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临床试验/NCT06271031
NCT06271031尚未招募不适用

Computer Simulation Model of Patients With Bloodstream Infection, Sepsis and Systemic Infection (CSM-BSI)

Liverpool University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Generation of a software simulation model that is fine tuned to the observed data.

研究概览

简要总结

The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:

  • Interviews with healthcare staff to understand patient care pathways.
  • Analysis of historical data on bacteria causing infections and antibiotic treatments.
  • A 30-day observational study to observe patient treatment for bloodstream infections.

详细描述

The main aim of this research is to create a computer simulation of patients with bloodstream infection. Bloodstream infection is often a severe infection (blood poisoning) that can lead to sepsis, which is a significant global health concern, causing around 66,096 deaths each year in the United Kingdom alone. Doctors and healthcare decision-makers have to make difficult decisions that balance the effective treatment of patients with sepsis and avoid the overuse of broad-spectrum antibiotics, which can lead to antibiotic resistance. By generating a virtual environment to test out different scenarios, this computer simulation model will provide insight into the projected effects of changes to hospital policy, changes in hospital resources (such as staff) and the impact of laboratory diagnostic tests. Proposed changes can be simulated in this virtual environment prior to implementation in the real healthcare system.

This study will be carried out in three parts. First, there will be interviews with healthcare staff over six months to comprehensively describe the patient pathways involved in management of bloodstream infection. Next, the project will analyse historical pseudonymised data from Liverpool University Hospitals NHS Foundation and Liverpool Clinical Laboratories to inform the characteristics of the model (in particular on the bacteria causing infections, the antibiotic treatments used, and the time it takes for patients to be treated). Finally, there will be a 30-day observational study where researchers observe the treatment of patients with bloodstream infection (without intervening or recording identifying details) to ensure that the computer model captures all the important steps involved in patient management.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Sub-study 2 (retrospective data collection)
  • Patients who were managed within a LUFT acute hospital site (Aintree or Royal) and had a concurrent blood culture investigation requested
  • Age ≥ 18 years at the time of the study. Sub-study 3 (observational study)
  • Patients with blood culture investigation requested during the observation period, and staff caring for the patients.

排除标准

  • Age < 18 years at the time of the study
  • Blood culture requested but patient not managed on an acute hospital site.

结局指标

主要结局

Generation of a software simulation model that is fine tuned to the observed data.

时间窗: 2 years

The main outcome is the generation of a software simulation model that is calibrated to the observed data. The study team consists of individuals with experience in model construction and calibration.

次要结局

  • Exploration of the performance of the model in different hypothesised scenarios.(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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