The Hospice Advanced Dementia Symptom Management & Quality of Life Trial

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Dementia

Clinical Trial Details

NCT number	NCT04175977
Study type	Interventional
Source	NYU Langone Health
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 1, 2020
Completion date	January 15, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms