Hospital Acquired Pneumonia Prevention (HAPPEN) Study: Statistical Analysis Plan

The Hospital-acquired Pneumonia Prevention (HAPPEN) study is a multi-site trial evaluating the clinical effectiveness of improving oral care among adult patients to reduce the incidence of non-ventilator, hospital-acquired pneumonia (HAP). The HAPPEN study design is a stepped-wedge cluster randomised trial across three public hospitals in Australia. This document is the Statistical Analysis Plan for evaluating primary and secondary effectiveness outcomes. The trial was preregistered on the Australian and New Zealand Clinical Trials registry (ACTRN12624000187549) and is funded by the Medical Research Future Fund (MRF2022645). A copy of the study protocol and a signed version of the Statistical Analysis Plan are available on request from the corresponding author (BM).