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The Dementia Symptom Management at Home Program Hospice Edition

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ClinicalTrials.gov Identifier: NCT03352791
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

November 21, 2017
November 24, 2017
September 27, 2018
August 1, 2018
January 2019   (Final data collection date for primary outcome measure)
  • Reduction in pain (PAINAD) [ Time Frame: Day 0 and Day 30 ]
    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): [ Time Frame: Day 0 and Day 30 ]
    13-item tool that measures caregiver perception of BPSD presence and severity in PWD
Same as current
Complete list of historical versions of study NCT03352791 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Dementia
  • 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
  • Behavioral: Usual Care
    control will receive usual care from a care team who has not received the performance improvement program.
  • 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.
    Intervention: Behavioral: DSM-H Hospice Edition performance improvement program
  • Active Comparator: Control Arm
    Usual Care
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
January 2020
January 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Tessa Manwaring Jones (917) 951 -5588 tessajonesis@gmail.com
United States
 
 
NCT03352791
17-01080
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Abraham Brody, MD New York University School of Medicine
New York University School of Medicine
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP