CHOSEN trial results paves the way for a nationwide phase 3 trial

by | Dec 20, 2023 | News, Research | 0 comments

Professor Craig Smith, theme lead for stroke at our centre and a consultant in stroke medicine at Northern Care Alliance NHS Foundation Trust presented the findings from the CHOSEN trial at the UK Stroke Forum in Birmingham earlier this month. CHOSEN (CHlorhexidine Or toothpaSte, manual or powered brushing to prEvent pNeumonia complicating stroke; ISRCTN52421361) is a multicentre, randomised clinical trial in the North West of England ( funded by the NIHR and led by Professor Smith. CHOSEN aimed to determine the feasibility of different oral healthcare treatments, supported by staff education and training, to prevent pneumonia in UK stroke unit care.

Pneumonia affects around 1 in 12 people after a stroke and increases their chances of death and disability. Poor oral health increases the risk of pneumonia, as inflammatory material and bacteria in the mouth can enter the lungs when there are swallowing problems (dysphagia). Improved oral healthcare is therefore a plausible approach to preventing pneumonia.

The trial team developed an online training and education programme to help stroke unit staff deliver the oral healthcare treatments to people after a stroke. In the main feasibility trial, 101 people admitted to hospital within 24 h of a stroke and with dysphagia were enrolled. Participants were randomly allocated to 1 of 4 oral healthcare treatments as follows: Chlorhexidine gel (with either a powered toothbrush or a manual toothbrush) versus non-foaming toothpaste (with either a powered toothbrush or a manual toothbrush). Recruitment of participants to the feasibility trial completed in January 2023 with final follow-up in April 2023.

All of the main trial feasibility criteria were met in terms of setting up and training the participating sites, recruitment and retention of participating patients, adherence to allocated treatment and collection of the outcome measures. There were no safety concerns overall, or between the different oral healthcare treatments. In exploratory secondary analyses, there were no differences in clinical outcomes between the different allocation groups. A parallel process evaluation will provide further context and help us understand how best to implement the training and oral healthcare treatments.

Professor Smith and the team now anticipate undertaking a much larger phase 3 trial across the UK to test cost-effectiveness of the oral healthcare treatments, which would change clinical practice.