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Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD)

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ClinicalTrials.gov Identifier: NCT03329521
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : May 19, 2021
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Ontario Renal Network (part of Ontario Health)
Trillium Gift of Life Network (part of Ontario Health)
Information provided by (Responsible Party):
Lawson Health Research Institute

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 Not Applicable

Detailed 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 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.
  3. 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.
  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 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.

  5. 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.

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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Number of key steps completed towards receiving a kidney transplant [ Time Frame: 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 :
  1. 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. [ Time Frame: 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.

  2. A living kidney donor candidate contacts a transplant centre for a patient and completes a health history questionnaire to begin their evaluation. [ Time Frame: 4.1 years ]
    Secondary outcome selected to examine the rate of living kidney donor transplant activity.

  3. 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. [ Time Frame: 4.1 years ]
    Secondary outcome selected to examine the rate of living kidney donor transplant activity.

  4. A patient receives a living donor kidney transplant [ Time Frame: 4.1 years ]
    Secondary outcome selected to examine the rate of living kidney donor transplant activity.

  5. Pre-emptive living donor kidney transplants [ Time Frame: 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:
  1. Rate of deceased donor kidney transplant [ Time Frame: 4.1 years ]
    Rate of deceased donor kidney transplant censoring at death and receipt of a living donor kidney transplant.

  2. Average number of months from the date of dialysis initiation (i.e. trial entry) to the date of referral [ Time Frame: 4.1 years ]
    This outcome is assessed in patients receiving maintenance dialysis who were referred to a transplant centre.

  3. Rate of living kidney donor transplants [ Time Frame: 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.

  4. Proportion of pre-emptive transplants [ Time Frame: 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.

  5. 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 [ Time Frame: 4.1 years ]
    This outcome is assessed in recipients of a living kidney donor transplant.

  6. Average number of months from the date of referral to a transplant centre to date of the transplant surgery [ Time Frame: 4.1 years ]
    This outcome is assessed in recipients of a living or deceased donor kidney transplant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • None. Including all Ontario CKD programs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329521


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Ontario Renal Network (part of Ontario Health)
Trillium Gift of Life Network (part of Ontario Health)
Investigators
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Principal Investigator: Amit Garg, MD, PhD London Health Sciences Centre
  Study Documents (Full-Text)

Documents provided by Lawson Health Research Institute:
Study Protocol  [PDF] May 4, 2021

Publications:
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03329521    
Other Study ID Numbers: R-17-088
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: While data sharing agreements prohibit ICES from making the data publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS. The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the programs may rely upon coding templates or macros that are unique to ICES.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Cluster Randomized Controlled Trial
Kidney Transplant
Living Kidney Donation
Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic