Abstract
Background
The UK’s living-donor kidney transplant (LDKT) activity falls behind that of many other countries internationally, with less than 20% of those eligible receiving a LDKT each year. Certain individuals with kidney disease in the UK appear to be particularly disadvantaged in accessing a LDKT; the most socioeconomically deprived people with kidney disease are 60% less likely to receive a LDKT than the least deprived. Improving equity in living-donor kidney transplantation has been highlighted as an international research priority.
Methods
This feasibility trial was designed to determine the feasibility of delivery and acceptability of a multicomponent intervention designed to improve access to living-donor kidney transplantation. The intervention comprises three main components: (i) a meeting between a home educator and the transplant candidate for a dedicated discussion about living-donor kidney transplantation, living kidney donation and potential donors; (ii) a standardized letter from a healthcare professional to a candidate’s potential donors and (iii) a home-based education and family engagement session including two home educators, the transplant candidate and their family. The primary objectives are to establish the feasibility (i) of delivering the developed intervention in existing care pathways and (ii) of undertaking a randomised controlled trial of the intervention. A mixed-methods parallel process evaluation will investigate the acceptability, implementation and mechanisms of impact of the intervention. The trial is based at two UK hospitals: a transplanting hospital and a non-transplanting referral hospital. Individuals are eligible if they are ≥ 18 years old, are active on the kidney transplant waiting list or have been referred for transplant listing and do not have a potential living-donor undergoing surgical assessment. Randomisation will be undertaken with concealed allocation. Participants will be randomly allocated 1:1 to (i) the intervention or (ii) usual care, stratified by site to ensure a balance in terms of local differences. Minimisation will be used to ensure balance in sex, age group and socioeconomic strata, with probability weighting of 0.8 in order to reduce predictability. The primary outcomes are recruitment (% of those eligible and invited who consent to randomisation) and retention (% of participants completing follow-up).
Discussion
Findings will inform the design of a future fully powered, randomised controlled trial to formally evaluate the effectiveness of the intervention at improving equitable access to living-donor kidney transplantation.
The UK’s living-donor kidney transplant (LDKT) activity falls behind that of many other countries internationally, with less than 20% of those eligible receiving a LDKT each year. Certain individuals with kidney disease in the UK appear to be particularly disadvantaged in accessing a LDKT; the most socioeconomically deprived people with kidney disease are 60% less likely to receive a LDKT than the least deprived. Improving equity in living-donor kidney transplantation has been highlighted as an international research priority.
Methods
This feasibility trial was designed to determine the feasibility of delivery and acceptability of a multicomponent intervention designed to improve access to living-donor kidney transplantation. The intervention comprises three main components: (i) a meeting between a home educator and the transplant candidate for a dedicated discussion about living-donor kidney transplantation, living kidney donation and potential donors; (ii) a standardized letter from a healthcare professional to a candidate’s potential donors and (iii) a home-based education and family engagement session including two home educators, the transplant candidate and their family. The primary objectives are to establish the feasibility (i) of delivering the developed intervention in existing care pathways and (ii) of undertaking a randomised controlled trial of the intervention. A mixed-methods parallel process evaluation will investigate the acceptability, implementation and mechanisms of impact of the intervention. The trial is based at two UK hospitals: a transplanting hospital and a non-transplanting referral hospital. Individuals are eligible if they are ≥ 18 years old, are active on the kidney transplant waiting list or have been referred for transplant listing and do not have a potential living-donor undergoing surgical assessment. Randomisation will be undertaken with concealed allocation. Participants will be randomly allocated 1:1 to (i) the intervention or (ii) usual care, stratified by site to ensure a balance in terms of local differences. Minimisation will be used to ensure balance in sex, age group and socioeconomic strata, with probability weighting of 0.8 in order to reduce predictability. The primary outcomes are recruitment (% of those eligible and invited who consent to randomisation) and retention (% of participants completing follow-up).
Discussion
Findings will inform the design of a future fully powered, randomised controlled trial to formally evaluate the effectiveness of the intervention at improving equitable access to living-donor kidney transplantation.
| Original language | English |
|---|---|
| Article number | 13 |
| Number of pages | 13 |
| Journal | Pilot and Feasibility Studies |
| Volume | 9 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 20 Jan 2023 |
Bibliographical note
Funding Information:The study is sponsored by the University of Bristol. The sponsor as the employer of the CI is responsible for study design, study conduct, data analysis and interpretation. The study funders reviewed the study design at the time of application for funding but were not involved in study design and will not be involved in the study’s conduct, data analysis and interpretation or manuscript writing.
Funding Information:
The study is funded by a Wellcome Trust Clinical Research Career Development Fellowship (Reference 214554/Z/18/Z) and a Kidney Care UK Project Grant.
Publisher Copyright:
© 2023, The Author(s).
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Additional file 1 of Investigating strategies to improve AccesS to Kidney transplantation (the ASK trial): a protocol for a feasibility randomised controlled trial with parallel process evaluation
Bailey, P. K. (Creator), Caskey, F. J. (Creator), MacNeill, S. J. (Creator), Ashford, R. J. (Creator), Pryce, L. (Creator), Kayler, L. (Creator) & Ben-Shlomo, Y. (Creator), figshare, 13 Apr 2023
DOI: 10.6084/m9.figshare.22607539, https://springernature.figshare.com/articles/dataset/Additional_file_1_of_Investigating_strategies_to_improve_AccesS_to_Kidney_transplantation_the_ASK_trial_a_protocol_for_a_feasibility_randomised_controlled_trial_with_parallel_process_evaluation/22607539 and one more link, https://springernature.figshare.com/articles/dataset/Additional_file_1_of_Investigating_strategies_to_improve_AccesS_to_Kidney_transplantation_the_ASK_trial_a_protocol_for_a_feasibility_randomised_controlled_trial_with_parallel_process_evaluation/22607539/1 (show fewer)
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