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

December 16, 2024 updated by: NYU Langone Health

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44143

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Wave 1: Usual Care for Months 1-7, Transition for Months 8-9, Intervention for Months 10-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 2: Usual Care for Months 1-8, Transition for Months 9-10, Intervention for Months 11-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 3: Usual Care for Months 1-9, Transition for Months 10-11, Intervention for Months 12-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 4: Usual Care for Months 1-10, Transition for Months 11-12, Intervention for Months 13-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 5: Usual Care for Months 1-11, Transition for Months 12-13, Intervention for Months 14-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 6: Usual Care for Months 1-12, Transition for Months 13-14, Intervention for Months 15-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 7: Usual Care for Months 1-13, Transition for Months 14-15, Intervention for Months 16-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency
Experimental: Wave 8: Usual Care for Months 1-14, Transition for Months 15-16, Intervention for Months 17-26
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.
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.
Behavioral: Usual Care
Usual care as provided by the hospice agency

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Antipsychotic Medication
Time Frame: Baseline, Month 26
Antipsychotic use measured using medical records.
Baseline, Month 26
Change from Baseline in Monthly Percentage of Home Hospice Patients who are Prescribed Non-Opioid Analgesic Medication
Time Frame: Baseline, Month 26
Non-opioid analgesic use measured using medical records.
Baseline, Month 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Monthly Hours of Continuous Hospice Use
Time Frame: Baseline, Month 26
Measured using hospice administrative data.
Baseline, Month 26
Change from Baseline in Monthly Days of Inpatient Hospice Use
Time Frame: Baseline, Month 26
Measured using hospice administrative data.
Baseline, Month 26
Change from Baseline in Monthly Days of Respite Care
Time Frame: Baseline, Month 26
Measured using hospice administrative data.
Baseline, Month 26
Change from Baseline in Monthly Percentage of Participants who are Permanently Institutionalized in a Nursing Home
Time Frame: Baseline, Month 26
Measured using hospice administrative data.
Baseline, Month 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abraham Brody, Ph.D., NYU Langone

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-01186
  • 5R33AG061904-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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