Artificial Intelligence, Caregiver, Care Transition, Dementia, Emergency Department
Conditions
Brief summary
The purpose of this research study is to develop and test an artificial intelligence intervention for emergency department (ED) discharge care transitions experienced by caregivers of older adults with cognitive impairment.
Interventions
OTHERNeuViCare application
Intervention arm participants will engage with NeuViCare AI, including all variations of its 5 components: 1) NeuViCare Planner - enables review of ordered tests and external resources recommended by the care provider; 2) NeuViCare Task-Support Service - provides context-sensitive, personalized text-based assistance to help patients' complete care plan captured in the NeuViCare Planner; 3) NeuViCare Resource Advisor - presents trusted, unbiased advice to locate nearby resources listed within their care plan; 4) NeuViCare Advisor - educates and trains Persons Living With Dementia (PLWD) and their care partners at the moment of need; and 5) NeuViCare Community Hub - a safe virtual space which enables care partners to interact with other peer care partners to gain their experiential knowledge and emotional support.
Sponsors
National Institute on Aging (NIA)
Emergency Medicine Foundation
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age ≥65 years with a diagnosis of dementia within the electronic health record OR new cognitive impairment identified during an ED visit * be fluent in English or Spanish * discharge after an ED visit * possession of a smart device (either a phone, tablet, or computer) that has internet access to utilize and interact with NeuViCare AI services
Exclusion criteria
\- evidence of delirium, by the 4-AT screening tool
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale | Day 7 and 30 | Usability encapsulates several aspects including subjective component assessments of effectiveness, efficiency, and satisfaction. The System Usability Scale consists of 10 questions on effectiveness, efficiency, and satisfaction, with an overall score range of 10-50 (higher scores suggest increased usability). Administration time is 3-5 minutes. Measured by survey. |
| Intervention Appropriateness Measure | Day 7 and 30 | Appropriateness is defined as the perceived fit, relevance, or compatibility of the innovation for a given setting or consumer, and/or perceived fit of the innovation to address a particular issue or problem. The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased appropriateness). Administration time is 1-2 minutes. Measured by survey. |
| Feasibility of Intervention Measure | Day 7 and 30 | Feasibility is defined as the extent to which a new innovation can be successfully used or carried out within a given setting. The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased feasibility). Administration time is 1-2 minutes. Measured by survey. |
| Acceptability of Intervention Measure | Day 7 and 30 | Acceptability is defined as the perception that a given innovation is agreeable, palatable, or satisfactory. The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased acceptability). Administration time is 1-2 minutes. Measured by survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD) | Day 0, 7 and 30 | Total score range 13-52; higher scores indicate better QOL. |
| Dyadic Relationship Scale (DRS) | Day 0, 7 and 30 | DRS to measure strain between the caregiver and recipient within the last 30 days. Total score range 4-20. High scores indicate high levels of strain. |
| Zarit Caregiver Burden Scale | Day 0, 7 and 30 | The Zarit Caregiver Burden Scale consists of 4 items with the total score ranging between 0-16. Higher scores indicate greater burden. Administration time is approximately 10-15 minutes. Measured by survey. |
| Fortinsky Caregiver Self-Efficacy Scale | Day 0, 7, and 30 | Used to evaluate the coping ability of daily living. The measure has a total score range from 10-100, with higher scores representing greater self-efficacy. Administration time is approximately 3-5 minutes. Measured by survey. |
Countries
United States
Participant flow
Pre-assignment details
This was a caregiver-focused study. Although both persons living with cognitive impairment (PLWCI) and their care partners were approached during the recruitment process, only care partners were considered enrolled participants. All baseline and outcome measures, including self-efficacy and burden assessments, were collected solely from enrolled care partners. The reported enrollment number and participant flow reflect the number of care partners enrolled, not the number of dyads or PLWCI. No s
Participants by arm
| Arm | Count |
|---|---|
| Intervention (NeuViCare AI) Participants will be part of the Intervention arm participants and will engage with NeuViCare AI, including all variations of its 5 components described further below.
NeuViCare application: Intervention arm participants will engage with NeuViCare AI, including all variations of its 5 components: 1) NeuViCare Planner - enables review of ordered tests and external resources recommended by the care provider; 2) NeuViCare Task-Support Service - provides context-sensitive, personalized text-based assistance to help patients' complete care plan captured in the NeuViCare Planner; 3) NeuViCare Resource Advisor - presents trusted, unbiased advice to locate nearby resources listed within their care plan; 4) NeuViCare Advisor - educates and trains Persons Living With Dementia (PLWD) and their care partners at the moment of need; and 5) NeuViCare Community Hub - a safe virtual space which enables care partners to interact with other peer care partners to gain their experiential knowledge and emotional support. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued intervention | 6 |
Baseline characteristics
| Characteristic | Intervention (NeuViCare AI) |
|---|---|
| Age, Continuous | 82.3 years STANDARD_DEVIATION 6.7 |
| Emergency Department chief complaint (Most common three) Altered mental state | 6 Participants |
| Emergency Department chief complaint (Most common three) Fall | 7 Participants |
| Emergency Department chief complaint (Most common three) Syncope | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Form of cognitive impairment Absence of dementia based on dementia screening score ≥ 2 | 16 Participants |
| Form of cognitive impairment Diagnosed dementia | 24 Participants |
| Living Situation Own home | 10 Participants |
| Living Situation With care partner | 30 Participants |
| Marital Status Divorced | 4 Participants |
| Marital Status Married | 20 Participants |
| Marital Status Single | 4 Participants |
| Marital Status Widowed | 12 Participants |
| Median number of chronic conditions | 3 conditions |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Acceptability of Intervention Measure
Acceptability is defined as the perception that a given innovation is agreeable, palatable, or satisfactory. The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased acceptability). Administration time is 1-2 minutes. Measured by survey.
