Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial.

Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial.
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DOI:
10.1186/s13063-023-07501-y
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发表时间:
2023-07-24
期刊:
影响因子:
2.5
通讯作者:
--
中科院分区:
医学4区
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--
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住院的老年人 95% 的时间都在床上度过,这可能会导致不良事件并延迟康复,同时增加费用。观察性研究表明,一般活动干预措施(例如步行)可以减轻不良事件并改善患者的功能状态。行动技术人员 (MT) 可以满足患者参与行动干预的需求,而不会给护士带来过重的负担。然而,没有数据表明 MT 辅助行走对不良事件或功能状态的影响,或者使用 MT 时的成本权衡。 AMBULATE 研究旨在确定 MT 辅助行走是否可以改善老年住院患者的活动状态并减少不良事件。它还将包括分析,以确定从 MT 辅助移动中受益最多的患者,并评估使用 MT 的成本效益。 AMBULATE 研究是一项多中心、单盲、平行对照设计、个体水平随机试验。它将包括在美国两个地区的五家医院接受医疗服务的患者。 65 岁以上患有轻度功能缺陷的患者将采用分组随机方案进行随机分组。干预组中的参与者将在约翰·霍普金斯大学移动目标计算器的指导下每天与 MT 一起走动最多 3 次。干预将在出院时结束,如果住院时间延长,则在 10 天后结束。主要结果是放电时的短期物理性能电池分数。次要结局是出院处理、住院时间、医院获得性并发症(跌倒、静脉血栓栓塞、压疮和医院获得性肺炎)和出院后功能状态。虽然医院的功能下降是多因素造成的,但对于许多患者来说,下床活动是一个可以改变的因素。 AMBULATE 研究将是最大的随机对照试验,旨在测试专门由一名护理团队成员促进老年住院患者活动的临床效果。它还将提供有用的成本影响估计,以帮助医院管理人员评估使用 MT 的可行性和效用。在美国国家医学图书馆 ClinicalTrials.gov 注册(# NCT05725928)。 2023 年 2 月 13 日。
Hospitalized older adults spend as much as 95% of their time in bed, which can result in adverse events and delay recovery while increasing costs. Observational studies have shown that general mobility interventions (e.g., ambulation) can mitigate adverse events and improve patients’ functional status. Mobility technicians (MTs) may address the need for patients to engage in mobility interventions without overburdening nurses. There is no data, however, on the effect of MT-assisted ambulation on adverse events or functional status, or on the cost tradeoffs if a MT were employed. The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients. It will also include analyses to identify the patients that benefit most from MT-assisted mobility and assess the cost-effectiveness of employing a MT. The AMBULATE study is a multicenter, single-blind, parallel control design, individual-level randomized trial. It will include patients admitted to a medical service in five hospitals in two regions of the USA. Patients over age 65 with mild functional deficits will be randomized using a block randomization scheme. Those in the intervention group will ambulate with the MT up to three times daily, guided by the Johns Hopkins Mobility Goal Calculator. The intervention will conclude at hospital discharge, or after 10 days if the hospitalization is prolonged. The primary outcome is the Short Physical Performance Battery score at discharge. Secondary outcomes are discharge disposition, length of stay, hospital-acquired complications (falls, venous thromboembolism, pressure ulcers, and hospital-acquired pneumonia), and post-hospital functional status. While functional decline in the hospital is multifactorial, ambulation is a modifiable factor for many patients. The AMBULATE study will be the largest randomized controlled trial to test the clinical effects of dedicating a single care team member to facilitating mobility for older hospitalized patients. It will also provide a useful estimation of cost implications to help hospital administrators assess the feasibility and utility of employing MTs. Registered in the United States National Library of Medicine clinicaltrials.gov (# NCT05725928). February 13, 2023.
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发表时间: 2015
影响因子: 2.8
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发表时间: 2017-07-01
影响因子: 0.5
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