A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney

Abstract

Kidney transplantation is the preferred treatment for patients with end-stage renal disease, as it substantially increases a patient's survival and is cost saving compared to a lifetime of dialysis. However, transplantation is not universally chosen by patients with renal failure, and limited knowledge about the survival benefit of transplantation vs. dialysis may play a role. We created a mobile application clinical decision aid called iChoose Kidney to improve access to individualized prognosis information comparing dialysis and transplantation outcomes. We describe the iChoose Kidney study, a randomized controlled trial designed to test the clinical efficacy of a mobile health decision aid among end-stage renal disease patients referred for kidney transplantation at three large, diverse transplant centers across the U.S. Approximately 450 patients will be randomized to receive either: (1) standard of care or "usual" transplantation education, or (2) standard of care plus iChoose Kidney. The primary outcome is change in knowledge about the survival benefit of kidney transplantation vs. dialysis from baseline to immediate follow-up; secondary outcomes include change in treatment preferences, improved decisional conflict, and increased access to kidney transplantation. Analyses are also planned to examine effectiveness across subgroups of race, socioeconomic status, health literacy and health numeracy. Engaging patients in health care choices can increase patient empowerment and improve knowledge and understanding of treatment choices. If the effectiveness of iChoose Kidney has a greater impact on patients with low health literacy, lower socioeconomic status, and minority race, this decision aid could help reduce disparities in access to kidney transplantation.

Keywords: Education; Kidney Transplantation; Mobile health; Randomized trial; Staff.

Figure 1

Screenshots of the iChoose Kidney decision aid (iPad version), which communicate both absolute and relative risk estimates in several messaging frames. By entering a patient’s clinical information (sex, age, race, ethnicity, time on dialysis, and several comorbidities), the risk prediction calculator generates individualized 1- and 3-year mortality and survival risk estimates for (i) dialysis versus kidney transplant and (ii) deceased- versus living-donor transplant.

Figure 2

iChoose Kidney Study schema shows the study process and points of data collection for both control and intervention patients, and clinical providers (i.e., nephrologists or surgeons). All patients will receive informed consent and a baseline survey before being evaluated by a transplant provider. Patients will complete a postconsultation survey after the provider consultation. Providers will receive a baseline survey prior to patient recruitment. After consulting with each patient, providers will take a postconsultation survey. At study completion, providers will complete a poststudy survey.