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HELLO:一项用于加强重症监护病房医护人员人际关系和团队凝聚力的整群随机对照试验方案。

HELLO: a protocol for a cluster randomized controlled trial to enhance interpersonal relationships and team cohesion among ICU healthcare professionals.

作者信息

Azoulay Elie, Barnes Nancy Kentish, Myatra Sheila Nainan, Delgado Maria-Cruz Martin, Arabi Yaseen, Boulanger Carole, Mistraletti Giovanni, Theodorakopoulou Maria, Van Heerden Vernon, Paiva José-Artur, Demirkýran Oktay, La Calle Gabriel Heras, Al Fares Abdulrahman, Burghi Gaston, Francois Guy, Barth Anita, De Waele Jan, Jaber Samir, Darmon Michael, Cecconi Maurizio

机构信息

Department of Intensive Care and Intensive Medicine, Paris-Cité University. Saint-Louis Hospital, APHP, Paris, France.

Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute Mumbai, Mumbai, India.

出版信息

Intensive Care Med Exp. 2024 Oct 7;12(1):90. doi: 10.1186/s40635-024-00677-w.

Abstract

BACKGROUND

Mental health symptoms among healthcare professionals (HCP) in intensive care units (ICUs) are a significant concern affecting both HCP well-being and patient care outcomes. Cross-sectional studies among members of the European Society of Intensive Care Medicine (ESICM) report up to 50% burnout rates. Determinants of burnout include communication, team cohesion, psychological support, and well-being promotion. We designed the 'Hello Bundle' intervention to mitigate burnout among ICU-HCPs by fostering positive social interactions and a supportive work environment. This justification synthesizes evidence from social psychology, positive psychology, and healthcare communication research to support the intervention. The 'Hello Bundle' aims to enhance interpersonal relationships, improve team cohesion, and reduce burnout rates. The six components include: Hello campaign posters, email reminders, integrating greetings in morning huddles, hello jars, lead-by-example initiatives, and a daily updated hello board in each ICU. This protocol describes a cluster randomized controlled trial to evaluate the effectiveness of the intervention.

METHODS

This protocol describes a cluster randomized controlled trial (RCT) conducted among ESICM-affiliated ICUs, consisting of at least 73 clusters with in average of 50 respondents per cluster, totaling approximately 7300 participants. Intervention clusters will implement the 6-component Hello Bundle between October 14 and November 10, 2024, while control clusters will be wait-listed to receive the intervention in January 2025 after the RCT concludes. Clusters will be matched based on ICU size (fewer or more than 20 beds), region, and average 2023 mortality. The primary outcome is the proportion of HCPs with burnout between intervention and control clusters at the end of the intervention. Secondary outcomes include comparing the following between clusters: (1) number of HCPs with high emotional exhaustion; (2) number with high depersonalization; (3) number with loss of accomplishment; (4) perception of ethical climate (5) satisfaction at work (VAS); (6) professional conflicts; (7) intention to leave the ICU (VAS); (8) patient-centered care rating; (9) family-centered care rating. The last secondary outcome is the comparison of burnout rates before and after the intervention in the intervention cluster. Outcomes will be based on HCP reports collected within four weeks before and after the intervention.

DISCUSSION

This is the first large trial of healthcare communication, social, and positive psychology intervention among ICU-HCPs. It holds the potential to provide valuable insights into effective strategies for addressing burnout in ICU settings, ultimately benefiting both HCPs and patients.

TRIAL REGISTRATION

This trial was registered on ClinicalTrials.Gov on June 18, 2024.

REGISTRATION

NCT06453616.

摘要

背景

重症监护病房(ICU)医护人员的心理健康症状是一个重大问题,影响着医护人员的福祉和患者护理结果。欧洲重症监护医学学会(ESICM)成员的横断面研究报告称,倦怠率高达50%。倦怠的决定因素包括沟通、团队凝聚力、心理支持和幸福感提升。我们设计了“问候包”干预措施,通过促进积极的社交互动和支持性的工作环境来减轻ICU医护人员的倦怠。本论证综合了社会心理学、积极心理学和医疗沟通研究的证据来支持该干预措施。“问候包”旨在加强人际关系、提高团队凝聚力并降低倦怠率。六个组成部分包括:问候活动海报、电子邮件提醒、在晨间碰头会上融入问候、问候罐、以身作则的倡议以及每个ICU每日更新的问候板。本方案描述了一项整群随机对照试验,以评估该干预措施的有效性。

方法

本方案描述了一项在隶属于ESICM的ICU中进行的整群随机对照试验(RCT),由至少73个群组组成,每个群组平均有50名受访者,总计约7300名参与者。干预组将在2024年10月14日至11月10日期间实施包含6个组成部分的“问候包”,而对照组将在随机对照试验结束后于2025年1月等待接受干预。群组将根据ICU规模(少于或多于20张床位)、地区和2023年平均死亡率进行匹配。主要结局是干预结束时干预组和对照组中出现倦怠的医护人员比例。次要结局包括比较各群组之间的以下方面:(1)情绪耗竭程度高的医护人员数量;(2)去个性化程度高的医护人员数量;(3)成就感丧失的医护人员数量;(4)对道德氛围的感知;(5)工作满意度(视觉模拟评分法);(6)职业冲突;(7)离开ICU的意愿(视觉模拟评分法);(8)以患者为中心的护理评分;(9)以家庭为中心的护理评分。最后一个次要结局是干预组干预前后倦怠率的比较。结局将基于干预前后四周内收集的医护人员报告。

讨论

这是第一项针对ICU医护人员进行的医疗沟通、社会和积极心理学干预的大型试验。它有可能为解决ICU环境中倦怠问题的有效策略提供有价值的见解,最终使医护人员和患者都受益。

试验注册

本试验于2024年6月18日在ClinicalTrials.Gov上注册。

注册号

NCT06

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4cf/11459960/e473a872ccb5/40635_2024_677_Fig1_HTML.jpg

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