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临床试验/NCT03003663
NCT03003663已完成2 期

Interrupted Time-Series Study for In-hospital Fall Reduction

MedicusTek, Inc1 个研究点 分布在 1 个国家目标入组 658 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
658
试验地点
1
主要终点
Fall Rate

研究概览

简要总结

The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting.

详细描述

The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting.

The study evaluates the SensableCare System for reducing bed falls. The SensableCare System will be used in three units of a hospital. It will be turned off for one month for the control group and then turned on the next month for the intervention group, repeating this sequence until the study concludes. To better inform the data analysis, the investigators collect baseline patient characteristics, fall risk scores, and the unit fall rate every month.

The SenableCare System: A pressure sensor pad is placed between the mattress surface and the bed sheet. The system lets nurses know how the patient is positioned in bed at the time of the alert, from which room number the alert is being generated, and informs other nurses when a patient is being assisted.

Using a predictive algorithm, the system can also monitor patient position in bed and send specific, customized alerts if nurses want to know when a patient begins to stir in bed, sits up in bed, attempts to leave the bed, or is already out of bed. When the system's software algorithm detects an increased probability of a bed exit, the system alerts the nursing staff via an app on mobile devices (i.e., smartphones) that nurses carry and via a dashboard at the nursing station. When the patient attempts to leave the bed, an audible message coming from a control box next to the patient's bed reminds the patient not to leave and that a nurse will arrive shortly. Concurrently, nurses receive alerts at a dashboard and through their smartphones via audible, vibratory, and visual alerts prompting a rapid response. Nurses respond to the alerts by tapping a control box in the patient room or returning the patient back to bed; this turns off alerts at the dashboard and on other nurses' smartphones.

Nurses can customize each individual patient's alert settings. Nurses receive bed leaving alerts when the System detects the patient is attempting to leave the bed or is out of the bed. Nurses may also choose to receive alerts when a patient is stirring after being still for >20 minutes and/or when a patient is sitting up in bed. Both the nurse and nurse aide responsible for an enrolled patient receive alerts directly through their smartphones via a real-time push notification. The charge nurse at the nursing station also receives alerts through the SensableCare app on the dashboard.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •inpatient
  • •consents to study (family members may sign on behalf of patients unable to consent)
  • •high fall risk patient (assessed fall risk score greater than or equal to 3 points

排除标准

  • •unable to cooperate
  • •under quarantine
  • •using special mattresses (cushion pad, air mattresses)

研究组 & 干预措施

SensableCare System

Experimental

Device:The interrupted time series design will alternate between the following on a monthly basis: (1) standard medical care and (2) standard medical care and the SensableCare System.

干预措施: SensableCare System (Device)

结局指标

主要结局

Fall Rate

时间窗: 18 months

次要结局

未报告次要终点

研究者

发起方
MedicusTek, Inc
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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