Enhance Access to Kidney Transplantation and Living Kidney Donation

End Stage Renal Disease Clinical Trial

— EnAKT LKD  

Official title:

Multicomponent Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: A Pragmatic, Registry-based, Cluster-Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329521
• Other study ID #: R-17-088
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared to dialysis, kidney transplantation is associated with improved survival, better quality of life and substantial cost savings to healthcare systems. Despite these advantages, many individuals with kidney failure will never receive a kidney transplant. A multicomponent intervention (vs. usual care) provided in chronic kidney disease (CKD) programs located in Ontario, Canada was developed to determine if it can enable more patients with no recorded contraindications to kidney transplant to complete more steps towards receiving a kidney transplant. These CKD programs provide care to individuals with CKD (including patients approaching the need for dialysis and patients receiving dialysis). The intervention has four main components: (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 (i.e. Transplant Ambassador Program); and (4) program-level performance reports and oversight by program leaders. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial will provide high-quality evidence on whether a multicomponent intervention helps patients complete more steps towards receiving a kidney transplant.

Description:

1. Statement of the health problem or issue: Compared with dialysis, a kidney transplant offers patients a better quality of life and many gain 10 or more years of life expectancy. A transplant also costs the healthcare system less-over a five-year period. Living donor transplants offer further advantages, including superior graft and patient survival compared with deceased donor transplants. Unfortunately, many patients with kidney failure who would benefit from a transplant will never receive one. There is a chronic shortage of organs from deceased donors, and in Canada, the rate of living donor kidney transplantation has stagnated. In addition to the shortage of transplantable kidneys, several other barriers impede patient access to transplantation.

2. Objective of your project: To determine if a multicomponent intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps towards receiving a kidney transplant.

3. How will you undertake your work? We will conduct a pragmatic two-arm, parallel-group, open-label, registry-based, cluster-randomized, superiority, clinical trial-the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Our study will include the 26 chronic kidney disease (CKD) programs in Ontario, Canada which are expected to care for over 10,000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant during the trial. Patients in 13 of the 26 CKD programs will receive a multicomponent intervention or usual care. The intervention has four main components: (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. Patients in the other 13 programs will receive usual care and will continue to receive support in accessing kidney transplantation and living kidney donation as usual.

4. What is unique/innovative about your project? An investigator usually needs to study a large number of patients in a clinical trial to reliably understand the effects of an intervention. Normally, a study with 10,000 patients would cost more than $10 million dollars to conduct; however, this study will provide a reliable answer to the question being asked and can be done at a fraction of the cost. This is because we will use data routinely collected by the healthcare system. The investigator will be able to analyze these healthcare data at the end of the study. This means that the study will cost less than a traditional clinical trial. Also unique to this trial, is that that the intervention was embedded and delivered in routine care.

This pragmatic trial includes all CKD programs in the province of Ontario. By including patients from a variety of backgrounds, the results of the trial should be broadly generalizable.

5. What is the impact of the proposed research? The EnAKT LKD trial will provide high-quality evidence on whether a multicomponent intervention helps patients complete more steps towards receiving a kidney transplant. This is important as compared to dialysis, kidney transplant offers patients a better quality of life and many gain 10 or more years of life expectancy. A transplant also costs the healthcare system less. If our intervention is successful, more transplants may ultimately be performed and result in improved survival and a better quality of life for patients with CKD. Kidney transplantation achieves the triple aim in healthcare: better outcomes, better experience of care, and lower costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

This is a pragmatic, two-arm, parallel-group, open-label, registry-based cluster randomized, superiority, clinical trial with eligibility criteria detailed below.

Inclusion Criteria:

• All 26 chronic kidney disease (CKD) programs in Ontario. These programs provide care for all chronic dialysis patients in the province. Each CKD program also provides a multi-care kidney clinic for patients with advanced CKD who are approaching the need for dialysis.

