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.
Jo Worthington,
Alexandra Soundy,
Jessica Frost,
Leila Rooshenas,
Stephanie J. MacNeill,
Alba Realpe Rojas,
Kirsty Garfield,
Yumeng Liu,
Karen Alloway,
Yoav Ben-Shlomo,
Aine Burns,
Joseph Chilcot,
Jos Darling,
Simon Davies,
Ken Farrington,
Andrew Gibson,
Samantha Husbands,
Richard Huxtable,
Helen McNally,
Emma Murphy,
Fliss E. M. Murtagh,
Hugh Rayner,
Caoimhe T. Rice,
Paul Roderick,
Chris Salisbury,
Jodi Taylor,
Helen Winton,
Jenny Donovan,
Joanna Coast,
J Athene Lane,
Fergus J. Caskey
Affiliations
Jo Worthington
Bristol Trials Centre, Bristol Medical School, University of Bristol
Alexandra Soundy
Bristol Trials Centre, Bristol Medical School, University of Bristol
Jessica Frost
Bristol Trials Centre, Bristol Medical School, University of Bristol
Leila Rooshenas
Population Health Sciences, Bristol Medical School, University of Bristol
Stephanie J. MacNeill
Bristol Trials Centre, Bristol Medical School, University of Bristol
Alba Realpe Rojas
Population Health Sciences, Bristol Medical School, University of Bristol
Kirsty Garfield
Bristol Trials Centre, Bristol Medical School, University of Bristol
Yumeng Liu
Bristol Trials Centre, Bristol Medical School, University of Bristol
Karen Alloway
North Bristol NHS Trust, Southmead Hospital
Yoav Ben-Shlomo
Population Health Sciences, Bristol Medical School, University of Bristol
Aine Burns
UCL Department of Nephrology, Royal Free Hospital, University College
Joseph Chilcot
Institute of Psychiatry, Psychology & Neuroscience, King’s College London
Jos Darling
Public and Patient Involvement Representative
Simon Davies
Institute for Science and Technology in Medicine, Keele University
Ken Farrington
Renal Unit, East and North Hertfordshire NHS Trust
Andrew Gibson
ARC West, Whitefriars, Lewins Mead
Samantha Husbands
Population Health Sciences, Bristol Medical School, University of Bristol
Richard Huxtable
Population Health Sciences, Bristol Medical School, University of Bristol
Helen McNally
North Bristol NHS Trust, Southmead Hospital
Emma Murphy
Centre for Care Excellence, Coventry University and University Hospitals Coventry and Warwickshire NHS Trust
Fliss E. M. Murtagh
Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull
Hugh Rayner
Renal Unit, Birmingham Heartlands Hospital, Bordesley Green E
Caoimhe T. Rice
Bristol Trials Centre, Bristol Medical School, University of Bristol
Paul Roderick
Faculty of Medicine, University of Southampton
Chris Salisbury
Population Health Sciences, Bristol Medical School, University of Bristol
Jodi Taylor
Bristol Trials Centre, Bristol Medical School, University of Bristol
Helen Winton
Bristol Trials Centre, Bristol Medical School, University of Bristol
Jenny Donovan
Population Health Sciences, Bristol Medical School, University of Bristol
Joanna Coast
Population Health Sciences, Bristol Medical School, University of Bristol
J Athene Lane
Bristol Trials Centre, Bristol Medical School, University of Bristol
Fergus J. Caskey
Population Health Sciences, Bristol Medical School, University of Bristol
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.
