An interventional study of Aliviado Dementia Care-Hospice Edition QAPI program and Usual Care in Dementia, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
2,231 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 44,143 is above the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Interdisciplinary Team (IDT) MEMBERS:
Exclusion Criteria:
IDT MEMBERS:
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program · Behavioral: Usual Care
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.
Usual care as provided by the hospice agency
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication
Antipsychotic use measured using medical records.
Time frame: 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.
Time frame: Baseline, Month 26
Change from Baseline in Monthly Hours of Continuous Hospice Use
Measured using hospice administrative data.
Time frame: Baseline, Month 26
Change from Baseline in Monthly Days of Inpatient Hospice Use
Measured using hospice administrative data.
Time frame: Baseline, Month 26
Change from Baseline in Monthly Days of Respite Care
Measured using hospice administrative data.
Time frame: Baseline, Month 26
Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home
Measured using hospice administrative data.
Time frame: Baseline, Month 26
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Immediately following publication. No end date.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Ran from Jan 2020 to primary completion in Aug 2024, 55 months.
Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 55 months is above that.
Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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