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Open Access Highly Accessed Study protocol

Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates

Francis L Weng12*, Diane R Brown2, John D Peipert3, Bart Holland24 and Amy D Waterman3

Author Affiliations

1 Renal and Pancreas Transplant Division, Saint Barnabas Medical Center, 94 Old Short Hills Road, East Wing, Suite 305, Livingston, NJ 07039, USA

2 Rutgers School of Public Health, 683 Hoes Lane West, Piscataway, NJ 08854, USA

3 Department of Medicine, Division of General Medical Sciences, Washington University School of Medicine, Mailstop: 90-31-661, 660 S. Euclid Ave., St., Campus Box 8005, Louis, MO 63110-1093, USA

4 New Jersey Medical School, Department of Preventive Medicine and Community Health, Rutgers University, Newark, NJ 07103, USA

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BMC Nephrology 2013, 14:256  doi:10.1186/1471-2369-14-256

Published: 19 November 2013

Abstract

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/design

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.

Discussion

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.

Trial registration

Clinicaltrials.gov number NCT01261910

Keywords:
Kidney transplantation; Live kidney donor; Education; Clinical trial; Randomized trial; Cluster randomization