Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Relevance of alerts
研究概览
简要总结
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
详细描述
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
The study will focus on adult, hospitalized patients who are monitored at the general hospital ward with continuous, real-time vital sign monitoring combined with the WARD-CSS (WARD clinical support system) that relays alerts to the clinical staff in case of significant deviations. The evaluation focus on the user perceived relevance and usefulness of the alerts generated by the system which includes a proprietary novel alerts logic. Specifically, investigators aim to assess how users evaluate the clinical relevance of triggered change-based alerts and the helpfulness of the accompanying alert descriptions.
During monitoring, the app will be used according to the intended use and additionally two questions will be prompted if alerts are sent.
Patients monitored will have an expected length of stay at the hospital, which supports at least one day of continuous monitoring. Readings from the WARD-CSS is not blinded for treating staff to get feedback on the use of the application. This study will include up to 100 patients.
An alerting feedback questionnaire will be constructed as simple feedback buttons/sliders, prompted after an alert is 'accepted' in the app. The feedback buttons will only be prompted for a representative proportion of the alerts. This will be done at random based on the alert frequencies determined in the retrospective analysis. This way, a close to equal amount of feedback responses will be prompted and obtained for different alert types with different occurrences. The feedback will be linked to the alert in the app, such that feedback can be submitted at any point in time, thus not disturbing the nurse while medical intervention is provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients can be included if they meet all the following criteria:
- •Age ≥ 18 years
- •Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration.
- •Expected admission for more than 24 hours to a general ward.
排除标准
- •Patients are excluded if they meet any of the following criteria:
- •Having implanted electronic devices (such as pacemaker or Implantable Cardioverter Defibrillator (ICD) device).
- •Known pregnancy or breastfeeding
- •Inability to give informed consent.
- •The participant expected not to cooperate with study procedures.
研究组 & 干预措施
Adult, hospitalized patients who are monitored for vital signs in the general wards
干预措施: Continuous vital sign monitoring (Device)
结局指标
主要结局
Relevance of alerts
时间窗: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
The staff evaluated relevance of alerts triggered during continuous vital signs monitoring Evaluated by 5-point Likert scale: 1\. Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant
次要结局
- Relevance of the description(Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.)
研究者
Eske Kvanner Aasvang
Professor, M.D., DMSCi
Rigshospitalet, Denmark