Genetic Testing (APOL1) Decisional Support for Potential Living Kidney Donors

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PROJECT SUMMARY The identification of the Apolipoprotein L-1 or APOL1 gene as an indicator of increased likelihood of developing chronic kidney disease has sparked a debate about point-of-care genetic testing for potential living kidney donors. While integrating genetic testing into the medical evaluation of potential living donors benefits patients, ensuring an informed, deliberative decision making process is paramount. The proposed study is premised on a large body of research demonstrating that traditional SDM processes and interventions fail to meet the needs of ethnic minority populations. Because SDM requires an informed patient to engage in the decision making process, novel methods are needed to assure a full, accurate understanding of risks, benefits, implications and alternate options. We propose a participatory approach to developing a decisional support tool for African American potential donors as they consider genetic testing as part of their medical evaluation. Specifically, this mixed-method study will conduct the formative research needed to develop and refine the tool. Up to 6 focus group interviews will explore potential donors' preferences for shared decision making and understanding of the risks, benefits and implications of genetic testing in the context of live kidney donation (Aim 1). The findings will inform the design of a brief quantitative survey assessing potential donors' decision-making preferences, communication style, and knowledge of and attitudes toward genetic testing, kidney transplantation and living donation. The survey (N=500) will be the first to include the Best-Worst Scaling methodology to assess the level of importance potential donors place on the risks and benefits of genetic testing as well as trade offs between risks and benefits donors are willing to make (Aim 2). A draft of the tool will be created, using the Ottowa Framwork as guide, to support African American patients and their families making decisions about both living donor kidney transplants and genetic testing in this context. Additional modifications will be made based on the findings of the focus group interviews and completed surveys. The tool will then be refined iteratively over four rounds of testing in simulated consultations with standardized providers and four rounds with a Delphi panel of transplant professionals (Aim 3). A Stakeholder Committee, comprised of transplant professionals and previous and potential living donors, will provide ongoing feedback and guidance across all study phases. In a subsequent R01, the fully-vetted, newly developed tool will be implemented and tested in clinical settings using a randomized controlled design. If successful, the tool will optimize care for the thousands of African American potential living kidney donors evaluated in the United States annually.