Tsakos Georgios, Brocklehurst Paul R, Watson Sinead, Verey Anna, Goulden Nia, Jenkins Alison, Hoare Zoe, Pye Kirstie, Wassall Rebecca R, Sherriff Andrea, Heilmann Anja, O'Neill Ciaran, Smith Craig J, Langley Joe, Venturelli Renato, Cairns Peter, Lievesley Nat, Watt Richard G, Kee Frank, McKenna Gerald
Department of Epidemiology and Public Health, University College London, London, UK.
NWORTH Clinical Trials Unit, Bangor University, Bangor, UK.
Pilot Feasibility Stud. 2021 Jul 2;7(1):138. doi: 10.1186/s40814-021-00872-6.
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.
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.
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.
ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613 .
关于促进养老院居民口腔健康干预措施的证据不足。英国国家卫生与临床优化研究所（NICE）的指南NG48旨在维持和改善养老院居民的口腔健康。已开展了一个与居民和养老院工作人员合作的协同设计过程，以了解如何在实践中最佳实施NG48指南，从而完善一项复杂干预措施。本研究的目的是评估该干预措施的可行性，为未来更大规模的确证性试验提供依据。
这是一项实用的整群随机对照试验方案，为期12个月的随访将在两个地点的12家养老院进行（伦敦6家，北爱尔兰6家）。随机分配到干预组（n = 6）的养老院将接受基于NG48指南的复杂干预措施，而随机分配到对照组（n = 6）的养老院将继续常规做法。干预措施将包括为养老院工作人员提供一个培训包，以提高其在口腔健康促进方面的知识和技能，由经过培训的养老院工作人员对居民使用口腔健康评估工具，以及一个“支持人员协助”的每日刷牙方案，使用含1500 ppm氟化物的牙膏。每家养老院将平均招募10名65岁及以上且至少有一颗天然牙的居民，从而获得120名参与者的招募样本。将在基线、6个月和12个月时进行评估，评估将包括由一名研究助理进行的牙科检查以及关于一般健康和口腔健康的问卷调查。将开展一个涉及半结构化访谈的平行过程评估，以探讨如何将干预措施融入标准实践中。还将记录招募和留存率以及干预保真度。一个成本后果模型将确定不同结局指标在决策背景下的相关性。
该研究将为试验者、政策制定者、临床医生和养老院工作人员提供关于英国养老院口腔健康促进的可行性及相关成本的宝贵信息。
ISRCTN10276613。于2020年4月17日注册。http://www.isrctn.com/ISRCTN10276613 。
