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APOL1 Genetic Testing Program for Living Donors, Part 2

Primary Purpose

Chronic Kidney Diseases, Genetic Predisposition

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APOL1 Counseling Training Program
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Kidney Diseases focused on measuring Implementation science, Ethics, African continental ancestry group, Culturally competent care, Shared decision making, Genetic couseling, Informed consent, Nephrology, Educational intervention, Surveys and questionnaires, Apolipoprotein L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (age 18 years and older)
  • English-speaking
  • Transplant nephrologists evaluating live kidney donor candidates practicing at the study sites
  • Not vision impaired
  • Not cognitively impaired

Exclusion Criteria:

  • Not a nephrologist

Sites / Locations

  • Medstar Georgetown Transplant Institute
  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Counseling Training Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Number and quality of prescribed Pre-Test counseling practices
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor kidney transplant candidates' about APOL1 testing, and living donation (before APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The fidelity minimum and maximum values are: 0-12 Higher fidelity scores mean that the pre-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
Number and quality of prescribed Post-Test counseling practices
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor candidates' about APOL1 test results and living donation (after APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The minimum and maximum values are: 0-12 Higher fidelity scores mean that the post-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.

Secondary Outcome Measures

Practical Knowledge and Self-Efficacy in Genetic Counseling
Nephrologists' knowledge and self-efficacy or confidence in their ability to deliver APOL1 counseling will be assessed using a 12-item Likert scale survey. This is the Pre-Test. The minimum and maximum values are: 1 to 5 Greater scores reflect greater knowledge or confidence with counseling.
Practical Knowledge and Self-Efficacy in Genetic Counseling
Nephrologists' knowledge and self-efficacy or confidence in their ability to deliver APOL1 counseling will be assessed using a 12-item Likert scale survey. This is the Post-Test. The minimum and maximum values are: 1 to 5 Greater scores reflect greater knowledge or confidence with counseling.
Acceptability of Intervention Measure (AIM)
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Acceptability of Intervention Measure (AIM)
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Acceptability of Intervention Measure (AIM)
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Intervention Appropriateness Measure (IAM)
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Intervention Appropriateness Measure (IAM)
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Intervention Appropriateness Measure (IAM)
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Clinical Sustainability Assessment Tool (CSAT)
This 9-item Likert scale will assess nephrologists' perceptions of the sustainability of delivering APOL1 counseling according to the APOL1 counseling training program. The minimum and maximum values are: 1 to 7 Higher scores indicate higher capacity for sustainability.

Full Information

First Posted
May 11, 2021
Last Updated
February 2, 2023
Sponsor
Northwestern University
Collaborators
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT04999436
Brief Title
APOL1 Genetic Testing Program for Living Donors, Part 2
Official Title
APOL1 Genetic Testing Program for Living Donors, Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, 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: Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 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 (n=6) 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Genetic Predisposition
Keywords
Implementation science, Ethics, African continental ancestry group, Culturally competent care, Shared decision making, Genetic couseling, Informed consent, Nephrology, Educational intervention, Surveys and questionnaires, Apolipoprotein L1

