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

这项多中心、随机、对照试验的目的是确定 重新安置有中度和高度压力风险的行动不便的护理机构居民 溃疡的发展谁是照顾高密度泡沫床垫的目的，防止压力 溃疡压迫性溃疡主要是由于压迫突出的骨质阻塞血流， 组织中传统上，床垫上的柔软表面和每2小时重新定位个人，以缓解 压力一直是预防溃疡护理的黄金标准。支撑表面的最新改进 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）有 a）中度风险（Braden量表评分， 13-14）与每3或4小时一次相比，随机分配的居民每2小时重新定位一次;或B） 高风险（Braden量表评分，10-12）居民每2小时翻身一次，而不是每3小时翻身一次; 2） 活动记录仪测量的活动度（自发或辅助）是重新定位的重要协变量 压疮的发生率和3）居民特征和居民影响因素 是重要的协变量的重新定位时间表上的压疮发生率，我们将使用2 × 2或3 实验设计，其中参与者处于两个压力溃疡风险水平（中度或高度） 开发将被随机分配到3个重新定位时间表之一，每2小时（当前 护理标准），与3或4小时进行3周相比。一个星期一戴的活动记录仪- 周五时段将确定流动性是否为显著协变量。65岁以上的居民（900人）， 给予同意或有一个代理人谁可以给予同意，并在中度或高度风险的压力 溃疡将被邀请参加。选择护理设施（3）是因为它们能够遵循 在国家合作项目期间制定了一项研究协议，并/或成功地参加了试点测试。 参与者将被随机分配到重新定位时间表，该时间表将由认证的 记录每次复位时间的护理助理。研究者将监测数据 日报除重新定位干预外，参与者将获得相同的预防护理 和所有居民一样。本研究的主要结局，压疮（是/否）将由护士记录 将对重新定位时间设盲的评估者。将进行数据分析和管理 ISIS。本研究的目的是通过定义风险水平， 流动性和居民的频繁重新定位可以减少压疮的发生率 改善居民的生活质量。减少频繁的重新定位将使居民有更长的时间 睡眠，将减少工作人员重新定位的时间，并可以更有效地分配时间。

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.