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The Dementia Symptom Management at Home Program Hospice Edition

Primary Purpose

Dementia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSM-H Hospice Edition performance improvement 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 SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PWD over the age of 65
  • Admitted to MJHS hospice agency
  • The patient and family caregiver speak English and/or Spanish.
  • The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.
  • Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).

Exclusion Criteria:

  • Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.
  • PWD residing in assisted living facilities, nursing homes or board and care homes
  • PWD solely receiving infusion or home health aide services.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DSM-H Hospice Edition

Control Arm

Arm Description

training, assigning of champions to serve as mentors and performance improvement leads, and workflow changes including caregiver education pamphlets, interdisciplinary care plans, treatment algorithms, and assessment instruments.

Usual Care

Outcomes

Primary Outcome Measures

Reduction in pain (PAINAD)
pain assessment tool for use in persons with moderate to severe dementia who cannot provide reliable report, and will be used if the QDRS>12
Reduction in Behavioral and Psychological Symptoms of Dementia (BPSD) using Neuropsychiatric Inventory Questionnaire (NPI-Q):
13-item tool that measures caregiver perception of BPSD presence and severity in PWD

Secondary Outcome Measures

Full Information

First Posted
November 21, 2017
Last Updated
December 2, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03352791
Brief Title
The Dementia Symptom Management at Home Program Hospice Edition
Official Title
A Cluster Randomized Controlled Trial (RCT) of the Dementia Symptom Management (DSM) at Home Program Hospice Edition
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to operational changes at the participating agency.
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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

5. Study Description

Brief Summary
Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will utilize a cluster randomized controlled design with 6 care teams at a single study site to examine the ability of a multi-component evidence-based practice hospice care quality improvement program for registered nurses, social workers and chaplains to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.

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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSM-H Hospice Edition
Arm Type
Active Comparator
Arm Description
training, assigning of champions to serve as mentors and performance improvement leads, and workflow changes including caregiver education pamphlets, interdisciplinary care plans, treatment algorithms, and assessment instruments.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
DSM-H Hospice Edition performance improvement program
Intervention Description
Patients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
control will receive usual care from a care team who has not received the performance improvement program.
Primary Outcome Measure Information:
Title
Reduction in pain (PAINAD)
Description
pain assessment tool for use in persons with moderate to severe dementia who cannot provide reliable report, and will be used if the QDRS>12
Time Frame
Day 0 and Day 30
Title
Reduction in Behavioral and Psychological Symptoms of Dementia (BPSD) using Neuropsychiatric Inventory Questionnaire (NPI-Q):
Description
13-item tool that measures caregiver perception of BPSD presence and severity in PWD
Time Frame
Day 0 and Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PWD over the age of 65 Admitted to MJHS hospice agency The patient and family caregiver speak English and/or Spanish. The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient. Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment). Exclusion Criteria: Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety. PWD residing in assisted living facilities, nursing homes or board and care homes PWD solely receiving infusion or home health aide services.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Brody, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Dementia Symptom Management at Home Program Hospice Edition

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