A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- % of Nursing Staff Who Want to Use the System Following the Trial
研究概览
简要总结
The purpose of this study is to test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in your unit.
This study has three specific aims:
- To assess the comfort of the system when used with hospitalized patients;
- To observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system.
- To analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: male or female
- •Age: 18 years and older
- •Racial and ethnic origin: all ethnic groups
- •Hospital status: admitted in-patient or a patient under observation
- •Expected hospital length of stay: minimum of 23 hours
- •Willingness to participate in the study
- •Moderate to High fall risk scoring a 2 or greater on the Mobility or Mental/LOC/Awareness status sections of the Hester Davis Fall Risk Assessment.
排除标准
- •Declined to participate
- •Patients less than 18 years old
- •Patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the Mobility or Mental/ LOC/Awareness status sections of the Hester Davis Fall Risk Assessment
- •Women who are documented as pregnant during the study period
- •Patients who are medically unstable; as per the discretion of the primary nurse
- •Patients who are actively in the dying process, at the discretion of the primary nurse
研究组 & 干预措施
SensableCareCare System
The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in the unit.
干预措施: SensableCare System (Device)
结局指标
主要结局
% of Nursing Staff Who Want to Use the System Following the Trial
时间窗: focus group at week 12 within the 13 week study period
Acceptance of SensableCare System after Trial Period
次要结局
- Rate of Bed Falls Decreased Over Study Period(through the 13 week study period)