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Publications

Journal Article Ahead of print

PubMed: 42259325 DOI: 10.1016/S1473-3099(26)00235-5

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

Lancet Infect Dis

Authors: Nicole M White, Philip L Russo, Georgia Matterson, Katrina Browne, Allen C Cheng, Martin Kiernan, Peta E Tehan, Andrew J Stewardson, Nicholas Graves, Auxillia Madhuvu, Helen Rawson, Jenny Sim, Sonja Dawson, Julee McDonagh, Caroline Marshall, Elizabeth Orr, Douglas Johnson, Irani Thevarajan, Pakhi Sharma, Rhonda Wilson, Brett G Mitchell

Affiliations

  • Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.
  • Nursing and Midwifery, Monash University, Melbourne, VIC, Australia; Cabrini Health, Malvern, VIC, Australia; School of Nursing and Health, Avondale University, Cooranbong, NSW, Australia; Centre to Impact AMR, Monash University, Clayton, VIC, Australia.
  • School of Nursing and Health, Avondale University, Cooranbong, NSW, Australia.
  • School of Education and Science, Avondale University, Cooranbong, NSW, Australia.
  • Infectious Diseases, Monash Health and School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.
  • School of Nursing and Health, Avondale University, Cooranbong, NSW, Australia; Richard Wells Research Centre, University of West London, Brentford, UK.
  • Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.
  • Department of Infectious Diseases, The Alfred Hospital and Monash University School of Translational Medicine, Melbourne, VIC, Australia; Centre to Impact AMR, Monash University, Clayton, VIC, Australia.
  • Duke-NUS Medical School, Singapore.
  • Nursing and Midwifery, Monash University, Melbourne, VIC, Australia.
  • School of Nursing, Midwifery & Paramedicine, Australian Catholic University, North Sydney, NSW, Australia.
  • School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, Australia; Centre for Chronic & Complex Care Research (CCCCR), Blacktown Hospital, Western Sydney Local Health District, Blacktown, NSW, Australia.
  • Infection Prevention and Surveillance Service, The Royal Melbourne Hospital, Parkville, VIC, Australia; The Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia; Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, VIC, Australia.
  • Infection Prevention and Surveillance Service, The Royal Melbourne Hospital, Parkville, VIC, Australia.
  • Department of General Medicine and Infectious Diseases, Royal Melbourne Hospital, Parkville, VIC, Australia; Department of Medicine, Royal Melbourne Hospital, Melbourne University, Parkville, VIC, Australia; Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, VIC, Australia.
  • The Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia; Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, VIC, Australia.
  • Department of Nursing, School of Health and Biomedical Science, RMIT University, Melbourne, VIC, Australia.
  • Nursing and Midwifery, Monash University, Melbourne, VIC, Australia; School of Nursing and Health, Avondale University, Cooranbong, NSW, Australia; Central Coast Local Health District, Gosford Hospital, Gosford, NSW, Australia; Hunter Medical Research Institute, John Hunter Hospital, Newcastle, NSW, Australia.

Abstract

BACKGROUND

Non-ventilator hospital-acquired pneumonia (NV-HAP) is among the most prevalent health-care-associated infections, yet remains under-reported, understudied, and infrequently targeted by infection prevention strategies. Oral care is considered a key preventive measure; however, there are few high-quality randomised controlled trials conducted in hospital settings. The aim of this study is to evaluate whether an enhanced oral care intervention reduces the incidence of NV-HAP.

METHODS

The Hospital Acquired Pneumonia Prevention (HAPPEN) trial was an open-cohort, stepped-wedge, cluster-randomised trial conducted across three Australian hospitals. Large public or private hospitals were eligible. Simple randomisation was used to allocate nine wards (clusters) across three treatment sequences. All patients aged 18 years or older admitted to a trial cluster were eligible, with outcomes assessed for patients admitted for at least 48 h. The intervention comprised three components: enhanced delivery of oral care and provision of products, patient and staff education, and audit and feedback, delivered by dedicated research nurses. The control was usual practice-ie, oral care performed by health-care workers as per hospital policy. Primary and secondary outcomes were analysed in the intention-to-treat population. The primary outcome was NV-HAP incidence, defined according to European Centre for Disease Prevention and Control criteria. Secondary outcomes included hospital-acquired lower and upper respiratory tract infections and oral cavity infections. Outcomes were defined using established definitions and determined following a review of medical records. This study was single blinded, with data collectors masked to allocated treatment sequences. The completed trial is registered with the Australia New Zealand Clinical Trials Registry (ACTRN12624000187549).

FINDINGS

The trial was conducted from June 3, 2024, to Aug 22, 2025. A total of 12 446 admitted patients were eligible to receive the intervention, 3336 of whom were excluded because they were admitted to a trial cluster for less than 48 h. A total of 8870 patients were analysed, with 4523 exposed to the control condition and 4347 exposed to the intervention condition. NV-HAP was confirmed in 78 (0·9%) of 8870 patients: 46 (1·0%) of 4523 under the control condition and 32 (0·7%) of 4347 under the intervention condition. Intervention exposure was associated with a cumulative hazard ratio of 0·40 (95% CI 0·19-0·82), representing a decrease from 1·00 to 0·41 infections per 100 admission-days at risk. Intervention exposure resulted in a cumulative hazard ratio of 1·64 (95% CI 0·61-4·39) for lower or upper respiratory tract infection, and 1·08 (0·66-1·77) for oral cavity infection. The proportion of participants who completed the oral care protocol increased from 474 (15·9%) of 2988 to 1727 (61·9%) of 2791 following intervention exposure.

INTERPRETATION

This multicentre randomised controlled trial demonstrates that improving oral care reduces NV-HAP incidence among hospitalised patients, compared with usual care. Our findings provide novel and clinically important evidence to inform future prevention guidelines and hospital infection control policy.

FUNDING

Medical Research Future Fund.

MeSH

Incidence, Respiratory Tract Infections, Pneumonia, Therapeutics, Mouth, Communicable Diseases, Infections