Yohanna Seychelle, Wilson Mackenzie, Naylor Kyla L, Garg Amit X, Sontrop Jessica M, Belenko Dmitri, Elliott Lori, McKenzie Susan, Macanovic Sara, Mucsi Istvan, Patzer Rachel, Voronin Irina, Lui Iris, Blake Peter G, Waterman Amy D, Treleaven Darin, Presseau Justin
Division of Nephrology, McMaster University, Hamilton ON, Canada.
St. Joseph's Healthcare Hamilton, ON, Canada.
Can J Kidney Health Dis. 2022 Mar 19;9:20543581221084502. doi: 10.1177/20543581221084502. eCollection 2022.
Many patients who would benefit from a kidney transplant never receive one. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) pragmatic, cluster-randomized clinical trial is testing whether a multi-component quality improvement intervention, provided in chronic kidney disease (CKD) programs (vs. usual care), can help patients with CKD with no recorded contraindications to kidney transplant complete more steps toward receiving a transplant (primary outcome of the trial). The EnAKT LKD intervention has 4 components: (1) quality Improvement teams and administrative support, (2) improved transplant education for patients and healthcare providers, (3) access to support and (4) program-level performance monitoring.
To conduct a process evaluation of the EnAKT LKD quality improvement intervention to determine if the components were delivered, received, and enacted as designed (fidelity), and if the intervention addressed intended barriers (mechanisms of change).
A mixed-methods process evaluation informed by new practice implementation and theories of behavior change.
Chronic kidney disease programs in Ontario, Canada, began receiving the EnAKT LKD intervention on November 1, 2017 and will continue to receive it until December 31, 2021. The process evaluation (interviews and surveys) will occur alongside the trial, between December 2020 to May 2021.
Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario's 27 CKD programs.
We will survey and interview healthcare providers at each CKD program, and complete an intervention implementation checklist. Quantitative data from the surveys and the intervention implementation checklist will assess fidelity to the intervention, while quantitative and qualitative data from surveys and interviews will provide insight into the mechanisms of change.
The long trial period may result in poor participant recall.
This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation.
Clinicaltrials.gov; identifier: NCT03329521.
许多能从肾移植中获益的患者从未接受过肾移植。“增强肾移植和活体肾捐赠可及性（EnAKT LKD）”实用型整群随机临床试验正在测试，在慢性肾脏病（CKD）项目中提供的多成分质量改进干预措施（与常规治疗相比）能否帮助没有肾移植记录禁忌症的CKD患者在接受移植方面完成更多步骤（该试验的主要结局）。EnAKT LKD干预措施有4个组成部分：（1）质量改进团队和行政支持，（2）改善患者和医疗服务提供者的移植教育，（3）获得支持，（4）项目层面的绩效监测。
对EnAKT LKD质量改进干预措施进行过程评估，以确定各组成部分是否按设计进行了交付、接受和实施（保真度），以及该干预措施是否解决了预期的障碍（改变机制）。
采用基于新实践实施和行为改变理论的混合方法过程评估。
加拿大安大略省的慢性肾脏病项目于2017年11月1日开始接受EnAKT LKD干预措施，并将持续接受至2021年12月31日。过程评估（访谈和调查）将在2020年12月至2021年5月期间与试验同步进行。
安大略省27个CKD项目的医疗服务提供者（如透析护士、肾病学家、多学科肾脏诊所团队成员）。
我们将对每个CKD项目的医疗服务提供者进行调查和访谈，并完成一份干预措施实施清单。来自调查和干预措施实施清单的定量数据将评估对干预措施的保真度，而来自调查和访谈的定量和定性数据将深入了解改变机制。
试验周期长可能导致参与者回忆不准确。
该过程评估将加强对试验结果的解读，指导干预措施组成部分的改进，并为未来的实施提供信息。
Clinicaltrials.gov；标识符：NCT03329521。
