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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Incident Delirium Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)
排除标准
- •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
结局指标
主要结局
Incident Delirium Rate
时间窗: From beginning to end of each participant's inpatient stay, an average of 4 days
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.
次要结局
- Change in Cognitive Function(From beginning to end of each participant's inpatient stay, an average of 4 days)
- Delirium Resolution Rate(From beginning to end of each participant's inpatient stay, an average of 4 days)
研究者
Victor Wang
Principal Investigator
care.coach corporation