Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection

Sepsis Clinical Trial

— CSM-BSI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271031
• Other study ID #: LHS0211
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: October 2023
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• Age < 18 years at the time of the study

• Blood culture requested but patient not managed on an acute hospital site.

Related Conditions & MeSH terms

• Bacteraemia
• Bacteremia
• Bloodstream Infection
• Communicable Diseases
• Infections
• Sepsis
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of a software simulation model that is fine tuned to the observed data.	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.	2 years
Secondary	Exploration of the performance of the model in different hypothesised scenarios.	Secondary outcomes of this study are the exploration of the performance of the model in different hypothesised scenarios. The scenarios and outcome metrics are dependant on the final model delivered, but as an example may include the following: Time from presentation to hospital to time to administration of antibiotics active against the infecting pathogen in a simulated model which includes a novel diagnostic test for antimicrobial resistance, vs a model that does not include one.	6 months