Prepare for Kidney Care: a randomised controlled trial of preparing for responsive management versus preparing for renal dialysis in advanced kidney disease

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.