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

描述(由申请人提供)：这项多点、随机、对照试验的目的是确定移动受限的护理机构居民的最佳重新安置频率，这些居民有中高风险的压疮发展，他们得到高密度泡沫床垫的护理，以防止压疮。压疮主要是由骨性隆起上方的压力造成的，它阻塞了流向组织的血液。传统上，床垫上柔软的表面和每两小时重新定位以缓解压力一直是预防溃疡的黄金护理标准。最近支撑面的改进可能会减少2小时重新定位的需要。这项研究的具体目的是确定：1)压疮的发病率在以下人群中是否存在显著差异：a)中等风险(Braden量表评分，13-14)的居民被随机分配到每2-，而不是每3-4小时重新安置一次；或者b)高风险(Braden-Scale，10-12)居民每2-与每3小时-转向一次；2)活动描记测量的活动能力(自发的或辅助的)是压疮重新定位频率的显著协变量，3)居民特征和居民影响因素是重新定位计划对压疮发生率的显著协变量。我们将采用2×2或3的实验设计，将处于两个压力溃疡发展风险(中或高)的参与者随机分配到每2小时(当前护理标准)的3个重新定位计划之一(当前护理标准)，而不是每3周执行3-或4小时。周一至周五期间佩戴的活动记录器将决定机动性是否是一个重要的协变量。65岁以上、能够给予同意或有能够给予同意的代孕人并且有中度或高度压疮风险的居民(900人)将被邀请参加。选择护理机构(3)是因为它们有能力在国家合作项目期间遵循研究方案和/或成功参与试点测试。参与者将被随机分配到重新定位时间表，该时间表将由注册护士助理执行，该助理将记录每次重新定位的时间。调查人员将每天监测数据。除了重新定位干预外，参与者将得到与所有居民相同的预防护理。这项研究的主要结果是，压疮(是/否)将由护士评估员记录下来，该评估员将掩盖重新定位的时间。数据分析和管理将由ISIS执行。这项研究的目标是通过确定住院医生的风险水平、流动性和重新安置的频率如何减少压疮的发生率和改善住院医生的结果来制定护理机构的政策。较少的搬迁频率将使居民有更长的睡眠时间，减少工作人员搬迁的时间，并允许更有效地分配时间。

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.