Alzheimer's Disease and Related Dementias
Conditions
Keywords
Behavioral and Psychological Symptoms of Dementia, Alzheimer's Disease and Related Dementias, Hospitalization
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.
Interventions
BEHAVIORALPES-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).
BEHAVIORALThe 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).
Sponsors
National Institute of Nursing Research (NINR)
Penn State University
Northwell Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Nonrandom preliminary efficacy trial comparing 2 groups, intervention and control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 3 Months | 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. |
| Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 3 Months | 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. |
| Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 15 Months | 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. |
| Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 15 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Approaches to Dementia Questionnaire Total Score at Baseline | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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). | 22 |
| 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.
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). | 32 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Related Lost of Followup | 11 | 13 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | The PES-4-BPSD Model | The Attention Control Condition | Total |
|---|---|---|---|
| Age, Customized 18-24 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Customized 25-34 years | 6 Participants | 12 Participants | 18 Participants |
| Age, Customized 35-44 years | 10 Participants | 3 Participants | 13 Participants |
| Age, Customized 45-54 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Customized 55-64 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Customized 65-74 years | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 27 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Previous Dementia Training/Education 1-2 Hours | 4 Participants | 3 Participants | 7 Participants |
| Previous Dementia Training/Education Full Day | 2 Participants | 0 Participants | 2 Participants |
| Previous Dementia Training/Education Half Day | 3 Participants | 0 Participants | 3 Participants |
| Previous Dementia Training/Education Missing | 0 Participants | 1 Participants | 1 Participants |
| Previous Dementia Training/Education None | 8 Participants | 26 Participants | 34 Participants |
| Previous Dementia Training/Education Other | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 20 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Female | 16 Participants | 26 Participants | 42 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
| Shift Day | 7 Participants | 14 Participants | 21 Participants |
| Shift Evening | 10 Participants | 9 Participants | 19 Participants |
| Shift Night | 5 Participants | 9 Participants | 14 Participants |
| Years Working in Acute Care 0-5 years | 5 Participants | 15 Participants | 20 Participants |
| Years Working in Acute Care 11-15 years | 2 Participants | 3 Participants | 5 Participants |
| Years Working in Acute Care 16-20 years | 2 Participants | 3 Participants | 5 Participants |
| Years Working in Acute Care > 20 years | 2 Participants | 5 Participants | 7 Participants |
| Years Working in Acute Care 6-10 years | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 32 |
| other Total, other adverse events | 0 / 22 | 0 / 32 |
| serious Total, serious adverse events | 0 / 22 | 0 / 32 |
Outcome results
Primary
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.
Time frame: Baseline and 15 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The PES-4-BPSD Model | Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 15 Months | -0.9 units on a scale |
| The Attention Control Condition | Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 15 Months | -4.5 units on a scale |
Primary
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.
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The PES-4-BPSD Model | Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 3 Months | -1.8 units on a scale |
| The Attention Control Condition | Change in Approaches to Dementia Questionnaire (ADQ) Total Score From Baseline to 3 Months | -2.3 units on a scale |
Primary
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.
Time frame: Baseline and 15 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The PES-4-BPSD Model | Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 15 Months | 4.8 units on a scale |
| The Attention Control Condition | Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 15 Months | 0.9 units on a scale |
Primary
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.
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The PES-4-BPSD Model | Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 3 Months | 2.9 units on a scale |
| The Attention Control Condition | Change in Staff Experiences of Working With Demented Residents Scale Total Score From Baseline to 3 Months | 4.0 units on a scale |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The PES-4-BPSD Model | Approaches to Dementia Questionnaire Total Score at Baseline | 70.3 score on a scale | Standard Deviation 6.4 |
| The Attention Control Condition | Approaches to Dementia Questionnaire Total Score at Baseline | 69.2 score on a scale | Standard Deviation 6.5 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The PES-4-BPSD Model | Staff Experiences of Working With Demented Residents Scale Total Score at Baseline | 52.2 score on a scale | Standard Deviation 10.1 |
| The Attention Control Condition | Staff Experiences of Working With Demented Residents Scale Total Score at Baseline | 50.8 score on a scale | Standard Deviation 10.2 |