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.

BackgroundThe use of full-population databases is under-explored to study the use, quality and costs of end-of-life care. Using the case of Belgium, we explored: (1) which full-population databases provide valid information about end-of-life care, (2) what procedures are there to use these databases, and (3) what is needed to integrate separate databases.MethodsTechnical and privacy-related aspects of linking and accessing Belgian administrative databases and disease registries were assessed in cooperation with the database administrators and privacy commission bodies. For all relevant databases, we followed procedures in cooperation with database administrators to link the databases and to access the data.ResultsWe identified several databases as fitting for end-of-life care research in Belgium: the InterMutualistic Agency's national registry of health care claims data, the Belgian Cancer Registry including data on incidence of cancer, and databases administrated by Statistics Belgium including data from the death certificate database, the socio-economic survey and fiscal data. To obtain access to the data, approval was required from all database administrators, supervisory bodies and two separate national privacy bodies. Two Trusted Third Parties linked the databases via a deterministic matching procedure using multiple encrypted social security numbers.ConclusionIn this article we describe how various routinely collected population-level databases and disease registries can be accessed and linked to study patterns in the use, quality and costs of end-of-life care in the full population and in specific diagnostic groups.

BackgroundMost patients with life-limiting illnesses are treated and cared for over a long period of time in primary care and guidelines suggest that ACP discussions should be initiated in primary care. However, a practical model to implement ACP in general practice is lacking. Therefore, the objective of this study is to develop an intervention to support the initiation of ACP in general practice.MethodsWe conducted a Phase 0-I study according to the Medical Research Council (MRC) Framework. Phase 0 consisted of a systematic literature review about the barriers and facilitators for GPs to engage in ACP, focus groups with GPs were held about their experiences, attitudes and concerns regarding initiating ACP in general practice and a review of ACP interventions to identify potential components for the development of our intervention. In Phase 1, we developed a complex intervention to support the initiation of ACP in general practice in patients at risk of deteriorating or dying, based on the results of Phase 0. The complex intervention and its components were reviewed and refined by two expert panels.ResultsPhase 0 resulted in the identification of the factors inhibiting or enabling GPs’ initiation of ACP and important components underpinning existing ACP interventions. Based on these findings, an intervention was developed in Phase 1 consisting of: (1) a training for GPs in initiating and conducting ACP discussions, (2) a register of patients eligible for ACP discussions, (3) an educational booklet on ACP for patients to prepare the ACP discussions that includes general information on ACP, a section on the role of GPs in the process of ACP and a prompt list, (4) a conversation guide to support GPs in the ACP discussions and (5) a structured documentation template to record the outcomes of discussions.ConclusionTaking into account the barriers and facilitators for GPs to initiate ACP as well as the key factors underpinning successful ACP intervention in other health care settings, a complex intervention for general practice was developed, after gaining feedback from two expert panels. The feasibility and acceptability of the intervention will subsequently be tested in a Phase II study.

BackgroundTo improve the quality of end-of-life care in geriatric hospital wards we developed the Care Programme for the Last Days of Life. It consists of 1) the Care Guide for the Last Days of Life, 2) supportive documentation and 3) an implementation guide. The aim of this study is (1) to determine the feasibility of implementing the Care Programme for the Last Days of Life in the acute geriatric hospital setting and (2) to explore the health care professionals’ perceptions of the effects of the Care Programme on end-of-life care.MethodsA phase 2 mixed methods study according with the MRC framework was performed in the acute geriatric ward of Ghent University Hospital between 1 April and 30 September 2013. During the implementation process a mixed methods approach was used including observation, interviews and the use of a quantitative process evaluation tool. This tool measured the success of implementation using several indicators, such as whether a steering group was formed, whether and how much of the health care staff was informed and trained and how many patients were cared for according to the Care Guide for the Last Days of Life.ResultsThe process evaluation tool showed that implementing the Care Programme for the Last Days of Life in the geriatric ward was successful and thus feasible; a steering group was formed consisting of two facilitators, health care staff of the geriatric ward were trained in using the Care Guide for the Last Days of Life which was subsequently introduced onto the ward and approximately 57 % of all dying patients were cared for according to the Care Guide for the Last Days of Life.With regard to health care professionals’ perceptions, nurses and physicians experienced the Care Guide for the Last Days of Life as improving the overall documentation of care, improving communication among health care staff and between health care staff and patient/family and improving the quality of end-of-life care. Barriers to implementing the Care Programme for the Last Days of Life successfully are, among others, difficulties with the content of the documents used within the Care Programme for the Last Days of Life and the low participation rate of physicians in the training sessions and audits.ConclusionsResults of this mixed methods study suggest that implementing the Care Programme for the Last Days of Life is feasible and that it has favorable effects on end-of-life care as reported by health care professionals. Based on the identified barriers during the implementation process, we were able to make recommendations for future implementation and further refine the Care Programme for the Last Days of Life before implementing it in a phase 3 cluster randomized controlled trial for the evaluation of its effectiveness.

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.