EnAKT LKD: Enhance Access to Kidney Transplantation and Living Kidney Donation

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03329521

Collaborator

Institute for Clinical Evaluative Sciences (Other), Canadian Institutes of Health Research (CIHR) (Other), Ontario Renal Network (part of Ontario Health) (Other), Trillium Gift of Life Network (part of Ontario Health) (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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 multi-component quality improvement 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) local quality improvement teams and administrative support; (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 multi-component quality improvement intervention helps patients complete more steps towards receiving a kidney transplant.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Kidney Failure End Stage Renal Disease	Other: Multi-component quality improvement intervention	N/A

Detailed Description

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.
Objective of your project: To determine if a quality improvement 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.
How will you undertake your work? We will conduct a pragmatic two-arm, parallel-group, open-label, registry-based, cluster-randomized 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 quality improvement intervention or usual care. The intervention has four main components: (1) local quality improvement teams and administrative support; (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 support access to kidney transplantation and living kidney donation as usual.
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 a treatment. 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 already 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.

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.

What is the impact of the proposed research? The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Quality Improvement 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

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multi-component quality improvement intervention A multi-component quality improvement intervention will be provided at chronic kidney disease (CKD) programs.	Other: Multi-component quality improvement intervention Patients in 13 of the 26 CKD programs will receive a quality improvement intervention or usual care. The intervention has four main components: (1) local quality improvement teams and administrative support; (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.
No Intervention: Usual Care CKD programs will continue to support access to kidney transplantation and living kidney donation as they usually do for CKD patients.

Arm

Intervention/Treatment

Experimental: Multi-component quality improvement intervention

A multi-component quality improvement intervention will be provided at chronic kidney disease (CKD) programs.

Other: Multi-component quality improvement intervention

Patients in 13 of the 26 CKD programs will receive a quality improvement intervention or usual care. The intervention has four main components: (1) local quality improvement teams and administrative support; (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.

No Intervention: Usual Care

CKD programs will continue to support access to kidney transplantation and living kidney donation as they usually do for CKD patients.

Outcome Measures

Primary Outcome Measures

Number of key steps completed towards receiving a kidney transplant [4.1 years]
The average number of key steps completed towards receiving a kidney transplant per 100 person-years during the trial period and analyzed at the cluster-level (chronic kidney disease program). Each step will only be counted once per patient (the first time it occurs), and each patient can contribute a maximum of four steps to their group total. The four steps include: Step I: patient referred to a transplant centre for evaluation, Step II: at least one living kidney donor candidate contacts a transplant centre for an intended recipient and completes a health history questionnaire to begin their evaluation, Step III: patient added to the deceased donor transplant wait list, and Step IV: patient receives a kidney transplant from a living or deceased donor. Patients who complete steps before the trial starts can contribute new steps during the trial period.

Secondary Outcome Measures

A living donor candidate contacts a transplant centre for a patient and completes a health history questionnaire to begin their evaluation or a patient receives a living donor transplant. [4.1 years]
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 the rate of living kidney donor transplant activity.
A living kidney donor candidate contacts a transplant centre for a patient and completes a health history questionnaire to begin their evaluation. [4.1 years]
Secondary outcome selected to examine the rate of living kidney donor transplant activity.
A transplant centre receives a patient's complete referral package from a CKD program and a living kidney donor candidate contacts a transplant centre for a patient and completes a health history questionnaire to begin their evaluation. [4.1 years]
Secondary outcome selected to examine the rate of living kidney donor transplant activity.
A patient receives a living donor kidney transplant [4.1 years]
Secondary outcome selected to examine the rate of living kidney donor transplant activity.
Pre-emptive living donor kidney transplants [4.1 years]
Secondary outcome selected to examine the rate of living kidney donor transplant activity. This outcome is restricted to patients who were not receiving dialysis when they entered the trial and not on dialysis at the time of transplant.

Other Outcome Measures

Rate of deceased donor kidney transplant [4.1 years]
Rate of deceased donor kidney transplant censoring at death and receipt of a living donor kidney transplant.
Average number of months from the date of dialysis initiation (i.e. trial entry) to the date of referral [4.1 years]
This outcome is assessed in patients receiving maintenance dialysis who were referred to a transplant centre.
Rate of living kidney donor transplants [4.1 years]
This outcome is assessed in patients waitlisted for a deceased donor kidney transplant and censored at death and receipt of a deceased donor kidney transplant.
Proportion of pre-emptive transplants [4.1 years]
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.
Average number of months from the date of referral to a transplant centre to the date the first living donor candidate contacts the transplant centre for the intended recipient [4.1 years]
This outcome is assessed in recipients of a living kidney donor transplant.
Average number of months from the date of referral to a transplant centre to date of the transplant surgery [4.1 years]
This outcome is assessed in recipients of a living or deceased donor kidney transplant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

This is a pragmatic, two-arm, parallel-group, open-label, registry-based cluster randomized 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.