Network Interventions to Reduce Disparities in Living Kidney Donation

Social Network Interventions to Reduce Race Disparities in Living Kidney Donation

For this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. This project will examine how network characteristics are associated with eventual living donor kidney transplant outcomes and test the efficacy of evidence-based interventions designed to assist kidney transplant candidates in participant donor search on a multi-center scale.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Behavioral: Script Intervention; Behavioral: Search Intervention

Detailed Description

The overall goal is to understand the process and assist participants who do not receive unsolicited offers to be evaluated as a living kidney donor in initiating and effectively conducting these critical conversations with participants kin and friends. In the search intervention, based on what they can tell investigators about the number, type, perceived health, perceived relationship, and potential willingness to donate, as well as analyses of data from the National Health and Nutrition Examination Survey (NHANES) investigators will counsel them on which members of participants family and friendship networks appear most biomedically promising as donors among the subset of these individuals that participants have not ruled out for known medical or perceived relationship reasons. In the rhetorical intervention, investigators will test non-coercive, promising verbal scripts that have proven promising in preliminary tests in vignette experiments in online and phone surveys.

AIM 1: Survey transplant candidates about their social network and transplant-related attitudes, knowledge, and characteristics; and randomize participants into one of two interventions or a control group.

AIM 2: Send network member participants a survey that measures potential donor attributes that are hypothesized to influence donation decisions, such as medical contraindications, blood type, health insurance status, and barriers to living donation.

AIM 3: Test whether participant social networks and interventions affect donation outcomes using medical records and follow-ups provided by Penn and UAB. Investigators will create the first predictive model of potential donor evaluation and actual donation. This information is critical to improve clinical practice and efforts to ethically influence the living donor search process.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama-Birmingham
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine-- University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are KT candidates at the University of Pennsylvania or University of Alabama-Birmingham OR were identified by KT candidate from the University of Pennsylvania or University of Alabama-Birmingham as a network member
• Are adults aged 18 or older
• Are able and willing to consent to participation in the survey

Exclusion Criteria:

• Person is not a KT candidate at University of Pennsylvania or University of Alabama-Birmingham OR was NOT identified by KT candidate from University of Pennsylvania or University of Alabama-Birmingham as a network member
• Individuals who are not yet 18
• Participant does not speak English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; This group will only complete study survey and refer members of their family and social network for participation in a web survey.
Experimental: Script Intervention; This group will complete the survey, refer members of their family and social network for participation in a web survey, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network.	Behavioral: Script Intervention; This intervention provides language to participants to allow them to discuss kidney transplantation with their social network.
Experimental: Search Intervention; This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation.	Behavioral: Search Intervention; This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation.
Experimental: Both Search and Script Intervention; This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network.	Behavioral: Script Intervention; This intervention provides language to participants to allow them to discuss kidney transplantation with their social network.; Behavioral: Search Intervention; This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Received a living donor kidney transplant	Living donor kidney transplant received by patient	up to 3 years
Received a deceased donor kidney transplant	Deceased donor kidney transplant received by patient	up to 3 years
Death	Patient died during the follow-up period	up to 3 years
Completed living kidney donor screening questionnaires	Number of completed living kidney donation screening questionnaires completed for patient	up to 3 years
Preliminary approval from living kidney donor screening questionnaires	Number of completed living kidney donor screening that received preliminary approval for patient	up to 3 years
Completed living kidney donor evaluations	Number of living kidney donor evaluations completed for patient	up to 3 years
Approvals for living kidney donor candidacy	Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference for living kidney donor	A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding preference for living kidney donor	Immediate
Concerns about living kidney donation	A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding concerns for living kidney donation	Immediate
Living donor kidney transplant willingness	A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding living donor kidney transplant willingness	Immediate
Self-rated kidney transplant knowledge	Respondent is asked to rate their level of knowledge related to kidney transplantation.	Immediate
Trust in medical institutions	Respondent is asked to rate their trust in medical institutions.	Immediate
Religious views' effect on kidney transplant willingness	Respondent is asked how strongly they agree that their religious views affect their willingness to pursue a kidney transplant.	Immediate

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: University of Pennsylvania; University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: October 10, 2021
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 849197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No