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

NCT06666738 | Not Yet Recruiting

• 1 other identifier: HCR24005 (559-24)
• Study Type: observational
• Target: 6,300
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Antimicrobial Stewardship

Keywords

Critical care; Antimicrobial Stewardship; Implementation; Quality improvement; Low or Middle Income Country (LMIC)

Outcome Measures

Primary Outcomes (3)

• 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.

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

• Reach

  Proportion of eligible patients who receive a review

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

• Adoption

  Proportion of prescriptions reviewed as intended once implementation support has been withdrawn

  Evaluated over the calendar month period of month 7

Secondary Outcomes (5)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• Nat Intensive Care Surveillence-MORU: collaborator

Related Publications (1)

• Wagstaff D, Amuasi J, Arfin S, Aryal D, Nor MBM, Bonney J, Dondorp A, Dongelmans D, Dullawe L, Fazla F, Ghose A, Hanciles E, Haniffa R, Hashmi M, Smith AH, Kumar B, Minh YL, Moonesinghe R, Pisani L, Sendagire C, Hasan MS, Ghalib MS, Frimpong MS, Ranzani O, Sultan M, Thomson D, Tripathy S, Thwaites L, Uddin RAME, Mazlan MZ, Waweru-Siika W, Beane A. Evidence based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU): protocol for type III hybrid implementation-effectiveness study. Implement Sci. 2025 Feb 25;20(1):12. doi: 10.1186/s13012-024-01413-4.

  PMID: 40001051 DERIVED

Study Officials

• Abi Beane, Dr.

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duncan Wagstaff, PhD

CONTACT

0044(0)2076799060; d.wagstaff@ucl.ac.uk

Arjen Dondorp, Prof

CONTACT

arjen@tropmedres.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study
• Access Criteria: Mahidol Oxford Tropical Medicine Research Unit (MORU) Data Sharing Policy