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Network Interventions to Reduce Disparities in Living Kidney Donation

Primary Purpose

End-stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Script Intervention
Search Intervention
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End-stage Renal Disease

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama-BirminghamRecruiting
  • Penn Medicine-- University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

No intervention

Script Intervention

Search Intervention

Both Search and Script Intervention

Arm Description

This group will only complete study survey and refer members of their family and social network for participation in a web survey.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Self-rated kidney transplant knowledge
Respondent is asked to rate their level of knowledge related to kidney transplantation.
Trust in medical institutions
Respondent is asked to rate their trust in medical institutions.
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.

Full Information

First Posted
October 10, 2021
Last Updated
September 26, 2023
Sponsor
Penn State University
Collaborators
University of Pennsylvania, University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT05255757
Brief Title
Network Interventions to Reduce Disparities in Living Kidney Donation
Official Title
Social Network Interventions to Reduce Race Disparities in Living Kidney Donation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
University of Pennsylvania, University of Alabama at Birmingham

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
There are two interventions randomly assigned to participants in a factorial experimental design. The first intervention is the search intervention. In addition to the candidate survey, transplant candidates assigned to this intervention will be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. The second intervention is the script intervention, where in addition to the survey, transplant candidates will review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. 25% of participants will be assigned to each of the following factorial experimental groups: no intervention, search intervention only, script intervention only, or both search and script intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
This group will only complete study survey and refer members of their family and social network for participation in a web survey.
Arm Title
Script Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Search Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Both Search and Script Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Script Intervention
Intervention Description
This intervention provides language to participants to allow them to discuss kidney transplantation with their social network.
Intervention Type
Behavioral
Intervention Name(s)
Search Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Received a living donor kidney transplant
Description
Living donor kidney transplant received by patient
Time Frame
up to 3 years
Title
Received a deceased donor kidney transplant
Description
Deceased donor kidney transplant received by patient
Time Frame
up to 3 years
Title
Death
Description
Patient died during the follow-up period
Time Frame
up to 3 years
Title
Completed living kidney donor screening questionnaires
Description
Number of completed living kidney donation screening questionnaires completed for patient
Time Frame
up to 3 years
Title
Preliminary approval from living kidney donor screening questionnaires
Description
Number of completed living kidney donor screening that received preliminary approval for patient
Time Frame
up to 3 years
Title
Completed living kidney donor evaluations
Description
Number of living kidney donor evaluations completed for patient
Time Frame
up to 3 years
Title
Approvals for living kidney donor candidacy
Description
Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Preference for living kidney donor
Description
A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding preference for living kidney donor
Time Frame
Immediate
Title
Concerns about living kidney donation
Description
A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding concerns for living kidney donation
Time Frame
Immediate
Title
Living donor kidney transplant willingness
Description
A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding living donor kidney transplant willingness
Time Frame
Immediate
Title
Self-rated kidney transplant knowledge
Description
Respondent is asked to rate their level of knowledge related to kidney transplantation.
Time Frame
Immediate
Title
Trust in medical institutions
Description
Respondent is asked to rate their trust in medical institutions.
Time Frame
Immediate
Title
Religious views' effect on kidney transplant willingness
Description
Respondent is asked how strongly they agree that their religious views affect their willingness to pursue a kidney transplant.
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Daw, PhD
Phone
814-7531329
Email
jddaw@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kassidy Shumaker, MPH
Phone
814-863-4821
Email
kls662@psu.edu
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kloda, PA-C
Phone
205-975-0157
Email
dkloda@uabmc.edu
Facility Name
Penn Medicine-- University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Mussell, MA
Phone
215-746-4177
Email
amussell@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Network Interventions to Reduce Disparities in Living Kidney Donation

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