Jeung Ye Sul, Kim Yejin, Kim Seyeon, Jung Yoon Sun, Kim Tae Jung, Yoo Shin Hye
Center for Palliative Care and Clinical Ethics, Seoul National University Hospital, Jongno-gu, Korea (the Republic of).
Department of Critical Care Medicine, Seoul National University Hospital, Jongno-gu, Korea (the Republic of).
BMJ Open. 2025 May 28;15(5):e093558. doi: 10.1136/bmjopen-2024-093558.
Critically ill patients in intensive care units (ICUs) receive life-sustaining treatments aimed at restoring or maintaining organ function. ICU admission often involves substantial multidimensional suffering that can burden patients, their families and surrogates. Multidisciplinary palliative care support can help alleviate their sufferings. In South Korea, however, palliative care has not yet been integrated into critical care settings, highlighting the need to explore the feasibility of its implementation within the ICU.
This study aims to test the feasibility of a consultation-based palliative care intervention in the ICU. The study will include 20 patients admitted to the ICU of a tertiary hospital due to sudden severe acute brain injury or progressive organ failure, along with their family caregivers. A palliative care team, comprising a social worker and a palliative care physician, will provide consultations to the ICU healthcare professionals based on the palliative care needs, following family counselling. Additional family meetings will be held if necessary. The primary outcomes will include participation rates, family counselling rates and study completion rates. The intervention's potential impact will be assessed by changes in surrogate decision-making conflict, self-efficacy, depression and anxiety, post-decision regret and the experience of patient-centred and family-centred care. The demand and acceptability of the intervention will be assessed through semi-structured interviews with family surrogates, followed by qualitative analysis.
This study will be conducted in accordance with the Declaration of Helsinki and applicable national laws and regulations. The clinical study protocol, along with any protocol amendments and the informed consent form, has been approved by the Institutional Review Board of the Hospital (2404-111-1532). We plan to submit the study results for presentation at conferences and for publication in international peer-reviewed journals. Data will also be made available on request to participants, funding agencies and interested researchers.
NCT06490835.
重症监护病房（ICU）中的重症患者接受旨在恢复或维持器官功能的维持生命治疗。入住ICU通常会带来多方面的巨大痛苦，给患者及其家人和代理人带来负担。多学科姑息治疗支持有助于减轻他们的痛苦。然而，在韩国，姑息治疗尚未纳入重症监护环境，这凸显了探索在ICU中实施姑息治疗的可行性的必要性。
本研究旨在测试ICU中基于咨询的姑息治疗干预措施的可行性。该研究将纳入20名因突发严重急性脑损伤或进行性器官衰竭入住三级医院ICU的患者及其家庭护理人员。一个由一名社会工作者和一名姑息治疗医生组成的姑息治疗团队将在家庭咨询后，根据姑息治疗需求为ICU医护人员提供咨询。如有必要，将举行额外的家庭会议。主要结果将包括参与率、家庭咨询率和研究完成率。将通过替代决策冲突、自我效能感、抑郁和焦虑、决策后遗憾以及以患者为中心和以家庭为中心的护理体验的变化来评估干预措施的潜在影响。将通过与家庭代理人进行半结构化访谈，随后进行定性分析，来评估干预措施的需求和可接受性。
本研究将按照《赫尔辛基宣言》以及适用的国家法律法规进行。临床研究方案以及任何方案修正案和知情同意书已获得医院机构审查委员会的批准（2404-111-1532）。我们计划提交研究结果，以便在会议上展示并在国际同行评审期刊上发表。数据也将根据参与者、资助机构和感兴趣的研究人员的要求提供。
NCT06490835。
