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

NCT03832192 | Completed Phase 2 Results DMC

• 1 other identifier: 1R44NR017842-02
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Fall Injury

Keywords

patient satisfaction; HCAHPS; loneliness; delirium; falls; HELP; hospitals; geriatrics; elder care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Delirium Resolution Rate

  From beginning to end of each participant's inpatient stay, an average of 4 days

• Change in Cognitive Function

  From beginning to end of each participant's inpatient stay, an average of 4 days

Other Outcomes (1)

• Change in Delirium Severity

  From beginning to end of each participant's inpatient stay, an average of 4 days

Study Arms (2)

care.coach Avatar

EXPERIMENTAL

Behavioral: care.coach Avatar (HELP-Protocolized)

Control

NO INTERVENTION

Interventions

care.coach Avatar (HELP-Protocolized) BEHAVIORAL

care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).

care.coach Avatar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Victor Wang: lead
• National Institute of Nursing Research (NINR): collaborator
• Pace University: collaborator

Study Sites (1)

Jamaica Hospital Medical Center

New York, New York, 11418, United States

Location

Related Links

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

MeSH Terms

Conditions

Delirium; Patient Satisfaction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Fall \& patient sitter data were not recorded at the first site. Secondary sites that were to record such data were stalled by COVID. Post-tests were missing for many patients, due largely to hospital discharges occurring before researchers could conduct post-tests. Incident delirium cases were too few to draw conclusions (far below the rate suggested by literature). The team began to mitigate these data integrity problems, but were not able to rebuild a viable research assistant team post-COVID.

Results Point of Contact

• Title: Principal Investigator
• Organization: care.coach

pi@care.coach

8554374569

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 6, 2019
• Study Start: January 8, 2019
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Locations

US (1)