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Reducing Behavioral and Psychological Symptoms of Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179721
Recruitment Status : Suspended (COVID-19; study will resume when restrictions are lifted.)
First Posted : November 27, 2019
Last Update Posted : May 28, 2020
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Penn State University
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
Persons with Alzheimer's Disease and Related Dementias (ADRD) currently account for 3.2 million hospital admissions per year and have over three times more hospitalizations than those without cognitive impairment. Yet, hospital caregivers are currently ill-prepared to manage patients with ADRD, with less than 5% reporting mandatory dementia care training. Three-quarters of hospitalized persons with ADRD display Behavioral and Psychological Symptoms of Dementia (BPSD), associated with functional and cognitive decline, increased resource consumption, institutionalization, premature death, and caregiver burden. The overall objective of this project is to test the preliminary efficacy of an innovative model of care, the PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialist (PES) to deliver dementia care for acutely-ill patients with ADRD. Traditionally, mental health assistants with training in crisis-prevention techniques provide care to psychiatric patients. On the intervention unit, these mental health assistants, as PES, purposefully engage patients with BPSD. In the pilot study, investigators found that patients with cognitive impairment admitted to the PES unit were significantly less likely to require constant observation, chemical and physical restraints, suggesting improved management of BPSD. The central hypothesis is that the PES-4-BPSD intervention will improve the ability of PES to create an "enabling" milieu that addresses the factors leading to BPSD and improves the experience of hospital caregivers. Guided by a social-ecological framework, the PES-4-BPSD model incorporates: dementia education and training, environmental modifications-cohorting, increased staffing-PES, and staff support. The investigators' multidisciplinary research team is well-positioned to accomplish the following aims: Aim 1: Determine the preliminary efficacy of the PES-4-BPSD intervention for reducing BPSD during hospitalization and Aim 2: Evaluate whether dementia care training improves the perceived ability of PES staff (intervention) and nurse assistant staff (control) to care for hospitalized persons with ADRD. For Aim 1, the investigators will conduct a non-randomized preliminary efficacy trial of the PES-4-BPSD intervention enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be the presence (through a multi-modal approach) of BPSD during hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). In Aim 2, the investigators will use survey methodology in a repeated measures design to evaluate within and between-group differences in attitudes, experience, and satisfaction toward managing patients with ADRD. Measures will be completed at baseline (T1), immediately following training (T2), and at end of the intervention period (T3). In response to the 2017 NIA Workshop, "Innovating the Next Generation of Dementia and Alzheimer's Disease Care Interventions", this proposal will be the first to study an innovative model of care utilizing PES as specialized hospital caregivers for reducing BPSD in the hospital setting. The investigators' findings will lay the essential groundwork for a multi-site trial of PES-4-BPSD, and will inform the development of a program that can be easily implemented in other hospitals.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease and Related Dementias Behavioral: PES-4-BPSD Model Behavioral: The attention control condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021


Arm Intervention/treatment
Experimental: The PES-4-BPSD Model
I. Cohorting. Patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES are mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks to implement the program for the PES staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the PES staff will receive weekly 20 minute sessions. IV. Staff Support. Once recruitment begins, the PI will hold monthly 20 minute group sessions, to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients.
Behavioral: PES-4-BPSD Model
I. Cohorting. Patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 10-bed medical unit. II. PES are mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. III. Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks to implement the program for the PES staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the PES staff will receive weekly 20 minute sessions. IV. Staff Support. Once recruitment begins, the PI will hold monthly 20 minute group sessions, to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients.

Active Comparator: The attention control condition
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 NA (1:8 ratio), that primarily cohorts older patients with geriatric syndromes. On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support.
Behavioral: The attention control condition
I. Cohorting. Patients with cognitive impairment AND past or present indication of BPSD, acutely admitted to the medicine or telemetry service, are cohorted on a 40-bed medical unit. II. Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks to implement the program for the NA staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the NA staff will receive weekly 20 minute sessions. III. Staff Support. Once recruitment begins, the PI will hold monthly 20 minute group sessions, to reinforce training and discuss challenging patient behaviors; meant to improve the attitude and empathy of HCGs towards patients.




Primary Outcome Measures :
  1. NPI-Q [ Time Frame: Duration of hospital admission; median of 4 days ]
    The NPI-Q is a validated tool used for the assessment of neuropsychiatric symptomatology in routine clinical practice settings. It is designed to be completed by caregivers of patients with Alzheimers disease and other dementias, and consists of 1 item for each of 12 behavioral domains. Informants are asked to report the presence or absence of each behavioral symptom, as well as a measure of the severity of the symptom for those that are present. A total score is calculated by summing each of the 12 domain severity scores. The NPI-Q will be completed using a multi-modal data collection approach, including direct observations healthcare giver and family care giver interviews, and chart reviews.


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: Participant length of stay varies, median of 4 days; will be assessed for 1 year duration of study ]
    Collected via chart review.

  2. Practices for the Management of BPSD [ Time Frame: Outcomes vary by participant; will be assessed through duration of study for 1 year ]
    Collected via chart review. Practices include orders placed for special observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric evaluation, as well as adverse events (falls).

  3. Family Caregiver (FCG) Satisfaction [ Time Frame: Collected within 48 hours of hospital discharge for the 1-year study duration ]
    FCGs will be interviewed by RC with a one-time telephone survey within 48 hours of discharge using the UK National Audit of Dementia Round 3, Caregiver Questionnaire. The survey consists of 10 items assessing perceptions of hospital quality of care provided by hospital staff.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 65 and above
  • English-speaking/reading, documentation of dementia in the medical record (based on ICD-9 codes) or nurse report of confusion and/or behavioral symptoms.

For patients without a prior history of dementia documented in the EMR, an AD8 score (obtained from the family caregiver, FCG) of greater than or equal to 2 will be required. The AD8 is an eight item, informant-based interview, used to screen for dementia.

Exclusion Criteria:

- Patients who are known to be terminally ill and/or receiving hospice or surgery; length of stay of less than 48 hours.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179721


Locations
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United States, New York
Long Island Jewish Medical Center
Glen Oaks, New York, United States, 11040
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
National Institute of Nursing Research (NINR)
Penn State University
Investigators
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Principal Investigator: Liron Sinvani, MD Northwell Health
Publications of Results:
Other Publications:
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04179721    
Other Study ID Numbers: 19-0800-FIMR
1R21NR018500-01 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northwell Health:
Behavioral and Psychological Symptoms of Dementia
Alzheimer's Disease and Related Dementias
Hospitalization
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders