Title:  Kidney paired donation: A randomized trial to increase knowledge and reduce perceived barriers

Funding:  HRSA (R39OT29876)

ClinicalTrials.gov:  NCT03013829

Summary

Kidney paired donation (KPD) was developed as a strategy to provide incompatible (blood type or cross-match positive) donor-recipient pairs with an innovative opportunity for live donor kidney transplantation (LDKT), which is the most beneficial treatment for transplant-eligible adults with kidney failure. In a KPD program, incompatible living donors and their intended recipients are registered and placed into a large electronic network of other incompatible pairs. Computerized algorithms are then used to conduct match-runs at specified time intervals to identify compatible pairings, thus permitting kidney graft “exchanges” or “swaps” to occur. Using these computer-generated algorithms, match runs might identify simple exchanges between two donor-recipient pairs at one or two centers or more complex exchanges involving multiple incompatible pairs at several different transplant programs.

Unfortunately, the uptake of this innovative matching program by potential donors and their intended LDKT recipients has been slow. Guided by our own conceptual model and our preliminary formative work, we will evaluate the effectiveness of a targeted educational approach that is designed to increase knowledge about the risks and benefits of living donation generally and KPD specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision-making about KPD among incompatible or cross-match positive donor-recipient pairs. Three hundred sixty incompatible LKDs (n=180) and their intended recipients (n=180) at two transplant centers will be randomly assigned to one of two KPD education conditions: (1) Usual Care (UC) or (2) UC plus video-based KPD education.

The specific aims to be examined in this study include:

Aim 1 (Primary): Determine the relative effectiveness of video-based KPD education on the knowledge of living donation and KPD-specific risks and benefits.

Aim 2 (Secondary): Determine the relative effectiveness of video-based KPD education on KPD self-efficacy, concerns, and informed decision-making among incompatible or cross-match positive LKDs and their intended recipients.

Aim 3 (Secondary): Identify sociodemographic, cultural, and clinical characteristics that are most strongly associated with education intervention effects.

Related Publications

Rodrigue JR, Leishman R, Vishnevsky T, Evenson AR, Mandelbrot DA. Concerns of ABO incompatible and crossmatch-positive potential donors and recipients about participating in kidney exchanges. Clin Transplant. 2015; 29:233-41.

Melcher ML, Blosser C, Baxter-Lowe LA, Delmonico F, Gentry S, Hanto R, Knoll G, Leffell MS, Leichtman A, Mast D, Nickerson P, Reed EF, Rees M, Rodrigue JR, Segev D, Serur D, Tullius S, Zavala EY, Feng S. Dynamic challenges inhibiting optimal adoption of kidney paired donation: Findings of a consensus conference. Am J Transplant. 2013; 13:851-60.

Clark E, Hanto R, Rodrigue JR. Barriers to implementing paired kidney donation and desensitization protocols: Survey of U.S. transplant programs. Prog Transplant. 2010; 20:357-65.

Waterman AD, Schenk E, Barrett AC, Waterman BM, Rodrigue JR, Woodle S, Shenoy S, Jendrisak M, Schnitzler M. Ruled-out donors’ willingness to participate in donor-exchange and altruistic donation programs. Am J Transplant 2006; 6:1631-38.