The Dementia Symptom Management at Home Program Hospice Edition

A Cluster Randomized Controlled Trial (RCT) of the Dementia Symptom Management (DSM) at Home Program Hospice Edition

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.

Study Overview

• Status: Terminated
• Conditions: Dementia
• Intervention / Treatment: Behavioral: DSM-H Hospice Edition performance improvement program; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DSM-H Hospice Edition; 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.	Behavioral: DSM-H Hospice Edition performance improvement program; Patients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program
Active Comparator: Control Arm; Usual Care	Behavioral: Usual Care; control will receive usual care from a care team who has not received the performance improvement program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0 and Day 30
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	Day 0 and Day 30

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Abraham Brody, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): October 5, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 17-01080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No