Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT04857060
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Educator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-18', 'releaseDate': '2024-02-20'}, {'resetDate': '2024-04-16', 'releaseDate': '2024-03-19'}, {'resetDate': '2024-10-02', 'releaseDate': '2024-09-09'}, {'resetDate': '2024-12-31', 'releaseDate': '2024-12-11'}, {'resetDate': '2025-03-21', 'releaseDate': '2025-03-04'}, {'resetDate': '2025-07-11', 'releaseDate': '2025-06-23'}, {'resetDate': '2025-10-14', 'releaseDate': '2025-09-24'}, {'resetDate': '2025-12-18', 'releaseDate': '2025-12-03'}, {'releaseDate': '2025-12-18'}], 'estimatedResultsFirstSubmitDate': '2024-02-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10802}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) during the Index Hospitalization', 'timeFrame': '12 months', 'description': 'Any documentation of a discussion pertaining to limitations of life sustaining treatment, palliative care, hospice, goals of care, time-limited trial, or surrogate decision makers.'}], 'secondaryOutcomes': [{'measure': 'Change in documentation of medical orders for resuscitation preferences in EHR', 'timeFrame': 'Baseline, 12 months', 'description': 'Presence and content of resuscitation and treatment preferences including: Full code, do not resuscitate (DNR), do not intubate (DNI), do not hospitalize (DNH), and documented preferences around feeding tubes, and dialysis.'}, {'measure': 'Change in Caregiver knowledge of ACP', 'timeFrame': 'Baseline, 12 months', 'description': "6 investigator designed questions to assess subject's knowledge of advance care planning, scores range 0-6, higher scores indicate greater knowledge"}, {'measure': 'Change in Caregiver confidence', 'timeFrame': 'Baseline, 12 months', 'description': '3 investigator designed questions with responses on a 5-point likert scale from lowest to highest confidence. Range of scores 3-15, higher scores are associated with more caregiver confidence.'}, {'measure': 'Change in Caregiver communication satisfaction', 'timeFrame': 'Baseline, 12 months', 'description': "10 investigator designed questions to assess subject's satisfaction with clinician communication. Scores range from 0-10 with higher scores indicating higher confidence. Range of scores 10-100, higher scores are associated with more satisfaction with clinician communication."}, {'measure': 'Change in Caregiver decisional satisfaction', 'timeFrame': 'Baseline, 12 months', 'description': '12 investigator designed questions with responses on a 5-point likert scale from lowest to highest satisfaction. Range of scores 12-60, higher scores are associated with more decisional satisfaction.'}, {'measure': 'Change in Caregiver decisional certainty', 'timeFrame': 'Baseline, 12 months', 'description': '2 investigator designed questions to assess level of certainty in decisions, scores range from 0-4 with highest scores indicating the highest certainty. Range of scores 0-8, higher scores are associated with more decisional certainty.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['video decision aid', 'palliative care educator'], 'conditions': ['Advance Care Planning', 'Palliative Care', "Alzheimer's Disease and Related Dementias", 'Doctor-patient Communication', 'Video Decision Aids']}, 'referencesModule': {'references': [{'pmid': '39196855', 'type': 'DERIVED', 'citation': 'Zupanc SN, Quintiliani LM, LeClair AM, Paasche-Orlow MK, Volandes A, Penumarthy A, Henault L, Itty JE, Davis AD, Lakin JR. The Sowers of Seeds: A Qualitative Analysis of the Role of Palliative Care Educators in Facilitating Goals-of-Care Conversations and Palliative Care Referrals. Am J Hosp Palliat Care. 2025 Aug;42(8):761-768. doi: 10.1177/10499091241267917. Epub 2024 Aug 28.'}, {'pmid': '37695586', 'type': 'DERIVED', 'citation': 'Volandes AE, Zupanc SN, Lakin JR, Cabral HJ, Burns EA, Carney MT, Lopez S, Itty J, Emmert K, Martin NJ, Cole T, Dobie A, Cucinotta T, Joel M, Caruso LB, Henault L, Dugas JN, Astone K, Winter M, Wang N, Davis AD, Garde C, Rodriguez PM, El-Jawahri A, Moseley ET, Das S, Sciacca K, Ramirez AM, Gromova V, Lambert S, Sanghani S, Lindvall C, Paasche-Orlow MK. Video Intervention and Goals-of-Care Documentation in Hospitalized Older Adults: The VIDEO-PCE Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332556. doi: 10.1001/jamanetworkopen.2023.32556.'}, {'pmid': '35879001', 'type': 'DERIVED', 'citation': 'Lakin JR, Zupanc SN, Lindvall C, Moseley ET, Das S, Sciacca K, Cabral HJ, Burns EA, Carney MT, Itty J, Lopez S, Emmert K, Martin NJ, Lambert S, Polo J, Sanghani S, Dugas JN, Gomez M, Winter MR, Wang N, Gabry-Kalikow S, Dobie A, Amshoff M, Cucinotta T, Joel M, Caruso LB, Ramirez AM, Salerno K, Ogunneye Q, Henault L, Davis AD, Volandes A, Paasche-Orlow MK. Study protocol for Video Images about Decisions to Improve Ethical Outcomes with Palliative Care Educators (VIDEO-PCE): a pragmatic stepped wedge cluster randomised trial of older patients admitted to the hospital. BMJ Open. 2022 Jul 25;12(7):e065236. doi: 10.1136/bmjopen-2022-065236.'