A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus standard care using a mixed methods approach.

Background: Haemodialysis (HD) can have extensive physiological, psychological and sociological impacts on patients. This is due not just to the physical side effects of HD but also the scheduling of treatment times, which results in patients ‘losing’ three days a week. Patient-reported quality of life is low, with many unable to continue paid employment. In-centre nocturnal HD offers patients the opportunity to dialyse overnight for longer while asleep. Despite growing evidence in support, it remains underutilised due to both equipoise in the renal community and uncertainty from commissioners about the cost benefit of implementation. Aim: To measure the effect of a 6-month programme of extended hours, in-centre nocturnal haemodialysis (INHD) on quality of life. Design: A pragmatic, two-arm, multi-centre, randomised controlled trial with a health economic analysis. An in-trial pilot with an on-going process evaluation is embedded in this study Randomisation: Patients will be allocated 1:1.33 to account for an additional 25% non-adherence rate in the intervention group using minimisation. Groups will be stratified by site and age. Target population: All prevalent adult patients receiving HD (or haemodiafiltration) in an out-patient hospital or satellite HD unit. Patients will be excluded if they: lack capacity to consent; have a life expectancy of less than, or are expecting a living kidney donor transplant within, 6 months; for whom allocation to standard hours care of 4-hours thrice weekly during the day would be clinically unacceptable. Health technology assessed: Patients allocated to the intervention group will receive 6-8 hours of HD delivered overnight, three times per week for 6-months. Controls will receive standard care (3.5-5 hours three times per week during the day). All other dialysis care will remain the same. Objective: The overall aim of this trial is to test the clinical and cost effectiveness of thrice weekly, extended hours nocturnal dialysis compared to standard dialysis care thrice weekly during the day. Primary outcome measure: Patient reported quality of life at 6-months measured using the composite score from the Kidney Disease Quality of Life tool (KDQoL). Secondary outcome measures: Additional quality of life questionnaires, safety and process measures. Sample size: The trial is powered to detect a 5-point difference in the KDQoL between groups at 6-months adjusted for baseline, the minimal clinically important difference for that instrument. To achieve 90% power and a type I error rate of 5%, 256 participants are required. Assuming an overall attrition rate of 15%, and 25% non-adherence with INHD in the intervention group, the targeted number of randomisations is 350. Analysis: The analysis will be by intention to treat. Point estimates and 95% confidence intervals from two-sided tests will be calculated for all main outcome measures. A Statistical Analysis Plan will be drawn up prior to any analysis and reviewed by the independent Data Safety Monitoring Committee. Timelines: Months 1-12 set up; Months 7-24 in-trial pilot and parallel process evaluation, recruitment commencing in 4 units with existing INHD programmes at month 12 and 4 additional units by month 24; Month 36 all 18 units open; Month 48 complete follow-up; Month 54 database lock; Month 60 complete dissemination of results.