The Flooring for Injury Prevention (FLIP) Study of compliant flooring for the prevention of fall-related injuries in long-term care: A randomized trial
The Flooring for Injury Prevention (FLIP) Study of compliant flooring for the prevention of fall-related injuries in long-term care: A randomized trial
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DOI：
10.1371/journal.pmed.1002843
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发表时间：
2019-06-01
期刊：
影响因子：
15.8
通讯作者：
Robinovitch, Stephen N.
中科院分区：
文献类型：
--
作者：
Mackey, Dawn C.;Lachance, Chantelle C.;Robinovitch, Stephen N.
背景：跌倒相关损伤给长期护理的老年人带来了巨大的健康负担。较软的着陆表面，例如由低刚度“顺从”地板提供的着陆表面，可以通过减少在坠落冲击时施加在身体上的力来防止与坠落有关的伤害。我们的主要目的是评估柔性地板在预防LTC居民严重跌倒相关伤害方面的临床有效性。方法和发现地板预防伤害（FLIP）研究是一项为期4年的随机优势试验，在加拿大一个LTC站点的150个单人居住房间中进行。2013年4月，居民房间被随机划分（1:1），安装干预地板（2.54厘米的SmartCells）或刚性控制地板（2.54厘米的胶合板），覆盖着相同的医院级乙烯基。主要结局是4年以上的严重跌倒相关损伤，需要急诊科访问或住院，并在医院进行治疗程序或诊断评估。次要结局包括轻微跌倒相关损伤、任何跌倒相关损伤、跌倒和骨折。2013年9月1日至2017年8月31日期间，通过盲法评估确定结果，并根据治疗意向进行分析。未评估不良结果。随访期间，184名居民占用74间干预室，173名居民占用76间控制室。居民中女性占64.3%，平均（SD）基线年龄81.7（9.5）岁（51.1 - 104.6岁），体重指数25.9 (7.7)kg/m(2)，随访1.64（1.39）年。据报道有1907人跌倒；23名干预居民有38次严重受伤（来自22个房间的29次跌倒），而23名对照居民有47次严重受伤（来自23个房间的34次跌倒）。符合要求的地板不影响赔率。1例严重跌倒相关损伤（干预组12.5%对对照组13.3%，优势比[OR]: 0.98, 95% CI: 0.52 ~ 1.84, p = 0.950）或>= 2例严重跌倒相关损伤（5.4%对7.5%,OR: 0.74, 95% CI: 0.31 ~ 1.75, p = 0.500）。依从性地板不影响严重跌倒相关伤害的发生率(0.362 vs 0.422 / 1000个床位夜，比率比[RR]: 1.04, 95% CI: 0.45 ~ 2.39, p = 0.925；0.038 vs 0.053次跌倒，RR: 0.81, 95% CI: 0.38 ~ 1.71, p = 0.560), >= 1次严重跌倒相关损伤的跌倒率（0.276 vs 0.303 / 1000个床位夜，RR: 0.97, 95% CI: 0.52 ~ 1.79, p = 0.920），或首次发生严重跌倒相关损伤的时间（0.237 vs 0.257，风险比[HR]: 0.92, 95% CI: 0.52 ~ 1.62, p = 0.760）。依从性地板在本研究中不影响任何次要结局。研究的局限性包括：研究结果是针对安装在LTC居民房间的2.54 cm SmartCells柔性地板的，标准的跌倒和伤害预防干预措施在整个研究中都在使用，可能会影响到柔性地板的观察效果，并且LTC居民脑震荡检测的挑战可能会阻止估计柔性地板对跌倒相关脑震荡的影响。结论：与之前的回顾性和非随机研究结果相比，本研究发现，医院级乙烯基下面的柔性地板不能有效预防LTC中严重的跌倒相关损伤。未来的研究需要确定预防LTC中跌倒相关损伤的有效方法。
BackgroundFall-related injuries exert an enormous health burden on older adults in long-term care (LTC). Softer landing surfaces, such as those provided by low-stiffness "compliant" flooring, may prevent fall-related injuries by decreasing the forces applied to the body during fall impact. Our primary objective was to assess the clinical effectiveness of compliant flooring at preventing serious fall-related injuries among LTC residents.Methods and findingsThe Flooring for Injury Prevention (FLIP) Study was a 4-year, randomized superiority trial in 150 single-occupancy resident rooms at a single Canadian LTC site. In April 2013, resident rooms were block randomized (1:1) to installation of intervention compliant flooring (2.54 cm SmartCells) or rigid control flooring (2.54 cm plywood) covered with identical hospital-grade vinyl. The primary outcome was serious fall-related injury over 4 years that required an emergency department visit or hospital admission and a treatment procedure or diagnostic evaluation in hospital. Secondary outcomes included minor fall-related injury, any fall-related injury, falls, and fracture. Outcomes were ascertained by blinded assessors between September 1, 2013 and August 31, 2017 and analyzed by intention to treat. Adverse outcomes were not assessed. During follow-up, 184 residents occupied 74 intervention rooms, and 173 residents occupied 76 control rooms. Residents were 64.3% female with mean (SD) baseline age 81.7 (9.5) years (range 51.1 to 104.6 years), body mass index 25.9 (7.7) kg/m(2), and follow-up 1.64 (1.39) years. 1,907 falls were reported; 23 intervention residents experienced 38 serious injuries (from 29 falls in 22 rooms), while 23 control residents experienced 47 serious injuries (from 34 falls in 23 rooms). Compliant flooring did not affect odds of. 1 serious fall-related injury (12.5% intervention versus 13.3% control, odds ratio [OR]: 0.98, 95% CI: 0.52 to 1.84, p = 0.950) or >= 2 serious fall-related injuries (5.4% versus 7.5%, OR: 0.74, 95% CI: 0.31 to 1.75, p = 0.500). Compliant flooring did not affect rate of serious fall-related injuries (0.362 versus 0.422 per 1,000 bed nights, rate ratio [RR]: 1.04, 95% CI: 0.45 to 2.39, p = 0.925; 0.038 versus 0.053 per fall, RR: 0.81, 95% CI: 0.38 to 1.71, p = 0.560), rate of falls with >= 1 serious fall-related injury (0.276 versus 0.303 per 1,000 bed nights, RR: 0.97, 95% CI: 0.52 to 1.79, p = 0.920), or time to first serious fall-related injury (0.237 versus 0.257, hazard ratio [HR]: 0.92, 95% CI: 0.52 to 1.62, p = 0.760). Compliant flooring did not affect any secondary outcome in this study. Study limitations included the following: findings were specific to 2.54 cm SmartCells compliant flooring installed in LTC resident rooms, standard fall and injury prevention interventions were in use throughout the study and may have influenced the observed effect of compliant flooring, and challenges with concussion detection in LTC residents may have prevented estimation of the effect of compliant flooring on fall-related concussions.ConclusionsIn contrast to results from previous retrospective and nonrandomized studies, this study found that compliant flooring underneath hospital-grade vinyl was not effective at preventing serious fall-related injuries in LTC. Future studies are needed to identify effective methods for preventing fall-related injuries in LTC.