Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)

Alzheimer's Disease and Related Dementias Clinical Trial

Official title:

Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481568
• Other study ID #: 19-0800-FIMR-1
• Secondary ID: 1R21NR018500-01
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: December 29, 2021

Study information

• Verified date: December 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Dementia

Intervention

Behavioral:
• PES-4-BPSD Model
We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
• The attention control condition
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 (please refer to NCT# 04179721 for more details on this aim).

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center	Glen Oaks	New York
United States	North Shore University Hospital	Manhasset	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Nursing Research (NINR), Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Astrom S, Nilsson M, Norberg A, Sandman PO, Winblad B. Staff burnout in dementia care--relations to empathy and attitudes. Int J Nurs Stud. 1991;28(1):65-75. doi: 10.1016/0020-7489(91)90051-4. — View Citation

Dewing J, Dijk S. What is the current state of care for older people with dementia in general hospitals? A literature review. Dementia (London). 2016 Jan;15(1):106-24. doi: 10.1177/1471301213520172. Epub 2014 Jan 23. — View Citation

Hessler JB, Schaufele M, Hendlmeier I, Junge MN, Leonhardt S, Weber J, Bickel H. Behavioural and psychological symptoms in general hospital patients with dementia, distress for nursing staff and complications in care: results of the General Hospital Study. Epidemiol Psychiatr Sci. 2018 Jun;27(3):278-287. doi: 10.1017/S2045796016001098. Epub 2017 Jan 9. — View Citation

Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001

Sampson EL, White N, Leurent B, Scott S, Lord K, Round J, Jones L. Behavioural and psychiatric symptoms in people with dementia admitted to the acute hospital: prospective cohort study. Br J Psychiatry. 2014 Sep;205(3):189-96. doi: 10.1192/bjp.bp.113.130948. Epub 2014 Jul 24. — View 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. — View 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 Impai — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission	The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.	Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
Secondary	Length of Stay	Collected via chart review.	Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
Secondary	Practices for the Management of BPSD	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). Orders for constant observation are reported below.	Outcomes vary by participant; will be assessed through duration of study for 1 year
Secondary	Family Caregiver (FCG) Satisfaction	FCGs will be interviewed by research coordinator 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. Responses of "Excellent" to the primary question assessed, "overall, how would you rate the care received by your loved one during their hospital stay?" is reported.	Collected within 48 hours of hospital discharge for the 1-year study duration

External Links

•   Please refer to NCT# 04179721 for more details on Aim 2: Hospital Caregivers