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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329521
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
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 never receive a kidney transplant. A multicomponent quality improvement initiative was developed to enhance access to kidney transplantation and living kidney donation in Ontario's chronic kidney disease (CKD) programs. These CKD programs provide care to individuals with reduced kidney function. The initiative includes four main components: Data (e.g., data collection and reports to CKD programs about their transplant related performance); 2. Education (e.g., education toolkits for CKD program staff, kidney patients and families, including living kidney donor candidates); 3. Transplant Ambassadors (e.g., kidney transplant recipients and living kidney donors who discuss transplantation and living donation to patients and their families) and 4. Administration (e.g., provincial administrative support and resources provided to CKD programs to support local work). This trial will provide high-quality evidence about the effectiveness of a multicomponent quality improvement initiative aimed to enhance access to kidney transplantation and living kidney donation.

Condition or disease Intervention/treatment Phase
Kidney Diseases Kidney Failure End Stage Renal Disease Other: Multicomponent Initiative Not Applicable

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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: A Protocol to Evaluate the Effectiveness of a Multicomponent Initiative to Enhance Access to Kidney Transplantation and Living Donation: the Enhance Access to Kidney Transplantation and Living Kidney Donation Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multicomponent Initiative
A number of quality improvement initiatives will be provided at the CKD programs.
Other: Multicomponent Initiative
The initiative is grounded in a quality improvement framework and has four main components for the chronic kidney disease (CKD) programs, including: 1. Data (e.g., data collection and reports to CKD programs about their performance using best practices in audit and feedback); 2. Education (e.g., education toolkits for CKD program staff, renal patients and families, including living donor candidates); 3. Transplant Ambassadors (e.g., kidney transplant recipients and living kidney donors who discuss transplantation and living donation to patients and their families) and 4. Administration (e.g., provincial administrative support and resources provided to CKD programs to support local work).

No Intervention: Routine 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. Composite outcome of living kidney donor candidate referral and transplant recipient referral event rate. [ Time Frame: Two years ]
    The primary outcome has not been finalized. It will be finalized well before the trial ends and before the analysis of results. The outcome will be published in the peer-reviewed protocol.


Secondary Outcome Measures :
  1. Kidney transplantation rate (living and deceased donor kidney transplants examined separately and together) [ Time Frame: Two years ]
    The secondary outcome has not been finalized. It will be finalized well before the trial ends and before the analysis of results. The outcome will be published in the peer-reviewed protocol.

  2. Rate of pre-emptive kidney transplantation [ Time Frame: Two years ]
    The secondary outcome has not been finalized. It will be finalized well before the trial ends and before the analysis of results. The outcome will be published in the peer-reviewed protocol.

  3. Rate of kidney transplant waitlisting [ Time Frame: Two years ]
    The secondary outcome has not been finalized. It will be finalized well before the trial ends and before the analysis of results. The outcome will be published in the peer-reviewed protocol.

  4. Average Healthcare Costs [ Time Frame: Two years ]
    The secondary outcome has not been finalized. It will be finalized well before the trial ends and before the analysis of results. The outcome will be published in the peer-reviewed protocol.



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 cluster randomized controlled 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 progressing to end-stage renal disease.

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)
Investigators
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Principal Investigator: Amit Garg, MD, PhD London Health Sciences Centre
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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: February 26, 2020
Last Verified: February 2020

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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