Genetic Counseling Chatbot for Kidney Donors

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byElisa J Gordon, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to: 1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice 2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent. The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.

Eligibility Criteria

This trial is for English-speaking adults over 18 who are not cognitively or vision impaired. It's specifically for transplant nephrologists evaluating live kidney donor candidates at the study sites, focusing on African American populations.

Inclusion Criteria

English-speaking

You do not have trouble seeing.

Doctors who evaluate people who want to donate a kidney at the study locations.

+2 more

Exclusion Criteria

Not a nephrologist

Participant Groups

The trial tests a culturally adapted APOL1 genetic testing program with a chatbot named Gia and counseling training for nephrologists. It aims to improve decision-making and satisfaction among African American living kidney donors regarding donation risks.

1Treatment groups

Experimental Treatment

Group I: Counseling Training ProgramExperimental Treatment1 Intervention

The APOL1 counseling training program is designed for transplant nephrologists who evaluate live kidney donor candidates of African ancestry who are at risk for having APOL1 risk variants and kidney failure post-donation. The training program aims to increase transplant nephrologists' practical knowledge, self-efficacy, and skills in counseling live donor candidates about APOL1 in a culturally competent manner. The program will include training in: current APOL1 data; the value of APOL1 testing and meaning of positive test results for living donor clinical evaluation; risks of having two APOL1 gene variants on the donor's kidney health; how to engage in shared decision making about donation; how to address cultural concerns about genetic testing; and how to protect donor candidates' privacy and confidentiality with APOL1 test results. The APOL1 counseling training program will be delivered by a genetic counselor through webinars and other interactive modalities and last 2-4 hours.