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

NCT ID: NCT06271031

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis Bloodstream Infection Bacteraemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro D Gerada

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

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Liverpool University Hospitals Foundation Trust

Liverpool, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Esha D Sheth

Role: CONTACT

07864026738

Facility Contacts

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Heather Rogers

Role: primary

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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LHS0211

Identifier Type: -

Identifier Source: org_study_id

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