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减少老年人伤害和增强信心的策略(STRIDE):一项多因素跌倒损伤预防策略的集群随机实用试验:设计与方法。

Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods.

机构信息

Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts.

Pepper Older Americans Independence Center, Yale University, New Haven, Connecticut.

出版信息

J Gerontol A Biol Sci Med Sci. 2018 Jul 9;73(8):1053-1061. doi: 10.1093/gerona/glx190.

Abstract

BACKGROUND

Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care.

METHODS

Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control.

RESULTS

Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing.

CONCLUSIONS

The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.

摘要

背景

跌倒伤害是导致老年人发病率和死亡率的主要原因。我们描述了一项实用试验的设计,旨在比较基于证据、以患者为中心的多因素跌倒伤害预防策略与增强的常规护理的有效性。

方法

减少伤害和增强老年人信心策略(STRIDE)是一项为期 40 个月的集群随机、平行组、优势、实用试验,在美国 10 个医疗保健系统的 86 个初级保健实践中进行。这 86 个实践使用基于协变量的约束随机化按医疗保健系统分层随机分配到干预组或对照组。参与者是居住在社区、年龄≥70 岁、有严重跌倒伤害风险增加的人。干预措施是一种共同管理模式,其中护士跌倒护理经理进行多因素风险评估,制定个体化护理计划,包括监测、随访评估和干预策略。对照组接受增强的常规护理,临床医生和患者收到有关跌倒预防的循证信息。主要结局是严重跌倒伤害,具体表现为需要医疗关注的伤害(非脊柱骨折、关节脱位、头部损伤、撕裂伤和其他主要后遗症)。次要结局包括所有跌倒伤害、所有跌倒和幸福感(对跌倒的担忧;焦虑和抑郁症状;身体功能和残疾)。目标样本量为 5322 名参与者,以提供 90%的效力,以检测与对照组相比主要结局率降低 20%。

结果

试验在 20 个月内招募了 5451 名受试者。干预和随访仍在进行中。

结论

STRIDE 研究的结果将对预防老年人跌倒伤害具有重要的临床和政策意义。

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