Evaluation of the Feasibility of an Expert Decision Support System for Patients Regarding the Optimization of the Management of Drugs With Conditional Administration in the Surgical Department: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- To evaluate the feasibility of the INSAMED computer tool
研究概览
简要总结
The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems.
The study hypothesis is that the clinical use of the experimental device is feasible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Male or Female 18 years or older (no upper age limit)
- •Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg
- •Patient understanding and reading French
- •Subject neurosensorially able of interacting with a tactile electronical interface
- •Subject able to understand research objectives, risks and provide dated and signed informed consent
- •Subject covered by a health insurance scheme
排除标准
- •Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface
- •Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.)
- •Pregnant or lactating woman (on declaration)
- •Patient under safeguard of justice, under guardianship, under curatorship
研究组 & 干预措施
prototype software
干预措施: software (Device)
结局指标
主要结局
To evaluate the feasibility of the INSAMED computer tool
时间窗: Day 2 post operative
agreement between INSAMED computer tool and the recommendations established by caregivers. The data from INSAMED computer tool will be collected by extracting the history of the digital interface (commercial smartphone) hosting the expert system.
Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm.
时间窗: Day 2 post operative
Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional, The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system. The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).
次要结局
- assess the security of the device(Day 2 post operative)
- Assess patient satisfaction with usual care(60 minutes after software activation.)
- Assess patient satisfaction with the ease of use of the experimental device(60 minutes after software activation.)
- Evaluate the time delay, in usual care setting, of rescue drug administrations after surgery, to confirm the interest of developing expert systems to improve the existing one.(60 minutes after software activation)