Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates.
BACKGROUND
The best treatment option for end-stage renal disease is usually a transplant, preferably a live donor kidney transplant (LDKT). The most effective ways to educate kidney transplant candidates about the risks, benefits, and process of LDKT remain unknown.


METHODS
We report the protocol of the Enhancing Living Donor Kidney Transplant Education (ELITE) Study, a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large, suburban U.S. transplant center. Five hundred potential transplant candidates are cluster randomized (by date of visit) to receive either: (1) standard-of-care ("usual") transplant education, or (2) intensive education that is based upon the Explore Transplant series of educational materials. Intensive transplant education includes viewing an educational video about LDKT, receiving print education, and meeting with a transplant educator. The primary outcome consists of knowledge of the benefits, risks, and process of LDKT, assessed one week after the transplant evaluation. As a secondary outcome, knowledge and understanding of LDKT are assessed 3 months after the evaluation. Additional secondary outcomes, assessed one week and 3 months after the evaluation, include readiness, self-efficacy, and decisional balance regarding transplant and LDKT, with differences assessed by race. Although the unit of randomization is the date of the transplant evaluation visit, the unit of analysis will be the individual potential transplant candidate.


CONCLUSIONS
The ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT.


BACKGROUND
Clinicaltrials.gov number NCT01261910.
Renal and Pancreas Transplant Division, Saint Barnabas Medical Center, 94 Old Short Hills Road, East Wing, Suite 305, Livingston, NJ 07039, USA. fweng@barnabashealth.org.
Francis L
FL
Weng
Diane R
DR
Brown
John D
JD
Peipert
Bart
B
Holland
Amy D
AD
Waterman
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004521:Educational Measurement / Q000706:statistics & numerical data; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D007676:Kidney Failure, Chronic / Q000453:epidemiology* / Q000601:surgery*; D016030:Kidney Transplantation / Q000193:education* / Q000706:statistics & numerical data*; D019520:Living Donors / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D009515:New Jersey / Q000453:epidemiology; D010353:Patient Education as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D012307:Risk Factors