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

Yohanna, Seychelle; Wilson, Mackenzie; Naylor, Kyla L.; Garg, Amit X.; Sontrop, Jessica M.; Belenko, Dmitri; Elliott, Lori; McKenzie, Susan; Macanovic, Sara; Mucsi, István; Patzer, Rachel E.; Voronin, Irina; Lui, Iris; Blake, Peter G.; Waterman, Amy D.; Treleaven, Darin; Presseau, Justin

doi:10.1177/20543581221084502

Cited by 2 publications

(5 citation statements)

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“…We acknowledge that it takes time to improve health care delivery and organize each transplant, and CKD programs faced many challenges during the COVID-19 pandemic. We are now completing a multimodal process evaluation to understand how the intervention can be improved . In the interim, we identified 2 staff-related opportunities.…”

Section: Discussionmentioning

confidence: 99%

“…We are now completing a multimodal process evaluation to understand how the intervention can be improved. 22 In the interim, we identified 2 staff-related opportunities. First, although many staff in CKD programs appreciated the support and resources, they indicated that growing patient-to-staff ratios meant they lacked time to enact this initiative fully.…”

Section: Discussionmentioning

confidence: 99%

“…Details are in the protocol, which features a recommended template to describe a complex intervention . The multicomponent intervention was codesigned by an 18-member panel to address complex barriers at multiple levels that prevent kidney transplant and living donation .…”

Section: Methodsmentioning

confidence: 99%

“…Details are in the protocol, which features a recommended template to describe a complex intervention. 5 , 21 , 22 The multicomponent intervention was codesigned by an 18-member panel to address complex barriers at multiple levels that prevent kidney transplant and living donation. 4 The panel had expertise in CKD, transplant, quality improvement, health care data, education, and patient support and included patients, health care staff, administrators, scientists, and representatives from CKD programs, transplant centers, and kidney and transplant government-funded agencies.…”

Section: Methodsmentioning

confidence: 99%

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Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation

Garg,

Yohanna,

Naylor

et al. 2023

JAMA Intern Med

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ImportancePatients 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.ObjectivesTo 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 ParticipantsThis 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).InterventionsUsing 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 MeasuresThe 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.ResultsThe 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 RelevanceThis 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 RegistrationClinicalTrials.gov Identifier: NCT03329521

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation

Garg,

Yohanna,

Naylor

et al. 2023

JAMA Intern Med

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“…We are also conducting a concurrent process evaluation using surveys and interviews to understand how the intervention was delivered in each CKD program, and we will ask respondents how the pandemic affected these activities. 20…”

Section: Statistical Principlesmentioning

confidence: 99%

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial

Dixon

Naylor

Yohanna

et al. 2022

Can J Kidney Health Dis

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Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the “clusters”). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the “registry”). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521 ). Statistical Analytic Plan: Version 1.0 August 26, 2022.

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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

Cited by 2 publications

References 31 publications

Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation

Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial

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