Exclusion Criteria:

• None. Including all Ontario CKD programs.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• Multicomponent intervention
Patients in 13 of the 26 CKD programs will receive a multicomponent intervention or usual care. The intervention has four main components: (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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences (ICES), Ontario Renal Network (part of Ontario Health), Trillium Gift of Life Network (part of Ontario Health)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Dixon SN, Naylor KL, Yohanna S, McKenzie S, Belenko D, Blake PG, Coghlan C, Cooper R, Elliott L, Getchell L, Ki V, Mucsi I, Nesrallah G, Patzer RE, Presseau J, Reich M, Sontrop JM, Treleaven D, Waterman AD, Zaltzman J, Garg AX. 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. doi: 10.1177/20543581221131201. eCollection 2022. — View Citation

Garg AX, Yohanna S, Naylor KL, McKenzie SQ, Mucsi I, Dixon SN, Luo B, Sontrop JM, Beaucage M, Belenko D, Coghlan C, Cooper R, Elliott L, Getchell L, Heale E, Ki V, Nesrallah G, Patzer RE, Presseau J, Reich M, Treleaven D, Wang C, Waterman AD, Zaltzman J, Blake PG. 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 Nov 3. doi: 10.1001/jamainternmed.2023.5802. Online ahead of print. — View Citation

Naylor KL, McKenzie SQ, Garg AX, Yohanna S, Sontrop JM. Partnering with Patients to Enhance Access to Kidney Transplantation and Living Kidney Donation. Healthc Q. 2022 Apr;24(SP):69-73. doi: 10.12927/hcq.2022.26771. — View Citation

Yohanna S, Naylor KL, Mucsi I, McKenzie S, Belenko D, Blake PG, Coghlan C, Dixon SN, Elliott L, Getchell L, Ki V, Nesrallah G, Patzer RE, Presseau J, Reich M, Sontrop JM, Treleaven D, Waterman AD, Zaltzman J, Garg AX. 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. doi: 10.1177/2054358121997266. eCollection 2021. — View Citation

Yohanna S, Wilson M, Naylor KL, Garg AX, Sontrop JM, Belenko D, Elliott L, McKenzie S, Macanovic S, Mucsi I, Patzer R, Voronin I, Lui I, Blake PG, Waterman AD, Treleaven D, Presseau J. 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. doi: 10.1177/20543581221084502. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of deceased donor kidney transplant	Rate of deceased donor kidney transplant censoring at receipt of a living donor kidney transplant and at the censoring events included in the main trial analysis (i.e., emigration, trial end date [December 31, 2021], death, evidence of recovered kidney function, or on the date a recorded contraindication to transplant occurs [with the exception of age >75]).	4.17 years
Other	Average number of months from the date of dialysis initiation (i.e. trial entry) to the date of referral	This outcome is assessed in patients receiving maintenance dialysis who were referred to a transplant centre.	4.17 years
Other	Rate of living kidney donor transplants	This outcome is assessed in patients waitlisted for a deceased donor kidney transplant and censored at receipt of a deceased donor kidney transplant and at the censoring events included in the main trial analysis (i.e., emigration, trial end date [December 31, 2021], death, evidence of recovered kidney function, or on the date a recorded contraindication to transplant occurs [with the exception of age >75]).	4.17 years
Other	Proportion of pre-emptive transplants	This outcome is assessed in recipients of a living kidney donor transplant and restricted to patients who were not receiving dialysis when they entered the trial and not on dialysis at the time of transplant.	4.17 years
Other	Average number of months from the date of referral to a transplant center to the date the first living donor candidate contacts the transplant centre for the intended recipient	This outcome is assessed in recipients of a living kidney donor transplant.	4.17 years
Other	Average number of months from the date of referral to a transplant center to date of the transplant surgery	This outcome is assessed in recipients of a living or deceased donor kidney transplant.	4.17 years
Primary	Completing key steps toward receiving a kidney transplant	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 wait list, and (4) patient receives a kidney transplant from a living or deceased donor.	4.17 years
Secondary	A potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient and/or a patient receives a living donor transplant.	Given that the average wait time for a deceased donor kidney transplant is five years on average in Ontario, our intervention is likely to have only a small impact on the rate of deceased donor kidney transplants. For this reason, we have pre-specified five secondary outcomes to examine the impact of our intervention on living kidney donor transplant activity.	4.17 years
Secondary	Time to first occurrence of a potential living kidney donor beginning their evaluation at a transplant center to donate a kidney to the patient.	Secondary outcome selected to understand living kidney donor transplant activity.	4.17 years
Secondary	A transplant center receives a patient's complete referral package from a chronic kidney disease program and at least one potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient.	Secondary outcome selected to understand living kidney donor transplant activity.	4.17 years
Secondary	A patient receives a living donor kidney transplant	Secondary outcome selected to understand living kidney donor transplant activity.	4.17 years
Secondary	A patient receives a pre-emptive living donor kidney transplant (restricted to patients who were not receiving dialysis when they entered the trial and not on dialysis at the time of transplant).	Secondary outcome selected to understand living kidney donor transplant activity.	4.17 years