Trial Outcomes & Findings for Reducing Behavioral and Psychological Symptoms of Dementia: Family Caregivers (Aim 1) (NCT 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

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

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

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=5 Participants	86.9 years STANDARD_DEVIATION 7.48 • n=7 Participants	85.2 years STANDARD_DEVIATION 8.13 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	52 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants	66 Participants n=7 Participants	138 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	9 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	59 Participants n=7 Participants	93 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Marital Status Married/Domestic Partnership	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Marital Status Divorced	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Marital Status Separated	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Marital Status Widowed	35 Participants n=5 Participants	40 Participants n=7 Participants	75 Participants n=5 Participants
Marital Status Single/Never Married	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Education Less than a high school diploma	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Education High school degree or equivalent	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Education Associates degree (e.g., AA, AS)	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Education Bachelors degree (e.g. BA, BS)	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Education Masters degree (e.g. MA, MS)	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Education Doctorate (e.g. PhD, PsyD)	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Education Other	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Residence Still in own home	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Residence Caregivers home	25 Participants n=5 Participants	9 Participants n=7 Participants	34 Participants n=5 Participants
Residence Assisted-living facility	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Residence Independent living	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Residence Nursing home	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Residence Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Previous history of dementia Yes	57 Participants n=5 Participants	70 Participants n=7 Participants	127 Participants n=5 Participants
Previous history of dementia No	22 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants
Charlson Comorbidity Index	8.09 score on a scale STANDARD_DEVIATION 2.66 • n=5 Participants	8.77 score on a scale STANDARD_DEVIATION 2.65 • n=7 Participants	8.43 score on a scale STANDARD_DEVIATION 2.67 • n=5 Participants
Clinical Dementia Rating Worksheet final score 0 - No Impairment	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Clinical Dementia Rating Worksheet final score 0.5 - Questionable Impairment	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Clinical Dementia Rating Worksheet final score 1 - Mild Impairment	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Clinical Dementia Rating Worksheet final score 2 - Moderate Impairment	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Clinical Dementia Rating Worksheet final score 3 - Severe Impairment	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Baseline Neuropsychiatric inventory questionnaire	15.8 score on a scale STANDARD_DEVIATION 7.49 • n=5 Participants	10.5 score on a scale STANDARD_DEVIATION 6.60 • n=7 Participants	13.1 score on a scale STANDARD_DEVIATION 7.51 • n=5 Participants

PRIMARY outcome

Timeframe: Participant length of stay varies, median of 7 days; will be assessed for 1 year duration of study

Outcome measures

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 study

Collected via chart review.

Outcome measures

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 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). Orders for constant observation are reported below.

Outcome measures

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 duration

FCGs 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

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