Phase 2
Completed N=301
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Delirium · Fall Injury
Source: ClinicalTrials.gov NCT03832192 ↗
Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Incident Delirium Rate — 6; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incident Delirium Rate |
6; 0 | — |
| SECONDARY Delirium Resolution Rate |
3; 5 | — |
| SECONDARY Change in Cognitive Function |
0.14; -0.15 | — |
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
Data sourced from ClinicalTrials.gov (NCT03832192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.