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试点群组随机对照试验研究地板材料对减少老年护理单元跌倒伤害的作用:研究方案。

Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol.

机构信息

School of Health Sciences & Social Work, University of Portsmouth, Portsmouth, Hampshire, UK.

出版信息

Inj Prev. 2011 Dec;17(6):e7. doi: 10.1136/injuryprev-2011-040154. Epub 2011 Sep 2.

Abstract

UNLABELLED

Falls are an issue disproportionately affecting older people who are at increased risk of falls and injury. This protocol describes a pilot study investigating shock-absorbing flooring for fall-related injuries in wards for older people.

OBJECTIVES

To inform future research by evaluating fall-related injuries on the intervention and existing flooring, assessing the sustainability of the flooring in ward environments, estimating the cost-effectiveness of the floor and assessing how the floor affects patients and other users.

DESIGN

This study uses mixed methods a pilot cluster randomised controlled trial, observation via mechanical testing and interviews. Eight participating wards (clusters) are randomised using a computer-generated list. No blinding is incorporated into the study. Each site has a baseline period of approximately 6 months. Then, four sites receive the intervention floor, while four continue using standard floors. Sites are then followed up for approximately 1 year.

PARTICIPANTS

Any person admitted to a bed in the 'study area' of a participating ward can be entered into the trial. Orientated patients, visitors and any hospital staff who use the floor in a study area are eligible for inclusion in an interview.

INTERVENTION

An 8.3 mm thick vinyl floor covering with polyvinyl chloride foam backing (Tarkett Omnisports EXCEL).

OUTCOMES

The primary outcome is fall-related injuries. Severity of injuries, falls, cost-effectiveness, user views and mechanical performance (shock absorbency and slip resistance) are also being assessed.

摘要

目的:通过评估干预和现有地板上的与跌倒相关的伤害,评估地板在病房环境中的可持续性,估算地板的成本效益,并评估地板如何影响患者和其他使用者,为未来的研究提供信息。

设计:本研究采用混合方法,即试点集群随机对照试验、通过机械测试和访谈进行观察。使用计算机生成的列表对 8 个参与病房(集群)进行随机分组。研究中未采用盲法。每个地点都有大约 6 个月的基线期。然后,四个地点铺设干预地板,而四个地点继续使用标准地板。随后对这些地点进行大约 1 年的随访。

参与者:任何入住参与病房“研究区域”病床的人都可以参加试验。定向患者、访客和任何在研究区域使用地板的医院工作人员都有资格接受访谈。

干预措施:一种 8.3 毫米厚的聚氯乙烯泡沫背衬乙烯基地板覆盖物(Tarkett Omnisports EXCEL)。

结果:主要结果是与跌倒相关的伤害。伤害的严重程度、跌倒、成本效益、用户意见和机械性能(减震和防滑)也在评估中。

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