- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179721
Reducing Behavioral and Psychological Symptoms of Dementia: Hospital Caregivers (Aim 2)
Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Glen Oaks, New York, United States, 11040
- Long Island Jewish Medical Center
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Approaches to Dementia Questionnaire (ADQ) 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 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.
|
Baseline and 3 months
|
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 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.
|
Baseline and 3 months
|
Change in Approaches to Dementia Questionnaire (ADQ) 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 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.
|
Baseline and 15 months
|
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 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.
|
Baseline and 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liron Sinvani, MD, Northwell Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. [PhD Thesis]. Prifysgol Bangor University; 2001.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-0800-FIMR-2
- 1R21NR018500-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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