Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities

描述（由申请人提供）：这项多地点、随机、对照试验的目的是确定在高密度泡沫床垫上护理的具有活动能力限制、具有中高压疮发展风险的护理机构居民重新安置的最佳频率，以防止压疮的发生。压疮主要是由于骨突出处的压力阻塞了组织的血液流动。传统上，床垫上柔软的表面和每2小时重新定位以减轻压力是预防溃疡的黄金标准。最近对支撑表面的改进可以减少2小时重新定位的需要。本研究的具体目的是确定：1)压疮发生率在以下人群中是否存在显著差异：a)中等风险（布雷登量表评分，13-14）随机分配每2小时重新定位一次的居民与每3或4小时重新定位一次的居民相比；或b)高风险（布雷登量表评分，10-12）居民，每2小时转一次，而每3小时转一次；2)活动测量（自发或辅助）是重新定位频率对压疮发生率的重要协变量，3)住院特征和住院影响因素是重新定位时间对压疮发生率的重要协变量。我们将采用2 × 2或3的实验设计，其中处于压疮发展两种风险水平（中度或高度）的参与者将被随机分配到三种重新定位中的一种每2小时的时间表（目前的护理标准），对比3或4小时进行3周。佩戴一个周一至周五期间的活动记录仪将确定是否流动性是显著的协变量。将邀请年龄在65岁以上、能够给予同意或有一个能够给予同意的代理人、有中等或高度压力性溃疡风险的居民（900人）参加。选择护理机构(3)是因为它们有能力在国家合作项目中遵循研究方案和/或成功地参与了试点测试。参与者将被随机分配到一个重新定位时间表，该时间表将由一名注册护理助理执行，他将记录每次重新定位的时间。数据将由调查人员每天监测。除了重新定位干预外，参与者将接受与所有住院医师相同的预防性护理。本研究的主要结果，压疮（是/否）将由一名护士评估员记录，该评估员将被告知重新定位的时间。数据分析和管理将由ISIS执行。本研究的目的是通过定义风险水平、流动性和居民重新定位的频率如何减少压疮的发生率并改善居民的预后，从而制定护理机构政策。减少换位的频率可以让住院医生有更长的睡眠时间，减少工作人员换位的时间，并能更有效地分配时间。

DESCRIPTION (provided by applicant): The purpose of this multi-site, randomized, controlled trial is to determine the optimal frequency of repositioning nursing facility residents with mobility limitations who are at moderate and high risk for pressure ulcer development who are cared for on high density foam mattresses for the purpose of preventing pressure ulcers. Pressure ulcers result primarily from pressure over a bony prominence that occludes blood flow to tissues. Traditionally, soft surfaces over mattress and repositioning individuals every 2 hours to relieve pressure have been the gold standard of care to prevent ulcers. Recent improvements in support surfaces may reduce the need for 2-hour repositioning. The specific aims of this study are to determine if: 1) there is a significant difference in the incidence of pressure ulcers among: a) moderate risk (Braden Scale Score, 13-14) residents randomly assigned to be repositioned every 2-, compared with every 3- or 4- hours; or b) high risk (Braden Scale Score, 10-12) residents who are turned every 2- compared with every 3-hours; 2) mobility (spontaneous or assisted) measured by actigraphy is a significant covariate with repositioning frequency in the incidence of pressure ulcers and 3) resident characteristics and resident influencing factors are significant covariates of repositioning schedules on pressure ulcer incidence We will use a 2 X 2 or 3 experimental design in which participants who are at two levels of risk (moderate or high) for pressure ulcer development will be randomly assigned to one of 3 repositioning schedules every 2-hours (the current standard of care), contrasted with 3- or 4- hours carried out for 3 weeks. Actigraphs worn for one Monday - Friday period will determine if mobility is a significant covariate. Residents (900) who are over 65 years, able to give consent or have a surrogate who can give consent and are at moderate or high risk for pressure ulcers will be invited to participate. Nursing facilities (3) were selected because of their ability to follow a research protocol during a national collaborative project and/or participated successfully in pilot testing. Participants will be randomly assigned to a repositioning schedule that will be carried out by a Certified Nursing Assistant who will document time of each repositioning. Data will be monitored by the investigators daily. With the exception of the repositioning intervention, participants will receive the same preventive care as all residents. The primary outcome of this study, pressure ulcers (yes/no) will be documented by a nurse assessor who will be masked to the repositioning timing. Data analysis and management will be performed by ISIS. The goal of this study is to shape Nursing Facility policy by defining how level of risk, mobility, and frequency of repositioning of residents can reduce the incidence of pressure ulcers and improve resident outcomes. Less frequent repositioning would allow residents longer periods of sleep, would reduce staff time for repositioning, and allow more efficient allocation of time.