CONTACT:在 COVID-19 大流行期间在英国护理院开展的一项关于蓝牙可穿戴设备用于接触追踪的非随机可行性研究。

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Carl A Thompson, Thomas Willis, Amanda Farrin, Adam Gordon, Amrit Dafu-O'Reilly, Catherine Noakes, Kishwer Khaliq, Andrew Kemp, Tom Hall, Chris Bojke, Karen Spilsbury
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引用次数: 0

摘要

背景:护理院仍然需要有效的非药物感染预防措施,如在大流行病中追踪接触者,但传统的接触者追踪方法在护理院中并不可行。接触追踪干预引入了蓝牙可穿戴设备(BLE 可穿戴设备),作为自动接触追踪的潜在解决方案。通过使用结构化报告和由护理院中 COVID-19 阳性病例触发的报告,我们将接触模式和趋势反馈给护理院,以支持更明智的感染预防决策,并减少一揽子限制性措施的应用。本文报告了在对 CONTACT BLE 可穿戴式干预措施进行明确的群组随机试验之前,对该干预措施的可行性和可接受性进行的评估:CONTACT是一项非随机的混合方法可行性研究,在英国四家护理院进行,为期两个月。在征得个人同意后,通过护理院研究网络进行招募。数据收集方法包括来自设备的常规数据、病例报告表、定性访谈(与员工和住户)、护理实地观察,以及改编版的 NoMaD 调查工具,以便利用规范化过程理论探讨实施情况。定量数据采用描述性统计方法进行分析。定性数据采用框架方法和归一化过程理论进行专题分析。根据预先确定的进展标准对干预和研究实施进行评估:在 156 名符合条件的居民中,105 人同意佩戴装置,其中 102 人(97%)开始接受干预。在 225 名符合条件的员工中,82%(n = 178)参与了干预。装置的丢失和损坏情况严重:11% 的居民装置丢失或损坏,~ 50%的居民装置被更换。员工的设备丢失率较低,仅为 6%,但更换率不到 10%。与卡片式设备相比,手环式可穿戴设备需要更换的电池更多(15% 对 0%)。各养老院对结构性和反应性反馈的理解程度不一,但不太可能采取行动。研究人员为解释报告提供的支持很有价值。当信息证实而不是质疑先入为主的联系模式时,疗养院认为信息是有用的。工作人员对隐私的担忧阻碍了信息的采用。研究程序增加了现有工作,使参与成为负担。参与研究的益处并没有超过预期的负担,而大流行病的背景又加重了这种益处。CONTACT未达到其定量或定性进展标准:CONTACT发现,在护理院进行大规模的BLE可穿戴设备用于接触追踪和反馈信息IPC的最终试验是不可行和不可接受的--至少在COVID-19大流行需求不断变化的情况下是如此。未来的研究应与护理院共同设计干预措施和研究,重点关注干预措施的成功实施以及技术效果:试验注册:ISRCTN 注册:11204126 registered 17/02/2021.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
CONTACT: a non-randomised feasibility study of bluetooth-enabled wearables for contact tracing in UK care homes during the COVID-19 pandemic.

Background: The need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth-enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes, we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention prior to a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention.

Methods: CONTACT was a non-randomised mixed-method feasibility study over 2 months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents), field observation of care, and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data were thematically analysed using a framework approach and Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria.

Results: Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82% (n = 178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~ 50% were replaced. Staff lost fewer devices, just 6%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but unlikely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and were amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria.

Conclusion: CONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable - at least in the context of shifting COVID-19 pandemic demands. Future research should co-design interventions and studies with care homes, focusing on successful intervention implementation as well as technical effectiveness.

Trial registration: ISRCTN registration: 11204126 registered 17/02/2021.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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