TY - JOUR
T1 - Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation
T2 - The EnAKT LKD Cluster Randomized Clinical Trial
AU - Garg, Amit X
AU - Yohanna, Seychelle
AU - Naylor, Kyla L
AU - McKenzie, Susan Q
AU - Mucsi, Istvan
AU - Dixon, Stephanie N
AU - Luo, Bin
AU - Sontrop, Jessica M
AU - Beaucage, Mary
AU - Belenko, Dmitri
AU - Coghlan, Candice
AU - Cooper, Rebecca
AU - Elliott, Lori
AU - Getchell, Leah
AU - Heale, Esti
AU - Ki, Vincent
AU - Nesrallah, Gihad
AU - Patzer, Rachel E
AU - Presseau, Justin
AU - Reich, Marian
AU - Treleaven, Darin
AU - Wang, Carol
AU - Waterman, Amy D
AU - Zaltzman, Jeffrey
AU - Blake, Peter G
N1 - Funding Information:
Conflict of Interest Disclosures: Dr Garg is supported by the Dr Adam Linton Chair in Kidney Health Analytics, a Clinician Investigator Award from the Canadian Institutes of Health Research (CIHR), a Clinician Research Salary Award from the CIHR, and has received partnership grant funding from Astellas Canada for research grants funded by the CIHR. Dr Yohanna received partnership grant funding from Astellas Canada for a research grant funded by the CIHR. SQ McKenzie received partnership grant funding from Astellas Canada for a research grant funded by the CIHR. I Mucsi is supported by investigator-initiated grants from CIHR, the Kidney Foundation of Canada, the Canadian Donation and Transplant Research Program, the Health Canada Health Policy Contribution Program, and the Mount Sinai Hospital-University Health Network Academic Medical Organization Innovation Funding; he also received an unrestricted education grant from Astellas Canada to adapt the Explore Transplant education program to the Ontario setting and from Paladin Labs, Inc; Canada, to develop a self-management support website. C Wang is supported by the Clinician Investigator Program in the Schulich School of Medicine and Dentistry at Western University, an award from the Physician Services Incorporated Foundation, and an Academic Realignment Clinical Fellowship from the London Health Sciences Centre.
Funding Information:
Funding/Support: We thank the Executive Committee of Can-SOLVE CKD (Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease), a patient-orientated research network to transform the care of people affected by kidney disease ( https://cansolveckd.ca/ ). We acknowledge the work of the Provincial Access to Kidney Transplantation and Living Donation Priority Panel and the Ontario Renal Network–Trillium Gift of Life Partnership. This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care (MLTC). The study was completed at the ICES Western site, where core funding is provided by the Academic Medical Organization of Southwestern Ontario, the Schulich School of Medicine and Dentistry, Western University, and the Lawson Health Research Institute. The research was conducted by members of the ICES Kidney, Dialysis, and Transplantation team, at the ICES Western facility. Parts of this material are based on data and/or information compiled and provided by the Canadian Institute for Health Information (CIHI) and the Ontario Ministry of Health. This study used data adapted from the Statistics Canada Postal Code Conversion File, which is based on data licensed from Canada Post Corporation, and/or data adapted from the Ontario Ministry of Health Postal Code Conversion File, which contains data copied under license from Canada Post Corporation and Statistics Canada. The authors acknowledge that the data used in this study were provided by the Trillium Gift of Life Network (Ontario Health), 2022; Toronto, Ontario. The researcher’s interpretations and statements in this publication are those of the researcher only and not those of Trillium Gift of Life Network (Ontario Health). Other parts of this material are based on data and information provided by Ontario Health (OH). The opinions, results, views, and conclusions reported in this article are those of the authors and do not necessarily reflect those of OH. No endorsement by OH is intended or should be inferred. We thank the Toronto Community Health Profiles Partnership for providing access to the Ontario Marginalization Index. Astellas Pharma Canada, Inc, provided partial funding to mass produce the educational program Explore Transplant Ontario and for the transplant ambassador program. OM
Publisher Copyright:
© 2023 American Medical Association. All rights reserved.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - IMPORTANCE: Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.OBJECTIVES: To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).INTERVENTIONS: Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.MAIN OUTCOMES AND MEASURES: The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.RESULTS: The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).CONCLUSIONS AND RELEVANCE: This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03329521.
AB - IMPORTANCE: Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.OBJECTIVES: To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).INTERVENTIONS: Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.MAIN OUTCOMES AND MEASURES: The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.RESULTS: The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).CONCLUSIONS AND RELEVANCE: This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03329521.
KW - Humans
KW - Kidney
KW - Kidney Transplantation
KW - Ontario
KW - Renal Dialysis
KW - Renal Insufficiency, Chronic/surgery
KW - Systems Analysis
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U2 - 10.1001/jamainternmed.2023.5802
DO - 10.1001/jamainternmed.2023.5802
M3 - Article
C2 - 37922156
SN - 2168-6106
VL - 183
SP - 1366
EP - 1375
JO - JAMA Internal Medicine
JF - JAMA Internal Medicine
IS - 12
ER -