Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.
Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.
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DOI：
10.1186/s12885-016-2298-x
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发表时间：
2016-04-08
期刊：
影响因子：
3.8
通讯作者：
van der Heide Pl A
中科院分区：
文献类型：
--
作者：
Rietjens JA;Korfage IJ;Dunleavy L;Preston NJ;Jabbarian LJ;Christensen CA;de Brito M;Bulli F;Caswell G;Červ B;van Delden J;Deliens L;Gorini G;Groenvold M;Houttekier D;Ingravallo F;Kars MC;Lunder U;Miccinesi G;Mimić A;Paci E;Payne S;Polinder S;Pollock K;Seymour J;Simonič A;Johnsen AT;Verkissen MN;de Vries E;Wilcock A;Zwakman M;van der Heide Pl A
对医疗护理偏好的认识应该是对晚期癌症患者护理的中心组成部分。开放的沟通可以促进这一点，但可以以临时或可变的方式发生。高级护理计划(ACP)是患者、亲属和专业护理人员之间就患者的价值观和护理偏好进行沟通的正式过程。它提高了人们对预测未来可能的健康恶化的必要性的认识。ACP有可能改善当前和未来的医疗决策，为患者提供控制感，并提高他们的生活质量。我们将研究ACP尊重选择计划对晚期肺癌或结直肠癌患者生活质量的影响。在第三阶段多中心群组随机对照试验中，6个国家的22家医院将被随机分组。在干预现场，患者将接受训练有素的促进者的采访。在控制点，患者将像往常一样接受治疗。总共将包括1360名患者。所有参与的患者将被要求在纳入时完成问卷调查，并在2.5个月和4.5个月后再次完成问卷调查。如果患者在纳入后一年内死亡，亲属将被要求完成一份关于临终关怀的问卷。将通过检查医疗档案来评估医疗保健的使用情况。主要终点是患者在纳入后2.5个月的生活质量。次要终点是指接受的护理在多大程度上与患者的偏好、患者对决策过程的评估、临终护理的质量和干预的成本效益相一致。将进行一项补充的定性研究，从患者、他们的个人代表、医疗保健提供者和促进者的角度来探索参与尊重选择计划的生活体验。将ACP的概念从照顾老年人转移到晚期癌症患者，这些患者平均更年轻，在很大程度上保持了他们的精神能力，这是一个日益关注以患者为中心的医疗保健和共享决策的时代的重要下一步。国际标准随机对照试验编号：ISRCTN63110516。报名日期：2014年10月3日。
Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers about patients’ values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control, and improve their quality of life. We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a trained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All participating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a patient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care. Use of medical care will be assessed by checking medical files. The primary endpoint is patients’ quality of life at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients’ preferences, patients’ evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.