Featured Module (Archived)
(Week of July 22, 2024)
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A new Exemplar Trial educational offering has been posted (1-1.5 hours of primary open access content). Modules include a general overview of the pragmatic trial (backgrounds, methods, results, discussion) and a discussion of the trial using all 12 sections of the curriculum wheel. This website will be updated every Monday (by 12:00 PM Eastern) or Tuesday (if Monday is a holiday).
This exemplar trial, under the direction of Dr. Amit Garg (London Health Sciences Centre, ICES, Western University), is titled: Effect of a multicomponent intervention to improve patient access to kidney transplant and living kidney donation: a pragmatic, cluster-randomized trial (EnAKT LKD).
Exemplar Trial
Effect of a multicomponent intervention to improve patient access to kidney transplant and living kidney donation: a pragmatic, cluster-randomized trial (EnAKT LKD)
Primary resources:
Primary resources:
Exemplar Trial Intro - EnAKT LKD: 2-min video.
Summary: Dr. Amit Garg introduces the exemplar EnAKT LKD pragmatic trial and the curriculum wheel.Â
Garg AX, et al. Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1366-1375. Erratum in: JAMA Intern Med. Feb 1;184(2):228. (10-page paper, 13-min video, & 33-slide presentation)
Summary: Dr. Amit Garg overviews EnAKT LKD, a pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial 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.
Exemplar Trial - EnAKT LKD: 12-min video & 14-slide presentation.
Summary: Dr. Amit Garg breaks down the EnAKT LKD trial across the 12 sections of the curriculum wheel.
Optional resources:
Optional resources:
Garg AX, et al. Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD). ClinicalTrials.gov identifier: NCT03329521. Updated 2023-11-09. (8-section website)
Summary: Public registration of the trial (i.e., study overview, contacts and locations, study plan, collaborators and investigators, publications, study record dates).
Yohanna S, et al. A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2021 Apr 15;8:2054358121997266. (18-page paper)
Summary: Trial protocol describing a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial - the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial.
Dixon SN, et al. Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2022 Nov 22;9:20543581221131201. (9-page paper)
Summary: Prespecified statistical analysis plan for the EnAKT LKD trial (i.e., using an intent-to-treat approach, the primary outcome was analyzed using a patient-level constrained multistate model adjusting for the clustering in chronic kidney disease programs).
Naylor KL, et al. Partnering with Patients to Enhance Access to Kidney Transplantation and Living Kidney Donation. Healthc Q. 2022 Apr;24(SP):69-73. (5-page paper)
Summary: Describes how patients and researchers collaborated on new strategies and programs to enhance access to kidney transplantation and living kidney donation.
Yohanna S, et al. 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. Can J Kidney Health Dis. 2022 Mar 19;9:20543581221084502. (13-page paper)
Summary: A protocol for a mixed-methods process evaluation of the four-component EnAKT LKD intervention: (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.
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