Over a 2.5 year period we will conduct a 2-arm parallel randomized trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of KidneyTIME versus usual care for KTX access over 12 months of intervention use and follow-up.
Participants will be recruited from the Transplant program at Erie County Medical Center, a safety-net hospital in Buffalo, New York. Each week, electronic records will be accessed to identify potential participants who had been referred to the transplant center for a kidney transplant, are aged 18 years and older, speak English, have internet access, and signed electronic consent as well as provided a text or email address. We will excude patients previously exposed to any component of the intervention.
Each potential participant will be sent an electronic invitation from the principal investigator (a transplant surgeon). This message will briefly described the study and include a personal link to an online consent form describing study procedures and potential risks. A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan.
The entire study and the progress tracker will be hosted on Alchemer. Those who sign electronic consent to participate will be automatically guided to a baseline sociodemographic survey (T0). Upon completion, computer-generated randomization will stratify participants by self-reported race (Black versus Other), with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment one they access the study educational content.
KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. All components of the intervention were developed through a user-centered design approach by involving kidney failure patients and social network members, to improve usability and increase the likelihood of adoption.
In the intervention arm, we chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. The first video sets the stage for the intervention and introduces the viewer to an overview of LDKT. The next 5 videos address common misconceptions about live kidney donation: Video 1: LDKT introduction, Video 2: Donor eligibility, Video 3: Donor evaluation, Video 4: Kidney paired donation, Video 5: Donation Costs, Video 6: Donor lifestyle. After completing the proscribed videos and an immediate-post exposure survey, everyone then receives a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website can be accessed using this link from any electronic device throughout the study. Website use will be prompted by automated messages (email or SMS) that introduced videos that may interest users, provided the website link, and encouraged video viewing and sharing. Messages will be personalized with their name and provide researchers contact information. Prompts will be sent monthly for 12 months.
Control participants will receive the transplant program's 13-minute usual care video, a nurse-narrated power-point-based video outlining recipient evaluation, surgery, recovery processes and outcomes while highlighting the option of LDKT. This condition was active since it intended to aid kidney transplant access. It was utilized to offer participants education with perceived benefit and encourage further study participation.
All participants routinely receive educational materials from non-study sources through usual Transplant Center protocols including written materials, nurse communications, and the usual care video shown on a clinic computer during transplant evaluation. Therefore control participants viewed the usual care video twice.
After completing the proscribed video education, all participants will be invited to fill out serial surveys immediately (T1) and 1 month (T2), 6 months (T3), and 12-months (T4) post-baseline. Participants will receive up to 6 reminders (5 automatic and 1 personalized) to complete surveys. At study conclusion, intervention participants will be invited to an exit interview and controls will be offered access to the intervention website. All participants will receive up to $125 for completing study milestones (4 surveys and an exit interview).
