Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study (AvatarHELP)
Primary Purpose
Delirium, Fall Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
care.coach Avatar (HELP-Protocolized)
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring patient satisfaction, HCAHPS, loneliness, delirium, falls, HELP, hospitals, geriatrics, elder care
Eligibility Criteria
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
Sites / Locations
- Jamaica Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
care.coach Avatar
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03832192
First Posted
January 29, 2019
Last Updated
July 20, 2023
Sponsor
Victor Wang
Collaborators
National Institute of Nursing Research (NINR), Pace University
1. Study Identification
Unique Protocol Identification Number
NCT03832192
Brief Title
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Acronym
AvatarHELP
Official Title
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium, Through Psychosocial Support and Protocol-Driven Interventions Based on the Hospital Elder Life Program: a Multi-Site Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
January 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Victor Wang
Collaborators
National Institute of Nursing Research (NINR), Pace University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Fall Injury
Keywords
patient satisfaction, HCAHPS, loneliness, delirium, falls, HELP, hospitals, geriatrics, elder care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Arm Title
care.coach Avatar
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
care.coach Avatar (HELP-Protocolized)
Intervention Description
care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
Primary Outcome Measure Information:
Title
Incident Delirium Rate
Description
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
Secondary Outcome Measure Information:
Title
Delirium Resolution Rate
Description
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
Title
Change in Cognitive Function
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Delirium Severity
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Jamaica Hospital Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11418
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://care.coach
Description
care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordination
Learn more about this trial
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
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