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| ID | Type | Description | Link |
|---|---|---|---|
| 5R33AG061904-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The Aliviado Dementia Care Program (formerly known as the Dementia Symptom Management at Home Program, or DSM-H) was developed to implement dementia friendly care for persons with Dementia and their caregivers living in the community. Aliviado Dementia Care-Hospice Edition is a systems level quality assurance performance improvement program that includes interdisciplinary team training, validated assessment instruments, patient-centered care plans, treatment algorithms for behavioral and psychological symptoms of dementia and terminal delirium, and caregiver education pamphlets. Utilizing the R61/R33 mechanism, the Aliviado Dementia Care-Hospice Edition was successfully implemented in 2 sequential pilot trials in the hospice setting in 2019 (R61 phase). Following the successful pilot trials and the attainment of the R61 milestones, the investigators now seek to test the effectiveness of Aliviado Dementia Care-Hospice Edition in a pragmatic RCT in 25 hospice agencies across the nation (R33 phase) on its ability to reduce antipsychotic use (primary outcome) and effect quality (secondary and exploratory outcomes).
As the population ages, the incidence rate of Alzheimer's Disease and Related Disorders (dementia) is expected to triple. The National Alzheimer's Plan recognizes that while the number of persons with dementia (PWD) is increasing substantially, the healthcare and long term care systems are unprepared to provide high quality, effective and efficient care to the PWD and their caregivers. PWD often have many behavioral and psychological symptoms of dementia (BPSD) including agitation, depression and sleep disturbances that affect both the quality of life (QOL) of the PWD and the caregiver. Unfortunately, due to a lack of programs to insert evidence-based care into the community, and hospice system specifically, PWD receive inappropriate and even harmful care. The investigators have developed the Aliviado Dementia Care Program (formerly known as the Dementia Symptom Management at Home Program, or DSM-H) to implement dementia friendly care for PWD and their caregivers in the community. Initially developed for use in home healthcare (HHC), the investigators have modified the program for use in hospice. The Aliviado Dementia Care-Hospice Edition is a systems level quality assurance performance improvement (QAPI) program that includes workforce training, and agency level workflow changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26 | Experimental | PWD at the hospice sites randomized to Wave 1 will receive usual care for 7 months, followed by the 2-month-long transition to the intervention over months 8 and 9, followed by the QAPI intervention for 16 Months from Month 10-26. |
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| Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26 | Experimental | PWD at the hospice sites randomized to Wave 2 will receive usual care for 8 months, followed by the 2-month-long transition to the intervention over months 9 and 10, followed by the QAPI intervention for 15 months from Month 11-26. |
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| Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26 | Experimental | PWD at the hospice sites randomized to Wave 3 will receive usual care for 9 months, followed by the 2-month-long transition to the intervention during months 10 and 11, followed by the QAPI intervention for 14 months from Months 12-26. |
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| Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26 | Experimental | PWD at the hospice sites randomized to Wave 4 will receive usual care for 10 months, followed by the 2-month-long transition to the intervention during months 11 and 12, followed by the QAPI intervention for 13 months from Months 13-26. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliviado Dementia Care-Hospice Edition QAPI program | Behavioral | Multi-modal QAPI program for improving the quality of care provided to PWD and support to their informal caregivers through hospice. It has been culturally tailored for use in diverse settings and tested with multiple minority communities in New York, including multiple Hispanic groups and African-Americans and Caribbean blacks. The intervention includes mentorship, training, a toolkit, and mobile app to assist clinicians in providing evidence-based symptom management to persons with dementia. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication | Antipsychotic use measured using medical records. | Baseline, Month 26 |
| Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Non-Opioid Analgesic Medication | Non-opioid analgesic use measured using medical records. | Baseline, Month 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Monthly Hours of Continuous Hospice Use | Measured using hospice administrative data. | Baseline, Month 26 |
| Change from Baseline in Monthly Days of Inpatient Hospice Use | Measured using hospice administrative data. |
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Inclusion Criteria:
Interdisciplinary Team (IDT) MEMBERS:
Exclusion Criteria:
IDT MEMBERS:
• IDT members who are per diem
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Brody, Ph.D. | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33377138 | Derived | Lin SY, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, Cortes T, Goldfeld KS, Kutner JS, Mitchell SL, Shega JW, Wu B, Zhu CW, Brody AA. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. Gerontologist. 2022 Feb 9;62(2):304-314. doi: 10.1093/geront/gnaa220. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Upon reasonable request. Requests should be directed to Abraham.Brody@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2025 | |
| Reset | Sep 10, 2025 | |
| Release | Sep 10, 2025 | |
| Reset | Sep 30, 2025 | |
| Release | Oct 17, 2025 | |
| Reset | Oct 30, 2025 | |
| Release | Jan 14, 2026 | |
| Reset | Jan 29, 2026 | |
| Release | Mar 25, 2026 | |
| Reset | Apr 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2025 | Sep 10, 2025 | |||
| Sep 10, 2025 |
| 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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|
| Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26 | Experimental | PWD at the hospice sites randomized to Wave 5 will receive usual care for 11 months, followed by the 2-month-long transition to the intervention during months 12 and 13, followed by the QAPI intervention for 12 months from Months 14-26. |
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| Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26 | Experimental | PWD at the hospice sites randomized to Wave 6 will receive usual care for 12 months, followed by the 2-month-long transition to the intervention during months 13 and 14, followed by the QAPI intervention for 11 months from Months 15-26. |
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| Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26 | Experimental | PWD at the hospice sites randomized to Wave 7 will receive usual care for 13 months, followed by the 2-month-long transition to the intervention during months 14 and 15, followed by the QAPI intervention for 10 months from Months 16-26. |
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| Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26 | Experimental | PWD at the hospice sites randomized to Wave 7 will receive usual care for 14 months, followed by the 2-month-long transition to the intervention during months 15 and 16, followed by the QAPI intervention for 9 months from Months 17-26. |
|
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| Usual Care | Behavioral | Usual care as provided by the hospice agency |
|
| Baseline, Month 26 |
| Change from Baseline in Monthly Days of Respite Care | Measured using hospice administrative data. | Baseline, Month 26 |
| Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home | Measured using hospice administrative data. | Baseline, Month 26 |
| Sep 30, 2025 |
| Oct 17, 2025 | Oct 30, 2025 |
| Jan 14, 2026 | Jan 29, 2026 |
| Mar 25, 2026 | Apr 13, 2026 |
| D001523 | Mental Disorders |