Title: Prepare for Kidney Care: a randomised controlled trial of preparing for responsive management versus preparing for renal dialysis in advanced kidney disease
Funder: Department of Health and Social Care

Abstract: DESIGN: An RCT comparing two care pathways: (a) preparing for conservative care and (b) preparing for dialysis. Stratified by age, site and rate of kidney function decline. SETTING: Secondary care renal units, but with preparation for conservative care delivered predominantly in the community. TARGET POPULATION: Patients known to renal services with new or existing stage 5 chronic kidney disease (eGFR <15) aged 65+ with World Health Organisation (WHO) performance status 3+, or with co-morbidity score 2+ (Davies Score), or aged 80+. EXCLUSION CRITERIA: 1. Unable to consent 2. Not medically fit for dialysis 3. Within 4 weeks of starting dialysis. HEALTH TECHNOLOGY ADDRESSED: Intervention = Prepare for conservative care, a phased, individualised package integrating primary and secondary care delivered at home by a care coordinator. This has been based on the Kidney Disease Improving Global Outcomes (KDIGO) Consensus statement and in collaboration with experts and patients. There will be three stages: (1) Assess and commence – Home visits x2-3 for advance care planning and to introduce existing community services including palliative care; (2) Maintain – Monthly phone contact; ~2-4 monthly review at home or clinic, and (3) Support enhancement – health care and local end-of-life services introduced rapidly. Control = Usual care, which entails preparing for dialysis, with clinic visits ~2-4 monthly, dialysis access surgery and dialysis initiation as clinically indicated and according to the National Institute for Health and Care Excellence (NICE)-endorsed Renal Association Clinical Guidelines. MEASURING COSTS & OUTCOMES The primary outcome will be QALYs gained over a median follow up of 3 years. Clinical data will be collected by research nurses at baseline then 4-monthly with QoL data from patient questionnaires. Resource use will be captured from routine records, trial documentation and patient questionnaires, and valued using unit cost data. Sensitivity analyses will cover areas of uncertainty. SAMPLE SIZE The total sample size of 512 will have 90% power to detect superiority (5%, two-sided) of one pathway over the other in terms of total QALYs over 3 years follow up. We want to be able to detect a clinically meaningful difference of 6 months between the two pathways, equivalent to 0.345 QALYs based on a median utility of 0.69. Data were obtained from a longitudinal study of pre-dialysis patients where utility score data were available at multiple points. As the data suggested a bimodal distribution of QALYs, we simulated datasets of 1,000,000 observations using the SKBIM command in STATA, shifting the two means by 0.345 QALYs to reflect a clinically meaningful difference we wanted to be able to detect. TIMETABLES & RECRUITMENT The duration of 60 months comprises 6 months set-up, 24 months recruitment in 4 sites and 18 months recruitment in a further 12 sites, 27 months minimum follow up and 3 months data analysis, dissemination and publication. Qualitative and mixed methods are integrated throughout the trial to optimise its design and delivery. These will proceed in three interconnected stages: optimising the trial intervention (stage 1), optimising recruitment and informed consent (stage 2), and understanding the acceptability of the intervention and reasons for non-compliance (stage 3). People that are eligible but decline participation will be offered registry follow up.

Lay abstract: AIM OF THE RESEARCH What impact does preparing for conservative care rather than preparing for dialysis have on the quality of life and survival in frail older people with multiple health problems and failing kidneys? BACKGROUND TO THE RESEARCH When kidney function drops to 15% of normal, symptoms such as tiredness, loss of appetite and sickness usually develop. At this stage, dialysis or kidney transplantation is considered. This more often affects older people – half of all patients starting dialysis now are aged 65+ with 3,500 patients affected per year in the UK. Dialysis involves visiting the hospital for 4 hours of treatment 3 times a week, or flushing fluid in and out of your system through your abdomen 4 times a day every day at home. Excluding transport and hospital admissions, dialysis costs £20-25,000 per patient per year. Some people receiving dialysis accommodate to its requirements well and achieve good quality of life, but others report very poor quality of life on dialysis. For these reasons, some patients choose to have as much symptom management and control as possible without dialysis - known as “conservative care”. There is evidence that some older people with many medical problems (co-morbidities) do just as well with conservative care as dialysis, but more evidence is needed to help patients and their families make the best decision. The PrepareME study aims to provide far better evidence to help patients and their families reach the best decision for them and influence NHS policy on care for this group of patients. DESIGN AND METHODS The study planned will involve people with kidney failure aged 80+ and those aged 65+ with multiple health problems. If they agree to take part, they will be allocated to: • Either, prepare for conservative care. This will involve home visits with a nurse to assess their care needs and their priorities during conservative care. The nurse will call the patient at home regularly to monitor symptoms and check that sufficient help is available. There will be regular check-ups with the nurse at home and in hospital visits. Hospital visits will be less frequent than in people preparing for dialysis. • Or, prepare for dialysis. This will involve coming to hospital clinic visits regularly as currently occurs. Surgery to prepare for dialysis will take place. Dialysis will be started when the doctor, nurse and patient agree it is needed. There will be regular visits to hospital for treatment or check ups The people needed for this research have many health problems. We have already been working with patients to make sure the study is important and appropriate. If funded we will talk more with patients to reduce the burden of participation and ensure participants are fully informed about the purpose of the study and what it entails. Similar approaches have allowed the researchers to successfully carry out other complex studies in the past. PATIENT AND PUBLIC INVOLVEMENT Patients and their families have already made significant improvements to the study design. This has happened in discussions in the hospital and in research planning meetings. Their input has led us to focus on quality of life as well as survival, and providing patients and their relatives with clear information to enable informed decisions. It has also emphasised the importance people place on being able to stay at home as much as possible and minimise the impact on family carers.

Research activity codes: 6.3 MEDICAL DEVICES;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: RENAL AND UROGENITAL