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Effectiveness of oral care for the prevention of non-ventilator hospital-acquired pneumonia (HAPPEN): a multicentre, stepped-wedge, cluster-randomised trial in Australia

The Lancet Infectious Diseases·June 8Open Access
Infectious DiseasesPractice changingHospital-Acquired InfectionNon-Ventilator Hospital-Acquired PneumoniaStepped-Wedge Cluster-Randomised TrialOral Hygiene InterventionAdult

Summary

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What was studied

This stepped-wedge cluster-RCT across 3 Australian hospitals tested whether an enhanced oral care intervention (structured oral care delivery, patient/staff education, audit and feedback) reduced NV-HAP incidence vs. usual care in 8,870 hospitalised adults admitted ≥48 h (June 2024–Aug 2025).

Key findings

NV-HAP occurred in 32/4347 (0·7%) intervention patients vs. 46/4523 (1·0%) control patients — a cumulative hazard ratio of 0·40 (95% CI 0·19–0·82), with infections dropping from 1·00 to 0·41 per 100 admission-days at risk. Oral care protocol completion jumped from 15·9% to 61·9% with the intervention.

Study limitations

- Open-label design; only data collectors were masked, raising risk of ascertainment bias. - Single-country, mostly large public/private hospitals, limiting generalisability to smaller or resource-limited settings. - No significant effect seen on secondary respiratory or oral cavity infection outcomes (HR 1·64 and 1·08 respectively), suggesting possible outcome misclassification or underpowering for these endpoints.

Clinical implications

A structured oral care programme — including dedicated nursing delivery, patient/staff education, and regular audit — can cut NV-HAP rates by roughly 60% in hospitalised adults. Hospitals should consider formalising enhanced oral care protocols as a core infection prevention strategy, not an optional add-on.

Related Questions

Explore related topics

What oral care protocols are most effective at preventing hospital-acquired pneumonia in non-ventilated patients?How does NV-HAP incidence compare to ventilator-associated pneumonia and what are the best prevention strategies?What is the evidence for nursing-led infection prevention bundles in reducing hospital-acquired respiratory infections?

Publication Details

Year
2026
Journal
The Lancet Infectious Diseases
Sample Size
n=8,870
Source
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