The ASK trial: a randomised controlled feasibility trial and process evaluation of a complex multicomponent intervention to improve AccesS to living-donor Kidney transplantation

Background Following identification of barriers to living-donor kidney transplantation, and subsequent development of a multicomponent intervention, we undertook a feasibility trial of the intervention. Trial design Two-arm, parallel group, pragmatic, individually-randomised, controlled, feasibility trial, comparing the new intervention with usual care, with a mixed-methods parallel process evaluation. Based at two UK hospitals. Participants Individuals were eligible if ≥18 years old, active on the kidney transplant waiting list or had been referred for transplant listing without a contraindication to transplantation. Individuals with a living-donor undergoing surgical assessment were excluded. Intervention i) A meeting between a home educator 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; iii) A home-based education and family engagement session undertaken by a living kidney donor and a nurse specialist. Objective To establish the acceptability and feasibility i) of delivering the developed intervention in existing care pathways, and ii) of undertaking a randomised controlled trial of the intervention. Primary outcomes Recruitment and retention. Randomisation Participants were randomly allocated 1:1 to i) the intervention or ii) usual care, stratified by site. Minimisation was used to ensure balance in sex, age group, and socioeconomic strata, with probability weighting of 0.8. Results 183 people were invited to participate. 62 people (34% recruitment) were randomised. 62/62 (100%) completed nurse assessed follow-up at 6 weeks. 51/62 (82%) completed follow-up questionnaires. 3/30 (10%) in the usual care arm and 9/32 (28%) in the intervention arm had individuals ask to be tested for living kidney donation following recruitment to the trial. Conclusions Intervention and trial delivery are feasible and acceptable. Findings have informed the design of an effectiveness and cost-effectiveness trial. Trial registration ISRCTN Registry ISRCTN10989132 https://doi.org/10.1186/ISRCTN10989132. The trial was registered on 6/11/2020.