Impact of Navigators on First Visit to a Transplant Center, Waitlisting, and Kidney Transplantation: A Randomized, Controlled Trial.Sullivan, C. M., Barnswell, K. V. et al. (2018).
Clinical Journal of The American Society of Nephrology: CJASN 13(10): 1550-1555.
This study aimed to determine the effect of navigators on helping patients overcome the barriers and steps required to obtain a kidney transplant.
Patients were randomized to control or intervention. Control patients received care from their nephrologists and hemodialysis facilities, but did not have Navigators interaction. Whereas, the intervention group had a navigator to assist.
The study included 40 hemodialysis facilities and four transplant centers in Ohio, Kentucky, and Indiana from January 1, 2014 to December 31, 2016.
Primary study outcomes were waiting list placement and receipt of a deceased or living donor transplant. Secondary outcome included the first visit to a transplant center.
Ten haemodialysis facilities were randomly selected from those within 30 miles of each of 4 transplant centres. Five of these haemodialysis facilities were randomly assigned to the control group and five to the study group (cluster randomisation). Each transplant centre in the intervention group hired a kidney transplant recipient to act as a navigator for patients on haemodialysis. Navigators are individuals who educate patients and help them to navigate through the health care system. Navigators underwent a 3-day training session. The study overall included 1877 patients, which was considerably more than would have been required to power the trial to detect an increase in annual listing from 18% to 25% and an increase in transplant rate from 6% to 10%. Navigators identified 869 eligible patients, 324 of whom declined to participate. On average navigators met with each participating patient 9.7 times. At the end of the trial, there were no significant differences in the proportion of patients making a first visit to the transplant unit, going onto the waiting list, or receiving a transplant. There were no significant differences between the groups identified on multivariate analysis either. The significant number of patients that declined to participate with the study arm will likely have influenced the results. The incremental value of the navigators may also be small given the work already done by the participating haemodialysis centres.
ClinicalTrial.gov - NCT01981603