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

Primary Purpose

Alzheimer's Disease and Related Dementias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PES-4-BPSD Model
The attention control condition
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease and Related Dementias focused on measuring Behavioral and Psychological Symptoms of Dementia, Alzheimer's Disease and Related Dementias, Hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Long Island Jewish Medical Center
  • North Shore University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The PES-4-BPSD Model

The attention control condition

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 3 Months
The Approaches to Dementia Questionnaire (ADQ) is a 19-item scale designed to evaluate staff attitudes to people with dementia and providing dementia care. A five-point Likert Scale (1-5) is used for each item. The ADQ total score ranges from 19-95 with higher scores indicating a more positive attitude. The ADQ will be completed by Patient Engagement Specialists and Nurse Assistants at baseline (enrollment) and 3 months from enrollment. The average ADQ score at baseline and at 3 months was calculated separately for each group and change was assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 3 Months
The Staff Experience of Working with Demented Residents Scale (SEWDR) is a 21-item scale measuring staff satisfaction in their work environment and working with people with dementia. A five-point Likert scale (0-4) is used for each item. The SEWDR total score ranges from 0-84; higher scores indicate greater satisfaction. Patient Engagement Specialists and Nurse Assistants will complete the SEWDR at baseline (enrollment) and 3 months from enrollment. The average score at baseline and at 3 months will be calculated separately for each group; change will be assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 15 Months
The Approaches to Dementia Questionnaire (ADQ) is a 19-item scale designed to evaluate staff attitudes to people with dementia and providing dementia care. A five-point Likert Scale (1-5) is used for each item. The ADQ total score ranges from 19-95 with higher scores indicating a more positive attitude. The ADQ will be completed by Patient Engagement Specialists and Nurse Assistants at baseline (enrollment) and 15 months from enrollment. The average ADQ score at baseline and at 15 months was calculated separately for each group and change was assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 15 Months
The Staff Experience of Working with Demented Residents Scale (SEWDR) is a 21-item scale measuring staff satisfaction in their work environment and working with people with dementia. A five-point Likert scale (0-4) is used for each item. The SEWDR total score ranges from 0-84; higher scores indicate greater satisfaction. Patient Engagement Specialists and Nurse Assistants will complete the SEWDR at baseline (enrollment) and 15 months from enrollment. The average score at baseline and at 15 months will be calculated separately for each group; change will be assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.

Secondary Outcome Measures

Approaches to Dementia Questionnaire Total Score at Baseline
The Approaches to Dementia Questionnaire (ADQ) is a 19-item scale designed to evaluate staff attitudes to people with dementia and providing dementia care. A five-point Likert Scale (1 to 5) is used for each survey item. The total score for the ADQ ranges from 19 to 95, with higher scores indicating a more positive attitude. The ADQ will be completed by Patient Engagement Specialist (PES) staff and Nurse Assistant (NA) staff at enrollment (baseline), and mean score will be compared between these groups.
Staff Experiences of Working With Demented Residents Scale Total Score at Baseline
The Staff Experience of Working with Demented Residents Scale (SEWDR) is a 21-item scale measuring staff satisfaction in their experiences working with people with dementia as well as their work environment. A five-point Likert scale (0 to 4) is used for each survey item. The total score for the SEWDR ranges from 0 to 84, with higher scores indicating greater satisfaction. The SEWDR will be completed by Patient Engagement Specialist (PES) staff and Nurse Assistant (NA) staff at enrollment (baseline), and mean score will be compared between these groups.

