Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)
2 other identifiers
interventional
158
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2020
CompletedFirst Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2021
CompletedResults Posted
Study results publicly available
December 23, 2022
CompletedDecember 23, 2022
December 1, 2022
1.9 years
July 15, 2020
October 10, 2022
December 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Length of Stay
Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
Practices for the Management of BPSD
Outcomes vary by participant; will be assessed through duration of study for 1 year
Family Caregiver (FCG) Satisfaction
Collected within 48 hours of hospital discharge for the 1-year study duration
Study Arms (2)
The PES-4-BPSD Model
EXPERIMENTALThe intervention arm consists of PES and nurse assistants who work on the intervention unit which consists of: I. Cohorting of 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 staff: 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. Staff Support: 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. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
The attention control condition
ACTIVE COMPARATORThe attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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 \[FCG\])
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- National Institute of Nursing Research (NINR)collaborator
- Penn State Universitycollaborator
Study Sites (2)
Long Island Jewish Medical Center
Glen Oaks, New York, 11040, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Related Publications (7)
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.
PMID: 25061120BACKGROUNDHessler 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.
PMID: 28065176BACKGROUNDAstrom 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.
PMID: 1856035BACKGROUNDDewing 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.
PMID: 24459188BACKGROUNDLintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001
BACKGROUNDScerri 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.
PMID: 27662075BACKGROUNDSinvani 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.
PMID: 30098015RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Liron Sinvani, Principal Investigator
- Organization
- Northwell Health
Study Officials
- PRINCIPAL INVESTIGATOR
Liron Sinvani, MD
Northwell Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2020
First Posted
July 22, 2020
Study Start
February 3, 2020
Primary Completion
December 29, 2021
Study Completion
December 29, 2021
Last Updated
December 23, 2022
Results First Posted
December 23, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share