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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

Tracking Information
First Submitted Date  ICMJE November 20, 2019
First Posted Date  ICMJE November 27, 2019
Last Update Posted Date August 3, 2020
Actual Study Start Date  ICMJE October 22, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
NPI-Q [ Time Frame: Duration of hospital admission; median of 4 days ]
The NPI-Q is a validated tool used for the assessment of neuropsychiatric symptomatology in routine clinical practice settings. It is designed to be completed by caregivers of patients with Alzheimers disease and other dementias, and consists of 1 item for each of 12 behavioral domains. Informants are asked to report the presence or absence of each behavioral symptom, as well as a measure of the severity of the symptom for those that are present. A total score is calculated by summing each of the 12 domain severity scores. The NPI-Q will be completed using a multi-modal data collection approach, including direct observations healthcare giver and family care giver interviews, and chart reviews.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • Length of Stay [ Time Frame: Participant length of stay varies, median of 4 days; will be assessed for 1 year duration of study ]
    Collected via chart review.
  • Practices for the Management of BPSD [ Time Frame: Outcomes vary by participant; will be assessed through duration of study for 1 year ]
    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).
  • Family Caregiver (FCG) Satisfaction [ Time Frame: Collected within 48 hours of hospital discharge for the 1-year study duration ]
    FCGs will be interviewed by RC 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Behavioral and Psychological Symptoms of Dementia: Hospital Caregivers (Aim 2)
Official Title  ICMJE Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Alzheimer's Disease and Related Dementias
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: PES-4-BPSD Model
  • 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.
    Intervention: Behavioral: The attention control condition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2020)
51
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2019)
158
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Liron Sinvani, MD 516-600-1410 LDanay@northwell.edu
Contact: Suzanne Ardito, MA 516-600-1481 SArdito@northwell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04179721
Other Study ID Numbers  ICMJE 19-0800-FIMR-2
1R21NR018500-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE
  • National Institute of Nursing Research (NINR)
  • Penn State University
Investigators  ICMJE
Principal Investigator: Liron Sinvani, MD Northwell Health
PRS Account Northwell Health
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP