Optimising Access to and Outcomes From Transplantation in Older Potential Kidney Transplant Recipients: Pilot Feasibility Study on Kidney Transplant-specific Comprehensive Geriatric Assessment (KT-CGA)
Optimising Access to and Outcomes From Transplantation in Older Potential Kidney Transplant Recipients: Pilot Feasibility Study on Kidney Transplant-specific Comprehensive Geriatric Assessment (KT-CGA)
The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are:
Is it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease?
What is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty?
Researchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone.
Participants will:
Continue with their usual transplant assessment process
If randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)
Older adults with advanced chronic kidney disease (CKD) are increasingly being assessed for kidney transplantation. However, multimorbidity, frailty, and cognitive impairment are highly prevalent in this population and may influence transplant eligibility, perioperative risk, recovery trajectories, and longer-term outcomes. Current transplant assessment pathways are not routinely designed to systematically identify or address these geriatric syndromes.
Comprehensive Geriatric Assessment (CGA) is a structured, multidimensional process that evaluates medical, functional, cognitive, psychological, and social domains, with the aim of informing personalised care planning and optimisation. CGA has demonstrated benefit in older surgical and oncological populations, but its feasibility and impact within kidney transplant assessment pathways remain uncertain.
The OK-POP study is a single-centre, randomised controlled feasibility trial evaluating the integration of a kidney transplant-specific CGA (KT-CGA) into routine outpatient transplant assessment at Guy's and St Thomas' NHS Foundation Trust. Participants undergoing transplant assessment are randomised in a 1:1 ratio to either usual transplant assessment care or usual care supplemented by KT-CGA delivered by a clinician trained in geriatric principles.
The primary focus of the study is to assess the feasibility and acceptability of delivering KT-CGA within an established transplant assessment pathway. This includes evaluation of recruitment and retention processes, completeness of study assessments, fidelity of KT-CGA delivery, and acceptability to both patients and clinical staff.
Secondary objectives explore the clinical, service-level, and patient-centred consequences of KT-CGA, including its influence on transplant assessment processes, optimisation actions triggered by assessment findings, healthcare utilisation, and longer-term clinical and patient-reported outcomes. Outcomes are collected longitudinally over a two-year follow-up period to characterise trajectories before and after transplant listing and, where applicable, transplantation.
The study also incorporates a preliminary health economic evaluation to explore the feasibility of estimating costs and outcomes associated with KT-CGA. Pseudonymised data are securely shared with King's College London to support exploratory analyses of healthcare utilisation and quality-adjusted life years, informing the design of a future definitive economic evaluation.
Findings from this feasibility trial will inform the refinement of the KT-CGA intervention, outcome selection, and trial procedures, and will be used to support the design of a future multicentre randomised controlled trial evaluating the effectiveness and cost-effectiveness of KT-CGA in older kidney transplant candidates.
Inclusion Criteria:
Either:
Exclusion Criteria:
john.holland9@nhs.net+447307073144