Rietjens Judith A C, Korfage Ida J, Dunleavy Lesley, Preston Nancy J, Jabbarian Lea J, Christensen Caroline Arnfeldt, de Brito Maja, Bulli Francesco, Caswell Glenys, Červ Branka, van Delden Johannes, Deliens Luc, Gorini Giuseppe, Groenvold Mogens, Houttekier Dirk, Ingravallo Francesca, Kars Marijke C, Lunder Urška, Miccinesi Guido, Mimić Alenka, Paci Eugenio, Payne Sheila, Polinder Suzanne, Pollock Kristian, Seymour Jane, Simonič Anja, Johnsen Anna Thit, Verkissen Mariëtte N, de Vries Esther, Wilcock Andrew, Zwakman Marieke, van der Heide Pl Agnes
Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
International Observatory on the End-of-Life Care, Lancaster University, Lancaster, LA1 4YG, UK.
BMC Cancer. 2016 Apr 8;16:264. doi: 10.1186/s12885-016-2298-x.
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.
METHODS/DESIGN: 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.
了解患者对医疗护理的偏好应是晚期癌症患者护理的核心内容。开放沟通有助于实现这一点，但可能以临时或多变的方式进行。预先护理计划（ACP）是患者、亲属和专业护理人员之间就患者价值观和护理偏好进行沟通的正式过程。它提高了对需要预见未来可能出现的健康恶化情况的认识。ACP有可能改善当前和未来的医疗保健决策，给予患者控制感，并提高他们的生活质量。
方法/设计：我们将研究ACP项目“尊重选择”对晚期肺癌或结直肠癌患者生活质量的影响。在一项III期多中心整群随机对照试验中，6个国家的22家医院将被随机分组。在干预组，患者将接受由经过培训的协调员进行的访谈。在对照组，患者将接受常规护理。总共将纳入1360名患者。所有参与的患者将在入组时、2.5个月和4.5个月后再次被要求填写问卷。如果患者在入组后一年内死亡，将要求亲属填写一份关于临终护理的问卷。通过查阅医疗档案来评估医疗护理的使用情况。主要终点是入组后2.5个月时患者的生活质量。次要终点包括所接受的护理与患者偏好的符合程度、患者对决策过程的评价、临终护理质量以及干预措施的成本效益。将开展一项补充性定性研究，从患者、其个人代表、医疗服务提供者和协调员的角度探索参与“尊重选择”项目的实际体验。
将ACP的概念从老年护理转移到晚期癌症患者护理，这些患者平均年龄较轻，在疾病进程的大部分时间里保持心智能力，这是在更加注重以患者为中心的医疗保健和共同决策的时代迈出的重要下一步。
国际标准随机对照试验编号：ISRCTN63110516。注册日期：2014年3月10日。
