Reducing Behavioral and Psychological Symptoms of Dementia: Hospital Caregivers (Aim 2)

NCT ID: NCT04179721

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2021-05-18

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 (please refer to NCT# 04481568 for more details on this aim), 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

We will 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. We 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). This study will utilize a repeated measures design to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training).

A 3 month dementia training program will be implemented on both the intervention and control units. On the intervention unit, training will target the PES and on the control to the nurse assistants. The 3 month dementia training program is based on the John A. Hartford Institute for Geriatric Nursing and the National Alzheimer Association publications Try This: Best Practices in Nursing Care for Persons with Dementia, "ACT" on Alzheimers guide to dementia friendly hospitals, and the Person-Centred Care Training Programme for Acute Hospitals (PCTAH), the research team will provide PES staff with weekly 20 minute sessions. The sessions will consists of the following topics: types and impact of dementia, providing person-centered care, identification of and meeting peoples emotional and physical needs, effective communication, connecting to the family caregiver (FCG), the impact of the physical environment, and redefining and supporting behaviors staff may describe as challenging. In order to ensure all staff get the training, sessions will be repeated 3 times per week during change of shift.

Conditions

Alzheimer's Disease and Related Dementias

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

The PES-4-BPSD Model

The intervention arm consists of PES and NAs 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. 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 hospital caregivers towards patients. IV. Staff Training

Group Type: EXPERIMENTAL

PES-4-BPSD Model

Intervention Type: BEHAVIORAL

Staff Training: Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks training the PES/NA staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the PES staff will receive weekly 20 minute sessions. This study aims to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training).

The attention control condition

The control group consists of NAs that work on 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. All components of the intervention arm are the same with the exception of the PES staff. The control arm (NAs) will receive the same training as the intervention arm.

Group Type: ACTIVE_COMPARATOR

The attention control condition

Intervention Type: BEHAVIORAL

Staff Training: Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks to train the PES/NA staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the PES staff will receive weekly 20 minute sessions. This study aims to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training).

Interventions

PES-4-BPSD Model

Staff Training: Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks training the PES/NA staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the PES staff will receive weekly 20 minute sessions. This study aims to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training).

Intervention Type: BEHAVIORAL

The attention control condition

Staff Training: Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks to train the PES/NA staff. Based on the "Try This: Best Practices in Nursing Care for Persons with Dementia," the PES staff will receive weekly 20 minute sessions. This study aims to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All PES staff on the intervention unit and nursing assistant staff on the control unit will be approached by research coordinator who has no authoritative responsibilities, emphasizing voluntary participation

Exclusion Criteria

• Staff who decline to participate in the study
• Staff that are not permanently based on either the intervention or control units

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liron Sinvani, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Long Island Jewish Medical Center

Glen Oaks, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25061120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28065176 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1856035 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24459188 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27662075 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30098015 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://clinicaltrials.gov/ct2/show/NCT04481568

Please refer to NCT# 04481568 for more details on Aim 1: Family Caregivers

Other Identifiers

1R21NR018500-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0800-FIMR-2

Identifier Type: -

Identifier Source: org_study_id