Clinical trial NCT04481568: Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)
Official title: Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Keywords: Behavioral and Psychological Symptoms of Dementia
Alzheimer's Disease and Related Dementias
Hospitalization
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Penn State University
First posted: 2020-07-22
Enrollment: 158
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Persons with Alzheimer's Disease and Related Dementias (ADRD) account for 3.2 million hospital admissions per year and have over three times more hospitalizations than those without cognitive impairment, yet hospital caregivers (HCGs) are 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 is to test the preliminary efficacy of an innovative model of care, PES-4-BPSD, for reducing BPSD by empowering Patient Engagement Specialists (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 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 PES-4-BPSD will improve the ability of PES to create an "enabling" milieu that addresses factors leading to BPSD and improves the experience of hospital caregivers. Guided by a social-ecological framework, PES-4-BPSD 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: Aim 1) Determine the preliminary efficacy of PES-4-BPSD 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, investigators will conduct a non-randomized preliminary efficacy trial of the PES-4-BPSD intervention enrolling N=158 patients (79 control, 79 intervention). The primary outcome will be presence of BPSD during hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). In Aim 2, 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 the end of the intervention period (T3). 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 inform the development of a program that can be easily implemented in other hospitals.

Detailed description: Prior to patient recruitment, a 3 month dementia training program will be implemented on both the intervention and control units. On the intervention unit, training will target the Patient Engagement Specialists (PES) and on the control to the nurse assistants (please refer to NCT# 04179721 for more details on this aim). Following the implementation of the dementia care training, eligible patients will be offered the opportunity to participate in the study. A research coordinator will offer the information and opportunity to participate to the patient's lawful caregiver. The signed consent forms will be stored in secured file cabinets. Once a participant has been enrolled in the study, demographic information will be obtained from the electronic medical records (EMR) and verified by Family Caregiver (FCG), including: age, gender, race/ethnicity, marital status, education, work status, current living situation, medical comorbidities, and reason for admission. A member of the research team will conduct a short interview with the FCG to verify patient background information and obtain baseline (1 month prior to admission) functional status (Barthel Index), dementia severity cognitive (Clinical Dementia Rating Scale)(5 stages of severity: no 0, questionable 0.5, mild 1, moderate 2, and severe 3), and behavioral symptoms using the Neuropsychiatric Inventory-Clinical version NPI-C.

A member of the research team will then complete daily NPI-Qs to determine the number of behaviors and symptoms for each patient on a daily basis. The data collector will use a multimodal approach drawing from electronic medical record (EMR) notes and interviews with nursing staff regarding the patient's behavior and treatment over the past 24 hours. Delirium will be assessed daily by the research coordinator using same multimodal approach and during the time of NPI observation. A final EMR chart review will be conducted collecting information such as length of stay, discharge disposition, in-hospital mortality as well as total usage practices for management of BPSD: use of special observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric evaluation. Within 48 hours of discharge, family caregivers will be interviewed regarding satisfaction with care using the Carer Questionnaire Data from the National Audit of Dementia Round 3.

Eligibility criteria: Inclusion criteria:

* Patients who have an acute medical admission to either the control unit (Geriatric Care Model) or intervention unit (PES-4-BPSD).
* Patients age 65 and above
* Documentation of dementia in the medical record (based on the International Classification of Diseases, Ninth and Tenth Revision codes \[ICD-9 and ICD-10\])
* AD8 score of 2 or greater (obtained from the family caregiver \[FCG\])

Exclusion Criteria:

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

Primary outcomes:
measure: Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission
timeFrame: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
Secondary outcomes:
measure: Length of Stay
timeFrame: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
measure: Practices for the Management of BPSD
timeFrame: Outcomes vary by participant; will be assessed through duration of study for 1 year
measure: Family Caregiver (FCG) Satisfaction
timeFrame: Collected within 48 hours of hospital discharge for the 1-year study duration
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Liron Sinvani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001
citation: Scerri A, Innes A, Scerri C. Dementia training programmes for staff working in general hospital settings - a systematic review of the literature. Aging Ment Health. 2017 Aug;21(8):783-796. doi: 10.1080/13607863.2016.1231170. Epub 2016 Sep 23.
citation: Sinvani L, Warner-Cohen J, Strunk A, Halbert T, Harisingani R, Mulvany C, Qiu M, Kozikowski A, Patel V, Liberman T, Carney M, Pekmezaris R, Wolf-Klein G, Karlin-Zysman C. A Multicomponent Model to Improve Hospital Care of Older Adults with Cognitive Impairment: A Propensity Score-Matched Analysis. J Am Geriatr Soc. 2018 Sep;66(9):1700-1707. doi: 10.1111/jgs.15452. Epub 2018 Aug 11.