Abstract
BackgroundEvidence for interventions promoting oral health amongst care home residents is weak. The National Institute for Health and Care Excellence (NICE) guideline NG48 aims to maintain and improve the oral health of care home residents. A co-design process that worked with residents and care home staff to understand how the NG48 guideline could be best implemented in practice has been undertaken to refine a complex intervention. The aim of this study is to assess the feasibility of the intervention to inform a future larger scale definitive trial.MethodsThis is a protocol for a pragmatic cluster randomised controlled trial with a 12-month follow-up that will be undertaken in 12 care homes across two sites (six in London, six in Northern Ireland). Care homes randomised to the intervention arm (n = 6) will receive the complex intervention based on the NG48 guideline, whilst care homes randomised to the control arm (n = 6) will continue with routine practice. The intervention will include a training package for care home staff to promote knowledge and skills in oral health promotion, the use of the Oral Health Assessment Tool on residents by trained care home staff, and a ‘support worker assisted’ daily tooth-brushing regime with toothpaste containing 1500 ppm fluoride. An average of ten residents, aged 65 years or over who have at least one natural tooth, will be recruited in each care home resulting in a recruited sample of 120 participants. Assessments will be undertaken at baseline, 6 months and 12 months, and will include a dental examination and questionnaires on general health and oral health administered by a research assistant. A parallel process evaluation involving semi-structured interviews will be undertaken to explore how the intervention could be embedded in standard practice. Rates of recruitment and retention, and intervention fidelity will also be recorded. A cost-consequence model will determine the relevance of different outcome measures in the decision-making context.DiscussionThe study will provide valuable information for trialists, policymakers, clinicians and care home staff on the feasibility and associated costs of oral health promotion in UK care homes.Trial registrationISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613.
Highlights
Poor oral health is an increasingly common problem for older adults
To determine the following: a) Proportion of care homes that agree to participate; b) Number of residents that are eligible and able to consent; c) Proportion of eligible residents that agree to participate; d) Proportion of participating residents that receive the intervention per the protocol; e) Proportion of care homes and residents that remain in the study; f) Proportion of completed measures used in the study: (i) oral health assessments, (ii) quality of life questionnaires, (iii) clinical measurement records, (iv) oral symptoms checklist diaries; and g) Impact on recruitment of varying the 6Cognitive Impairment Tool (6-CIT) [20] screening tool threshold
Instructions as to how to implement the NG48 guideline in care homes are provided by National Institute for Health and Care Excellence (NICE), the suggestions do not contain specific, tangible actions required by care home staff to effectively implement the guideline
Summary
Background and rationale Poor oral health is an increasingly common problem for older adults (defined as those over 65 years of age). Good daily oral hygiene is essential for oral health and the maintenance of complex dental restorations that are common amongst older adults. Diets can become rich in sugars [13]; especially in those who have a diminished appetite and rely on sugar to improve taste as well as provide additional calories to manage or prevent malnutrition and frailty. All these factors increase the risk of oral disease and directly impact on comorbidities, which in turn can worsen oral health. The aim of this study is to assess the feasibility of the intervention to inform a future larger scale definitive trial
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