Kidney Paired Donation Video-Based Education Trial

NCT03013829 | Completed

• 1 other identifier: 2016P000409
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision-making about KPD among potential live kidney donor and kidney transplant patients.

Conditions

Kidney Paired Donation

Keywords

Kidney Paired Donation

Outcome Measures

Primary Outcomes (3)

• Living Donation and KPD Knowledge

  A questionnaire will be used to assess living donation and KPD knowledge.

  at baseline

• Living Donation and KPD Knowledge

  A questionnaire will be used to assess living donation and KPD knowledge.

  2 weeks post-intervention

• Living Donation and KPD Knowledge

  A questionnaire will be used to assess living donation and KPD knowledge.

  three months post-intervention

Secondary Outcomes (8)

• Living Donation and KPD Concerns

  at baseline

• Living Donation and KPD Concerns

  2 weeks post-intervention

• Informed Decision-Making

  at baseline

• Informed Decision-Making

  2 weeks post-intervention

• Living Donation and KPD Self-Efficacy

  at baseline

Other Outcomes (1)

• Living donation and KPD Activation- Evaluation of Actions Taken

  three months post-intervention

Study Arms (2)

Usual Care

NO INTERVENTION

Potential LKDs and recipients will receive standard-of-care LD (Live Donor) and KPD education. As noted previously, during standard care, incompatible potential LKDs are informed of the KPD option and the potential LKD is provided with living donation information and a link to the UNOS KPD website, which includes a written description of KPD. This information is available in English and Spanish. For those who do not have internet access, the written educational materials are mailed. The potential LKD is advised to call the donor nurse coordinator with any questions about KPD and/or to initiate the full donation evaluation. This process occurs for the intended recipient only if their potential donor decides to initiate the full evaluation. For study purposes, potential LKDs and waitlisted recipients assigned to the UC group will be sent an email after randomization, which will include a link and a reminder to review their transplant center's standard of care educational materials.

Video-Based KPD education

EXPERIMENTAL

LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch the embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.

Behavioral: KPD Educational Video

Interventions

KPD Educational Video BEHAVIORAL

LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch an embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.

Video-Based KPD education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LKDs
• Speaks English or Spanish
• Completed the initial living donation health screening
• Transplant Candidates
• Speaks English or Spanish
• On that transplant waitlist (active or inactive)

You may not qualify if:

• LKD's
• Non-directed (i.e., anonymous) potential LKDs
• Previously undergone donor evaluation
• Participation in another study to increase knowledge about living donation/LDK
• Transplant Candidates
• Had a prior LDKT
• Previously enrolled in a KPD program
• Previous or current participation in another study to increase knowledge about living donation/LDKT
• Listed for a liver

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Medical University of South Carolina: collaborator
• Erie County Medical Center: collaborator

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Clinical Research

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 9, 2017
• Study Start: June 26, 2018
• Primary Completion: October 8, 2020
• Study Completion: January 31, 2021
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)