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安全与健康检查在减少老年人跌倒及改善生活质量方面的有效性:萤火虫随机对照试验

Effectiveness of Safe and Well Visits in reducing falls and improving quality of life among older people: The FIREFLI RCT.

作者信息

Cockayne Sarah, Fairhurst Caroline, Cunningham-Burley Rachel, Mann Jo, Stanford-Beale Richard, Hampton Sarah, Wilkinson Sarah, Adamson Joy, Crossland Shelley, Drummond Avril, Hewitt Catherine E, Pighills Alison, Roberts Gareth, Ronaldson Sarah, Scantlebury Arabella, Torgerson David J

机构信息

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Humberside Fire and Rescue Service, Hull, UK.

出版信息

Public Health Res (Southampt). 2025 Sep;13(7):1-62. doi: 10.3310/DJHF6633.

Abstract

BACKGROUND

Fire and rescue services in England routinely carry out Home Fire Safety Visits which aim to reduce risk of fire, support independent living and improve quality of life. The visits include a person-centred assessment and providing general advice on health-related topics such as preventing falls.

PLANNED OBJECTIVE

To assess the effectiveness and cost-effectiveness of Home Fire Safety Visits (also known as Safe and Well Visits) to reduce falls and improve quality of life in older adults living in the community.

DESIGN, SETTING AND PARTICIPANTS: We designed a multicentre, randomised controlled trial with economic and qualitative evaluations, involving two fire and rescue services in England, to recruit 1156 community-dwelling adults aged 65 years and over.

INTERVENTIONS

All participants could continue to access routine care from healthcare professionals and were provided with a falls prevention leaflet as part of the trial. The intervention group were additionally offered a Home Fire Safety Visit. The usual care group were offered a visit after they had completed the trial. Blinding was not possible. Participants were randomised 1 : 1 using a secure web-based system.

MAIN OUTCOMES MEASURES

The primary outcomes were (1) the number of falls per participant and (2) health-related quality of life (EuroQol-5 Dimensions, five-level version) over 12 months from randomisation. Secondary outcomes included fire risk-taking behaviours, loneliness, fear of falling and time to first fall. The planned economic evaluation comprised cost-utility and cost-effectiveness analyses. The qualitative study was designed to examine intervention fidelity and acceptability.

RESULTS

It proved impossible to conduct the trial as planned in the current research landscape. We faced significant delays in setting up and starting recruitment, in large part due to this coinciding with the start of the COVID-19 pandemic. Obtaining regulatory approval took longer than anticipated. Additionally, we were unable to access general practitioner registration data to identify participants as planned and so we had to use Consumer Classification Platform data to identify potential households to send study invitations to. This resulted in a less targeted and non-personalised mail-out as this is not patient-level data so the householder names were unavailable. Ultimately, recruitment was much lower than expected. In total, 237 participants were assessed for eligibility and 63 randomised (intervention,  = 32; usual care,  = 31). The Home Fire Safety Visits were delivered as planned to both groups; however, the planned statistical and health economic analyses could not be conducted due to the limited data. Data from the qualitative evaluation indicated the intervention was largely acceptable to staff and service users.

CONCLUSIONS

Conducting trials in this setting is currently extremely challenging. To facilitate future research, we recommend an urgent review of research governance issues related to the types of personal data that can be accessed and used for research. This review should aim to provide support and avoid creating additional obstacles to research in this area.

FUTURE WORK

The evidence for the effectiveness and cost-effectiveness of Home Fire Safety Visits remains inconclusive. Research governance in local authorities needs urgent review.

TRIAL REGISTRATION

This trial is registered as Current Controlled Trials NCT04717258.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: NIHR128341) and is published in full in Public Health Research; Vol. 13, No. 7. See the NIHR Funding and Awards website for further award information.

摘要

背景

英国的消防和救援服务机构定期开展家庭消防安全访问,旨在降低火灾风险、支持独立生活并改善生活质量。这些访问包括以个人为中心的评估,并就预防跌倒等与健康相关的主题提供一般性建议。

计划目标

评估家庭消防安全访问(也称为安全与健康访问)在减少社区老年人跌倒及改善其生活质量方面的有效性和成本效益。

设计、地点和参与者:我们设计了一项多中心随机对照试验,并进行经济和定性评估,涉及英国的两个消防和救援服务机构,以招募1156名65岁及以上的社区居住成年人。

干预措施

所有参与者都可以继续接受医疗保健专业人员的常规护理,并在试验中获得一份预防跌倒的宣传册。干预组还额外接受一次家庭消防安全访问。常规护理组在完成试验后接受一次访问。无法实施盲法。参与者通过一个安全的基于网络的系统以1∶1的比例随机分组。

主要结局指标

主要结局为:(1)每位参与者的跌倒次数;(2)随机分组后12个月内与健康相关的生活质量(欧洲五维健康量表,五等级版本)。次要结局包括火灾冒险行为、孤独感、跌倒恐惧以及首次跌倒时间。计划中的经济评估包括成本效用分析和成本效益分析。定性研究旨在考察干预的保真度和可接受性。

结果

事实证明,在当前的研究环境下,按计划开展该试验是不可能的。我们在设立和开始招募方面面临重大延误,很大程度上是因为这与新冠疫情的开始恰逢其时。获得监管批准的时间比预期更长。此外,我们无法按计划获取全科医生注册数据来识别参与者,因此不得不使用消费者分类平台数据来识别潜在家庭并发送研究邀请。这导致邮件发送的针对性降低且缺乏个性化,因为这不是患者层面的数据,所以无法获取户主姓名。最终,招募人数远低于预期。总共对237名参与者进行了资格评估,63人被随机分组(干预组=32人;常规护理组=31人)。家庭消防安全访问按计划对两组进行;然而,由于数据有限,无法进行计划中的统计和健康经济分析。定性评估的数据表明,该干预在很大程度上为工作人员和服务使用者所接受。

结论

在这种情况下开展试验目前极具挑战性。为便于未来的研究,我们建议紧急审查与可获取并用于研究的个人数据类型相关的研究治理问题。此次审查应旨在提供支持,并避免给该领域的研究造成额外障碍。

未来工作

家庭消防安全访问的有效性和成本效益的证据仍然不确凿。地方当局的研究治理需要紧急审查。

试验注册

该试验在“当前对照试验”注册,注册号为NCT04717258。

资金来源

本研究由英国国家卫生与保健研究所(NIHR)公共卫生研究项目资助(NIHR资助编号:NIHR128341),并全文发表于《公共卫生研究》;第13卷,第7期。有关进一步的资助信息,请访问NIHR资助与奖项网站。

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