}]}, 'descriptionModule': {'briefSummary': "The investigators propose to conduct a stepped wedge cluster randomized trial of an advance care planning (ACP) educator-led intervention among hospitalized patients aged 65 and over, or any patient with Alzheimer's Disease and Related Dementias (ADRD) and their proxy decision-makers in the ward and ICU settings of two major hospitals: Boston Medical Center and North Shore University Hospital in New York. Patient outcomes will be abstracted from electronic health records with Natural Language Processing. The effectiveness of the intervention will be evaluated by comparing the following outcomes among 9,000 hospitalized patients (Aim 1): ACP documentation; preferences for resuscitation; palliative care consults; and, hospice use. The investigators will characterize caregiver-centered outcomes of patients with ADRD, including (Aim 2): (1) knowledge, (2) confidence in future care, (3) communication satisfaction, and (4) decisional certainty in 600 caregivers of patients with ADRD admitted to the hospital. COVID-19 poses a unique dilemma for older Americans and patients with ADRD and their caregivers, who must balance their desire to live against the risk of a lonely and potentially traumatic hospital death. Video decision support is a practical, evidence-based, and innovative approach to assist patients facing such choices. If proven effective, this innovative care model can be immediately deployed across the country to improve the quality of care for millions of Americans.", 'detailedDescription': "The majority of patients aged 65 or over, and patients with Alzheimer's Disease and Related Dementias (ADRD), have never communicated their preferences to clinicians or completed advance care planning (ACP) documents. Palliative care has the potential to improve ADRD care, improve patient-clinician communication and patient-centered outcomes, while decreasing unwanted burdensome treatments and improving care at the end of life. The novel Coronavirus Disease 2019 (COVID-19) has acutely escalated the importance of integrating ACP and palliative care services into medical care. The default response to critical illness for patients with ADRD (and all others) is intubation, mechanical ventilation, and aggressive care despite having no change in mortality outcome. ADRD patients and their caregivers may prefer to avoid these interventions.\n\nTo address these gaps, the investigators have developed a COVID-19 ACP Educator-led, video-assisted palliative care intervention to improve patient-clinician communication, increase ACP documentation, and lead to more patient-centered care at the end of life. The investigators will identify all hospitalized patients aged 65 and older, and any patient with ADRD, and then an ACP Educator will proactively proceed with primary palliative care services of ACP, leveraging certified video decision aids developed by the research team. This will be considered the standard of care for all patients meeting eligibility criteria. The ACP Educator to be tested in this proposal represents a new role and proactive function for the palliative care team. The ACP Educator will work with older patients or patients with ADRD and proxy decision-makers to learn about and document patients' wishes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Aim 1\n\n* Inpatient at study sites\n* Age 65 and older\n\nInclusion Criteria: Aim 2 (Caregiver Survey)\n\n* Age 18 and older\n* Designated caregiver of inpatient identified in Aim 1 who are diagnosed with Alzheimer's Disease and Related Dementias or other cognitive impairments\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT04857060', 'acronym': 'VIDEO-PCE', 'briefTitle': 'Palliative Care Educator', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Meeting the Challenges of COVID-19 by Expanding the Reach of Palliative Care: Proactive Advance Care Planning With Videos for the Elderly and All Patients With Dementia', 'orgStudyIdInfo': {'id': 'H-41482'}, 'secondaryIdInfos': [{'id': '1R01AG072911-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG072911-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Subjects in this arm do not meet with ACP Educator during their index hospitalization.'}, {'type': 'EXPERIMENTAL', 'label': 'ACP Educator led, video assisted discussion', 'description': 'For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.', 'interventionNames': ['Behavioral: ACP Educator led, video assisted discussion']}], 'interventions': [{'name': 'ACP Educator led, video assisted discussion', 'type': 'BEHAVIORAL', 'description': 'For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.', 'armGroupLabels': ['ACP Educator led, video assisted discussion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Michael Paasche-Orlow, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Outcome data will be deposited into Open Science Framework repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. Data will remain available for a period of 5 years.', 'ipdSharing': 'YES', 'description': 'The phenotypic data associated with enrolled participants will be shared by depositing these data in the Open Science Framework data repository. Additional data documentation and de-identified IPD including demographics, diagnoses, and outcomes will be deposited. Resources such as study protocols and statistical analysis codes will also be made available.', 'accessCriteria': 'Data and supporting information will be shared with investigators working in accordance to guidelines set by the data repository. Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be made available to investigators through the Open Science Framework data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-20', 'type': 'RELEASE'}, {'date': '2024-03-18', 'type': 'RESET'}, {'date': '2024-03-19', 'type': 'RELEASE'}, {'date': '2024-04-16', 'type': 'RESET'}, {'date': '2024-09-09', 'type': 'RELEASE'}, {'date': '2024-10-02', 'type': 'RESET'}, {'date': '2024-12-11', 'type': 'RELEASE'}, {'date': '2024-12-31', 'type': 'RESET'}, {'date': '2025-03-04', 'type': 'RELEASE'}, {'date': '2025-03-21', 'type': 'RESET'}, {'date': '2025-06-23', 'type': 'RELEASE'}, {'date': '2025-07-11', 'type': 'RESET'}, {'date': '2025-09-24', 'type': 'RELEASE'}, {'date': '2025-10-14', 'type': 'RESET'}, {'date': '2025-12-03', 'type': 'RELEASE'}, {'date': '2025-12-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tufts Medical Center'}}}}