<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03013829</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000409</org_study_id>
    <nct_id>NCT03013829</nct_id>
  </id_info>
  <brief_title>Kidney Paired Donation Video-Based Education Trial</brief_title>
  <official_title>Kidney Paired Donation: A Randomized Trial to Increase Knowledge and Informed Decision-Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erie County Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of a targeted educational approach&#xD;
      designed to increase knowledge about the risks and benefits of living donation generally and&#xD;
      KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns,&#xD;
      and facilitate informed decision-making about KPD among potential live kidney donor and&#xD;
      kidney transplant patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a randomized controlled trial (RCT) to examine the&#xD;
      effectiveness of a video-based KPD education intervention to improve knowledge,&#xD;
      self-efficacy, concerns, and informed decision-making about KPD among potential live kidney&#xD;
      donor and kidney transplant patients.&#xD;
&#xD;
      There will be equal allocation of LKDs and intended recipients to both KPD education&#xD;
      conditions: (1) Usual Care (UC) group and (2) UC plus video-based KPD education group. All&#xD;
      enrolled LKDs and intended recipients will complete a baseline survey and another survey 2&#xD;
      weeks post-intervention. Additionally, follow-up data will be gathered on KPD&#xD;
      decision-making, participation, and reasons for non-participation at 3 months&#xD;
      post-intervention.&#xD;
&#xD;
      Settings and target population:&#xD;
&#xD;
      The study will be conducted at three kidney transplant programs in the United States: Beth&#xD;
      Israel Deaconess Medical Center (BIDMC; Boston, MA), the Medical University of South Carolina&#xD;
      (MUSC; Charleston, SC), and Erie County Medical Center (ECMC; Buffalo, NY). BIDMC will act as&#xD;
      the coordinating center for this study and will be responsible for study design, oversite,&#xD;
      reporting, updates, and final data analysis. MUSC and ECMC will rely on the CCI at BIDMC for&#xD;
      review. This study will target potential LKDs and their intended recipients.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Random assignment to the usual education or usual education plus video intervention group&#xD;
      will occur within the 48 hours following completion of the baseline survey. The BIDMC study&#xD;
      coordinator will oversee randomization after receiving an automated notification of baseline&#xD;
      completion by participants from all study sites. Randomization will be done with the LKD,&#xD;
      with the randomized group matched to the intended recipient. We have decided to ensure that&#xD;
      the randomized group is the same for any LKD-recipient pairs to reduce the risk of&#xD;
      contamination, which is a critical threat to internal validity in this type of study. For&#xD;
      instance, if a LKD was assigned to the KPD video-based education group and their intended&#xD;
      recipient was assigned to the UC group, there is the real possibility that there would be&#xD;
      some diffusion of treatments in which the LKD discusses some elements of the intervention&#xD;
      with the recipient and this, in turn, may influence the recipient's living donation and KPD&#xD;
      knowledge, concerns, and decision-making processes. A simple unrestricted random allocation&#xD;
      sequence will be used. We will use REDCap to generate the randomization sequence, which will&#xD;
      be accessible to the site coordinators and transplant educators. The PI and Co-Investigators&#xD;
      will be blinded to the subjects' allocation assignment.&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
      Usual Care (UC) Living Donation and KPD Education:&#xD;
&#xD;
      Potential LKDs and recipients will receive living donation and KPD-specific education as they&#xD;
      usually do at their respective kidney transplant programs.&#xD;
&#xD;
      Typically, potential LKDs are informed of their incompatibility during a phone call with the&#xD;
      donor nurse coordinator. At this time, the KPD option is described and the potential LKD is&#xD;
      provided with kidney paired donation information. This information is available in English&#xD;
      and Spanish. For those who do not have internet access, the written educational materials are&#xD;
      mailed. The potential LKD is advised to call the donor nurse coordinator with any questions&#xD;
      about KPD and/or to initiate the full donation evaluation. An identical KPD educational&#xD;
      process occurs for the intended recipient, although this is done with their own transplant&#xD;
      nurse coordinator and only if their potential donor decides to initiate the full donation&#xD;
      evaluation.&#xD;
&#xD;
      For study purposes, we will approach waitlisted recipients and any potential donors who&#xD;
      complete an online health screening. LKDs and recipients assigned to the UC group will be&#xD;
      sent an email after randomization, which will include a reminder to visit the usual&#xD;
      educational websites and link to the usual care brochures. Participants will only be shown&#xD;
      the materials provided as standard of care at their respective institutions.&#xD;
&#xD;
      Video-Based KPD Education:&#xD;
&#xD;
      LKDs and recipients assigned to the video-based KPD education group will receive the same&#xD;
      living donation and KPD educational materials as those in the UC group. Also, as in the UC&#xD;
      group, they will be encouraged by the site coordinator to review the educational materials.&#xD;
      In addition, following randomization to this group, participants will be sent an email&#xD;
      encouraging them to watch the embedded KPD education video. This video will be professionally&#xD;
      designed and will highlight the operational features of KPD and address the specific barriers&#xD;
      highlighted in our formative research. The primary goal of these sessions is to increase&#xD;
      living donation and KPD knowledge of risks and benefits and to reduce specific concerns that&#xD;
      are based on inaccurate information. The intent is not to persuade LKDs or recipients to&#xD;
      pursue living donation or KPD, but to ensure that they have sufficient information to make an&#xD;
      informed choice that is consistent with their own values and preferences.&#xD;
&#xD;
      Assessment Time-points:&#xD;
&#xD;
      Study data will be collected from participants at three different time points.&#xD;
&#xD;
      Baseline. Participants will complete a 30-minute online assessment via REDCap following email&#xD;
      consent but prior to randomization. The questionnaire assessment will gather sociodemographic&#xD;
      information, assess primary and secondary outcomes, and measure important covariates.&#xD;
&#xD;
      Post-Intervention. Two weeks after randomization, participants will complete a 20-minute&#xD;
      REDCap assessment of the primary and secondary outcomes, uptake of the written and video&#xD;
      educational elements, any discussions they have had with others about living donation or KPD,&#xD;
