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临床试验/NCT05706740
NCT05706740已完成不适用

Understanding Patterns of Deprescribing Antithrombotic Medication During End-of-Life Care in Cancer Patients Across the European Union

Johannes Gutenberg University Mainz12 个研究点 分布在 8 个国家目标入组 467 人开始时间: 2023年2月28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
467
试验地点
12
主要终点
Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy

研究概览

简要总结

Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, antithrombotic therapy is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY aims to develop an information-driven, palliative care shared decision-making process enabled by a user-friendly, easily accessible, web-based shared-decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of antithrombotic therapy in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, qualitative interviews, epidemiologic studies, and a randomized controlled trial.

The sub-project described here uses the flashmob research approach to address healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients.The survey will be conducted with approx. 800 physicians from eight European countries, all represented in the SERENITY consortium.

详细描述

Deprescribing is an important part of palliative care to prevent polypharmacy, which is associated with increased risk of adverse drug events, drug-drug and drug-disease interactions, reduced functional capacity, multiple geriatric syndromes, medication nonadherence, and higher healthcare costs. One of the most widely used cardiovascular drug classes in cancer patients in a palliative setting are antithrombotics, including anticoagulant and anti-platelet substances. Antithrombotic drugs, e.g., direct oral anticoagulants (DOACs), low-molecular-weight heparins (LMWH), vitamin-K antagonists (VKA) and so-called antiplatelet agents (such as acetyl salicylic acid and P2Y12 inhibitors), are indicated in patients with prosthetic heart valves, in those with venous thromboembolism (VTE) or pulmonary embolism (PE), for stroke prevention in atrial fibrillation as well as in patients with established atherosclerotic cardiovascular disease (such as myocardial infarction, stroke, or peripheral artery disease). Most patients have been receiving these drugs chronically before their cancer was diagnosed, while others are prescribed them in order to treat or prevent cancer-associated thrombosis. Obviously, decisions on deprescribing antithrombotics heavily depend on the indication of the antithrombotic drug in addition to patient and healthcare professional preferences and experience, and on the estimated life expectancy of the patient.

Understanding current patterns of management of antithrombotic therapy as well as the rationale and preferences behind these patterns is crucial for improving clinical practice. Since deprescribing patterns and rationale may largely differ across the European Union, relevant data at a large scale is needed to fully understand and appreciate the relevant decision processes.

The insights gained in this study are a first step towards the development of a clinical decision tool supporting decisions on antithrombotic therapy in cancer patients.

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

  • Healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients

排除标准

  • 未提供

结局指标

主要结局

Relevance of patient's medication burden for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Relevance of patient's performance status (Eastern Cooperative Oncology Group

时间窗: 7 days

(ECOG)) for the decision on continuation or discontinuation of antithrombotic therapy

Relevance of patient's bleeding risk for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Relevance of patient's preference (pro/contra continuation) for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Relevance of patient's prognosis for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care

时间窗: 7 days

Relevance of patient's type of antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Relevance of patient's thrombotic risk for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Current practice patterns across Europe with regard to the use of antithrombotic treatment in end-of-life care of cancer patients

时间窗: 7 days

The main analysis of the FMR will be descriptive. Responses to the Discrete Choice Experiments will be used to generate preference coefficients for each level (e.g., high/low) of each attribute (e.g., bleeding risk)

Relevance of patient's indication for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Relevance of patient's age for the decision on continuation or discontinuation of antithrombotic therapyin cancer patients during end-of-life care

时间窗: 7 days

Relevance of patient's symptom burden for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

Relevance of physician's experience (with deprescribing) for antithrombotic medication for the decision on continuation or discontinuation of antithrombotic therapy

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Stavros Konstantinides, MD

Coordinating Investigator

Johannes Gutenberg University Mainz

研究点 (12)

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