JRO study summary
Simple summary as per UCLH JRO interventional studies protocol
IRAS Number
REC Reference No.
Sponsor Reference No.
Other research reference number(s) (if applicable)
(e.g. UCL Data Protection number)
Full (Scientific) title
INGLES-Resistance In‑situ Nudges for Guidelines, Local resistance, Estimated Susceptibility
Health condition(s) or problem(s) studied
Bug-drug mismatch via electronic point-of-care alerts about historical resistance
Study Type i.e. Cohort etc
Randomised controlled trial
Aim(s):
Reduce bug-drug mismatch when prescribing antibiotics through targeted notifications about historical resistance at the point of care
Objectives:
Primary To reduce the proportion of new antibiotic prescriptions that have a recent documented risk of antibiotic resistance on laboratory testing
Secondary - balancing measures
To reduce or preserve rates of of 'watch' or 'reserve' antibiotic prescriptions
Secondary - patient centred
To reduce the rate of antibiotic treatment failure (e.g. subsequent switch to broader spectrum)
To reduce complications associated with antibiotic prescribing (resistance, diarrhoea etc.)
Type of trial:
Single centre, parallel assignment, randomised controlled trial without masking
Trial design and methods:
PICO
Trial duration per participant:
7 days
Key Study milestones
Approved peer review of protocol
JRO submission and sponsorship
HRA and NHS REC approval
1st patient recruited
Estimated total trial duration:
Planned trial sites:
University College Hospital London
Total number of participants planned:
Main inclusion/exclusion criteria:
Patients presenting to UCLH with a new community acquired urinary tract infection
Statistical methodology and analysis:
Briefly describe the statistical methodology to be used in the trial.
FUNDING & OTHER
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Funding
UCLH Biomedical Research Centre
Other support
Insert details of the non-financial support given, and the names & contact details of all organisation providing the non-financial support.
STORAGE of SAMPLES / DATA (if applicable)
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Human tissue samples
Insert name and contact details for where samples will be transferred and/or analysed if external to the organisation.
Data collected / Storage
Insert name and contact details were the data will be transferred to for storage and analysis if external to the research group and institution.
KEY STUDY CONTACTS
Full contact details including phone, email and fax numbers
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Committees
Name(s) of committees, full contact details including, phone and email. E.g. study steering groups. For each committee/group, the protocol should state their roles and responsibilities and degree of independence from the Sponsor and Investigators.
Sub-contractors
Other relevant study personnel
(E.g. Data Custodian and Data Processors)
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