Antibiotic Resistant InfectionEPICIMPOCNCT04013737
Enhanced, Personalized and Integrated Care for Infection Management at the Point-Of-Care
An observational study of Antibiotic Resistant Infection and Infection, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Infection, Infection
- What is being tested?
- EPIC IMPOC
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2017to 8 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- healthcare professionals for evaluation phases: Have read the PIL and consent to participate in the study
- 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
- 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
Who cannot join
- 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
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Antibiotic Resistant Infection, Infection
- Being tested
- EPIC IMPOC
- Keywords
- Antimicrobial Resistance, Antibiotic prescribing, Clinical Decision Support Systems
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIC IMPOCDevice
Clinical Decision Support System for antibiotic prescribing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EPIC IMPOC | |
| Prescribers | Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making. Receives: Device: EPIC IMPOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Single time point before and after use of the device in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start28 Feb 2017
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Holmes, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013737
- Sponsor's protocol ID
- 16HH3526
- Acronym
- EPICIMPOC
- Status last verified
- Aug 2021
- First submitted
- 31 Jan 2019
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be considered on individual request in accordance with local information governance and research ethics approvals.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced, Personalized and Integrated Care for Infection Management at the Point-Of-Care
- ClinicalTrials.gov ID
- NCT04013737
- Acronym / sponsor ID
- EPICIMPOC / 16HH3526
- Conditions
- Antibiotic Resistant Infection, Infection
- Keywords
- Antimicrobial Resistance, Antibiotic prescribing, Clinical Decision Support Systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients and Public | – | Device: EPIC IMPOCExploration 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. |
| Prescribers | – | Device: EPIC IMPOCQuantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- healthcare professionals for evaluation phases: Have read the PIL and consent to participate in the study
- 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
- 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
Key exclusion criteria (2 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPIC IMPOCClinical Decision Support System for antibiotic prescribing. | Device | Patients and Public, Prescribers |
Primary outcome
Percentage of Appropriate Antimicrobial Prescriptions Recommended
Time frame: Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)
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.
Evaluation of Effectiveness Assessed by User Acceptance of the Device
Time frame: Single time point before and after use of the device in the study
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Data sharing will be considered on individual request in accordance with local information governance and research ethics approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Holmes principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistant Infection and Infection, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Appropriate Antimicrobial Prescriptions Recommended (time frame: Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.