The ASK trial: improving AccesS to Kidney Transplantation
Research type
Research Study
Full title
The ASK trial: a feasibility trial of strategies to improve AccesS to Kidney transplantation
IRAS ID
287507
Contact name
Pippa Bailey
Contact email
Sponsor organisation
The University of Bristol
ISRCTN Number
ISRCTN10989132
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary:
A living-donor kidney transplant (LDKT) describes a transplant in which a kidney has been donated to a person with kidney disease from another living person, usually a relative or friend. It is one of the best treatments for people whose own kidneys have failed.Sometimes hospital teams help people who have kidney disease to find someone who might want to give them a kidney. However, we don’t know if this extra help does increase someone’s chance of getting a kidney transplant, or whether it doesn’t. This study is the first step in understanding if the extra support is helpful and whether it is something the NHS should fund across the UK.
This study aims to test a programme of support that is designed to support people to have a LDKT, if this is something they would like. The support offered includes simple-language patient and family information, letters from doctors to family and friends introducing the option of kidney donation, and home engagement and education visits.The study will find out:
• whether the programme of support is acceptable to patients and their families
• whether the support can be delivered in practice as intended, and the impact on other healthcare services, and
• the predicted costs of delivering the support.If this study shows that the programme of care can be delivered in the NHS and is acceptable to people with kidney disease and their families, we will carry out a larger trial to see whether the support offered actually helps people to receive a LDKT.
Summary of Results:
Introduction The UK’s living-donor kidney transplant (LDKT) activity falls behind that of many other countries: less than 20% of those eligible receive a LDKT each year. There is socioeconomic and ethnic inequity in LDKT access.
We have developed a multicomponent patient and family outreach service combining approaches used in other countries (Norway/The Netherlands/USA). Existing randomised controlled trials (RCTs) of home-based family engagement were underpowered to demonstrate effectiveness at increasing LDKTs. We aimed to determine the feasibility of intervention delivery in the UK, and of undertaking a definitive effectiveness RCT.Methods
The intervention comprised:
• a meeting with a LDKT educator to discuss LDKTs, living kidney donation and potential donors
• written outreach to a candidate’s potential donors
• home-based family education and engagement delivered by a nurse LDKT educator and a living donor.
The trial was based at two hospitals. Adult transplant candidates were eligible. Participants were randomised with concealed allocation 1:1 intervention:usual care, stratified by site. Minimisation was used to ensure balance in sex, age, and socioeconomic strata. Primary outcomes were recruitment and retention.Results
Recruitment was 34% (62/183). We over-recruited individuals of UK minority ethnicity, and achieved a population representative sample with respect to sex, age and socioeconomic status.
100% of participants completed nurse-assessed follow-up. 81% of participants completed follow-up questionnaires. The feasibility trial was not powered to determine intervention effectiveness, but findings will inform the sample-size calculation for the effectiveness RCT. At time of submission, 28% (9/32) of intervention participants had people undergoing donor assessment, compared to 10% (3/30) receiving usual care. 6% (2/32) of intervention participants have received a LDKT, compared to 0% receiving usual care.Discussion
This feasibility trial demonstrated population reach, and determined the parameters required to design an RCT to evaluate the effectiveness of the intervention at improving access to living-donor kidney transplantation.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0003
Date of REC Opinion
11 Feb 2021
REC opinion
Further Information Favourable Opinion