跳至主要内容
临床试验/NCT04175977
NCT04175977已完成不适用

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

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 44,143 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44,143
试验地点
1
主要终点
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • IDT MEMBERS:
  • IDT members who are per diem

结局指标

主要结局

Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication

时间窗: Baseline, Month 26

Antipsychotic use measured using medical records.

Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Non-Opioid Analgesic Medication

时间窗: Baseline, Month 26

Non-opioid analgesic use measured using medical records.

次要结局

  • Change from Baseline in Monthly Hours of Continuous Hospice Use(Baseline, Month 26)
  • Change from Baseline in Monthly Days of Inpatient Hospice Use(Baseline, Month 26)
  • Change from Baseline in Monthly Days of Respite Care(Baseline, Month 26)
  • Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home(Baseline, Month 26)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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