Investigating the effect of enhanced cleaning and disinfection of shared medical equipment on health-care-associated infections in Australia (CLEEN): a stepped-wedge, cluster randomised, controlled trial

Background: There is a paucity of high-quality evidence based on clinical endpoints for routine cleaning of shared medical equipment. We assessed the effect of enhanced cleaning and disinfection of shared medical equipment on health-care-associated infections (HAIs) in hospitalised patients. Methods: We conducted a stepped-wedge, cluster randomised, controlled trial in ten wards of a single hospital located on the central coast of New South Wales, Australia. Hospitals were eligible for inclusion if they were classified as public acute group A according to the Australian Institute of Health and Welfare, were located in New South Wales, had an intensive care unit, had a minimum of ten wards, and provided care for patients aged 18 years or older. Each cluster consisted of two randomly allocated wards (by use of simple randomisation), with a new cluster beginning the intervention every 6 weeks. Wards were informed of their allocation 2 weeks before commencement of intervention exposure, and the researcher collecting primary outcome data and audit data was masked to treatment sequence allocation. In the control phase, there was no change to environmental cleaning practices. In the intervention phase, a multimodal cleaning bundle included an additional 3 h per weekday for the dedicated cleaning and disinfection of shared medical equipment by 21 dedicated cleaning staff, with ongoing education, audit, and feedback. The primary outcome was the number of confirmed cases of HAI, as assessed by a fortnightly point prevalence survey and measured in all patients admitted to the wards during the study period. The completed trial is registered with Australia New Zealand Clinical Trials Registry (ACTRN12622001143718). Findings: The hospital was recruited on July 31, 2022, and the study was conducted between March 20 and Nov 24, 2023. We assessed 220 hospitals for eligibility, of which five were invited to participate, and the first hospital to formally respond was enrolled. 5002 patients were included in the study (2524 [50·5%] women and 2478 [49·5%] men). In unadjusted results, 433 confirmed HAI cases occurred in 2497 patients (17·3%, 95% CI 15·9 to 18·8) in the control phase and 301 confirmed HAI cases occurred in 2508 patients (12·0%, 10·7 to 13·3) in the intervention phase. In adjusted results, there was a relative reduction of –34·5% (–50·3 to –17·5) in HAIs following the intervention (odds ratio 0·62, 95% CI 0·45 to 0·80; p=0·0006), corresponding to an absolute reduction equal to –5·2% (–8·2 to –2·3). No adverse effects were reported. Interpretation: Improving the cleaning and disinfection of shared medical equipment significantly reduced HAIs, underscoring the crucial role of cleaning in improving patient outcomes. Findings emphasise the need for dedicated approaches for cleaning shared equipment. Funding: National Health and Medical Research Council.