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Clinical Trials/NCT06666738
NCT06666738
Not yet recruiting
Not Applicable

Evidence Based QUality Improvement for Prescribing Stewardship in ICU: Can a Structured Antimicrobial Review be Implemented in LMIC ICUs?

University of Oxford0 sites6,300 target enrollmentNovember 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antimicrobial Stewardship
Sponsor
University of Oxford
Enrollment
6300
Primary Endpoint
Fidelity
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
November 2024
End Date
September 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • ICU's which demonstrate adoption and reach of 80% or greater (median over 2 months) of a pre-existing structured antimicrobial review

Outcomes

Primary Outcomes

Fidelity

Time Frame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)

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.

Reach

Time Frame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)

Proportion of eligible patients who receive a review

Adoption

Time Frame: Evaluated over the calendar month period of month 7

Proportion of prescriptions reviewed as intended once implementation support has been withdrawn

Secondary Outcomes

  • Antimicrobial Density (AD)(Evaluated over calendar month periods during months 1-7 of the study.)
  • Duration of Therapy(Evaluated over calendar month periods during months 1-7 of the study)
  • Antimicrobial Redundancy Rate(Evaluated over calendar month periods during months 1-7 of the study)
  • Antimicrobial resistance rate(Evaluated over calendar month periods during months 1-7 of the study)
  • Antimicrobial prescribing rate(Evaluated over calendar month periods during months 1-7 of the study)

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