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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04175977
• Other study ID #: 19-01186
• Secondary ID: 5R33AG061904-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 15, 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44143
• Est. completion date: January 15, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Aliviado 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.
• Usual Care
Usual care as provided by the hospice agency

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication	Antipsychotic use measured using medical records.	Baseline, Month 26
Primary	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
Secondary	Change from Baseline in Monthly Hours of Continuous Hospice Use	Measured using hospice administrative data.	Baseline, Month 26
Secondary	Change from Baseline in Monthly Days of Inpatient Hospice Use	Measured using hospice administrative data.	Baseline, Month 26
Secondary	Change from Baseline in Monthly Days of Respite Care	Measured using hospice administrative data.	Baseline, Month 26
Secondary	Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home	Measured using hospice administrative data.	Baseline, Month 26