients with documented discussion of overall goals of care.'}, {'measure': 'Shared Decision-making - Hospitalization (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.'}, {'measure': 'Shared Decision-making - Burdensome Treatment (Patients)', 'timeFrame': '60 days post hospital discharge', 'description': 'Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.'}, {'measure': 'Caregiver Distress Score (Caregivers)', 'timeFrame': '60 days post hospital discharge', 'description': 'Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress.'}, {'measure': 'Caregiver Burden (Caregiver)', 'timeFrame': '60 days post hospital discharge', 'description': 'Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Dementia, Vascular', 'Dementia With Lewy Bodies', 'Dementia Frontal', 'Dementia, Mixed', 'Dementia Alzheimers', 'Alzheimer Disease', 'Dementia Severe']}, 'referencesModule': {'references': [{'pmid': '37743478', 'type': 'DERIVED', 'citation': "Toles M, Kistler C, Lin FC, Lynch M, Wessell K, Mitchell SL, Hanson LC. Palliative care for persons with late-stage Alzheimer's and related dementias and their caregivers: protocol for a randomized clinical trial. Trials. 2023 Sep 25;24(1):606. doi: 10.1186/s13063-023-07614-4."}]}, 'descriptionModule': {'briefSummary': "Millions of Americans have late-stage Alzheimer's and related dementias (ADRD), causing suffering due to loss of awareness of self and family, progressive dependency, physical and neuropsychiatric symptoms, and physical, emotional and financial strain for caregivers. Investigators now propose a multi-site randomized clinical trial of the ADRD Palliative Care (ADRD-PC) program for persons with late-stage ADRD and their family caregivers, triggered during hospitalization. Investigators aim to learn if this program of dementia-specific palliative care, standardized caregiver education, and transitional care is effective to reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and to improve caregiver outcomes of communication, shared decision-making and distress.", 'detailedDescription': 'Investigators have designed the ADRD Palliative Care (ADRD-PC) program of dementia-specific palliative and transitional care, and shown its feasibility and potential efficacy. Delivered by interdisciplinary hospital palliative care teams, ADRD-PC addresses 1) prognostic awareness, 2) symptom management, 3) shared decision-making, and 4) transition to community support services.\n\nThe research objective is to conduct a multi-site efficacy randomized clinical trial (RCT) of the ADRD-PC program. Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD (Global Deterioration Scale (GDS) 6-7 or GDS 5 with significant co-morbidity) with their family caregivers, and an additional 50 dyads that identify as Hispanic/Latino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), Indiana University, and Emory University. The primary hypothesis is that ADRD-PC will reduce hospital transfers (Aim 1). Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment, symptom control, use of community palliative care or hospice, and nursing home transitions (Aim 2); and caregiver outcomes of communication, decision-making and distress (Aim 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeople with ADRD Inclusion Criteria:\n\n* aged 55 or older\n* hospitalized\n* have a physician-confirmed diagnosis of ADRD\n* staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher\n\nCaregiver Inclusion Criteria:\n\n* the adult (aged 18 or older) legally authorized representative (LAR) for healthcare and have capacity to serve in this role\n* support the person with ADRD\n* can complete interviews in English or Spanish.\n\nExclusion Criteria:\n\nDyads will be excluded if\n\n* the LAR is not a family caregiver\n* the patient currently receives palliative care or hospice\n* patient or caregiver would be unduly stressed\n* dyad is not successfully randomized.'}, 'identificationModule': {'nctId': 'NCT04948866', 'acronym': 'ADRD-PC', 'briefTitle': "Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers", 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': "Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers", 'orgStudyIdInfo': {'id': '20-2764'}, 'secondaryIdInfos': [{'id': 'R01AG065394', 'link': 'https://reporter.nih.gov/quickSearch/R01AG065394', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Condition: ADRD-PC Program', 'description': '1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.\n2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.\n3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls.', 'interventionNames': ['Behavioral: ADRD-PC Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Condition', 'description': "Patient-family caregiver dyads randomized to the control arm will receive educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patient will receive usual hospital and post-acute care.", 'interventionNames': ['Behavioral: ADRD-PC Program']}], 'interventions': [{'name': 'ADRD-PC Program', 'type': 'BEHAVIORAL', 'description': 'Included in arm/group descriptions', 'armGroupLabels': ['Control Condition', 'Intervention Condition: ADRD-PC Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Laura C Hanson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '9 to 36 months following publication', 'ipdSharing': 'YES', 'description': 'This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Data may be requested to achieve aims in an approved proposal by contacting the Palliative Care Research Collaborative Group Data Repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}