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临床试验/NCT04577079
NCT04577079已完成不适用

Validation of Intelligent Patient Flow Management System in Kuopio University Hospital Emergency Department

Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
273
试验地点
1
主要终点
Specificity (%) of intelligent patient flow management (IPFM) correlated with the evaluation of trained emergency (triage) nurse.

研究概览

简要总结

Digital health technologies (DHT) are increasingly developed to support healthcare systems around the world. However, they are frequently lacking evidence-based medicine and medical validation. There is considerable need in the western countries to allocate healthcare resources accurately and give the population detailed and reliable health information enabling to take greater responsibility for their health. Intelligent patient flow management system (IPFM, product name Klinik Frontline) is developed to meet these needs. In practice, IPFM is used for decision support in the triaging and diagnostic processes as well as automatizing the management of inflow of the patients. The core of the IPFM is a clinical artificial intelligence (AI), which utilizes a comprehensive medical database of clinical correlations generated by medical doctors.

The study population of this research consists of patients from the Emergency Department of Kuopio University Hospital (KUH). Data will be gathered during 2 weeks of piloting, after which the results will be analysed. Anticipated number of patients to the study is minimum of 246 patients, with objective to be several hundreds. When attending to the hospital, patients will report their demographics, background information and symptoms using structured IPFM online form. Patients entering the unit in an ambulance or with need of immediate care of healthcare professionals due to severe and acute conditions are referred similar to normal process to ensure the patient safety. Results obtained from IPFM are blinded from the healthcare professional and IPFM does not affect professional's clinical decision making in any way. The data obtained from IPFM online form and clinical data from the emergency department and KUH will be analysed after the data collection.

The main aim of the research is to validate the use of IPFM by evaluating the association of IPFM output with 1) urgency and severity of the conditions (using Emergency Severity Index [ESI], an international triaging protocol for emergency units, and an assessment by triage nurse); and 2) actual diagnoses diagnosed by medical doctors. The main hypotheses of the research are that 1) IPFM is safe and sensitive in evaluating the urgency of the conditions of arriving patients at the emergency department and that 2) IPFM has sufficient correlation of differential diagnosis with actual diagnosis made by medical doctor.

详细描述

  1. Background

Continuous development of digital technology provides new opportunities also in healthcare area. As healthcare costs are constantly growing both worldwide and in Finland (1), innovations are needed to enhance allocation of limited healthcare resources and to reduce economic burden. Digital health technologies (DHT) have the potential to reduce these costs. They are increasingly developed to support healthcare systems around the world. DHT are, however, often lacking evidence-based medicine (2) and both the importance and the lack of their validation has been acknowledged widely (3, 4).

Work in triage and urgent care centers is highly demanding, with considerable time pressure. When operating with high patient volumes, acute conditions and severe stress, human errors are likely to result at least at some extent. Physicians have been found to have a ~5 % diagnostic error rate (5) with half of these potentially harmful (6). DHT have been suggested to have a significant role helping both patient management and triage (7), and thus, reducing also potential human errors. For instance, crude online clinical decision support tool has been found to reliably demonstrate emergency triage severity in experimental setting (7).

The validation of DHT and decision support tools is highly crucial. Tools with false negative rates could have serious consequences when ignoring severe conditions such as cardiac ischaemia (4). DHT should be thorough and optimal in the medical field and their internal and external validity should have been evaluated. Recently, guidelines for evaluating DHT have been published (4). According to guidelines, the first step in the assessment is to show the results in an early observational study in clinical setting. In addition to safety, also efficacy and effectiveness of DHT should be evaluated.

To meet these needs, Intelligent Patient Flow Management system (IPFM) has been developed to help the user (i.e. patient) and the healthcare professionals to evaluate user's condition and its severity. IPFM enables semi-automated triaging of patients and enhances the management of patient inflow and demand. In addition, IPFM provides written and precise information for the healthcare professionals communicated by the patients themselves of their conditions and symptoms. The core of IPFM is a broad medical database generated by medical doctors, combined with artificial intelligence (AI) and feedback loops for accuracy improvement. In other words, IPFM is an AI-induced triage and decision support tool developed and monitored by medical doctors to help healthcare professionals to evaluate the urgency of the patients. It evaluates user's condition and infers the urgency using user demographics, background information and symptoms.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult (>18 years of age) patients independently (walking) entering emergency care ward with written consent.

排除标准

  • Patients arriving with ambulance
  • Patients needing immediate care
  • Patients under 18 years of age
  • Patients with restricted capabilities or developmental disorders.

结局指标

主要结局

Specificity (%) of intelligent patient flow management (IPFM) correlated with the evaluation of trained emergency (triage) nurse.

时间窗: Through study completion, estimated until the end of 2020.

The number of missed emergency cases evaluated by IPFM.

Sensitivity (%) of intelligent patient flow management (IPFM) correlated with the evaluation of trained emergency (triage) nurse.

时间窗: Through study completion, estimated until the end of 2020.

The number of correct emergency severity index (ESI) class

次要结局

  • Correlation (%) of differential diagnosis(Through study completion, estimated until the end of 2020.)

研究者

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tero Martikainen

Head physician of Emergency Care Department

Kuopio University Hospital

研究点 (1)

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