Delirium, Fall Injury
Conditions
Keywords
patient satisfaction, HCAHPS, loneliness, delirium, falls, HELP, hospitals, geriatrics, elder care
Brief summary
Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration with hospital-based electronic medical record (EMR) systems. In the present study, the investigators seek to validate the efficacy of the new avatar platform, as measured by reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to gather patient and outcomes data at a scale sufficient to begin developing machine learning algorithms for intelligent, automatic assignment of protocols to maximize patient engagement and clinical efficacy, and for intelligent, automatic screening of delirium to assist care teams in positive identification of delirium. Therefore, the present study comprises a two-year randomized between-groups comparison across multiple hospitals to compare outcomes with the new generation of care.coach avatars as the intervention versus usual care only as the control. Each study group will be geographically distributed across participating research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New York, with additional hospitals to join the study over the course of two years.
Interventions
BEHAVIORALcare.coach Avatar (HELP-Protocolized)
care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
Sponsors
National Institute of Nursing Research (NINR)
Pace University
Victor Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)
Exclusion criteria
* aggression or combativeness with intent to harm self or others * severe hearing impairment and simultaneous severe vision impairment, despite assistive devices * no comprehension of either Spanish or English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident Delirium Rate | From beginning to end of each participant's inpatient stay, an average of 4 days | For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delirium Resolution Rate | From beginning to end of each participant's inpatient stay, an average of 4 days | For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable. |
| Change in Cognitive Function | From beginning to end of each participant's inpatient stay, an average of 4 days | For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Delirium Severity | From beginning to end of each participant's inpatient stay, an average of 4 days | For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention HELP-protocolized digital avatar with daily nurse student check-in | 152 |
| Control Usual care with daily nurse student social check-in | 149 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participants are disenrolled upon hospital discharge. | 152 | 149 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 9 | 75 years STANDARD_DEVIATION 8 | 76 years STANDARD_DEVIATION 9 |
| Confusion Assessment Method | 23 number of positive screens | 8 number of positive screens | 31 number of positive screens |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 26 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 117 Participants | 236 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Memorial Delirium Assessment Scale | 8.2 scores on a scale STANDARD_DEVIATION 4.6 | 14.3 scores on a scale STANDARD_DEVIATION 4.6 | 12.6 scores on a scale STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 76 Participants | 58 Participants | 134 Participants |
| Sex: Female, Male Male | 76 Participants | 91 Participants | 167 Participants |
| Short Portable Mental Status Questionnaire | 2.0 number of questions incorrectly answered STANDARD_DEVIATION 1.8 | 2.6 number of questions incorrectly answered STANDARD_DEVIATION 2.4 | 2.3 number of questions incorrectly answered STANDARD_DEVIATION 2.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 152 | 0 / 149 |
| other Total, other adverse events | 0 / 152 | 0 / 149 |
| serious Total, serious adverse events | 0 / 152 | 0 / 149 |
Outcome results
Primary
Incident Delirium Rate
For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
Population: Patients without prevalent delirium and have a final CAM screen on record
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Incident Delirium Rate | 6 Participants |
| Control | Incident Delirium Rate | 0 Participants |
Secondary
Change in Cognitive Function
For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
Population: Patients with both pre- and post-test data on record
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Cognitive Function | 0.14 score on a scale | Standard Deviation 1.8 |
| Control | Change in Cognitive Function | -0.15 score on a scale | Standard Deviation 2.4 |
Secondary
Delirium Resolution Rate
For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
Population: Patients with prevalent delirium and a final CAM screen on record
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Delirium Resolution Rate | 3 Participants |
| Control | Delirium Resolution Rate | 5 Participants |
Other Pre-specified
Change in Delirium Severity
For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.
Time frame: From beginning to end of each participant's inpatient stay, an average of 4 days
Population: Patients with both pre- and post-test MDAS data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Delirium Severity | -2 score on a scale |
| Control | Change in Delirium Severity | -5 score on a scale |