University of Exeter Medical School, University of Exeter, Exeter, UK.
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Health Technol Assess. 2019 Oct;23(59):1-208. doi: 10.3310/hta23590.
BACKGROUND: Fall-related injuries are a significant cause of morbidity and mortality in people with dementia. There is presently little evidence to guide the management of such injuries, and yet there are potentially substantial benefits to be gained if the outcomes of these injuries could be improved. This study aimed to design an appropriate new health-care intervention for people with dementia following a fall and to assess the feasibility of its delivery in the UK NHS. OBJECTIVES: To determine whether or not it is possible to design an intervention to improve outcomes of falls in dementia, to investigate the feasibility and acceptability of the DIFRID (Developing an Intervention for Fall related Injuries in Dementia) intervention and to investigate the feasibility of a future randomised controlled trial and the data collection tools needed to evaluate both the effectiveness and the cost-effectiveness of the DIFRID intervention. DESIGN: This was a mixed-methods feasibility study. A systematic review (using Cochrane methodology) and realist review [using Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) methodology] explored the existing evidence base and developed programme theories. Searches were carried out in November 2015 (updated in January 2018) for effectiveness studies and in August 2016 for economic studies. A prospective observational study identified service use via participant diary completion. Qualitative methods (semistructured interviews, focus groups and observation) were used to explore current practice, stakeholder perspectives of the health and social care needs of people with dementia following a fall, ideas for intervention and barriers to and facilitators of change. Each of the resulting data sets informed intervention development via Delphi consensus methods. Finally, a single-arm feasibility study with embedded process evaluation was conducted. SETTING: This study was set in the community. PARTICIPANTS: The participants were (1) people with dementia presenting with falls necessitating health-care attention in each setting (primary care, the community and secondary care) at three sites and their carers, (2) professionals delivering the intervention, who were responsible for training and supervision and who were members of the intervention team, (3) professionals responsible for approaching and recruiting participants and (4) carers of participants with dementia. INTERVENTIONS: This was a complex multidisciplinary therapy intervention. Physiotherapists, occupational therapists and support workers delivered up to 22 sessions of tailored activities in the home or local area of the person with dementia over a period of 12 weeks. MAIN OUTCOME MEASURES: (1) Assessment of feasibility of study procedures; (2) assessment of the acceptability, feasibility and fidelity of intervention components; and (3) assessment of the suitability and acceptability of outcome measures for people with dementia and their carers (number of falls, quality of life, fear of falling, activities of daily living, goal-setting, health-care utilisation and carer burden). RESULTS: A multidisciplinary intervention delivered in the homes of people with dementia was designed based on qualitative work, realist review and recommendations of the consensus panel. The intervention was delivered to 11 people with dementia. The study suggested that the intervention is both feasible and acceptable to stakeholders. A number of modifications were recommended to address some of the issues arising during feasibility testing. The measurement of outcome measures was successful. CONCLUSIONS: The study has highlighted the feasibility of delivering a creative, tailored, individual approach to intervention for people with dementia following a fall. Although the intervention required greater investment of time than usual practice, many staff valued the opportunity to work more closely with people with dementia and their carers. We conclude that further research is now needed to refine this intervention in the context of a pilot randomised controlled trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41760734 and PROSPERO CRD42016029565. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 59. See the NIHR Journals Library website for further project information.
背景：与跌倒相关的伤害是痴呆患者发病和死亡的一个重要原因。目前，几乎没有证据可以指导此类伤害的管理，但如果能够改善这些伤害的结果，就有可能获得实质性的好处。本研究旨在为跌倒后的痴呆患者设计一种新的适当的医疗干预措施，并评估其在英国国民保健制度（NHS）中实施的可行性。
目的：确定是否有可能设计一种干预措施来改善痴呆患者跌倒的结果，研究 DIFRID（预防痴呆相关跌倒损伤）干预措施的可行性和可接受性，并研究未来随机对照试验的可行性以及评估 DIFRID 干预措施的有效性和成本效益所需的数据收集工具。
设计：这是一项混合方法可行性研究。系统评价（使用 Cochrane 方法）和真实主义评价[使用真实主义和元叙事证据综合：不断发展的标准（RAMESES）方法]探讨了现有的证据基础，并制定了方案理论。2015 年 11 月（2018 年 1 月更新）进行了有效性研究搜索，2016 年 8 月进行了经济性研究搜索。前瞻性观察性研究通过参与者日记完成来确定服务使用情况。定性方法（半结构式访谈、焦点小组和观察）用于探索当前的实践、痴呆患者跌倒后健康和社会护理需求的利益相关者观点、干预想法以及变革的障碍和促进因素。每个由此产生的数据集都通过 Delphi 共识方法为干预措施的开发提供了信息。最后，进行了一项具有嵌入式过程评估的单臂可行性研究。
地点：本研究在社区进行。
参与者：参与者包括（1）在三个地点的初级保健、社区和二级保健环境中，因跌倒需要医疗关注的痴呆患者及其照顾者，（2）负责培训和监督的干预措施实施者，他们是干预团队的成员，（3）负责接近和招募参与者的专业人员，以及（4）痴呆患者的照顾者。
干预措施：这是一种复杂的多学科治疗干预措施。物理治疗师、职业治疗师和支持工作人员在 12 周内为痴呆患者在家中或当地提供最多 22 次量身定制的活动。
主要观察结果：（1）评估研究程序的可行性；（2）评估干预措施组成部分的可接受性、可行性和保真度；以及（3）评估适用于痴呆患者及其照顾者的结果测量工具的适宜性和可接受性（跌倒次数、生活质量、跌倒恐惧、日常生活活动、目标设定、卫生保健利用和照顾者负担）。
结果：基于定性工作、真实主义评价和共识小组的建议，设计了一种在痴呆患者家中提供的多学科干预措施。对 11 名痴呆患者进行了干预。研究表明，该干预措施对利益相关者来说是可行且可接受的。提出了一些修改建议，以解决可行性测试中出现的一些问题。结果测量得到了成功。
结论：该研究强调了为跌倒后的痴呆患者提供创造性、量身定制、个体化干预措施的可行性。尽管该干预措施比常规实践需要更多的时间投入，但许多工作人员非常重视有机会更密切地与痴呆患者及其照顾者合作。我们得出结论，现在需要进一步研究在试点随机对照试验的背景下对这种干预措施进行改进。
试验注册：当前对照试验 ISRCTN41760734 和 PROSPERO CRD42016029565。
资金：该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将在 ; Vol. 23, No. 59 中全文发表。请访问 NIHR 期刊库网站以获取更多项目信息。
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