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Process Evaluation Alongside a Cluster-Randomized Trial of a Multicomponent Intervention Designed to Improve Patient Access to Kidney Transplantation

Cancer control : journal of the Moffitt Cancer Center(2025)SCI 4区

Division of Nephrology | Clinical Epidemiology Program | Department of Epidemiology & Biostatistics | Ontario Renal Network | University Health Network | Transplant Ambassador Program

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Abstract
Background: In a cluster-randomized trial, we learned that a novel multicomponent intervention designed to improve access to kidney transplantation did not significantly increase the rate of completed steps toward receiving a kidney transplant. Alongside the trial, we conducted a process evaluation to help interpret our findings. Objective: To determine whether the intervention addressed targeted barriers to transplant and whether the implementation occurred as planned. Design: Mixed-methods process evaluation informed by implementation science theories. Setting: Chronic kidney disease (CKD) programs in Ontario, Canada. These programs, providing care to patients with advanced CKD, participated in the trial from November 1, 2017 to December 31, 2021 (either in the intervention or usual care group). Participants: Health care providers (eg, nurses, managers) at Ontario’s 27 CKD programs. Methods: We conducted surveys (n = 114/162 [70.4%]) and semi-structured interviews (n = 17/26 [65.4%]) with providers in CKD programs in Ontario, Canada. In both the intervention-group and control-group surveys, using the Theoretical Domains Framework, we assessed perceived barriers to transplant and how barriers changed throughout the trial period. In the intervention-group surveys and interviews, using the normalization process theory, we assessed the extent to which the intervention was embedded into daily routines. In the intervention-group surveys, and by completing an implementation checklist, we assessed fidelity of implementation. Results: Perceived barriers to transplant did not substantially differ between providers in the intervention and usual care groups, and both groups reported disagreeing or feeling neutral that the targeted barriers impeded transplant access. Intervention-group providers reported that intervention activities were becoming a regular part of their work and that they engaged with its components. However, they also felt the intervention was complex and described needing more resources, a better execution plan, and more buy-in from frontline staff. Fidelity was high for administrative support, quality improvement teams, delivery of educational resources, and patient peer support. The use of performance reports was low. Conclusions: We identified several possible reasons why the intervention was unsuccessful. Improving access to kidney transplantation remains a high priority for health care systems. We will continue to foster a quality improvement culture, and our results will guide future interventions. Limitations: Two of the 13 intervention-group CKD programs did not participate in this evaluation. Trial Registration: ClinicalTrials.gov Identifier: NCT03329521
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要点】:本研究通过混合方法过程评估,探讨了旨在提高肾移植访问率的多组分干预措施是否解决了预定的移植障碍,并按计划实施,发现干预措施虽然被逐渐融入日常工作中,但复杂性和资源不足影响了其效果。

方法】:采用混合方法过程评估,包括实施科学理论指导的问卷调查和半结构化访谈,评估了干预措施在实施过程中的嵌入程度和忠实度。

实验】:在加拿大安大略省的27个慢性肾病(CKD)项目中,对健康保健提供者(如护士、管理者)进行了调查(n = 114/162 [70.4%])和半结构化访谈(n = 17/26 [65.4%]),使用理论领域框架评估感知到的移植障碍,并使用规范化过程理论评估干预措施在日常流程中的融入程度,同时通过实施清单评估实施忠实度。结果显示,干预组和常规护理组感知到的移植障碍没有显著差异,干预活动逐渐成为日常工作的一部分,但干预复杂性及资源需求影响了其效果。实施忠实度在行政支持、质量改进团队、教育资源的提供和患者同伴支持方面较高,但绩效报告的使用率低。