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

Primary Purpose

Dementia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aliviado Dementia Care-Hospice Edition QAPI program
Usual Care
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26

Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26

Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26

Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26

Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26

Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26

Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26

Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication
Antipsychotic use measured using medical records.
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2019
Last Updated
August 23, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04175977
Brief Title
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)
Official Title
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL) Stepped Wedge Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26
Arm Type
Experimental
Arm Description
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.
Arm Title
Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aliviado Dementia Care-Hospice Edition QAPI program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care as provided by the hospice agency
Primary Outcome Measure Information:
Title
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication
Description
Antipsychotic use measured using medical records.
Time Frame
Baseline, Month 26
Title
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Non-Opioid Analgesic Medication
Description
Non-opioid analgesic use measured using medical records.
Time Frame
Baseline, Month 26
Secondary Outcome Measure Information:
Title
Change from Baseline in Monthly Hours of Continuous Hospice Use
Description
Measured using hospice administrative data.
Time Frame
Baseline, Month 26
Title
Change from Baseline in Monthly Days of Inpatient Hospice Use
Description
Measured using hospice administrative data.
Time Frame
Baseline, Month 26
Title
Change from Baseline in Monthly Days of Respite Care
Description
Measured using hospice administrative data.
Time Frame
Baseline, Month 26
Title
Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home
Description
Measured using hospice administrative data.
Time Frame
Baseline, Month 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Brody, Ph.D.
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Upon reasonable request. Requests should be directed to Abraham.Brody@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Citations:
PubMed Identifier
33377138
Citation
Lin SY, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, Cortes T, Goldfeld KS, Kutner JS, Mitchell SL, Shega JW, Wu B, Zhu CW, Brody AA. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. Gerontologist. 2022 Feb 9;62(2):304-314. doi: 10.1093/geront/gnaa220.
Results Reference
derived

Learn more about this trial

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

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