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NCT Number: NCT06666738

Evidence Based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU)

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).

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Key information

Conditions

Antimicrobial Stewardship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured antimicrobial review

Behavioral

The 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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Antimicrobial Density (AD)

    Time frame: Evaluated over calendar month periods during months 1-7 of the study.

    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.

  2. Duration of Therapy

    Time frame: Evaluated over calendar month periods during months 1-7 of the study

    Number of Days of antimicrobial Therapy / 1000 patient-days Analysed at the ICU level

  3. Antimicrobial Redundancy Rate

    Time frame: Evaluated over calendar month periods during months 1-7 of the study

    Days of Therapy of prespecified redundant combinations of antimicrobials. Analysed at the ICU level.

  4. Antimicrobial resistance rate

    Time frame: Evaluated over calendar month periods during months 1-7 of the study

    Number of multidrug-resistant pathogens (as specified by WHO priority list) / number of patients

  5. Antimicrobial prescribing rate

    Time frame: Evaluated over calendar month periods during months 1-7 of the study

    Number of patients receiving at least 1 antimicrobial / number of patients admitted to ICU in the same period

Study contacts

Contact information is provided by the study sponsor or research team.

Arjen Dondorp, Prof

CONTACT

[email protected]

Duncan Wagstaff, PhD

CONTACT

[email protected]

0044(0)2076799060

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Nat Intensive Care Surveillence-MORU

Registry information

Official study title

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

Acronym: EQUIPS-ICU

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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