Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT05001620
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Implementation of a Telehealth Palliative Care Model for Persons With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joan.carpenter@umaryland.edu', 'phone': '443-880-1430', 'title': 'Dr. Joan G. Carpenter', 'organization': 'University of Maryland School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Despite multiple, iterative adaptations to implementation, including recruiting new sites and clinical partners, we were unable to enroll the targeted 30 patients in the trial. Two PLWD enrolled in the clinical trial, one completed the study.'}}, 'adverseEventsModule': {'timeFrame': '30 days post admission', 'eventGroups': [{'id': 'EG000', 'title': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.\n\nPalliative Care Consultation: The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.\n\nPalliative Care Consultation: The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).'}, {'id': 'OG001', 'title': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.'}], 'timeFrame': '30 days post admission', 'description': "Investigators will determine a recommendation adherence score after each participants' encounter. Each recommendation will be assigned 2 points, then will define full (2 points), partial (1 point) and no adherence (0 point) to each recommendation. Investigators will sum the points for each SNF-PCC recommendation and use this as the denominator. Investigators will sum each recommendation with full, partial, no adherence and use this as the numerator. The fraction will be converted to a percentage ranging from 0-100% reflecting the recommendation adherence score.", 'reportingStatus': 'POSTED', 'populationDescription': 'no data were collected'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.\n\nPalliative Care Consultation: The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).'}, {'id': 'OG001', 'title': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post admission', 'description': 'Number of hospitalization(s)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant that completed the study did not have any hospitalizations. The Stakeholders were not included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Completed Stakeholder Interviews/Focus Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.\n\nPalliative Care Consultation: The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).'}, {'id': 'OG001', 'title': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'We engaged participants in focus groups and semi-structured interviews to deepen understanding of barriers and facilitators to telehealth palliative care implementation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'no arm 1 participants were enrolled in arm 2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.\n\nPalliative Care Consultation: The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).'}, {'id': 'FG001', 'title': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': "Didn't complete the telehealth Palliative Care Consultation", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.\n\nPalliative Care Consultation: The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).'}, {'id': 'BG001', 'title': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>18 years of age', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-09-21', 'size': 362505, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-17T13:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2021-07-27', 'resultsFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-19', 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Completed Stakeholder Interviews/Focus Groups', 'timeFrame': '1 year', 'description': 'We engaged participants in focus groups and semi-structured interviews to deepen understanding of barriers and facilitators to telehealth palliative care implementation.'}], 'primaryOutcomes': [{'measure': 'Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations', 'timeFrame': '30 days post admission', 'description': "Investigators will determine a recommendation adherence score after each participants' encounter. Each recommendation will be assigned 2 points, then will define full (2 points), partial (1 point) and no adherence (0 point) to each recommendation. Investigators will sum the points for each SNF-PCC recommendation and use this as the denominator. Investigators will sum each recommendation with full, partial, no adherence and use this as the numerator. The fraction will be converted to a percentage ranging from 0-100% reflecting the recommendation adherence score."}], 'secondaryOutcomes': [{'measure': 'Number of Hospitalizations', 'timeFrame': '30 days post admission', 'description': 'Number of hospitalization(s)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Palliative Care', 'Telehealth', 'Nursing Homes'], 'conditions': ['Palliative Care', 'Dementia']}, 'descriptionModule': {'briefSummary': 'Grounded in the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Model, this study will assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention for persons living with dementia (PLWD) and their care-partners newly admitted to nursing homes (NHs) for post-acute care.', 'detailedDescription': 'This single arm embedded pragmatic pilot clinical trial will provide data to assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention among 30 persons living with dementia (PLWD) and their care-partners newly admitted to one nursing homes (NH) for post-acute care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStakeholders:\n\n* (1) PC provider\n* (2) Social Work (SW) NH champions\n* (3) post-acute care unit nursing staff and providers (including medical directors)\n* (4) NH leadership, information technology staff\n* (5) PLWD and their care partner(s).\n\nPerson Living with Dementia (PLWD)\n\n* documented dementia diagnosis\n* admitted for post-acute care\n* age ≥ 60 years\n* if unable to participate in a conversation or lacking capacity to make healthcare decisions as determined by the NH staff/providers, a care partner who can act as a surrogate decision maker in the PCC-PAC.\n\nExclusion Criteria:\n\nStakeholders:\n\n-PLWD who receives the intervention\n\nPLWD:\n\n* planned discharge within 48 hours of screening\n* currently receiving hospice care'}, 'identificationModule': {'nctId': 'NCT05001620', 'acronym': 'IMPACT', 'briefTitle': 'Implementation of a Telehealth Palliative Care Model for Persons With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Implementation of a Telehealth Palliative Care Model for Persons With Dementia', 'orgStudyIdInfo': {'id': 'HP-00095001'}, 'secondaryIdInfos': [{'id': 'U54AG063546', 'link': 'https://reporter.nih.gov/quickSearch/U54AG063546', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palliative Care Consultation in Post-Acute Care', 'description': 'Subjects will receive usual care plus a telehealth palliative care consultation by specialty providers who will document their findings in the Electronic Health Record (EHR), and communicate their findings and recommendations to the clinical team.', 'interventionNames': ['Other: Palliative Care Consultation']}, {'type': 'NO_INTERVENTION', 'label': 'Stakeholder Engagement', 'description': 'We will engage stakeholders in a stakeholder engagement plan that include Palliative Care providers; Social Work (SW) NH champions; post-acute care unit nursing staff and providers (including medial directors); NH leadership, information technology staff; and a PLWD and their care partners in focus groups and one on one semi structured interviews via phone or videoconference.'}], 'interventions': [{'name': 'Palliative Care Consultation', 'type': 'OTHER', 'description': 'The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).', 'armGroupLabels': ['Palliative Care Consultation in Post-Acute Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Collingswood Rehabilitation and Healthcare Center', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joan Carpenter', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}