Trial Outcomes & Findings for Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1) (NCT NCT04481568)
NCT ID: NCT04481568
Last Updated: 2022-12-23
Results Overview
The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
158 participants
Primary outcome timeframe
Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study
Results posted on
2022-12-23
Participant Flow
Participant milestones
| Measure |
The PES-4-BPSD Model
The intervention arm consists of PES and nurse assistants 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: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. 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 HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
|
The Attention Control Condition
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
79
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1)
Baseline characteristics by cohort
| Measure |
The PES-4-BPSD Model
n=79 Participants
The intervention arm consists of PES and nurse assistants 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: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. 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 HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
|
The Attention Control Condition
n=79 Participants
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.5 years
STANDARD_DEVIATION 8.44 • n=99 Participants
|
86.9 years
STANDARD_DEVIATION 7.48 • n=107 Participants
|
85.2 years
STANDARD_DEVIATION 8.13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Marital Status
Married/Domestic Partnership
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Marital Status
Separated
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
35 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Marital Status
Single/Never Married
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
Less than a high school diploma
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Education
High school degree or equivalent
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Education
Associates degree (e.g., AA, AS)
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education
Bachelors degree (e.g. BA, BS)
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Education
Masters degree (e.g. MA, MS)
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Education
Doctorate (e.g. PhD, PsyD)
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Education
Other
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Residence
Still in own home
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Residence
Caregivers home
|
25 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Residence
Assisted-living facility
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Residence
Independent living
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Residence
Nursing home
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Residence
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Previous history of dementia
Yes
|
57 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Previous history of dementia
No
|
22 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Charlson Comorbidity Index
|
8.09 score on a scale
STANDARD_DEVIATION 2.66 • n=99 Participants
|
8.77 score on a scale
STANDARD_DEVIATION 2.65 • n=107 Participants
|
8.43 score on a scale
STANDARD_DEVIATION 2.67 • n=206 Participants
|
|
Clinical Dementia Rating Worksheet final score
0 - No Impairment
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Dementia Rating Worksheet final score
0.5 - Questionable Impairment
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Clinical Dementia Rating Worksheet final score
1 - Mild Impairment
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Clinical Dementia Rating Worksheet final score
2 - Moderate Impairment
|
30 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Clinical Dementia Rating Worksheet final score
3 - Severe Impairment
|
33 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Baseline Neuropsychiatric inventory questionnaire
|
15.8 score on a scale
STANDARD_DEVIATION 7.49 • n=99 Participants
|
10.5 score on a scale
STANDARD_DEVIATION 6.60 • n=107 Participants
|
13.1 score on a scale
STANDARD_DEVIATION 7.51 • n=206 Participants
|
PRIMARY outcome
Timeframe: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of studyThe Neuropsychiatric Inventory Questionnaire (NPI-Q) is a validated tool with 12 behavioral domains for the assessment of neuropsychiatric symptomology designed for completion by caregivers of patients with Alzheimer's Disease and Related Dementias. The tool asks the interviewee to rate each symptom, if present, as mild, moderate, or severe. Total scores range from 0-36 with higher scores indicating greater prominence of dementia symptoms. A Research Coordinator (RC) will utilize a multimodal approach, consisting of daily NPI-Q interviews with Hospital Caregivers and daily reviews of the patient's medical record, to provide a daily assessment of the 12 NPI-Q domains during hospitalization. Upon discharge, the average of each patient's daily NPI-Q total scores will be calculated, and this average will serve as the primary outcome.
Outcome measures
| Measure |
The PES-4-BPSD Model
n=79 Participants
The intervention arm consists of PES and nurse assistants 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: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. 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 HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
|
The Attention Control Condition
n=79 Participants
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
|
|---|---|---|
|
Neuropsychiatric Inventory Questionnaire Average Score During Hospital Admission
|
5.36 score on a scale
Standard Deviation 4.64
|
3.87 score on a scale
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of studyCollected via chart review.
Outcome measures
| Measure |
The PES-4-BPSD Model
n=79 Participants
The intervention arm consists of PES and nurse assistants 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: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. 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 HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
|
The Attention Control Condition
n=79 Participants
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
|
|---|---|---|
|
Length of Stay
|
7.00 days
Interval 6.4 to 8.14
|
7.86 days
Interval 5.88 to 9.8
|
SECONDARY outcome
Timeframe: Outcomes vary by participant; will be assessed through duration of study for 1 yearCollected 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). Orders for constant observation are reported below.
Outcome measures
| Measure |
The PES-4-BPSD Model
n=79 Participants
The intervention arm consists of PES and nurse assistants 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: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. 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 HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
|
The Attention Control Condition
n=79 Participants
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
|
|---|---|---|
|
Practices for the Management of BPSD
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Collected within 48 hours of hospital discharge for the 1-year study durationFCGs will be interviewed by research coordinator 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. Responses of "Excellent" to the primary question assessed, "overall, how would you rate the care received by your loved one during their hospital stay?" is reported.
Outcome measures
| Measure |
The PES-4-BPSD Model
n=79 Participants
The intervention arm consists of PES and nurse assistants 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: mental health assistants with high school level education, who receive training in de-escalation and crisis prevention techniques and provide direct personal care to psychiatric patients. On the intervention unit, these PES purposefully engage patients with BPSD. 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 HCGs towards patients. IV. Staff Training (please refer to NCT# 04179721 for more details on staff support and training).
PES-4-BPSD Model: We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
|
The Attention Control Condition
n=79 Participants
The attention control condition will consist of a 40-bed medicine unit, staffed with 39 nurses (1:6 ratio) and 26 nursing assistants (1:8 ratio), that primarily cohorts older patients with geriatric syndromes.
The attention control condition: On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
|
|---|---|---|
|
Family Caregiver (FCG) Satisfaction
|
34 Participants
|
26 Participants
|
Adverse Events
The PES-4-BPSD Model
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
The Attention Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Liron Sinvani, Principal Investigator
Northwell Health
Phone: 646-766-7169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place