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We will collect observational data to assess the impact of the training program on clinical practice. We will collect pre-test data before the intervention, and post-test data after the intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counseling Training Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
APOL1 Counseling Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number and quality of prescribed Pre-Test counseling practices
Description
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor kidney transplant candidates' about APOL1 testing, and living donation (before APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The fidelity minimum and maximum values are: 0-12 Higher fidelity scores mean that the pre-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
Time Frame
Post-intervention, up to 5 years
Title
Number and quality of prescribed Post-Test counseling practices
Description
We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor candidates' about APOL1 test results and living donation (after APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The minimum and maximum values are: 0-12 Higher fidelity scores mean that the post-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.
Time Frame
Post-intervention, up to 5 years
Secondary Outcome Measure Information:
Title
Practical Knowledge and Self-Efficacy in Genetic Counseling
Description
Nephrologists' knowledge and self-efficacy or confidence in their ability to deliver APOL1 counseling will be assessed using a 12-item Likert scale survey. This is the Pre-Test. The minimum and maximum values are: 1 to 5 Greater scores reflect greater knowledge or confidence with counseling.
Time Frame
Day 1
Title
Practical Knowledge and Self-Efficacy in Genetic Counseling
Description
Nephrologists' knowledge and self-efficacy or confidence in their ability to deliver APOL1 counseling will be assessed using a 12-item Likert scale survey. This is the Post-Test. The minimum and maximum values are: 1 to 5 Greater scores reflect greater knowledge or confidence with counseling.
Time Frame
Approximately Day 14
Title
Acceptability of Intervention Measure (AIM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Time Frame
Approximately Day 21
Title
Acceptability of Intervention Measure (AIM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Time Frame
Approximately Month 2
Title
Acceptability of Intervention Measure (AIM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the acceptability of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased acceptability of the intervention.
Time Frame
Approximately Month 12
Title
Intervention Appropriateness Measure (IAM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Time Frame
Approximately Day 21
Title
Intervention Appropriateness Measure (IAM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Time Frame
Approximately Month 2
Title
Intervention Appropriateness Measure (IAM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the appropriateness of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Time Frame
Approximately Month 12
Title
Feasibility of Intervention Measure (FIM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Time Frame
Approximately Day 21
Title
Feasibility of Intervention Measure (FIM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Time Frame
Approximately Month 2
Title
Feasibility of Intervention Measure (FIM)
Description
This 4-item Likert scale will assess nephrologists' perceptions of the feasibility of the APOL1 counseling training program. The minimum and maximum values are: 1 to 5 Higher scores indicate increased perceived appropriateness of the intervention.
Time Frame
Approximately Month 12
Title
Clinical Sustainability Assessment Tool (CSAT)
Description
This 9-item Likert scale will assess nephrologists' perceptions of the sustainability of delivering APOL1 counseling according to the APOL1 counseling training program. The minimum and maximum values are: 1 to 7 Higher scores indicate higher capacity for sustainability.
Time Frame
Approximately Month 36
Other Pre-specified Outcome Measures:
Title
Racial attributes in clinical evaluation (RACE) scale
Description
This 8-item survey will assess the degree to which nephrologists report using race in their clinical decision making processes. The minimum and maximum values are: 0 to 28 Higher scores mean greater use of race in clinical decision-making.
Time Frame
Day 1
Title
Racial attributes in clinical evaluation (RACE) scale
Description
This 8-item survey will assess the degree to which nephrologists report using race in their clinical decision making processes. The minimum and maximum values are: 0 to 28 Higher scores mean greater use of race in clinical decision-making.
Time Frame
Approximately Day 14
Title
Genetic variation knowledge assessment index (GKAI)
Description
This 8-item survey will assess nephrologists' scientific knowledge of human genetic variation. The minimum and maximum values are: 0 to 6 Higher scores mean greater knowledge of genetic variation.
Time Frame
Day 1
Title
Genetic variation knowledge assessment index (GKAI)
Description
This 8-item survey will assess nephrologists' scientific knowledge of human genetic variation. The minimum and maximum values are: 0 to 6 Higher scores mean greater knowledge of genetic variation.
Time Frame
Approximately Day 14
Title
Health Professionals Beliefs about Race (HPBR) scale
Description
This 9-item survey will assess nephrologists' beliefs about the relationship between race and genetics in terms of race as a biological phenomenon, and the clinical importance of race. The scale is scored as two domains: HPBR-Biological domain (contains 4 items that are summed) and HPBR-Clinical domain (contains 3 items that are summed) Min-Max: 4 - 20 Biological Domain Min-Max: 3-15 Clinical Domain Higher scores indicate greater beliefs about relationships between genetics and race.
Time Frame
Day 1
Title
Health Professionals Beliefs about Race (HPBR) scale
Description
This 9-item survey will assess nephrologists' beliefs about the relationship between race and genetics in terms of race as a biological phenomenon, and the clinical importance of race. The scale is scored as two domains: HPBR-Biological domain (contains 4 items that are summed) and HPBR-Clinical domain (contains 3 items that are summed) Min-Max: 4 - 20 Biological Domain Min-Max: 3-15 Clinical Domain Higher scores indicate greater beliefs about relationships between genetics and race.
Time Frame
Approximately Day 14
Title
Barriers and Facilitators to APOL1 testing Implementation
Description
The Consolidated Framework for Implementation Research Interview guide will be used to assess nephrologists' perceived facilitators and barriers, organizational capacity, and adaptations to the APOL1 testing and counseling program This is a qualitative interview guide, thus, there is no minimum or maximum value to be obtained.
Time Frame
Approximately Day 21
Title
Barriers and Facilitators to APOL1 testing Implementation
Description
The Consolidated Framework for Implementation Research Interview guide will be used to assess nephrologists' perceived facilitators and barriers, organizational capacity, and adaptations to the APOL1 testing and counseling program This is a qualitative interview guide, thus, there is no minimum or maximum value to be obtained.
Time Frame
Approximately Month 3
Title
Barriers and Facilitators to APOL1 testing Implementation
Description
The Consolidated Framework for Implementation Research Interview guide will be used to assess nephrologists' perceived facilitators and barriers, organizational capacity, and adaptations to the APOL1 testing and counseling program This is a qualitative interview guide, thus, there is no minimum or maximum value to be obtained.
Time Frame
Approximately Month 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (age 18 years and older) English-speaking Transplant nephrologists evaluating live kidney donor candidates practicing at the study sites Not vision impaired Not cognitively impaired Exclusion Criteria: Not a nephrologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa J Gordon, PhD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Georgetown Transplant Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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APOL1 Genetic Testing Program for Living Donors, Part 2

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