Preparing for responsive management versus preparing for renal dialysis in multimorbid older people with advanced chronic kidney disease (Prepare for Kidney Care): Study protocol for a randomised controlled trial.
Authors: Worthington Jo , Soundy Alexandra , Frost Jessica , Rooshenas Leila , MacNeill Stephanie J. , Realpe Rojas Alba , Garfield Kirsty , Liu Yumeng , Alloway Karen , Ben-Shlomo Yoav , Burns Aine , Chilcot Joseph , Darling Jos , Davies Simon , Farrington Ken , Gibson Andrew , Husbands Samantha , Huxtable Richard , McNally Helen , Murphy Emma , Murtagh Fliss E. M. , Rayner Hugh , Rice Caoimhe T. , Roderick Paul , Salisbury Chris , Taylor Jodi , Winton Helen , Donovan Jenny , Coast Joanna , Lane J Athene , Caskey Fergus J. 
Published: October 2024

Abstract
Background
Chronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death. Prepare for Kidney Care aims to compare preparation for a renal dialysis pathway with preparation for a conservative kidney management pathway, in relation to quantity and quality of life in multimorbid, frail, older people with advanced CKD.

Methods
This is a two-arm, superiority, parallel group, non-blinded, individual-level, multi-centre, pragmatic trial, set in United Kingdom National Health Service (NHS) kidney units. Patients with advanced CKD (estimated glomerular filtration rate < 15 mL/min/1.73 m2, not due to acute kidney injury) who are (a) 80 years of age and over regardless of frailty or multimorbidity, or (b) 65–79 years of age if they are frail or multimorbid, are randomised 1:1 to ‘prepare for responsive management’, a protocolised form of conservative kidney management, or ‘prepare for renal dialysis’. An integrated QuinteT Recruitment Intervention is included. The primary outcome is mean total number of quality-adjusted life years during an average follow-up of 3 years. The primary analysis is a modified intention-to-treat including all participants contributing at least one quality of life measurement. Secondary outcomes include survival, patient-reported outcomes, physical functioning, relative/carer reported outcomes and qualitative assessments of treatment arm acceptability. Cost-effectiveness is estimated from (i) NHS and personal social services and (ii) societal perspectives.

Discussion
This randomised study is designed to provide high-quality evidence for frail, multimorbid, older patients with advanced CKD choosing between preparing for dialysis or conservative kidney management, and healthcare professionals and policy makers planning the related services.

Trial registration
ISRCTN, ISRCTN17133653 (https://doi.org/10.1186/ISRCTN17133653). Registered 31 May 2017.