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临床试验/NCT06245525
NCT06245525已完成不适用

Palliative Care and Legal Aspects of Treatment Limitation Decisions in ICU: A Survey of Clinicians' Perceptions

University of Athens2 个研究点 分布在 1 个国家目标入组 523 人开始时间: 2024年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
523
试验地点
2
主要终点
Clinicians' perceptions of legislation relevant to palliative care.

研究概览

简要总结

The primary objective of the current survey study is to obtain detailed information about European intensive care unit (ICU) clinicians' awareness of palliative care and relevant, local end-of-life (EoL) legislation.

详细描述

INTRODUCTION In countries with patient/family autonomy-oriented end-of-life (EOL) legislation, published data indicate variation of healthcare professionals' awareness of the specific legal provisions and/or regulations enabling limitation of life-sustaining treatments. Furthermore, communication difficulties and/or uncertainties about the validity of previously recorded patient preferences (e.g. in the form of advance directives) may result in heterogenous application of pertinent EOL laws/regulations. This may include cases of poor compliance with, or even opposition to new laws.

The absence of accurate and in-depth EOL legal knowledge of clinicians may be associated with perceptions that applicable laws/regulations are either too restrictive or excessively "liberal" for the patient. Furthermore, critical care physicians and/or nurses may lack specific knowledge about palliative care. Accordingly, physicians/nurses may also not be aware of the palliative nature of their everyday practice or have a clear understanding of primary and specialist palliative care.

Given the above-mentioned knowledge gaps of healthcare professionals caring for critically ill patients, the investigators propose to conduct a Europewide, descriptive survey for intensive care unit (ICU) clinicians, primarily aimed at addressing the following questions: 1) "How much of ICU everyday practice is palliative care and how is it practiced?"; and 2) "How do clinicians perceive the medico-legal framework around therapy limitations, patient autonomy and prognostication discussions with patients and families?" In addition, this survey will enable the investigators to comparatively assess the perceived extent of ICU palliative care practice in the presence vs. absence of EOL legislation.

METHODS Study participants and protocol approval The target population of this descriptive, open survey will include ICU physicians and nurses working in at least 100 ICUs across 50 European countries and Israel. Each one of participating ICUs will be represented by one or more healthcare professionals, and the target convenience-sample size will amount to at least 500 respondents (see also below-provided statistical analysis plan). This survey study is part of the European Union-funded Enhancing Palliative Care in ICU (EPIC) project (Proposal number: 101137221; HORIZON-HLTH-2023-DISEASE-03-01). The study protocol has been approved by the Scientific Council of Evaggelismos Hospital, Athens, Greece.

Informed consent and data protection A similar methodology has been recently described. According to the Helsinki declaration, participation in research requires informed consent of the participant. According to Regulation 679/2016 {or General Data Protection regulation (GDPR) of the European Parliament and of the Council, "consent" of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her." Participation in and completion of the current survey means that the participant accepts to share their knowledge on palliative care practice, EOL legislation and EOL practice in their country. The estimated time for survey completion is between 30 and 60 min.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • European and Iraeli intensive care unit physicians or nurses.

排除标准

  • Absence of informed consent for study participation.

结局指标

主要结局

Clinicians' perceptions of legislation relevant to palliative care.

时间窗: February 1 to July 1 2024.

The absolute numbers of positive (i.e. yes) responses to question groups 15 through 23 of section 3. This will comprise the end-of-life legislation score, which ranges from 0 to 49, with greater values indicating higher level of awareness of a comprehensive legal framework.

Clinicians' percreptions of their daily end-of-life and palliative care practice.

时间窗: February 1 to July 1 2024.

The absolute numbers of positive (i.e. yes) responses to question groups 24 and 25 of section 4. This will comprise the end-of-life and palliative care practice score, which ranges from 0 to 13, with higher values indicating a higher quality of end-of-life practice.

Clinicians' perceptions of palliative care.

时间窗: February 1 to July 1 2024.

The absolute numbers of positive (i.e. yes) responses to question groups 10 through 14 of survey section 2. This will comprise the palliative care score, which ranges from 0 to 29, with greater values indicating a higher quality of palliative care practice.

End-of-Life Practice and Perceived Palliative Practice Quality

时间窗: February 1 to July 1 2024.

This composite outcome consists of two complementary measures derived from Section 4 of the survey: End-of-Life Practice Score (0-12): Calculated as the absolute number of positive ("yes") responses to the 12 binary items in Question Group 24. Each item is scored 0 (No) or 1 (Yes), yielding a total score from 0 to 12. Higher scores indicate greater implementation of recommended ICU end-of-life practices. Perceived Palliative Practice Quality (0-4): Assessed using Question 25.1, which captures clinicians' perceived adequacy of palliative care focus in their ICU. Responses are coded ordinally from 0 ("not at all") to 4 ("very high degree"), with higher values indicating greater perceived adequacy. "Do not know" responses are treated as missing.

次要结局

  • Clinicians' perceptions of palliative care, in the absence of country end-of-life legislation.(February 1 to July 1 2024.)
  • Clinicians' perceptions of palliative care, in the presence of country end-of-life legislation.(February 1 to July 1 2024.)

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Spyros D. Mentzelopoulos

Professor of Intensive Care Medicine

National and Kapodistrian University of Athens

研究点 (2)

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