METHODS: We propose a type III hybrid implementation/effectiveness interventional cohort trial in 35 ICUs in up to 11 low- and middle- income countries. The study intervention is a structured review of antimicrobial prescriptions as recommended by the World Health Organisation. Strategies to support stakeholder-led implementation include development of local protocols, registry-enabled audit and feedback, and education. Evaluation of implementation, and the determinants of its success, is informed by the RE-AIM framework and the Consolidated Framework for Implementation Research respectively. The primary outcome is a composite measure of fidelity, reach and adoption. Secondary outcomes describe the effectiveness of the intervention on improving antimicrobial prescribing. Qualitative interviews will assess relevant implementation acceptability, adaptations and maintenance. A baseline survey will investigate ICU-level antimicrobial stewardship structures and processes.

DISCUSSION: This study addresses global policy priorities by supporting implementation research of antimicrobial stewardship, and strengthening associated healthcare professional competencies. It does this in a setting where improvement is sorely needed: low- and middle- income country ICUs. The study will also describe the influence of pre-existing antimicrobial stewardship structures and processes on implementation and improve understanding about the efficacy of strategies to overcome barriers to implementation in these settings.

METHODS: Using rapid evaluation methods, we will use four data collection methods: 1) registry embedded indicators to assess quality of care processes and their associated outcomes; 2) process mapping to provide a preliminary framework to understand gaps between current and desired care practices; 3) structured observations of processes of interest identified from the process mapping and; 4) focus group discussions with stakeholders to identify barriers and enablers influencing the gap between current and desired care practices. We will also collect self-assessments of readiness for quality improvement. Data collection and analysis will be led by local stakeholders, performed in parallel and through an iterative process across eight countries: Kenya, India, Malaysia, Nepal, Pakistan, South Africa, Uganda and Vietnam.