Genetic Counseling Chatbot for Kidney Donors

Recruiting at 1 trial location

Overseen By Jessica Gacki-Smith, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Not a nephrologist

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Elisa J Gordon, PhD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Not a nephrologist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Counseling Training Program

Transplant nephrologists undergo a 2-4 hour APOL1 counseling training program delivered by a genetic counselor through webinars and other interactive modalities.

2-4 hours

Implementation and Evaluation

The effectiveness of the APOL1 counseling training program is evaluated by assessing nephrologists' skills and knowledge in delivering counseling for APOL1, using pre-post tests and qualitative analysis.

5 years

Follow-up

Participants are monitored for safety and effectiveness after the intervention, focusing on nephrologists' counseling practices and live donor candidates' satisfaction with informed consent.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• APOL1 Counseling Training Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Counseling Training Program Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+