Time frame: Day 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Acceptability of Intervention Measure | Day 7 | 15.9 score on a scale | Standard Deviation 3.2 |
| Intervention (NeuViCare AI) | Acceptability of Intervention Measure | Day 30 | 15.8 score on a scale | Standard Deviation 3.9 |
Primary
Feasibility of Intervention Measure
Feasibility is defined as the extent to which a new innovation can be successfully used or carried out within a given setting. The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased feasibility). Administration time is 1-2 minutes. Measured by survey.
Time frame: Day 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Feasibility of Intervention Measure | Day 7 | 15.1 score on a scale | Standard Deviation 3.1 |
| Intervention (NeuViCare AI) | Feasibility of Intervention Measure | Day 30 | 15.5 score on a scale | Standard Deviation 3.6 |
Primary
Intervention Appropriateness Measure
Appropriateness is defined as the perceived fit, relevance, or compatibility of the innovation for a given setting or consumer, and/or perceived fit of the innovation to address a particular issue or problem. The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased appropriateness). Administration time is 1-2 minutes. Measured by survey.
Time frame: Day 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Intervention Appropriateness Measure | Day 7 | 15.1 score on a scale | Standard Deviation 3.6 |
| Intervention (NeuViCare AI) | Intervention Appropriateness Measure | Day 30 | 15.8 score on a scale | Standard Deviation 3.9 |
Primary
System Usability Scale
Usability encapsulates several aspects including subjective component assessments of effectiveness, efficiency, and satisfaction. The System Usability Scale consists of 10 questions on effectiveness, efficiency, and satisfaction, with an overall score range of 10-50 (higher scores suggest increased usability). Administration time is 3-5 minutes. Measured by survey.
Time frame: Day 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | System Usability Scale | Day 7 | 30.1 score on a scale | Standard Deviation 3.8 |
| Intervention (NeuViCare AI) | System Usability Scale | Day 30 | 29.7 score on a scale | Standard Deviation 3.7 |
Secondary
Dyadic Relationship Scale (DRS)
DRS to measure strain between the caregiver and recipient within the last 30 days. Total score range 4-20. High scores indicate high levels of strain.
Time frame: Day 0, 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Dyadic Relationship Scale (DRS) | Day 0 | 10.7 score on a scale | Standard Deviation 3.9 |
| Intervention (NeuViCare AI) | Dyadic Relationship Scale (DRS) | Day 7 | 10.4 score on a scale | Standard Deviation 2.6 |
| Intervention (NeuViCare AI) | Dyadic Relationship Scale (DRS) | Day 30 | 10.8 score on a scale | Standard Deviation 3.5 |
Secondary
Fortinsky Caregiver Self-Efficacy Scale
Used to evaluate the coping ability of daily living. The measure has a total score range from 10-100, with higher scores representing greater self-efficacy. Administration time is approximately 3-5 minutes. Measured by survey.
Time frame: Day 0, 7, and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Fortinsky Caregiver Self-Efficacy Scale | Day 0 | 52 score on a scale | Standard Deviation 26.3 |
| Intervention (NeuViCare AI) | Fortinsky Caregiver Self-Efficacy Scale | Day 7 | 57.6 score on a scale | Standard Deviation 23.1 |
| Intervention (NeuViCare AI) | Fortinsky Caregiver Self-Efficacy Scale | Day 30 | 65.8 score on a scale | Standard Deviation 17.8 |
Secondary
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Total score range 13-52; higher scores indicate better QOL.
Time frame: Day 0, 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD) | Day 0 | 40.5 score on a scale | Standard Deviation 7.4 |
| Intervention (NeuViCare AI) | Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD) | Day 7 | 33.8 score on a scale | Standard Deviation 9.2 |
| Intervention (NeuViCare AI) | Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD) | Day 30 | 36.6 score on a scale | Standard Deviation 8 |
Secondary
Zarit Caregiver Burden Scale
The Zarit Caregiver Burden Scale consists of 4 items with the total score ranging between 0-16. Higher scores indicate greater burden. Administration time is approximately 10-15 minutes. Measured by survey.
Time frame: Day 0, 7 and 30
Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (NeuViCare AI) | Zarit Caregiver Burden Scale | Day 0 | 9.2 score on a scale | Standard Deviation 4.3 |
| Intervention (NeuViCare AI) | Zarit Caregiver Burden Scale | Day 7 | 9 score on a scale | Standard Deviation 2.1 |
| Intervention (NeuViCare AI) | Zarit Caregiver Burden Scale | Day 30 | 8.2 score on a scale | Standard Deviation 3.7 |