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

描述（由申请人提供）：本多中心、随机、对照试验的目的是确定对活动受限的护理机构住院患者进行重新定位的最佳频率，这些患者有中度和高度压疮发展风险，在高密度泡沫床垫上接受护理，以预防压疮。压迫性溃疡主要是由于压迫骨突起阻塞了流向组织的血液。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）压疮的发生率是否存在显著差异：a）中度风险（Braden量表评分，13 - 14）居民随机分配到每2小时重新定位，与每3或4小时相比;或B）高风险（Braden量表评分，10 - 12）每2小时转一次的居民与每3小时转一次的居民相比; 2）流动性在压疮的发生率中，通过体动记录仪测量的（自发或辅助）是与复位频率相关的显著协变量，3）居民特征和居民影响因素是压疮发生率的复位时间表的重要协变量。我们将使用2 × 2或3的实验设计，其中参与者处于两个风险水平（中度或高度）将被随机分配至3个复位方案之一，每2小时一次（目前的护理标准），与3或4小时进行3周相比。在周一至周五期间佩戴活动记录仪将确定活动性是否是显著协变量。将邀请年龄超过65岁、能够提供知情同意书或有代理人提供知情同意书且有中度或高度压疮风险的居民（900人）参加研究。护理设施（3）之所以被选中，是因为它们有能力在国家合作项目期间遵循研究协议和/或成功参与试点测试。受试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士助理执行，该护士助理将记录每次重新定位的时间。研究者将每日监测数据。除了重新定位干预外，参与者将获得与所有居民相同的预防护理。本研究的主要结局，压疮（是/否）将由护士评估员记录，护士评估员将对重新定位时间设盲。将由ISIS进行数据分析和管理。本研究的目的是通过定义住院医师的风险水平、流动性和重新定位频率如何降低压疮的发生率并改善住院医师的预后来制定护理设施政策。较不频繁的重新定位将允许居民更长的睡眠时间，将减少工作人员重新定位的时间，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.