Table_4_Non-pharmacological prevention of postoperative delirium by occupational therapy teams: A randomized clinical trial.DOCX

BackgroundPatients who develop postoperative delirium (POD) have several clinical complications, such as increased morbidity, increased hospital stays, higher hospital costs, cognitive and functional impairment, and higher mortality. POD is a clinical condition preventable by standard non-pharmacological measures An intensive Occupational Therapy (OT) intervention has been shown to be highly effective in preventing delirium in critically ill medical patients, but it is unknown the effect in surgical patients. Thus, we designed a prospective clinical study with the aim to determine whether patients undergoing intervention by the OT team have a lower incidence of POD compared to the group treated only with standard measures.
MethodsA multicenter, single-blind, randomized clinical trial was conducted between October 2018 and April 2021, in Santiago of Chile, at a university hospital and at a public hospital. Patients older than 75 years undergoing elective major surgery were eligible for the trial inclusion. Patients with cognitive impairment, severe communication disorder and cultural language limitation, delirium at admission or before surgery, and enrolled in another study were excluded. The intervention consisted of OT therapy twice a day plus standard internationally recommended non-pharmacological prevention intervention during 5 days after surgery. Our primary outcome was development of delirium and postoperative subsyndromal delirium.
ResultsIn total 160 patients were studied. In the interventional group, treated with an intensive prevention by OT, nine patients (12.9%) developed delirium after surgery and in the control group four patients (5.5%) [p = 0.125, RR 2.34 CI 95 (0.75–7.27)]. Whereas subsyndromal POD was present in 38 patients in the control group (52.1%) and in 34 (48.6%) in the intervention group [p = 0.4, RR 0.93 CI95 (0.67–1.29)]. A post hoc analysis determined that the patient’s comorbidity and cognitive status prior to hospitalization were the main risk factors to develop delirium after surgery.
DiscussionPatients undergoing intervention by the OT team did not have a lower incidence of POD compared to the group treated only with standard non-pharmacological measures in adults older than 75 years who went for major surgery.
Clinical trial registrationwww.ClinicalTrials.gov, identifier NCT03704090.

背景
术后谵妄（postoperative delirium, POD）患者会出现多种临床并发症，包括发病率升高、住院时间延长、住院费用增加、认知与功能受损，以及死亡率升高。术后谵妄是一种可通过标准非药物手段预防的临床病症。既往研究显示，强化作业疗法（Occupational Therapy, OT）干预在预防重症内科患者谵妄方面效果显著，但该干预对外科患者的作用尚不明确。为此，我们设计了这项前瞻性临床研究，旨在明确与仅接受标准预防措施的对照组相比，接受作业疗法团队干预的患者术后谵妄发生率是否更低。

方法
本研究于2018年10月至2021年4月在智利圣地亚哥的一所大学医院与一所公立医院开展，为多中心单盲随机临床试验。研究纳入标准为：年龄超过75岁、接受择期大手术的患者。排除标准包括：存在认知障碍、严重沟通障碍或语言文化障碍者，入院时或术前已出现谵妄者，以及已参与其他研究的患者。干预组患者在术后5天内每日接受2次作业疗法，联合国际推荐的标准非药物预防干预措施；对照组仅接受标准非药物预防干预。本研究的主要结局指标为术后谵妄与术后亚综合征谵妄的发生情况。

结果
本研究共纳入160例患者。在接受强化作业疗法预防的干预组中，有9例（12.9%）患者术后出现谵妄；对照组则有4例（5.5%）出现谵妄（p=0.125，相对风险RR=2.34，95%置信区间CI：0.75–7.27）。亚综合征术后谵妄的发生率方面，对照组有38例（52.1%），干预组有34例（48.6%）（p=0.4，RR=0.93，95%CI：0.67–1.29）。事后分析显示，患者住院前的共病情况与认知状态是术后发生谵妄的主要危险因素。

讨论
对于接受大手术的75岁以上成人患者，与仅接受标准非药物预防措施的对照组相比，接受作业疗法团队干预的患者术后谵妄发生率并未显著降低。

临床试验注册
临床试验注册平台为www.ClinicalTrials.gov，注册号为NCT03704090。