Clinical trial NCT06666738: Evidence Based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU)
Official title: Evidence Based QUality Improvement for Prescribing Stewardship in ICU: Can a Structured Antimicrobial Review be Implemented in LMIC ICUs?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antimicrobial Stewardship
Keywords: Critical care
Antimicrobial Stewardship
Implementation
Quality improvement
Low or Middle Income Country (LMIC)
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Nat Intensive Care Surveillence-MORU
First posted: 2024-10-31
Enrollment: 6300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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).


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

Primary outcomes:
measure: Fidelity
timeFrame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)
measure: Reach
timeFrame: Evaluated over calendar month periods during months 4-6 (i.e. the three months immediately following implementation)
measure: Adoption
timeFrame: Evaluated over the calendar month period of month 7
Secondary outcomes:
measure: Antimicrobial Density (AD)
timeFrame: Evaluated over calendar month periods during months 1-7 of the study.
measure: Duration of Therapy
timeFrame: Evaluated over calendar month periods during months 1-7 of the study
measure: Antimicrobial Redundancy Rate
timeFrame: Evaluated over calendar month periods during months 1-7 of the study
measure: Antimicrobial resistance rate
timeFrame: Evaluated over calendar month periods during months 1-7 of the study
measure: Antimicrobial prescribing rate
timeFrame: Evaluated over calendar month periods during months 1-7 of the study
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Abi Beane, Dr.
role: PRINCIPAL_INVESTIGATOR
References: