Georgios Tsakos1, Paul R Brocklehurst2, Sinead Watson3, Anna Verey1, Nia Goulden2, Alison Jenkins2, Zoe Hoare2, Kirstie Pye2, Rebecca R Wassall4, Andrea Sherriff5, Anja Heilmann1, Ciaran O'Neill6, Craig J Smith7,8, Joe Langley9, Renato Venturelli1, Peter Cairns6,10, Nat Lievesley6,11, Richard G Watt1, Frank Kee6, Gerald McKenna6. 1. Department of Epidemiology and Public Health, University College London, London, UK. 2. NWORTH Clinical Trials Unit, Bangor University, Bangor, UK. 3. Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK. s.watson@qub.ac.uk. 4. School of Dental Sciences, Newcastle University, Newcastle, UK. 5. Dental School, University of Glasgow, Glasgow, UK. 6. Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK. 7. Division of Cardiovascular Sciences, Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK. 8. Manchester Centre for Clinical Neurosciences, Manchester Academic Health Science Centre, Salford Royal Foundation NHS Trust, Salford, UK. 9. Art and Design Research Centre, Sheffield Hallam University, Sheffield, UK. 10. BELONG PPI Group, Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, UK. 11. Centre for Policy on Ageing, London, UK.
Abstract
BACKGROUND: Evidence 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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613 .
RCT Entities:
BACKGROUND: Evidence 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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613 .
Entities:
Keywords:
Care homes; Cluster randomised controlled trial; Complex intervention; Feasibility study; Older adults; Oral health
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