An enhanced oral-care program reduced non-ventilator hospital-acquired pneumonia (NV-HAP) among adults admitted to hospital wards, according to results of the randomized HAPPEN trial published in The Lancet Infectious Diseases.
Nicole M. White, PhD, of the Australian Centre for Health Services Innovation at Queensland University of Technology in Brisbane, and colleagues conducted the Hospital Acquired Pneumonia Prevention (HAPPEN) trial at three Australian hospitals. NV-HAP is a common but underreported health care-associated infection, and oral care is considered an important preventive strategy because reducing oral bacterial burden may lower the risk of aspiration-related pneumonia. However, high-quality randomized evidence in hospital settings has been limited.
Study details
HAPPEN was an open-cohort, stepped-wedge, cluster-randomized trial involving nine wards across three hospitals in New South Wales and Victoria. Three wards at each hospital were randomly assigned to one of three treatment sequences and transitioned from usual care to the intervention at 3-month intervals. Adults aged 18 years or older admitted to participating medical or stroke wards were eligible, with outcomes assessed among patients admitted for at least 48 hours.
The intervention combined oral-care products and assistance, patient and staff education, and audit and feedback. Dedicated research nurses provided toothbrushes and toothpaste, educated patients and staff and assisted with oral care when needed. Care included cleaning the teeth or dentures and tongue and moisturizing the lips. No antiseptic mouthwash was used.
During the control period, patients performed oral care themselves or received it from health care workers according to hospital policy, without additional products, education or research-nurse support.
The primary outcome was NV-HAP based on European Centre for Disease Prevention and Control criteria. Secondary outcomes included hospital-acquired lower and upper respiratory tract infections and infections of the eye, ear, nose, throat or mouth.
Oral care reduced NV-HAP
Of 12,446 patients admitted to participating wards and eligible to receive the intervention, 8,870 met the criteria for inclusion in the final analysis: 4,523 under control conditions and 4,347 under intervention conditions. The mean age was 72.5 years, and 51.7% of participants were female.
NV-HAP was confirmed in 78 patients overall, occurring in 46 patients (1%) under control conditions and 32 (0.7%) after the oral-care intervention. In the adjusted analysis, the intervention was associated with a 60% lower hazard of NV-HAP (hazard ratio, 0.40; 95% CI, 0.19–0.82). No reduction was observed in lower or upper respiratory tract infections or infections of the eye, ear, nose, throat or mouth.
Among participants with documentation available on the last day of ward admission, 473 of 2,988 (15.8%) completed the oral-care protocol under control conditions compared with 1,727 of 2,791 (61.9%) following intervention exposure. No adverse events were reported.
“Providing oral care in hospitals is often deprioritized in busy environments,” the investigators wrote. “Our study provides evidence that improving oral care can reduce the risk of NV-HAP.” They added that providing oral-care products, educating patients and staff, and using audit and feedback helped increase oral-care frequency.
Implementation questions remain
The trial involved relatively few clusters and short intervention-exposure periods, fell short of its planned sample size and had microbiologic confirmation for only a few patients. Vaccination status and antimicrobial duration were not collected, and baseline antimicrobial use differed between the control and intervention conditions.
The intervention also relied on dedicated research nurses, who were employed for 20 hours per week per cluster to support oral-care activities. The authors acknowledged that this approach “might not represent the most feasible or scalable model for routine hospital implementation.” Further implementation-focused research is needed, and a cost-effectiveness analysis of HAPPEN is planned separately.
The investigators concluded that the findings strengthen the evidence supporting oral care as an NV-HAP prevention strategy. “In resource-constrained settings, our results show that oral care should remain a clinical priority,” they wrote.
The study was funded by the Medical Research Future Fund. Brett G. Mitchell reported institutional grants from the Medical Research Future Fund and National Health and Medical Research Council, honoraria, royalties and payments for expert testimony. Peta E. Tehan reported consulting fees and honoraria. Philip L. Russo reported consulting fees, expert-testimony payments, royalties and a former board role. All other authors declared no competing interests.
