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

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ClinicalTrials.gov Identifier: NCT04179721
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : August 3, 2020
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Penn State University
Information provided by (Responsible Party):
Northwell Health

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease and Related Dementias Behavioral: PES-4-BPSD Model Behavioral: The attention control condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021


Arm Intervention/treatment
Experimental: 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
Behavioral: 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).

Active Comparator: 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.
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).




Primary Outcome Measures :
  1. Change in Approaches to Dementia Questionnaire Total Score from baseline to 3 months [ Time Frame: Baseline and 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 will be calculated separately for each group and change will be assessed by subtracting each group's average score at baseline from their average score at 3 months. Differences in individual subject scores across time cannot be calculated because the survey data must be anonymous. However, the mean of the individual differences from baseline to 3 months is equal to the difference of the means at baseline and 3 months. A positive value for the change outcome represents improvement in staff attitudes.

  2. Change in Staff Experiences of Working with Demented Residents Scale Total Score from baseline to 3 months [ Time Frame: Baseline and 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 baseline from their average score at 3 months. Differences in individual subject scores over time cannot be calculated because survey data must be anonymous. However, the mean of the individual differences from baseline to 3 months is equal to the difference of the means at baseline and 3 months. A positive value for the change outcome represents improvement in satisfaction.

  3. Change in Approaches to Dementia Questionnaire Total Score from baseline to 15 months [ Time Frame: Baseline and 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; higher scores indicate 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 will be calculated separately for each group and change will be assessed by subtracting each group's average score at baseline from their average score at 15 months. Differences in individual subject scores across time cannot be calculated because the survey data must be anonymous. However, the mean of the individual differences from baseline to 15 months is equal to the difference of the means at baseline and 15 months. A positive value for the change outcome represents improvement in staff attitudes.

  4. Change in Staff Experiences of Working with Demented Residents Scale Total Score from baseline to 15 months [ Time Frame: Baseline and 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 baseline from their average score at 15 months. Differences in individual subject scores over time cannot be calculated because survey data must be anonymous. However, the mean of the individual differences from baseline to 15 months is equal to the difference of the means at baseline and 15 months. A positive value for the change outcome represents improvement in satisfaction.


Secondary Outcome Measures :
  1. Approaches to Dementia Questionnaire Total Score at baseline [ Time Frame: 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.

  2. Staff Experiences of Working with Demented Residents Scale Total Score at baseline [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179721


Contacts
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Contact: Liron Sinvani, MD 516-600-1410 LDanay@northwell.edu
Contact: Suzanne Ardito, MA 516-600-1481 SArdito@northwell.edu

Locations
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United States, New York
Long Island Jewish Medical Center Recruiting
Glen Oaks, New York, United States, 11040
Contact: Liron Sinvani, MD    516-600-1410    LDanay@northwell.edu   
Principal Investigator: Liron Sinvani, MD         
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Liron Sinvani, MD    516-600-1410    LDanay@northwell.edu   
Principal Investigator: Liron Sinvani, MD         
Sponsors and Collaborators
Northwell Health
National Institute of Nursing Research (NINR)
Penn State University
Investigators
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Principal Investigator: Liron Sinvani, MD Northwell Health
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04179721    
Other Study ID Numbers: 19-0800-FIMR-2
1R21NR018500-01 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northwell Health:
Behavioral and Psychological Symptoms of Dementia
Alzheimer's Disease and Related Dementias
Hospitalization
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders