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| ID | Type | Description | Link |
|---|---|---|---|
| U54AG063546 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative Care Consultation in Post-Acute Care | Experimental | 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. |
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| Stakeholder Engagement | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Consultation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations | 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. | 30 days post admission |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations | Number of hospitalization(s) | 30 days post admission |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Completed Stakeholder Interviews/Focus Groups | We engaged participants in focus groups and semi-structured interviews to deepen understanding of barriers and facilitators to telehealth palliative care implementation. | 1 year |
Inclusion Criteria:
Stakeholders:
Person Living with Dementia (PLWD)
Exclusion Criteria:
Stakeholders:
-PLWD who receives the intervention
PLWD:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collingswood Rehabilitation and Healthcare Center | Rockville | Maryland | 20850 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palliative Care Consultation in Post-Acute Care | 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. Palliative 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). |
| FG001 | Stakeholder Engagement | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Palliative Care Consultation in Post-Acute Care | 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. Palliative 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations | 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. | no data were collected | Posted | 30 days post admission |
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30 days post admission
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palliative Care Consultation in Post-Acute Care | 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. Palliative 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). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joan G. Carpenter | University of Maryland School of Nursing | 443-880-1430 | joan.carpenter@umaryland.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2022 | May 17, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| BG001 | Stakeholder Engagement | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Stakeholder Engagement | 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. |
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| Secondary | Number of Hospitalizations | Number of hospitalization(s) | The one participant that completed the study did not have any hospitalizations. The Stakeholders were not included in the analysis. | Posted | Count of Participants | Participants | 30 days post admission |
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| Other Pre-specified | Number of Participants With Completed Stakeholder Interviews/Focus Groups | We engaged participants in focus groups and semi-structured interviews to deepen understanding of barriers and facilitators to telehealth palliative care implementation. | no arm 1 participants were enrolled in arm 2 | Posted | Count of Participants | Participants | 1 year |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Stakeholder Engagement | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001523 | Mental Disorders |