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多因素策略预防严重跌倒伤害的随机试验。

A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

机构信息

From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).

出版信息

N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183.


DOI:10.1056/NEJMoa2002183
PMID:32640131
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7421468/
Abstract

BACKGROUND: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

摘要

背景:老年人跌倒造成的伤害是导致并发症和死亡的主要原因。尽管有疗效试验的证据表明许多跌倒可以预防,但导致受伤的跌倒率并没有下降。

方法:我们进行了一项实用的、基于群组的随机试验,以评估一种多因素干预措施的有效性,该干预措施包括风险评估和个体化计划,由经过专门培训的护士实施,以预防跌倒伤害。共有 10 个医疗保健系统中的 86 个初级保健实践随机分配到干预组或增强常规护理(对照组)(每组 43 个实践)。参与者为 70 岁或以上、有跌倒受伤高风险的社区居民。主要结局是首次严重跌倒伤害,使用参与者报告、电子健康记录和索赔数据进行裁决的时间-事件分析。我们假设干预组的事件发生率将比对照组低 20%。

结果:干预组(2802 名参与者)和对照组(2649 名参与者)的参与者人口统计学和基线特征相似;平均年龄为 80 岁,62.0%的参与者为女性。在时间-首次事件分析中,两组之间首次裁决的严重跌倒伤害发生率无显著差异(每 100 人年随访的事件发生率,干预组为 4.9,对照组为 5.3;风险比,0.92;95%置信区间[CI],0.80 至 1.06;P=0.25)。在干预组中,每 100 人年随访报告的首次跌倒伤害发生率为 25.6 例,对照组为 28.6 例(风险比,0.90;95%CI,0.83 至 0.99;P=0.004)。两组的住院或死亡率相似。

结论:由护士实施的多因素干预措施并未导致首次裁决的严重跌倒伤害发生率显著低于增强常规护理。(由患者中心的结果研究学会和其他机构资助;STRIDE ClinicalTrials.gov 编号,NCT02475850。)

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