ASK试验：一项随机对照可行性试验及对一项复杂多组分干预措施的过程评估，以改善活体供肾移植的可及性。
The ASK trial: a randomised controlled feasibility trial and process evaluation of a complex multicomponent intervention to improve AccesS to living-donor Kidney transplantation.
作者信息
Bailey Pippa, Caskey Fergus, Babu Adarsh, Ashford Rachel, Pryce Lindsay, Selman Lucy, Kayler Liise, Ben-Shlomo Yoav
机构信息
Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, England, UK.
Southmead Hospital, North Bristol NHS Trust, Westbury on Trym, England, UK.
出版信息
Wellcome Open Res. 2024 Oct 29;9:628. doi: 10.12688/wellcomeopenres.22631.1. eCollection 2024.
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.
背景
在确定活体供肾移植的障碍并随后制定多成分干预措施后，我们对该干预措施进行了可行性试验。
试验设计
双臂、平行组、实用、个体随机、对照的可行性试验，将新干预措施与常规护理进行比较，并进行混合方法的平行过程评估。试验在英国的两家医院进行。
参与者
年龄≥18岁、在肾移植等待名单上活跃或已被转介进行移植登记且无移植禁忌症的个体符合条件。正在接受活体供体手术评估的个体被排除在外。
干预措施
i）由家庭教育者进行一次会议，专门讨论活体供肾移植、活体肾捐赠和潜在捐赠者；ii）医疗保健专业人员给候选人潜在捐赠者的一封标准化信件；iii）由活体肾捐赠者和护士专家进行一次居家教育和家庭参与活动。
目的
确定i）在现有护理途径中实施已开发的干预措施，以及ii）对该干预措施进行随机对照试验的可接受性和可行性。
主要结局
招募和保留情况。
随机化
参与者按1:1随机分配到i）干预组或ii）常规护理组，按地点分层。采用最小化法确保性别、年龄组和社会经济阶层的平衡，概率加权为0.8。
结果
183人被邀请参与。62人（招募率34%）被随机分组。62/62（100%）完成了6周时护士评估的随访。51/62（82%）完成了随访问卷。在常规护理组中，3/30（10%）的个体在试验招募后要求进行活体肾捐赠检测；在干预组中，9/32（28%）的个体有此要求。
结论
干预措施和试验实施是可行且可接受的。研究结果为有效性和成本效益试验的设计提供了依据。
试验注册
ISRCTN注册库ISRCTN10989132 https://doi.org/10.1186/ISRCTN10989132。该试验于2020年11月6日注册。
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