Kidney Paired Donation Video-Based Education Trial

The investigators will conduct a randomized controlled trial (RCT) to examine the
effectiveness of a video-based KPD education intervention to improve knowledge,
self-efficacy, concerns, and informed decision-making about KPD in incompatible potential
living kidney donors (LKDs) and intended transplant recipients. 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 two kidney transplant programs in the United States: Beth
Israel Deaconess Medical Center (BIDMC; Boston, MA) and Medical University of South Carolina
(MUSC; Charleston, SC). 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
will rely on the CCI at BIDMC for review. This study will target potential LKDs and their
intended recipients whose histocompatibility testing has determined them to be incompatible
with each other.

Randomization:

Random assignment to education 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 both BIDMC and MUSC.
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 the
LKD-recipient pair 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 subjects' allocation
assignment.

Interventions:

Usual Care (UC) Living Donation and KPD Education. Incompatible potential LKDs and recipients
will receive living donation and KPD-specific education as they usually do in both the BIDMC
and MUSC kidney transplant programs. As noted previously, 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 living donation information
and a link to the UNOS (United Network for Organ Sharing) KPD website
(https://www.unos.org/donation/kidney-paired-donation/), 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. 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. . Incompatible LKDs and recipients
assigned to the UC group will be sent an email after randomization, which will include a
reminder to visit the UNOS or NKR website with the appropriate link and a PDF version of the
usual care KPD brochure. BIDMC and MUSC participants will only be shown the materials
provided as standard of care at their respective institutions.

Video-Based KPD Education. Incompatible 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.

Inclusion Criteria:

LKDs

- Speaks English or Spanish

- Has a valid email address

- Completed and passed the initial living donation health screening

- Documented blood group or human leukocyte antigen (HLA) incompatibility with intended
recipient

- Documentation that incompatibility has been communicated to the potential donor by the
nurse coordinator.

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

- Speaks English or Spanish

- Has a valid email address

- Has a potential LKD who has completed and passed the initial health screening

- Documented blood group or HLA incompatibility with LKD

- Documentation that incompatibility has been communicated to the potential donor by the
nurse coordinator

Exclusion Criteria:

- Had a prior LDKT

- Previously enrolled in a KPD program

- Previous or current participation in another study to increase knowledge about living
donation/LDKT