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

NCT04013737 | Completed Results

• 1 other identifier: 16HH3526
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antibiotic Resistant Infection; Infection

Keywords

Antimicrobial Resistance; Antibiotic prescribing; Clinical Decision Support Systems

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Prescribers

Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making.

Device: EPIC IMPOC

Interventions

EPIC IMPOC DEVICE

Clinical Decision Support System for antibiotic prescribing.

Patients and Public; Prescribers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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

You may not qualify if:

• (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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Head of Operations
• Organization: Health Protection Research Unit in HCAI and AMR, Imperial College London

head.ops@imperial.ac.uk

020 3313 2732

Study Officials

• Alison Holmes

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: July 10, 2019
• Study Start: February 28, 2017
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: August 31, 2021
• Results First Posted: August 31, 2021

Record last verified: 2021-08

Locations

GB (1)