Evidence Based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU)
ConditionAntimicrobial Stewardship
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
The goal of this observational study is to learn about the implementation of a process to review antimicrobial prescriptions for adult patients in Intensive Care Unit (ICU).
The main question it aims to answer is: can a structured antimicrobial review can be implemented in ICUs?
Implementation will be supported by the use of local protocols, audit and feedback, and education. It will be evaluated by daily data collection of clinical processes and interviews with local champions.
Resources to conduct the study are provided by the Wellcome Flagship Innovations award. ("Collaboration for Research, Implementation and Training in Critical Care in Asia and Africa", reference 224048/Z/21/Z).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All adult ICUs within CCAA-affiliated Care Quality Registries
ICUs must appoint a named Champion to facilitate implementation
All antimicrobial prescriptions for adult patients within the ICUs described above
Disqualifiers
None
Trial population
All adult ICUs within CCAA-affiliated CQRs, where surveillance of antimicrobial utilisation has already been established will be considered for participation. ICUs must appoint a named Champion in order to participate. A survey will be conducted to determine pre-existing prescribing practice and the presence, characteristics and current adoption of structured review activities. Pre-existing antimicrobial review processes are neither a requirement for an ICU to participate nor an exclusion criterion. Instead, parallel to the survey, pre-implementation patient-level data pertaining to current antimicrobial prescribing review practices will be measured during months 1-2. ICU's which are found to already have a structured antimicrobial review in place, and which demonstrate adoption and reach of 80% or greater (median over the 2 months) will not be eligible to participate in the implementation to reduce confounding of the selected measures for implementation success.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Structured antimicrobial review
BehavioralThe appropriateness of the documented indication, route of administration, expected duration and stop date of all antimicrobials will be reviewed within 48 hours of their prescription.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Fidelity
The proportion of prescriptions reviewed as intended (reviewed within 48hours with documentation of all 4 review components: indication, route, duration, stop date). Reported as a proportion of the number of possible reviews.
Time frame
Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)2
Reach
Proportion of eligible patients who receive a review
Time frame
Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)3
Adoption
Proportion of prescriptions reviewed as intended once implementation support has been withdrawn
Time frame
Evaluated over the calendar month period of month 7Secondary outcomes
1
Antimicrobial Density (AD)
Defined Daily Dose / 1000 patient-days. This measure of antimicrobial consumption will compare prescribed daily doses of antimicrobials to those specified by the World Health Organization (WHO) (Anatomical Therapeutic Classification (ATC) J01 Defined Daily Doses). To correct for ICU unit size the investigators will standardise by number of admitted patient-days during that month in that ICU.
Time frame
Evaluated over calendar month periods during months 1-7 of the study.2
Duration of Therapy
Number of Days of antimicrobial Therapy / 1000 patient-days Analysed at the ICU level
Time frame
Evaluated over calendar month periods during months 1-7 of the study3
Antimicrobial Redundancy Rate
Days of Therapy of prespecified redundant combinations of antimicrobials. Analysed at the ICU level.
Time frame
Evaluated over calendar month periods during months 1-7 of the study4
Antimicrobial resistance rate
Number of multidrug-resistant pathogens (as specified by WHO priority list) / number of patients
Time frame
Evaluated over calendar month periods during months 1-7 of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
Nat Intensive Care Surveillence-MORU
Collaborator
Source ClinicalTrials.gov