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The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)

The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL) Stepped Wedge Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04175977
Enrollment
44143
Registered
2019-11-25
Start date
2020-01-01
Completion date
2024-08-13
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALAliviado Dementia Care-Hospice Edition QAPI program

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.

BEHAVIORALUsual Care

Usual care as provided by the hospice agency

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Interdisciplinary Team (IDT) MEMBERS: * All English speaking IDT members * Employed or contracted by the participating agency who are receiving Aliviado Dementia Care-Hospice Edition online or champion training * All PWD (Persons with dementia) who are newly admitted to a participating hospice during the timeframe following implementation of the intervention who are over the age of 50 and have an ICD-10 code corresponding to a dementia diagnosis in their chart will be eligible. * Greater than 18 years of age

Exclusion criteria

IDT MEMBERS: • IDT members who are per diem

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic MedicationBaseline, Month 26Antipsychotic use measured using medical records.
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Non-Opioid Analgesic MedicationBaseline, Month 26Non-opioid analgesic use measured using medical records.

Secondary

MeasureTime frameDescription
Change from Baseline in Monthly Hours of Continuous Hospice UseBaseline, Month 26Measured using hospice administrative data.
Change from Baseline in Monthly Days of Inpatient Hospice UseBaseline, Month 26Measured using hospice administrative data.
Change from Baseline in Monthly Days of Respite CareBaseline, Month 26Measured using hospice administrative data.
Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing HomeBaseline, Month 26Measured using hospice administrative data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026