TY - JOUR

T1 - Advance care planning - a multi-centre cluster randomised clinical trial

T2 - the research protocol of the ACTION study

AU - Rietjens, Judith A C

AU - Korfage, Ida J

AU - Dunleavy, Lesley

AU - Preston, Nancy J

AU - Jabbarian, Lea J

AU - Christensen, Caroline Arnfeldt

AU - de Brito, Maja

AU - Bulli, Francesco

AU - Caswell, Glenys

AU - Červ, Branka

AU - van Delden, Johannes

AU - Deliens, Luc

AU - Gorini, Giuseppe

AU - Groenvold, Mogens

AU - Houttekier, Dirk

AU - Ingravallo, Francesca

AU - Kars, Marijke C

AU - Lunder, Urška

AU - Miccinesi, Guido

AU - Mimić, Alenka

AU - Paci, Eugenio

AU - Payne, Sheila

AU - Polinder, Suzanne

AU - Pollock, Kristian

AU - Seymour, Jane

AU - Simonič, Anja

AU - Johnsen, Anna Thit

AU - Verkissen, Mariëtte N

AU - de Vries, Esther

AU - Wilcock, Andrew

AU - Zwakman, Marieke

AU - van der Heide Pl, Agnes

PY - 2016/4/8

Y1 - 2016/4/8

N2 - BACKGROUND: 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.DISCUSSION: 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.TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516 . Date of registration: 10/3/2014.

AB - BACKGROUND: 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.DISCUSSION: 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.TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516 . Date of registration: 10/3/2014.

U2 - 10.1186/s12885-016-2298-x

DO - 10.1186/s12885-016-2298-x

M3 - Journal article

C2 - 27059593

VL - 16

JO - B M C Cancer

JF - B M C Cancer

SN - 1471-2407

M1 - 264

ER -