End-stage Renal Disease
Conditions
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.
Interventions
BEHAVIORALScript Intervention
This intervention provides language to participants to allow them to discuss kidney transplantation with their social network.
BEHAVIORALSearch 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.
Sponsors
University of Pennsylvania
University of Alabama at Birmingham
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Approvals for living kidney donor candidacy | up to 3 years | Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient |
| Received a living donor kidney transplant | up to 3 years | Living donor kidney transplant received by patient |
| Received a deceased donor kidney transplant | up to 3 years | Deceased donor kidney transplant received by patient |
| Death | up to 3 years | Patient died during the follow-up period |
| Completed living kidney donor screening questionnaires | up to 3 years | Number of completed living kidney donation screening questionnaires completed for patient |
| Preliminary approval from living kidney donor screening questionnaires | up to 3 years | Number of completed living kidney donor screening that received preliminary approval for patient |
| Completed living kidney donor evaluations | up to 3 years | Number of living kidney donor evaluations completed for patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concerns about living kidney donation | Immediate | 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 | Immediate | 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 | Immediate | Respondent is asked to rate their level of knowledge related to kidney transplantation. |
| Trust in medical institutions | Immediate | Respondent is asked to rate their trust in medical institutions. |
| Religious views' effect on kidney transplant willingness | Immediate | Respondent is asked how strongly they agree that their religious views affect their willingness to pursue a kidney transplant. |
| Preference for living kidney donor | Immediate | A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding preference for living kidney donor |
Countries
United States
Outcome results
None listed