Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT04999436
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-28
First Post:
2021-05-11
Brief Title:
APOL1 Genetic Testing Program for Living Donors Part 2
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
APOL1 Genetic Testing Program for Living Donors Part 2
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 33-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
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
Detailed Description:
Clinical practice guidelines advise considering APOL1 genotyping in live kidney donor candidates with sub-Saharan African ancestors and using shared decision making until the NIH APOLLO study of APOL1 outcomes in living donors provides population-level data Transplant physicians are increasingly adopting APOL1 testing However physicians do not consistently inform live donor candidates about APOL1 perform genetic counseling or practice shared decision making with live donor candidates Our prior research has shown that this variation results from lack of knowledge and skill in counseling about APOL1 and fear that APOL1 testing will deter live donor candidates from donating It is unknown if they address African American live donor candidates cultural concerns about genetic testing while counseling
Effective counseling about APOL1 test results is critical especially because genetic information can magnify live kidney donor candidates decisional conflict about donating The consequences of such decisional conflict may be reduced donation rates which could exacerbate disparities in African Americans patients access to living donor kidney transplants and health outcomes Therefore effective culturally competent counseling is ethically essential to reduce live donor candidates decisional conflict and enable informed decisions about donation
This project will entail adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve live donor candidates informed consent for living donation The APOL1 counseling training program will address nephrologists practical knowledge and counseling skill deficits about APOL1 as identified in our prior work The specific duration and format of the counseling training program will be finalized through a final nephrologist needs assessment early in Year 1 Our preliminary needs assessment revealed a preference for a 2-4 hour educational program delivered by a genetics counselor through a live webinar format The investigators plan to enroll all transplant nephrologists who evaluate live kidney donor candidates n6 across both sites for participation in the counseling training program
The effectiveness of the nephrologist counseling training program will be assessed primarily by assessing increases in nephrologists skill in delivering counseling for APOL1 by comparing the number and quality of prescribed counseling behaviors observed between nephrologists counseling live donor candidates in the control group year 1 versus intervention group years 2-5 Secondarily we will evaluate the counseling training program via paired tests of pre-post scores of validated surveys assessing practical knowledge and skills in counseling Additionally we will qualitatively analyze nephrologists perceptions of their APOL1 counseling over time
Training materials will be updated after two years of implementing the APOL1 intervention based on lessons learned and will be available for future dissemination The findings generated from this research have the potential to meaningfully protect donor candidate safety by providing culturally competent counseling and shared decision making to improve candidates informed consent As such we believe this proposal is both timely and responsive to the NIDDK Program Announcement PA-18-330 Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK
Effective counseling about APOL1 test results is critical especially because genetic information can magnify live kidney donor candidates decisional conflict about donating The consequences of such decisional conflict may be reduced donation rates which could exacerbate disparities in African Americans patients access to living donor kidney transplants and health outcomes Therefore effective culturally competent counseling is ethically essential to reduce live donor candidates decisional conflict and enable informed decisions about donation
This project will entail adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve live donor candidates informed consent for living donation The APOL1 counseling training program will address nephrologists practical knowledge and counseling skill deficits about APOL1 as identified in our prior work The specific duration and format of the counseling training program will be finalized through a final nephrologist needs assessment early in Year 1 Our preliminary needs assessment revealed a preference for a 2-4 hour educational program delivered by a genetics counselor through a live webinar format The investigators plan to enroll all transplant nephrologists who evaluate live kidney donor candidates n6 across both sites for participation in the counseling training program
The effectiveness of the nephrologist counseling training program will be assessed primarily by assessing increases in nephrologists skill in delivering counseling for APOL1 by comparing the number and quality of prescribed counseling behaviors observed between nephrologists counseling live donor candidates in the control group year 1 versus intervention group years 2-5 Secondarily we will evaluate the counseling training program via paired tests of pre-post scores of validated surveys assessing practical knowledge and skills in counseling Additionally we will qualitatively analyze nephrologists perceptions of their APOL1 counseling over time
Training materials will be updated after two years of implementing the APOL1 intervention based on lessons learned and will be available for future dissemination The findings generated from this research have the potential to meaningfully protect donor candidate safety by providing culturally competent counseling and shared decision making to improve candidates informed consent As such we believe this proposal is both timely and responsive to the NIDDK Program Announcement PA-18-330 Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None