Full Information

First Posted
November 20, 2019
Last Updated
November 1, 2022
Sponsor
Northwell Health
Collaborators
National Institute of Nursing Research (NINR), Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT04179721
Brief Title
Reducing Behavioral and Psychological Symptoms of Dementia: Hospital Caregivers (Aim 2)
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Nursing Research (NINR), Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementias
Keywords
Behavioral and Psychological Symptoms of Dementia, Alzheimer's Disease and Related Dementias, Hospitalization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The PES-4-BPSD Model
Arm Type
Experimental
Arm Description
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
Arm Title
The attention control condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PES-4-BPSD Model
Intervention Description
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
Intervention Name(s)
The attention control condition
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 3 Months
Description
The Approaches to Dementia Questionnaire (ADQ) is a 19-item scale designed to evaluate staff attitudes to people with dementia and providing dementia care. A five-point Likert Scale (1-5) is used for each item. The ADQ total score ranges from 19-95 with higher scores indicating a more positive attitude. The ADQ will be completed by Patient Engagement Specialists and Nurse Assistants at baseline (enrollment) and 3 months from enrollment. The average ADQ score at baseline and at 3 months was calculated separately for each group and change was assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Time Frame
Baseline and 3 months
Title
Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 3 Months
Description
The Staff Experience of Working with Demented Residents Scale (SEWDR) is a 21-item scale measuring staff satisfaction in their work environment and working with people with dementia. A five-point Likert scale (0-4) is used for each item. The SEWDR total score ranges from 0-84; higher scores indicate greater satisfaction. Patient Engagement Specialists and Nurse Assistants will complete the SEWDR at baseline (enrollment) and 3 months from enrollment. The average score at baseline and at 3 months will be calculated separately for each group; change will be assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Time Frame
Baseline and 3 months
Title
Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 15 Months
Description
The Approaches to Dementia Questionnaire (ADQ) is a 19-item scale designed to evaluate staff attitudes to people with dementia and providing dementia care. A five-point Likert Scale (1-5) is used for each item. The ADQ total score ranges from 19-95 with higher scores indicating a more positive attitude. The ADQ will be completed by Patient Engagement Specialists and Nurse Assistants at baseline (enrollment) and 15 months from enrollment. The average ADQ score at baseline and at 15 months was calculated separately for each group and change was assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Time Frame
Baseline and 15 months
Title
Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 15 Months
Description
The Staff Experience of Working with Demented Residents Scale (SEWDR) is a 21-item scale measuring staff satisfaction in their work environment and working with people with dementia. A five-point Likert scale (0-4) is used for each item. The SEWDR total score ranges from 0-84; higher scores indicate greater satisfaction. Patient Engagement Specialists and Nurse Assistants will complete the SEWDR at baseline (enrollment) and 15 months from enrollment. The average score at baseline and at 15 months will be calculated separately for each group; change will be assessed by subtracting each group's average score at their respective timepoints. Missing values for each item were imputed using the group mode for that item. 95% confidence intervals were calculated based on the t-distribution assuming independence of observations across time periods. Paired analysis was not feasible given anonymous data.
Time Frame
Baseline and 15 months
Secondary Outcome Measure Information:
Title
Approaches to Dementia Questionnaire Total Score at Baseline
Description
The Approaches to Dementia Questionnaire (ADQ) is a 19-item scale designed to evaluate staff attitudes to people with dementia and providing dementia care. A five-point Likert Scale (1 to 5) is used for each survey item. The total score for the ADQ ranges from 19 to 95, with higher scores indicating a more positive attitude. The ADQ will be completed by Patient Engagement Specialist (PES) staff and Nurse Assistant (NA) staff at enrollment (baseline), and mean score will be compared between these groups.
Time Frame
Baseline
Title
Staff Experiences of Working With Demented Residents Scale Total Score at Baseline
Description
The Staff Experience of Working with Demented Residents Scale (SEWDR) is a 21-item scale measuring staff satisfaction in their experiences working with people with dementia as well as their work environment. A five-point Likert scale (0 to 4) is used for each survey item. The total score for the SEWDR ranges from 0 to 84, with higher scores indicating greater satisfaction. The SEWDR will be completed by Patient Engagement Specialist (PES) staff and Nurse Assistant (NA) staff at enrollment (baseline), and mean score will be compared between these groups.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liron Sinvani, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Medical Center
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25061120
Citation
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.
Results Reference
background
PubMed Identifier
28065176
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.
Results Reference
background
PubMed Identifier
1856035
Citation
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.
Results Reference
background
PubMed Identifier
24459188
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.
Results Reference
background
Citation
Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001.
Results Reference
background
PubMed Identifier
27662075
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.
Results Reference
background
PubMed Identifier
30098015
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.
Results Reference
result
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT04481568
Description
Please refer to NCT# 04481568 for more details on Aim 1: Family Caregivers

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

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