Enhanced, Personalized and Integrated Care for Infection Management at the Point-Of-Care (EPICIMPOC)

Antimicrobials (drugs that kill or stop the growth of microorganisms including bacteria, thereby treating infections) commonly used to treat patients with infections are becoming less effective over time as bacteria develop resistance to them. Antimicrobial usage itself can lead to development and spread of antimicrobial resistance. Antimicrobial resistance is now a major threat to patient safety. To conserve the effectiveness of antimicrobials the investigator need to develop ways to use them more sensibly healthcare professionals who diagnose and treat infections must be able to access antimicrobial guidelines and test results at the patient bedside. This needs to be provided rapidly and with support to make sure that the decisions on prescribing antimicrobials are the best that can be made.

Study Overview

• Status: Completed
• Conditions: Infection; Antibiotic Resistant Infection
• Intervention / Treatment: Device: EPIC IMPOC

Detailed Description

Prototype software to achieve this has been developed through collaboration between healthcare professionals and biomedical engineers. This prototype software (run on a mobile device) retrieves patient results from various laboratory and clinical databases (securely within the Trust firewall) and displays this to the clinician making the prescribing decision. Furthermore a machine learning algorithm is applied to the data, and similar anonymised historical cases (and the antimicrobials prescribed and the clinical outcomes) are also displayed to the clinician to further inform their decision making. The prototype has been designed for use in intensive care, where the risk of infection is high, but through the research project detailed here, the software will be developed and validated across other areas of hospital patient care. Furthermore there is a key need to engage patients with how decisions are made around antimicrobial prescribing. The investigator propose to adapt the prototype to meet these needs. This system should improve patient safety and help preserve the effectiveness of existing antimicrobials

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0NN
    • Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients may be asked to participate in the evaluation of the the patient module.

For prescriber recruitment to use the application the following methods of identifying participants will be undertaken:

Phase 1: Participants will be identified based on their roles within the infectious disease team (level and areas of the hospital covered) and will be directly approached by the study PI / clinical infection lead to request their support with this phase of the project.

Phase 2: Participants (physicians) will be identified based on the wards that they work in.

Description

Inclusion Criteria:

(i) healthcare professionals for evaluation phases: Have read the PIL and consent to participate in the study

(ii) patients for whom the clinician chooses to use the POC DSS as a resource when prescribing antimicrobials: Adult patients > 18 years old Being managed for infection outside of the critical care setting in Imperial College Healthcare NHS Trust Deemed appropriate for management with POC DSS by attending physician Prescribed antimicrobial agents outside of the critical care setting in last 5 days

(iii) Prescriber / healthcare professional for using POC DSS: Trained Healthcare Professional Working within wards under assessment Deemed suitable for recruitment by senior member of their team

Exclusion Criteria:

(i) healthcare professionals: Do not wish to participate in the study Working across wards which is acting as a control ward Deemed no suitable for recruitment by a senior member of their team Non-permanent member of the Trust Information governance training not up-to-date

(ii) patients recruits Critical care patients Paediatric patients < 18 years old Deemed not suitable for management using POC DSS by attending physician On palliative care, end of life pathway Prisoners / young offenders in custody of HM Prison Service Involved in current research or have recently been involved in any research prior to recruitment (last 3 months)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients and Public; Exploration of patient and public engagement with antibiotic decision making in secondary care. Prospective evaluation of a co-designed intervention to support enhanced knowledge and understanding of infections and their management.	Device: EPIC IMPOC; Clinical Decision Support System for antibiotic prescribing.
Prescribers; Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making.	Device: EPIC IMPOC; Clinical Decision Support System for antibiotic prescribing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Appropriate Antimicrobial Prescriptions Recommended	This will be measured by assessing the appropriateness of prescriptions recommended by the system compared to current clinical practice. Appropriateness is determined by evaluating prescribing against current clinical guidelines or infection expert opinion on best practice and is expressed as a proportion of the total number of antibiotic prescriptions made. Each individual patient has a single antibiotic prescription evaluated.	Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)
Evaluation of Effectiveness Assessed by User Acceptance of the Device	This was assessment was a single time point at baseline (Pre-intervention) and single time point after use of the device in the study. Scores were pre-determined based on anticipated answers provided by participants pre- and post- intervention using a bespoke mark scheme (https://aricjournal.biomedcentral.com/articles/10.1186/s13756-018-0333-1). Participants could score between 0 (lowest) and 13 (highest) marks based on their responses to questions assessing knowledge and understanding.	Single time point before and after use of the device in the study

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Alison Holmes, Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Clinical Decision Support Systems; Antibiotic prescribing; Antimicrobial Resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 16HH3526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing will be considered on individual request in accordance with local information governance and research ethics approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No