Award Title: CHlorhexidine Or toothpaSte, manual or powered brushing to prEvent pNeumonia complicating stroke (CHOSEN): a 2x2 factorial randomised controlled feasibility trial
Funder: Department of Health and Social Care

Abstract: Research question: Is a phase 3, randomised controlled trial of guideline oral healthcare (OHC) to prevent stroke-associated pneumonia (SAP) in dysphagic acute stroke patients feasible?     Background: 100,000 people in the UK have a stroke each year. Pneumonia is a serious complication, affecting around 1 in 12 patients and increasing their chances of death and disability. Poor oral health increases the risk of developing pneumonia, as bacteria in the mouth can enter the lungs when there are swallowing problems (dysphagia). Poor oral health and dysphagia are common in people with stroke. Improved OHC is therefore a plausible approach to preventing SAP, but ensuring effective OHC in acute stroke patients is challenging. National stroke guidelines for OHC are not evidence-based. We do not know if powered brushes or chlorhexidine dental gel are safe, acceptable or well-tolerated by dysphagic acute stroke patients, or if they confer any benefit over and above manual brushes and toothpaste.     Aims and objectives: To determine whether a phase 3, definitive randomised controlled trial of OHC guideline interventions to prevent SAP, supported by staff education and training, is feasible in UK stroke units. To achieve this aim, we will undertake a 2x2 factorial randomised controlled feasibility trial (workstream 1), with a theoretically embedded process evaluation (workstream 2). Objectives are to determine:       Can planned recruitment of sites and patients be achieved within the required timescale?  What proportion of eligible patients will participate and complete the study?  Will participants adhere to the allocated OHC treatments?  Are the OHC treatments acceptable to patients, their carers and staff?  Are the OHC treatments well-tolerated by patients?  What are the facilitators and barriers to delivery of the OHC treatments and the staff education/ training?  How appropriate are the outcome measures and can they be collected?      Methods: 120 patients with acute stroke and dysphagia within 24 h of onset will be recruited from 4 stroke units in the North West and randomised (1:1:1:1) to one of 4 OHC treatments:       Non-foaming toothpaste and manual toothbrush  Non-foaming toothpaste and powered toothbrush  Chlorhexidine 1% gel and manual toothbrush  Chlorhexidine 1% gel and powered toothbrush      Stroke unit nursing staff will receive training to deliver the treatments. Assessment of feasibility will include recruitment and set-up of sites, recruitment and retention of participants, adherence to allocated OHC treatment, acceptability and tolerability. Feasibility outcomes will be assessed on a Stop/Review/Go basis to determine progression. We will also record incident SAP, antibiotic doses received, length of stay and independence at 3 months. In the parallel process evaluation we will focus on implementation and fidelity to the OHC, by undertaking focus groups at each site and employing behaviour change techniques to establish an implementation package.     Anticipated outcome: Establish whether feasibility progression criteria are met for a phase 3 trial, and whether further piloting is required.     Pathway to impact: If feasible, a simple, well-tolerated and effective OHC intervention could have considerable impact on service delivery, resource utilisation and patient outcomes in the NHS.

Lay Abstract: Aim: We want to find out whether cleaning the mouth after a stroke could reduce the likelihood of getting infections in the lung (pneumonia). Before we can test this in a large clinical trial, we need to conduct a smaller trial to check if our plans are achievable.     Background: 100,000 people in the UK have a stroke each year. After a stroke it can be difficult for people to swallow or to keep their teeth and mouth clean. Together, these problems can lead to harmful bacteria building up in the mouth and causing pneumonia. As many people with stroke and swallowing problems suffer from pneumonia we want to know how best to keep their mouths clean when they are in hospital. At this stage, we don t know which approach is best to prevent pneumonia, or even which approach is most suitable for people with stroke.     Design and Methods: We will undertake a trial in stroke units at four hospitals. Nurses on the stroke units will receive training in how to deliver our mouth care intervention. 120 stroke patients with swallowing problems will be consented within 24 hours of coming into hospital and divided randomly into one of 4 groups:       Toothpaste and manual toothbrush  Toothpaste and powered toothbrush  Antiseptic gel and manual toothbrush  Antiseptic gel and powered toothbrush      We will assess whether these mouth care treatments are feasible by looking at how many stroke patients agree to participate, how often they receive the treatment and how many complete the trial. We will see whether the treatments are acceptable by gathering the views of patients, their carers and the nursing staff. We will also collect information about how often pneumonia develops, how long participants stay in hospital, their quality of life and how well they recover. If this trial is positive, it will provide important information for a larger trial to see whether mouth care treatments can actually reduce the chances of pneumonia developing after stroke.     Patient and Public Involvement (PPI): Working closely with our stroke PPI group has ensured that the trial design includes the priorities and views of stroke survivors. Stroke survivors will continue to advise the research team at all stages of the trial including trial management, development of participant information documents, staff training and the content of the participant interviews.     Dissemination: The study will be publicised to stroke survivors, their carers and healthcare professionals. We will update progress on social media and relevant websites in scientific and lay formats. We will present our findings at meetings for stroke care and oral healthcare, and stroke service-user meetings in collaboration with our PPI partners. We will publish in medical and dental journals and produce a final report to the funders.

Research Activity Codes: 6.1 PHARMACEUTICALS
Health Categories: INFECTION;STROKE