Implementing "Explore Transplant"- A Pilot Study

May 7, 2024 updated by: Istvan Mucsi, University Health Network, Toronto

Reducing Barriers in Access to Kidney Transplantation: Implementing the "Explore Transplant" Education Program to Increase Patient Knowledge and to Facilitate Informed Decision Making- A Pilot Study

Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT has been associated with better quality of life (QOL) [1-3], reduced morbidity and mortality[4, 5], and reduced healthcare costs[6]. Studies in the US have shown that patients receiving tailored transplant education were more likely to complete the transplant evaluation [9, 14, 15]. For instance, patients receiving the Explore Transplant (ET) education program designed by Dr. Waterman, were more knowledgeable about KT and more likely to complete KT evaluation than control patients. Currently, there is a lack of standardized KT education in Ontario. Traditional approaches have been insufficient in providing the necessary education and information to enable patients to make an informed decision about their care. To address this issue, the study will assess the impact of kidney transplant related education using the Explore Transplant Ontario (ETO) education program on kidney transplant-related knowledge and on readiness to consider KT, readiness to consider living donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis.

In order to comprehensively measure this impact, 5 variables will be explored.

  1. Readiness to consider DDKT
  2. Readiness to consider LDKT
  3. KT related knowledge in patients
  4. Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after administration of ETO
  5. Proportion of patients who have identified at least one potential living donor at 6 and 12 months after administration of ETO

The hypotheses are as follows:

  1. Readiness to consider DDKT will be higher in the "intervention" group compared to the "control" group at follow up.
  2. Readiness to consider LDKT will be higher in the "intervention" group compared to the "control" group at follow up.
  3. The KT related knowledge of the patients will be higher in the "intervention" group compared to the "control" group at follow up.
  4. The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.
  5. The proportion of patients who have at least one potential living donor at 6 and 12 month after the KT education will be higher in the "intervention" group compared to the "control" group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ESKD impairs quality of life (QOL)QoL and leads to increased morbidity and premature mortality. In addition, healthcare costs for ESKD amounted to $1.3 billion in Canada in 2000 [22]. KT has clear survival [4] and QOL [1-3], and economic benefits [6]. Studies in the US documented that tailored education improves KT knowledge and enhances access to KT and LDKT [14, 23-26]. Current education materials and teaching for KT candidates in Ontario are not based on theoretical foundations or on research evidence. This has resulted in gaps in transplant education in Ontario and has been unable to meet the needs of the patients. By building upon research data from the US we aim to implement a culturally sensitive patient education tool that will address the current needs as well as reduce barriers whereby enhancing access to KT.

This project will increase KT knowledge among health care professionals and among patients. We will establish ongoing support for the participating nephrology centers. This will also increase KT knowledge in patients and families and enhance access to KT. The ultimate goal is to improve health outcomes and QOL by reducing barriers to KT and LDKT and to help patients and families make informed treatment decisions.

The Explore Transplant Ontario (ETO) is a parallel, non-randomized, controlled pilot study exploring the impact of an educational intervention designed to increase knowledge about kidney transplantation (KT) and readiness to consider KT. For this pilot study we will utilize a convenience sample of stable patients on hemodialysis in two large dialysis units. The "intervention" will be administered at the hemodialysis unit at Humber River Hospital; the "control" group will be recruited from the hemodialysis unit at Toronto General Hospital. Currently around 500 patients are being treated with maintenance hemodialysis in both dialysis units, with an estimate that about 300 of these patients will fulfill our inclusion criteria.

The estimated study period will be 21 months. Baseline study recruitment will occur over a period of 3 months at each of the participating dialysis centers. Data management, follow-up, and analysis will take place over the subsequent 18 months.The study recruitment period has about 60 business days and as such, recruitment rate is estimated at 5-6 patients per day of screening.

The entire study will take place over 4 distinct stages

Stage 1:

Baseline data collection will be conducted at both dialysis centers

Stage 2:

A full day training will be organized to train a selected group of dialysis nurses. This group will act as a group of clinical experts and help facilitate training and use of the ETO amongst the other health care practitioners.

Stage 3:

Following the training session, ETO will be implemented at the hemodialysis unit at Humber River Hospital as the "intervention" arm and at the Toronto General Hospital as the "control" arm. It is estimated that 300 of the hemodialysis patients will fulfill the inclusion criteria, resulting in an enrollment of 150 patients in each study arm.

Stage 4:

The study duration will take approximately 21 months to accomplish. Baseline recruitment will occur over a period of 3 months at each participating dialysis centers, estimating 5-6 patients per day of screening. Data management, follow-up, and analysis will take place over the subsequent 18 months.

Statistical Analysis Plan:

Categorical variables ("early versus "late" stage of readiness, high versus low knowledge) will be compared using logistic regression models (knowledge or readiness stage as the dependent variable; exposure to ETO education is the primary explanatory variable). Continuous knowledge score will also be analyzed in linear regression models (score as the dependent variable, exposure to ET as the primary explanatory variable). These analyses will then be adjusted for age, gender, education, ethnicity/race and comorbidity.

Chi-square test will be used to compare the proportions of patients on KT waiting list and under KT evaluation in the control versus the intervention group, both at baseline and at the 3 month follow up.

Baseline data about the proportion of patients on the KT waiting list and under KT evaluation in participating dialysis centers will be collected at the participating dialysis units.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years, < 80 years
  • Patients undergoing maintenance hemodialysis for more than 3 months
  • Able to understand English at a grade 5 level
  • Those willing and able to provide informed consent

Exclusion Criteria:

  • Patients with severe acute illness or condition that hampers questionnaire completion
  • Dementia indicated in the medical record, indicated by the managing healthcare team
  • Dialysis initiation between 0-90 days prior to enrollment
  • Current, active malignancy or a history of malignancy within 2 years of successful treatment
  • Current active chronic infection that is an absolute contraindication to kidney transplantation
  • Unwilling or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Explore Transplant Ontario
Intervention 'Implementing "Explore Transplant" Education'
Other: Implementing "Explore Transplant" Education
The "Explore Transplant Ontario" (ETO) education program
No Intervention: Control
The control arm (Usual Treatment) is at the Toronto General Hospital dialysis center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients in "early stages" of kidney transplant readiness
Time Frame: An average of 1 year and a half
An average of 1 year and a half

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Istvan Mucsi, Toronto General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimated)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-5314-AE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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