Title: Mouth cAre to Prevent Pneumonia in older people Study (MAPPS): a feasibility study
Funder: Department of Health and Social Care

Abstract: Background Hospital acquired pneumonia (HAP) is the commonest healthcare associated infection in Europe, with a mortality of up to 30%. HAP occurs in approximately 1.5% of hospitalised patients, and develops due to microaspiration of pathogenic oral bacteria, which in turn appear during periods of illness. Patients with HAP stay on average an extra 12 days in hospital, with attendant increase in hospital costs and personal costs for patients. Low quality evidence suggests that increased frequency of mouth care with antiseptic mouthwash may reduce the risk of HAP. An RCT is needed to provide definitive evidence to allow policy and practice change. However initial implementation work is required in an NHS setting in order to efficiently assess a trial of the efficacy of mouth care in prevention of HAP. We have designed a feasibility study to provide key information to allow us to conduct a robust RCT of mouth care to prevent HAP. Aims/objectives In this study, we aim to: better understand how to implement a mouth care intervention so that we can be confident that it can be delivered consistently to most patients. investigate how best to collect information about the diagnosis of HAP and cost-effectiveness of the intervention, which will be primary and secondary outcomes for the larger future trial Methods This is a feasibility study to inform a later stepped-wedge cluster randomised trial. Four wards which admit patients with hip fracture and mean length of stay >7 days will be recruited. We will develop a training video and conduct face to face interviews with clinical teams to understand usual mouth care practice and to learn how best to integrate the intervention into routine practice. Following randomisation, each site will begin the intervention in turn every three months. Three times a day tooth/tongue/denture brushing with an antiseptic mouthwash will be delivered and recorded by trained healthcare assistants. Interviews will be held with staff and patients to hear their experiences of delivering and receiving mouth care. We will also assess our ability to collect data on antibiotic prescriptions for hospital-acquired pneumonia and the potential costs of the intervention. Primary outcome: average number of mouth care episodes per day Secondary outcomes: number of days to achieve twice daily mouth care in 80% of patients recruitment rate per unit per month acceptability to patients/carers/staff assessed by themes from interviews and observations of mouth care completeness of data for cost effectiveness analysis completeness of data on episodes of antibiotic data for HAP Timelines for delivery The study will be conducted over 18 months, with an initial 3 month period for development of documentation and training videos. Each site will be added in turn every three months. Anticipated impact This trial will prepare the groundwork that would allow us to conduct an effective, robust and well-informed, cluster RCT to investigate whether mouth care reduces the risk of HAP. This intervention has the potential to make a significant improvement to the clinical outcomes of older patients in hospital.

Lay abstract: Rationale Pneumonia acquired in hospital (Hospital acquired pneumonia, or HAP) is the commonest healthcare associated infection in Europe. Up to 30% of patients with HAP die during their hospital stay. HAP is common and occurs because certain bacteria start to live in the mouth when patients become unwell. These bacteria can travel from the mouth to the lungs via a process called aspiration. Patients with HAP stay on average an extra 12 days in hospital and this is unpleasant for patients and costly for the NHS. Research suggests that frequent mouth care might prevent pneumonia whilst in hospital. However the evidence for this is not strong enough to make changes to clinical care. A large trial is therefore needed, but some initial work is required to guide its successful design and delivery. Objectives In this study, we aim to: better understand how to implement a mouth care intervention so that we can be confident that it can be delivered consistently to most patients. investigate how best to collect the primary outcome (diagnosis of HAP) and secondary outcome (cost-effectiveness of the intervention) for the larger study Patient and public involvement A patient advisory group was convened at the outset, and this group, along with our PPI co-applicant will be involved in every step of the set up, delivery and analysis of the study. Methods/Design This is a feasibility study to inform a later trial. Four wards which admit patients with hip fracture and have length of stay >7 days will be recruited (James Cook University Hospital and three other sites). We will develop a training video and spend time with clinical teams to understand usual mouth care and to learn how best to integrate the intervention into routine practice. The sites will be randomised and each site will begin the intervention in turn every three months. Three times a day tooth/tongue/denture brushing with an antiseptic mouthwash will be delivered and recorded by trained healthcare assistants. Interviews will be held with staff and patients to hear their experiences of delivering and receiving mouthcare. We will also assess our ability to collect data on antibiotic prescriptions for hospital-acquired pneumonia and the potential costs of the intervention. Outcomes Primary outcome: average number of mouth care episodes per day Secondary outcomes: recruitment rate per unit number of days to achieve twice daily mouth care in 80% of patients Acceptability to patients/carers/staff assessed by themes from interviews and observations of mouth care completeness of data for cost effectiveness analysis completeness of data on episodes of HAP Progression to a larger trial will be dependent on achieving specific targets for recruitment, data collection and being able to complete the mouth care intervention.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: INFECTION