The ASK Trial: a hybrid effectiveness-implementation trial of a patient and family outreach service to improve AccesS to living-donor Kidney transplantation

Research question Does a patient and family outreach service improve access to living-donor kidney transplantation and is it cost-effective? Background A living-donor kidney transplant (LDKT) describes a transplant in which a healthy living person donates a kidney to someone with kidney failure. It is one of the best treatments for kidney failure. Living kidney donors are usually relatives or friends of someone with kidney disease. The risks to the donor of donating a kidney are very small. The UK’s LDKT activity falls behind that of many other countries including the USA and the Netherlands: less than 20% of those eligible receive a LDKT each year. There is also evidence of socioeconomic and ethnic inequity. Improving equity in living-donor kidney transplantation has been highlighted as an international research priority. In some countries hospital teams try to help people who need a kidney transplant to find a relative or friend who might want to give them a kidney. This is not standard practice in the UK. We have developed, adapted, and undertaken a feasibility trial of a support and outreach service combining approaches used in other countries. We do not know if this service is effective or cost-effective. Aims and objectives This study will test whether the developed support and outreach service is effective at helping people to receive a LDKT, if it increases equitable access, if it is cost-effective, and if it is something the NHS should provide in the UK. Methods People with kidney disease who take part in the study will be randomised to one of two groups. People in Group 1 will receive usual NHS care. People in Group 2 will receive the following care that might increase their chances of getting a LDKT: • Potential donor identification: A meeting with a LDKT nurse specialist to elicit any personal barriers to LDKT, and to discuss their network of family and friends and their possible suitability for donation. • NHS outreach to potential donors: A letter from a hospital doctor to their family and friends about kidney donation and how to donate. • Home-based family engagement and education: A LDKT nurse specialist and a kidney donor visit the participant and their family at home, to talk about kidney disease, transplantation and what it is like to donate a kidney. Our feasibility trial of 62 people at 2 NHS hospitals demonstrated that the intervention and trial methods were acceptable and feasible to deliver. In this effectiveness trial we will study 592 people at 20 hospitals. At the end of the study we will look at hospital records to see if people in Group 2 are more likely to have a LDKT than people in Group 1. Timelines for delivery Months 1-8: Preparation and site approvals Months 9-37: Recruitment at 20 sites Months 38-55: Follow-up and process evaluation interviews Months 56-60: Analysis and publications Anticipated impact and dissemination Findings will directly benefit people with kidney failure. If the outreach service is effective, increased LDKT activity will improve recipients’ quality of life and survival. It will increase equitable access and, if cost-effective, result in economic savings for the NHS. Findings will be shared with patients, families, healthcare professionals and policymakers via: • patient charities and kidney patient associations • a study website and social media • national and international medical conferences • published research and visual abstracts • NHS Blood and Transplant media