Original Investigation | Caring for the Critically Ill Patient

Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial

Regis Goulart Rosa, Maicon Falavigna, Daiana Barbosa da Silva, et al

JAMA. 2019;322(3):216-228. doi:10.1001/jama.2019.8766

Abstract

Importance 背景

The effects of intensive care unit (ICU) visiting hours remain uncertain.

ICU访视时间的影响并不确定。

Objective 目的

To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium.

确定ICU患者家属弹性访视政策是否能够降低谵妄发生率

Design, Setting and Participants 设计，场景及研究对象

Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018.

在巴西36个限制访视时间（每天< 4.5小时）的成人ICU进行的群组交叉随机临床试验，纳入患者、家属及临床医生。从2017年4月至2018年6月入选，最后随访日期为2018年7月。

Interventions 干预措施

Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation.

弹性访视时间（每天不超过12小时）辅助以家属宣教（n = 837 名患者，652 名家属，以及435 名医务人员）或常规限制访视时间（中位数，每天1.5 小时；n = 848 名患者，643 名家属和 391 名医务人员）。

Main Outcomes and Measures 主要预后指标

Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory).

主要预后指标为ICU住院期间谵妄发生率，通过CAM-ICU进行评估。次要预后指标包括ICU获得性感染（患者）；采用HADS（范围 0 [最佳] - 21 [最差]）评估的焦虑和抑郁症状（家属）；以及ICU医务人员倦怠（Maslch倦怠量表）。

Results 结果

Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, −1.7% [95% CI, −6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, −0.8% [95% CI, −2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, −3.8% [95% CI, −4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, −1.6 [95% CI, −2.3 to −0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, −1.2 [95% CI, −2.0 to −0.4]; P = .003) were significantly better with flexible visitation.

总共 1685 名患者，1295 名家属以及 826 名医务人员入选，1685 名患者 (100%)（平均年龄，58.5 岁；47.2% 女性），1060 名家属 (81.8%)（平均年龄，45.2 岁；70.3% 女性），以及 737 名医务人员 (89.2%)（平均年龄，35.5 岁；72.9% 女性）完成试验。弹性访视组每天平均访视时间显著演唱（4.8 vs 1.4 小时；校正后差异，3.4 小时 [95% CI, 2.8 to 3.9]; P < .001）。弹性访视组与限制访视组患者ICU住院期间谵妄发生率无显著差异（18.9% vs 20.1%；校正后差异，−1.7% [95% CI, −6.1% to 2.7%]; P = .44）。在9个预先确定的次要预后指标中，6项指标在两组间没有显著差异，包括ICU获得性感染（3.7% vs 4.5%；校正后差异，−0.8% [95% CI, −2.1% to 1.0%]; P = .38）和医务人员倦怠（22.0% vs 24.8%；校正后差异，−3.8% [95% CI, −4.8% to 12.5%]; P = .36）。对于家属而言，弹性访视组焦虑中位评分（6.0 vs 7.0；校正后差异，−1.6 [95% CI, −2.3 to −0.9]; P < .001）及抑郁中位评分（4.0 vs 5.0；校正后差异，−1.2 [95% CI, −2.0 to −0.4]; P = .003）显著优于限制访视组。

Conclusions and Relevance 结论与意义

Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium.

对于ICU患者，与标准的限制访视时间相比，家属弹性访视政策并不显著减少谵妄发生率。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02932358

评论[仅代表个人观点]

• 恐怕需要首先了解引起谵妄最重要的因素是什么（或许存在地域差异），再讨论弹性访视政策能否改善谵妄
• 人文话题从来不是国内重症医学界关注的话题。这一点我们真的对吗？