Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04910867
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-05-08
Brief Title:
APOL1 Genetic Testing Program for Living Donors
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Integrating a Culturally Competent APOL1 Genetic Testing Program Into Living Donor Evaluation
Status:
RECRUITING
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 APOL1 is 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 APOL1 testing 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 APOL1 is 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 APOL1 testing 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:
This project Integrating a culturally competent APOL1 genetic testing program into living donor evaluation will integrate APOL1 testing into the evaluation of living kidney donor candidates of African ancestry The study aims to reduce decisional conflict improve preparedness for decision making and increase satisfaction with informed consent for living donation for donor candidates at elevated risk of post-donation kidney failure The APOL1 testing program will entail adapting established artificial intelligence conversational agents or chatbots to provide APOL1-specific information in preparation for donor candidates to undergo APOL1 testing and adapting established genetic counseling discussions for transplant nephrologists to counsel donor candidates about APOL1 test results and engage in shared decision making to improve donor candidates informed consent for living donation APOL1 test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists The study will involve community engagement to ensure that testing and counseling is delivered in a culturally competent manner
Using a hybrid effectiveness-implementation design this study will simultaneously evaluate the effectiveness and implementation of the APOL1 testing program to more efficiently translate evidence into practice as service delivery system factors for adoption and scale up are considered while effectiveness is tested The study will be conducted at two geographically distinct transplant programs Northwestern University in Chicago IL and Georgetown University in Washington DC
Participants include live kidney donor candidates of African ancestry undergoing donor evaluation The investigators will recruit potential participants consecutively with participants recruited in year 1 serving as the control group and participants recruited in years 2-5 serving as the intervention group Participants will be eligible for participation if they respond positively to one of three questions assessing African ancestry Participants in the intervention group will use the chatbot for 5-7 minutes Immediately thereafter research staff will ask for participants informed consent to undergo APOL1 genetic testing those who agree will provide a saliva sample for testing APOL1 test results will be integrated into the respective transplant programs electronic health records Thereafter transplant nephrologists will engage in a counseling discussion with donor candidates about APOL1 and living donation
Distributional assumptions will be assessed to evaluate appropriateness of model specifications For primary analyses the mixed model framework will allow for incorporation of a random center effect to separate within- and between-center variance estimates As participants will not be randomized to intervention arms the proposed statistical analysis plan will also incorporate a multivariable modeling approach with inclusion of potential confounders to reduce bias in intervention effect estimates Effect estimates will be reported with confidence intervals to convey variability in estimates
Methods for sample size estimates were based on a simplified comparisons of means between the two arms pre-post implementation periods Necessary sample sizes were then inflated to account for multivariable model and to account for loss-to-follow-up to ensure adequate power The proposed sample size of 74 participants in the control period and 316 in the intervention period will provide at least 80-90 power to detect meaningful differences in mean Decisional Conflict Scale DCS score ranging from 50 to 77 units
The impact of this study will be the creation of a model for integrating genetic testing into clinical practice that shows how to scale up genetic counseling services through the use of chatbots to deliver foundational information and training nephrologists to deliver components of genetic counseling Specifically this model will demonstrate how to deliver APOL1 testing of live donor candidates which can then be implemented across the country via implementation science approaches The proposed study will prepare transplant programs to deliver culturally competent counseling coterminous with the completion of the NIH APOLLO study in 5 years The findings generated from this research have the potential to protect donor candidates safety by improving their informed consent As such this proposal is timely and responsive to the NIDDK Program Announcement PA-18-330 Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK
Using a hybrid effectiveness-implementation design this study will simultaneously evaluate the effectiveness and implementation of the APOL1 testing program to more efficiently translate evidence into practice as service delivery system factors for adoption and scale up are considered while effectiveness is tested The study will be conducted at two geographically distinct transplant programs Northwestern University in Chicago IL and Georgetown University in Washington DC
Participants include live kidney donor candidates of African ancestry undergoing donor evaluation The investigators will recruit potential participants consecutively with participants recruited in year 1 serving as the control group and participants recruited in years 2-5 serving as the intervention group Participants will be eligible for participation if they respond positively to one of three questions assessing African ancestry Participants in the intervention group will use the chatbot for 5-7 minutes Immediately thereafter research staff will ask for participants informed consent to undergo APOL1 genetic testing those who agree will provide a saliva sample for testing APOL1 test results will be integrated into the respective transplant programs electronic health records Thereafter transplant nephrologists will engage in a counseling discussion with donor candidates about APOL1 and living donation
Distributional assumptions will be assessed to evaluate appropriateness of model specifications For primary analyses the mixed model framework will allow for incorporation of a random center effect to separate within- and between-center variance estimates As participants will not be randomized to intervention arms the proposed statistical analysis plan will also incorporate a multivariable modeling approach with inclusion of potential confounders to reduce bias in intervention effect estimates Effect estimates will be reported with confidence intervals to convey variability in estimates
Methods for sample size estimates were based on a simplified comparisons of means between the two arms pre-post implementation periods Necessary sample sizes were then inflated to account for multivariable model and to account for loss-to-follow-up to ensure adequate power The proposed sample size of 74 participants in the control period and 316 in the intervention period will provide at least 80-90 power to detect meaningful differences in mean Decisional Conflict Scale DCS score ranging from 50 to 77 units
The impact of this study will be the creation of a model for integrating genetic testing into clinical practice that shows how to scale up genetic counseling services through the use of chatbots to deliver foundational information and training nephrologists to deliver components of genetic counseling Specifically this model will demonstrate how to deliver APOL1 testing of live donor candidates which can then be implemented across the country via implementation science approaches The proposed study will prepare transplant programs to deliver culturally competent counseling coterminous with the completion of the NIH APOLLO study in 5 years The findings generated from this research have the potential to protect donor candidates safety by improving their informed consent As such this proposal is 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