Clinical trial NCT03832192: Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Fall Injury
Keywords: patient satisfaction
HCAHPS
loneliness
delirium
falls
HELP
hospitals
geriatrics
elder care
Lead sponsor: care.coach corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Nursing Research (NINR)
name: Pace University
First posted: 2019-02-06
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incident Delirium Rate
timeFrame: From beginning to end of each participant's inpatient stay, an average of 4 days
Secondary outcomes:
measure: Delirium Resolution Rate
timeFrame: From beginning to end of each participant's inpatient stay, an average of 4 days
measure: Change in Cognitive Function
timeFrame: From beginning to end of each participant's inpatient stay, an average of 4 days
Other outcomes:
measure: Change in Delirium Severity
timeFrame: From beginning to end of each participant's inpatient stay, an average of 4 days
Locations:
city: New York
country: United States
facility: Jamaica Hospital Medical Center
state: New York
Study officials:
References: