Improving the Oral Health of Older People In Care Homes: the TOPIC randomised feasibility study

The National Institute for Health and Care Excellence guideline NG48 aims to maintain and improve the oral health of care home residents. However, evidence on oral health interventions among care home residents is weak. A co-design process with residents and care home staff refined National Institute for Health and Care Excellence guidance NG48 aspects to facilitate implementation. This study aimed to assess the feasibility of undertaking a large-scale definitive trial on this intervention. A parallel theoretically informed process evaluation explored factors affecting implementation. The feasibility of collecting data to inform a cost-consequence model was also explored.

A pragmatic cluster randomised feasibility study with 12-month follow-up was undertaken in 22 care homes across two sites (London, Northern Ireland). Care homes were randomised into an intervention arm (n = 11) that received the National Institute for Health and Care Excellence guidance NG48-based complex oral health intervention, and a control arm (n = 11) that continued with routine practice. The complex intervention included a training package for care home staff in oral health promotion knowledge and skills; using the Oral Health Assessment Tool to assess residents' oral health needs; and a 'support worker assisted' daily toothbrushing regime with 1500 ppm fluoride toothpaste. Dentate residents aged 65 years or over without severe cognitive impairment were recruited, resulting in a sample of 119 participants. Assessments were undertaken at baseline and 12 months through clinical dental examination and questionnaires. A parallel process evaluation involved semistructured interviews to explore how the intervention could be embedded in standard practice. Rates of recruitment and retention and intervention fidelity were also recorded. Economic evaluation or cost-consequence indicators were collected through interviews with stakeholders, survey and questionnaire data.

Eighty-four per cent of care homes and 88% of residents agreed to participate; 86% of care homes and 69% of residents were retained at 12-month follow-up. Researcher-collected data on clinical and subjective measures had successful completion rates, but completion rates were very low for the weekly symptoms checklist collected by care home staff. The process evaluation highlighted that most care homes were keen to participate, as accessing oral care provision was challenging. The values and beliefs of managers and staff within each care home were key to intervention adoption. Collecting outcomes relevant for cost-consequence modelling is feasible, therefore, supporting an economic evaluation alongside the definite trial. Residents' quality of life was identified as a key outcome for stakeholders, including care home managers.

As ethical approval was granted for care home residents without or with mild cognitive impairment, the inclusion criteria excluded a considerable proportion of residents that had severe cognitive impairment, meaning that the findings are less generalisable to the wider population of care home residents. Attrition rates were high, and recruitment was affected by the coronavirus disease pandemic.

The study documented the feasibility of undertaking a National Institute for Health and Care Excellence guidance NG48-based intervention in care homes. Recruitment and retention were feasible but challenging. A definitive trial should accommodate these challenges.

A definitive trial should assess the effectiveness of the co-designed intervention, with more inclusive recruitment, improving retention, minimising missing data and outcome selection being important issues to consider.

This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number 17/03/11.