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DementiaNCT04175977

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

A study testing Aliviado Dementia Care-Hospice Edition QAPI program in people with Dementia, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
Aliviado Dementia Care-Hospice Edition QAPI program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44,143 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 13 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • IDT MEMBERS:
  • IDT members who are per diem

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

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

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).

Read the 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.

Conditions
Dementia
Being tested
Aliviado Dementia Care-Hospice Edition QAPI program, Usual Care
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aliviado Dementia Care-Hospice Edition QAPI programBehavioural

    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 CareBehavioural

    Usual care as provided by the hospice agency

Study groups in NCT04175977
Study groupRoleWhat they receive
Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care
Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26ExperimentalPWD 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.
Receives: Behavioral: Aliviado Dementia Care-Hospice Edition QAPI program; Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Antipsychotic use measured using medical records.

    Measured: Baseline, Month 26

  2. 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.

    Measured: Baseline, Month 26

Secondary outcomes (4)
  1. Change from Baseline in Monthly Hours of Continuous Hospice Use

    Measured using hospice administrative data.

    Measured: Baseline, Month 26

  2. Change from Baseline in Monthly Days of Inpatient Hospice Use

    Measured using hospice administrative data.

    Measured: Baseline, Month 26

  3. Change from Baseline in Monthly Days of Respite Care

    Measured using hospice administrative data.

    Measured: Baseline, Month 26

  4. Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home

    Measured using hospice administrative data.

    Measured: Baseline, Month 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start1 Jan 2020
  3. Primary completion13 Aug 2024
  4. Study completion13 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
44,143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04175977
Sponsor's protocol ID
19-01186
Other IDs
5R33AG061904-05
Status last verified
Dec 2024
First submitted
12 Nov 2019
Last updated
19 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 33377138

Questions about this trial

What is this clinical trial studying?

A study testing Aliviado Dementia Care-Hospice Edition QAPI program in people with Dementia, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication (time frame: Baseline, Month 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04175977, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.

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