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.

Autor: Worthington J; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Soundy A; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Frost J; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Rooshenas L; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., MacNeill SJ; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Realpe Rojas A; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., Garfield K; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Liu Y; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Alloway K; North Bristol NHS Trust, Southmead Hospital, Bristol, BS10 5NB, UK., Ben-Shlomo Y; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., Burns A; UCL Department of Nephrology, Royal Free Hospital, University College, London, NW3 2QG, UK., Chilcot J; Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, WC2R 2LS, UK., Darling J; Public and Patient Involvement Representative, London, UK., Davies S; Institute for Science and Technology in Medicine, Keele University, Keele, ST5 5BG, UK., Farrington K; Renal Unit, East and North Hertfordshire NHS Trust, Coreys Mill Lane, Stevenage, SG1 4AB, UK., Gibson A; ARC West, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK., Husbands S; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., Huxtable R; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., McNally H; North Bristol NHS Trust, Southmead Hospital, Bristol, BS10 5NB, UK., Murphy E; Centre for Care Excellence, Coventry University and University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.; Institute for Cardio-Metabolic Medicine, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK., Murtagh FEM; Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, HU6 7RX, UK., Rayner H; Renal Unit, Birmingham Heartlands Hospital, Bordesley Green E, Birmingham, B9 5SS, UK., Rice CT; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Roderick P; Faculty of Medicine, University of Southampton, University Road, Southampton, SO17 1BJ, UK., Salisbury C; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., Taylor J; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Winton H; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Donovan J; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., Coast J; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK., Lane JA; Bristol Trials Centre, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK., Caskey FJ; Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Fergus.caskey@bristol.ac.uk.; North Bristol NHS Trust, Southmead Hospital, Bristol, BS10 5NB, UK. Fergus.caskey@bristol.ac.uk.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Oct 17; Vol. 25 (1), pp. 688. Date of Electronic Publication: 2024 Oct 17.
DOI: 10.1186/s13063-024-08509-8
Abstrakt: 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 m 2 , 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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