Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial.

Autor:	Garg AX; Division of Nephrology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; ICES, Ontario, Canada.; Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.; Kidney Patient & Donor Alliance, Canada.; Transplant Ambassador Program, Ontario, Canada., Yohanna S; Division of Nephrology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada., Naylor KL; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; ICES, Ontario, Canada.; Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada., McKenzie SQ; Kidney Patient & Donor Alliance, Canada.; Transplant Ambassador Program, Ontario, Canada., Mucsi I; Ajmera Transplant Centre, University Health Network, Toronto, Ontario, Canada.; Division of Nephrology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada., Dixon SN; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; ICES, Ontario, Canada.; Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada., Luo B; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; ICES, Ontario, Canada., Sontrop JM; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada., Beaucage M; Patient Governance Circle, Indigenous Peoples Engagement and Research Council and Executive Committee, Can-Solve CKD, Vancouver, British Columbia, Canada.; Provincial Patient and Family Advisory Council, Ontario Renal Network, Toronto, Ontario, Canada.; Patient co-lead Theme 1-Improve a Culture of Donation, Canadian Donation and Transplantation Research Program, Edmonton, Alberta, Canada., Belenko D; Division of Nephrology, University of Toronto, Toronto, Ontario, Canada., Coghlan C; Centre for Living Organ Donation, University Health Network, Toronto, Ontario, Canada., Cooper R; Ontario Renal Network, Toronto, Ontario, Canada.; Trillium Gift of Life Network, Ontario Health, Toronto, Ontario, Canada., Elliott L; Ontario Renal Network, Ontario Health, Toronto, Ontario, Canada., Getchell L; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; Can-SOLVE CKD Network, Vancouver BC, Canada., Heale E; Ontario Renal Network, Ontario Health, Toronto, Ontario, Canada., Ki V; Ontario Renal Network, Ontario Health, Toronto, Ontario, Canada.; Trillium Health Partners, Mississauga, Ontario, Canada., Nesrallah G; Division of Nephrology, University of Toronto, Toronto, Ontario, Canada.; Department of Medicine, Humber River Regional Hospital, Toronto, Ontario, Canada., Patzer RE; Regenstrief Institute, Indianapolis, Indiana.; Department of Surgery, Division of Transplantation, Indiana University School of Medicine, Indianapolis., Presseau J; Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Ontario, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ontario, Canada., Reich M; Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-Solve CKD), Patient Council, Vancouver, British Columbia, Canada., Treleaven D; Trillium Gift of Life Network, Ontario Health, Toronto, Ontario, Canada.; McMaster University, Hamilton, Ontario, Canada., Wang C; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; Division of Nephrology, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.; Department of Research Methods, Evidence and Uptake, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada., Waterman AD; Department of Surgery and J.C. Walter Jr. Transplant Center, Houston Methodist Hospital, Houston, Texas., Zaltzman J; Trillium Gift of Life Network, Ontario Health, Toronto, Ontario, Canada.; Division of Nephrology, St. Michael's Hospital, Toronto, Ontario, Canada., Blake PG; Lawson Health Research Institute and London Health Sciences Centre, London, Ontario, Canada.; Ontario Renal Network, Ontario Health, Toronto, Ontario, Canada.; Division of Nephrology, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	JAMA internal medicine [JAMA Intern Med] 2023 Dec 01; Vol. 183 (12), pp. 1366-1375.
DOI:	10.1001/jamainternmed.2023.5802
Abstrakt:	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.
Databáze:	MEDLINE
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