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

NCT04175977 | Completed DMC

• 2 other identifiers: 19-011865R33AG061904-05
• Study Type: interventional
• Target: 44,143
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

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

  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

  Non-opioid analgesic use measured using medical records.

  Baseline, Month 26

Secondary Outcomes (4)

• Change from Baseline in Monthly Hours of Continuous Hospice Use

  Baseline, Month 26

• Change from Baseline in Monthly Days of Inpatient Hospice Use

  Baseline, Month 26

• Change from Baseline in Monthly Days of Respite Care

  Baseline, Month 26

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

  Baseline, Month 26

Study Arms (8)

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

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

EXPERIMENTAL

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; Behavioral: Usual Care

Interventions

Aliviado Dementia Care-Hospice Edition QAPI program BEHAVIORAL

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.

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

Usual Care BEHAVIORAL

Usual care as provided by the hospice agency

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• IDT MEMBERS:
• IDT members who are per diem

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 33377138 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Abraham Brody, Ph.D.

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 25, 2019
• Study Start: January 1, 2020
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)