Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
588 participants
INTERVENTIONAL
2018-06-26
2021-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
NCT00785265
Living Donation and Kidney Transplantation Information
NCT04285203
Your Path to Transplant: A Randomized Control Trial of A Tailored Computer Education Intervention for Living Donor Kidney Transplant
NCT02181114
Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication
NCT05154773
Using Shared Decision Making to Improve Kidney Transplantation Rates
NCT06141499
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There will be equal allocation of LKDs and intended recipients to both KPD education conditions: (1) Usual Care (UC) group and (2) UC plus video-based KPD education group. All enrolled LKDs and intended recipients will complete a baseline survey and another survey 2 weeks post-intervention. Additionally, follow-up data will be gathered on KPD decision-making, participation, and reasons for non-participation at 3 months post-intervention.
Settings and target population:
The study will be conducted at three kidney transplant programs in the United States: Beth Israel Deaconess Medical Center (BIDMC; Boston, MA), the Medical University of South Carolina (MUSC; Charleston, SC), and Erie County Medical Center (ECMC; Buffalo, NY). BIDMC will act as the coordinating center for this study and will be responsible for study design, oversite, reporting, updates, and final data analysis. MUSC and ECMC will rely on the CCI at BIDMC for review. This study will target potential LKDs and their intended recipients.
Randomization:
Random assignment to the usual education or usual education plus video intervention group will occur within the 48 hours following completion of the baseline survey. The BIDMC study coordinator will oversee randomization after receiving an automated notification of baseline completion by participants from all study sites. Randomization will be done with the LKD, with the randomized group matched to the intended recipient. We have decided to ensure that the randomized group is the same for any LKD-recipient pairs to reduce the risk of contamination, which is a critical threat to internal validity in this type of study. For instance, if a LKD was assigned to the KPD video-based education group and their intended recipient was assigned to the UC group, there is the real possibility that there would be some diffusion of treatments in which the LKD discusses some elements of the intervention with the recipient and this, in turn, may influence the recipient's living donation and KPD knowledge, concerns, and decision-making processes. A simple unrestricted random allocation sequence will be used. We will use REDCap to generate the randomization sequence, which will be accessible to the site coordinators and transplant educators. The PI and Co-Investigators will be blinded to the subjects' allocation assignment.
Interventions:
Usual Care (UC) Living Donation and KPD Education:
Potential LKDs and recipients will receive living donation and KPD-specific education as they usually do at their respective kidney transplant programs.
Typically, potential LKDs are informed of their incompatibility during a phone call with the donor nurse coordinator. At this time, the KPD option is described and the potential LKD is provided with kidney paired donation information. This information is available in English and Spanish. For those who do not have internet access, the written educational materials are mailed. The potential LKD is advised to call the donor nurse coordinator with any questions about KPD and/or to initiate the full donation evaluation. An identical KPD educational process occurs for the intended recipient, although this is done with their own transplant nurse coordinator and only if their potential donor decides to initiate the full donation evaluation.
For study purposes, we will approach waitlisted recipients and any potential donors who complete an online health screening. LKDs and recipients assigned to the UC group will be sent an email after randomization, which will include a reminder to visit the usual educational websites and link to the usual care brochures. Participants will only be shown the materials provided as standard of care at their respective institutions.
Video-Based KPD Education:
LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch the embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.
Assessment Time-points:
Study data will be collected from participants at three different time points.
Baseline. Participants will complete a 30-minute online assessment via REDCap following email consent but prior to randomization. The questionnaire assessment will gather sociodemographic information, assess primary and secondary outcomes, and measure important covariates.
Post-Intervention. Two weeks after randomization, participants will complete a 20-minute REDCap assessment of the primary and secondary outcomes, uptake of the written and video educational elements, any discussions they have had with others about living donation or KPD, educational intervention process and evaluation, and any steps they have taken to pursue further donation evaluation. The rationale for the timing of this assessment is to re-assess the primary and secondary outcomes in close proximity to the delivery of living donation and KPD-specific education yet that provides sufficient time for the participant to assimilate and consider the information acquired.
Follow-up. Three months following the living donation and KPD-specific education, participants will complete a final REDCap assessment on living donation and KPD knowledge, as well as a brief assessment to learn of their final decision regarding living donation and the factors that contributed to it. The rationale for the timing of this follow-up assessment is that the vast majority of incompatible potential LKDs and recipients who have been offered KPD have achieved a final disposition within this time period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual Care
Potential LKDs and recipients will receive standard-of-care LD (Live Donor) and KPD education. As noted previously, during standard care, incompatible potential LKDs are informed of the KPD option and the potential LKD is provided with living donation information and a link to the UNOS KPD website, which includes a written description of KPD. This information is available in English and Spanish. For those who do not have internet access, the written educational materials are mailed. The potential LKD is advised to call the donor nurse coordinator with any questions about KPD and/or to initiate the full donation evaluation. This process occurs for the intended recipient only if their potential donor decides to initiate the full evaluation.
For study purposes, potential LKDs and waitlisted recipients assigned to the UC group will be sent an email after randomization, which will include a link and a reminder to review their transplant center's standard of care educational materials.
No interventions assigned to this group
Video-Based KPD education
LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch the embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.
KPD Educational Video
LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch an embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KPD Educational Video
LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch an embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Speaks English or Spanish
* Completed the initial living donation health screening
Transplant Candidates
* Speaks English or Spanish
* On that transplant waitlist (active or inactive)
Exclusion Criteria
* Non-directed (i.e., anonymous) potential LKDs
* Previously undergone donor evaluation
* Participation in another study to increase knowledge about living donation/LDK
Transplant Candidates
* Had a prior LDKT
* Previously enrolled in a KPD program
* Previous or current participation in another study to increase knowledge about living donation/LDKT
* Listed for a liver
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of South Carolina
OTHER
Erie County Medical Center
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
James Rodrigue
Vice Chair of Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Erie County Medical Center
Buffalo, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016P000409
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.