The Dementia Symptom Management at Home Program Hospice Edition

NCT03352791 | Terminated

• 1 other identifier: 17-01080
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

DSM-H Hospice Edition

ACTIVE COMPARATOR

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

Control Arm

ACTIVE COMPARATOR

Usual Care

Behavioral: Usual Care

Interventions

DSM-H Hospice Edition performance improvement program BEHAVIORAL

Patients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program

DSM-H Hospice Edition

Usual Care BEHAVIORAL

control will receive usual care from a care team who has not received the performance improvement program.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Abraham Brody, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 24, 2017
• Study Start: August 1, 2018
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

US (1)