TY - JOUR
T1 - Protocol for a Process Evaluation of the Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) Cluster-Randomized Clinical Trial
AU - Yohanna, Seychelle
AU - Wilson, Mackenzie
AU - Naylor, Kyla L.
AU - Garg, Amit X.
AU - Sontrop, Jessica M.
AU - Belenko, Dmitri
AU - Elliott, Lori
AU - McKenzie, Susan
AU - Macanovic, Sara
AU - Mucsi, Istvan
AU - Patzer, Rachel
AU - Voronin, Irina
AU - Lui, Iris
AU - Blake, Peter G.
AU - Waterman, Amy D.
AU - Treleaven, Darin
AU - Presseau, Justin
N1 - Funding Information:
The authors thank Drs. Adeera Levin and Braden Manns for leading Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD), a patient-oriented research network to transform the care of people affected by kidney disease. They thank the Access to Kidney Transplantation and Living Donation Priority Panel and the ORN-TGLN Partnership Core Project Team. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study is funded/sponsored by the Ontario Renal Network (part of Ontario Health) and the Canadian Institutes of Health Research (CIHR) SPOR Networks in Chronic Disease (Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease [Can-SOLVE CKD]). Astellas Pharma Canada Inc. provided partial funding for the delivery of Explore Transplant Ontario educational program. A.X.G. is supported by the Dr. Adam Linton Chair in Kidney Health Analytics and a Clinician Investigator Award from the Canadian Institutes of Health Research.
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study is funded/sponsored by the Ontario Renal Network (part of Ontario Health) and the Canadian Institutes of Health Research (CIHR) SPOR Networks in Chronic Disease (Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease [Can-SOLVE CKD]). Astellas Pharma Canada Inc. provided partial funding for the delivery of Explore Transplant Ontario educational program. A.X.G. is supported by the Dr. Adam Linton Chair in Kidney Health Analytics and a Clinician Investigator Award from the Canadian Institutes of Health Research.
Publisher Copyright:
© The Author(s) 2022.
PY - 2022/3
Y1 - 2022/3
N2 - Background: 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. Objective: 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). Design: A mixed-methods process evaluation informed by new practice implementation and theories of behavior change. Setting: 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. Participants: Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario’s 27 CKD programs. Methods: 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. Limitations: The long trial period may result in poor participant recall. Conclusion: This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.
AB - Background: 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. Objective: 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). Design: A mixed-methods process evaluation informed by new practice implementation and theories of behavior change. Setting: 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. Participants: Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario’s 27 CKD programs. Methods: 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. Limitations: The long trial period may result in poor participant recall. Conclusion: This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.
KW - chronic kidney disease
KW - fidelity
KW - kidney transplantation
KW - living kidney donation
KW - mechanisms of change
KW - normalization process theory
KW - process evaluation
KW - protocol
KW - theoretical domains framework
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U2 - 10.1177/20543581221084502
DO - 10.1177/20543581221084502
M3 - Article
AN - SCOPUS:85127794451
SN - 2054-3581
VL - 9
JO - Canadian Journal of Kidney Health and Disease
JF - Canadian Journal of Kidney Health and Disease
ER -