Clinical trial NCT05255757: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Alabama at Birmingham
First posted: 2022-02-25
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Received a living donor kidney transplant
timeFrame: up to 3 years
measure: Received a deceased donor kidney transplant
timeFrame: up to 3 years
measure: Death
timeFrame: up to 3 years
measure: Completed living kidney donor screening questionnaires
timeFrame: up to 3 years
measure: Preliminary approval from living kidney donor screening questionnaires
timeFrame: up to 3 years
measure: Completed living kidney donor evaluations
timeFrame: up to 3 years
measure: Approvals for living kidney donor candidacy
timeFrame: up to 3 years
Secondary outcomes:
measure: Preference for living kidney donor
timeFrame: Immediate
measure: Concerns about living kidney donation
timeFrame: Immediate
measure: Living donor kidney transplant willingness
timeFrame: Immediate
measure: Self-rated kidney transplant knowledge
timeFrame: Immediate
measure: Trust in medical institutions
timeFrame: Immediate
measure: Religious views' effect on kidney transplant willingness
timeFrame: Immediate
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Philadelphia
country: United States
facility: Penn Medicine-- University of Pennsylvania
state: Pennsylvania
Study officials:
References: