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

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care

• Registration Number: NCT04175977
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2020-01-01
• Disposition First Submitted: 2023-07-31
• Disposition First Posted: 2023-09-11
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44143

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

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Exclusion Criteria

IDT MEMBERS:

• IDT members who are per diem

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26	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.
Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26	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.
Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26	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.
Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26	Usual Care	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.
Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26	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.
Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26	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.
Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26	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.
Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26	Aliviado Dementia Care-Hospice Edition QAPI program	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.
Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication	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	Baseline, Month 26	Non-opioid analgesic use measured using medical records.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Monthly Days of Respite Care	Baseline, Month 26	Measured using hospice administrative data.
Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home	Baseline, Month 26	Measured using hospice administrative data.
Change from Baseline in Monthly Hours of Continuous Hospice Use	Baseline, Month 26	Measured using hospice administrative data.
Change from Baseline in Monthly Days of Inpatient Hospice Use	Baseline, Month 26	Measured using hospice administrative data.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States