Advance care planning – a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study

BMC Cancer

Study Protocol

Guido Miccinesi¹  Francesco Bulli¹  Eugenio Paci¹  Giuseppe Gorini¹  Francesca Ingravallo²  Lea J. Jabbarian³  Agnes van der Heide (Pl)³  Ida J. Korfage³  Suzanne Polinder³  Esther de Vries³  Judith A. C. Rietjens³  Caroline Arnfeldt Christensen⁴  Mogens Groenvold⁵  Mariëtte N. Verkissen⁶  Dirk Houttekier⁶  Luc Deliens⁷  Sheila Payne⁸  Nancy J. Preston⁸  Lesley Dunleavy⁸  Johannes van Delden⁹  Marieke Zwakman⁹  Marijke C. Kars⁹  Kristian Pollock^1,10  Glenys Caswell^1,10  Jane Seymour^1,10  Andrew Wilcock^1,11  Anna Thit Johnsen^1,12  Maja de Brito^1,13  Anja Simonič^1,13  Alenka Mimić^1,13  Branka Červ^1,13  Urška Lunder^1,13 

[1] Clinical and Descriptive Epidemiology Unit, ISPO Cancer Prevention and Research Institute, Florence, Italy;Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy;Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands;Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, København, Denmark;Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, København, Denmark;The Research Unit, Department of Palliative Medicine, Bispebjerg / Frederiksberg Hospital, Bispebjerg Bakke 23, 2400, København, NV, Denmark;End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium;End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium;Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium;International Observatory on the End-of-Life Care, Lancaster University, LA1 4YG, Lancaster, UK;Julius Center for Health Sciences and Primary Care, Medical School of Utrecht University, Utrecht, The Netherlands;School of Health Sciences, Sue Ryder Centre for the Study of Supportive, Palliative and End of Life Care, University of Nottingham, Queen’s Medical Centre, Nottingham, UK;School of Medicine, University of Nottingham, Nottingham University Hospitals NHS Trust, Nottingham, UK;The Research Unit, Department of Palliative Medicine, Bispebjerg / Frederiksberg Hospital, Bispebjerg Bakke 23, 2400, København, NV, Denmark;Department of Psychology, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark;University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia;

关键词: Advance care planning;    Oncology;    Quality of life;    Medical decision-making;   

DOI  :  10.1186/s12885-016-2298-x

 received in 2015-09-04, accepted in 2016-03-30,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundAwareness 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/DesignWe 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.DiscussionTransferring 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.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.

【 授权许可】

CC BY   
© Rietjens et al. 2016