Title: Understanding factors that affect decision making and variation in the quality of end of life care for patients with stage 5 chronic kidney disease (CKD) on dialysis: the QUALYCARE Renal study
Funder: Health Education England

Abstract: Background Dialysis withdrawal is common practice and reported as the second leading cause of death in patients with end stage renal disease. Nevertheless, we know little about this complex phenomenon and there is only one UK dialysis withdrawal study available to inform practice in this area. The literature to date has focused on dialysis withdrawal practice; the incidence of dialysis withdrawal and medical factors predictive of dialysis withdrawal prior to death. There is a paucity of evidence about patient and carer experiences and the quality of care as the end of life approaches and few studies have adopted a patient centred approach. This has implications for studying and improving care at the end of life for patients with stage 5 chronic kidney disease (CKD) following dialysis withdrawal. The aims of this study are therefore to understand factors that influence decision making and variation in the quality of end of life care for patients with stage 5 chronic kidney disease (CKD) on dialysis This study addresses the question: what factors influence the decision making quality of end of life care for dialysis patients in the last three months of life? Methods/DesignA robust conceptual model of the interaction between patient, carer and professional decision-making processes and their effects in shaping patients' clinical trajectories built on findings from qualitative enquiry. The model will generate hypotheses for the quantitative component of the study: mortality follow back survey (with a case-control study of dialysis withdrawal deaths versus deaths on dialysis) conducted with bereaved relatives of renal dialysis patients in 10 renal units in England. Potential participants will be identified and approached by the renal unit in complete confidence. Data are collected via a postal questionnaire to identify the formal care received in the three months before death, relatives' satisfaction with care, and palliative outcomes (such as symptom burden) for the patients and their relatives. A well-established questionnaire to measure relatives' views on the care integrates four brief and robust tools - the Client Service Receipt Inventory, the Palliative Outcome Scale, the EQ-5 D and the Texas Revised Inventory of Grief. The survey will aim to recruit a sample of 390 bereaved relatives (78 who experienced a dialysis withdrawal death and 312 a death on dialysis). Bivariate and multivariate analyses will explore differences in mode of death (DOD versus DW) in patients' palliative outcomes and relatives' bereavement outcomes, in relation to place of death. Factors influencing dialysis withdrawal will be identified. Potential impact: The potential outcomes include better understanding of factors influencing dialysis withdrawal and how that might help integrate palliative care into nephrological care and potentially transferable to other patients in high technological environments approaching the end of life.

Lay abstract: Around 50,000 people in the UK have stage 5 Chronic Kidney Disease, meaning they have lost most of their kidney function. The majority are elderly. Dialysis is an effective but invasive treatment. Dialysis can be performed at home but most patients in the UK have their dialysis treatment in a dialysis unit in hospital, usually three times a week. During dialysis treatment blood is taken from the body, pumped through an artificial kidney and then back to the body. The time spent on the machine for each patient is usually four hours per session. For patients that are not medically fit to have a kidney transplant, their dialysis treatment is life-long. Despite dialysis treatment, some patients experience symptoms such as pain, breathlessness, itching, lethargy and weakness. In addition, patients are required to adhere to strict dietary and fluid restrictions, and manage multiple medicines. Life depends on continual reconnection to the dialysis machine; complex self-monitoring and treatment regimens. Some patients reach a stage when they consider that dialysis can no longer provide them with any benefit to their health or enjoyment of life and they may choose to stop dialysis. Sometimes, the medical team may advise that dialysis treatment is no longer beneficial and should end. This situation may arise if a patient's health has deteriorated despite receiving dialysis. Questions frequently asked by patients include: How long do I have to live? What will happen at the end? The answers to these questions will inform patient's expectations and may influence their treatment decisions. We do know that people who withdraw from dialysis treatment generally survive for one to two weeks. However, we do not know what drives the person to make the decision to stop and die in a defined time. In addition, we have no evidence to guide symptom control, psychological, spiritual and other palliative and supportive care needs for dialysis patients at the end of life. Historically patients who are approaching the end of life with kidney disease have not had access to health professionals in palliative care who give specialist care and information to people facing serious illness. Part of the reason is the lack of research that we need to inform and lead to substantial improvements in care. Care for the kidney patient in the last months of life has received much less attention than many other areas in kidney care. Yet this phase needs equal levels of attention if we are to ensure a good quality death for all. It is really important that we understand this phase of patient management, not only to provide the best care for individuals but also aid in the planning of services to support patients at the end of their lives. The QUALYCARE kidney study aims to examine the quality of care received in their last stages of life. We will contact 1000 people who are relatives of a kidney dialysis patient that has recently died to ask for their help. We will ask them to complete a survey about the quality of care that their relative received in the last three months of life and what influenced their decision to either continue or stop dialysis. This information will be analysed using statistical software with the help of experts. The study will take place across 10 kidney units across the UK. Its purpose is to improve the care provided by kidney and palliative care services. This study aims to understand the variations in quality of end of life care for patients with stage 5 chronic kidney disease on dialysis. By analysing the views of families and friends on the care their deceased relative received, we may be able to work out why some people received care which met their needs, while others did not. This will be used to improve care for kidney dialysis patients and their families. The QUALYCARE kidney study is not intended to help directly those who take part but it should give future patients a much better chance of being well cared for, living well in the last months of life as well as possible.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;7.2 END OF LIFE CARE
Health categories: RENAL AND UROGENITAL