Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study (AvatarHELP)

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Fall Injury
• Intervention / Treatment: Behavioral: care.coach Avatar (HELP-Protocolized)

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11418
      • Jamaica Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: care.coach Avatar	Behavioral: care.coach Avatar (HELP-Protocolized); care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From beginning to end of each participant's inpatient stay, an average of 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From beginning to end of each participant's inpatient stay, an average of 4 days
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.	From beginning to end of each participant's inpatient stay, an average of 4 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From beginning to end of each participant's inpatient stay, an average of 4 days

Collaborators and Investigators

• Sponsor: Victor Wang
• Collaborators: National Institute of Nursing Research (NINR); Pace University

Publications and helpful links

Helpful Links

• care.coach human-in-the-loop avatars for psychosocial support, health coaching, and care coordination

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): January 7, 2021

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: delirium; falls; geriatrics; patient satisfaction; loneliness; hospitals; HCAHPS; HELP; elder care
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 1R44NR017842-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No