      educational intervention process and evaluation, and any steps they have taken to pursue&#xD;
      further donation evaluation. The rationale for the timing of this assessment is to re-assess&#xD;
      the primary and secondary outcomes in close proximity to the delivery of living donation and&#xD;
      KPD-specific education yet that provides sufficient time for the participant to assimilate&#xD;
      and consider the information acquired.&#xD;
&#xD;
      Follow-up. Three months following the living donation and KPD-specific education,&#xD;
      participants will complete a final REDCap assessment on living donation and KPD knowledge, as&#xD;
      well as a brief assessment to learn of their final decision regarding living donation and the&#xD;
      factors that contributed to it. The rationale for the timing of this follow-up assessment is&#xD;
      that the vast majority of incompatible potential LKDs and recipients who have been offered&#xD;
      KPD have achieved a final disposition within this time period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2018</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 8, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Living Donation and KPD Knowledge</measure>
    <time_frame>at baseline</time_frame>
    <description>A questionnaire will be used to assess living donation and KPD knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Living Donation and KPD Knowledge</measure>
    <time_frame>2 weeks post-intervention</time_frame>
    <description>A questionnaire will be used to assess living donation and KPD knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Living Donation and KPD Knowledge</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>A questionnaire will be used to assess living donation and KPD knowledge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Living Donation and KPD Concerns</measure>
    <time_frame>at baseline</time_frame>
    <description>Living donation and KPD concerns will be assessed using a Concerns about Living Donation scale and the Kidney Exchange Concerns (KEC) questionnaire.Questionnaire results will be aggregated to evaluate concerns about living donation and KPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Living Donation and KPD Concerns</measure>
    <time_frame>2 weeks post-intervention</time_frame>
    <description>Living donation and KPD concerns will be assessed using a Concerns about Living Donation scale and the Kidney Exchange Concerns (KEC) questionnaire. Questionnaire results will be aggregated to evaluate concerns about living donation and KPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Informed Decision-Making</measure>
    <time_frame>at baseline</time_frame>
    <description>The investigators will measure living donation and KPD informed decision-making using five true-false items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Informed Decision-Making</measure>
    <time_frame>2 weeks post-intervention</time_frame>
    <description>The investigators will measure living donation and KPD informed decision-making using five true-false items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Living Donation and KPD Self-Efficacy</measure>
    <time_frame>at baseline</time_frame>
    <description>The investigators will assess self-efficacy using a measure developed for the current NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)-funded House Calls RCT. This measure includes a list of actions or behaviors that are related to KPD, to which participants will indicate their level of confidence in carrying them out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Living Donation and KPD Self-Efficacy</measure>
    <time_frame>2 weeks post-intervention</time_frame>
    <description>The investigators will assess self-efficacy using a measure developed for the current NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)-funded House Calls RCT. This measure includes a list of actions or behaviors that are related to KPD, to which participants will indicate their level of confidence in carrying them out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Living Donation and KPD Discussions</measure>
    <time_frame>at baseline</time_frame>
    <description>For the House Calls RCT, the investigators developed and validated a measure designed to assess the amount of time individuals spend talking to others about living donation. This measure asks whether the LKD or intended recipient talked to the donor/recipient, family members, friends, or healthcare providers about living donation and KPD, and if so, approximately how much time was spent discussing donation (TALKeD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Living Donation and KPD Discussions</measure>
    <time_frame>2 weeks post-intervention</time_frame>
    <description>For the House Calls RCT, the investigators developed and validated a measure designed to assess the amount of time individuals spend talking to others about living donation. This measure asks whether the LKD or intended recipient talked to the donor/recipient, family members, friends, or healthcare providers about living donation and KPD, and if so, approximately how much time was spent discussing donation (TALKeD).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Living donation and KPD Activation- Evaluation of Actions Taken</measure>
    <time_frame>three months post-intervention</time_frame>
    <description>As part of the final follow-up assessment, the investigators will assess living donation and KPD activation, which asks participants to indicate whether they spoke to the donor/recipient about living donation and KPD, pursued further evaluation for living donation and KPD, entered the KPD registry, and/or donated or received a transplant. Participants will also be asked about reasons for not pursuing further evaluation or not registering for KPD. This outcome will measure action steps taken with regards to living donation and KPD.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">588</enrollment>
  <condition>Kidney Paired Donation</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video-Based KPD education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>KPD Educational Video</intervention_name>
    <description>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.</description>
    <arm_group_label>Video-Based KPD education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        LKDs&#xD;
&#xD;
          -  Speaks English or Spanish&#xD;
&#xD;
          -  Completed the initial living donation health screening&#xD;
&#xD;
        Transplant Candidates&#xD;
&#xD;
          -  Speaks English or Spanish&#xD;
&#xD;
          -  On that transplant waitlist (active or inactive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        LKD's&#xD;
&#xD;
          -  Non-directed (i.e., anonymous) potential LKDs&#xD;
&#xD;
          -  Previously undergone donor evaluation&#xD;
&#xD;
          -  Participation in another study to increase knowledge about living donation/LDK&#xD;
&#xD;
        Transplant Candidates&#xD;
&#xD;
          -  Had a prior LDKT&#xD;
&#xD;
          -  Previously enrolled in a KPD program&#xD;
&#xD;
          -  Previous or current participation in another study to increase knowledge about living&#xD;
             donation/LDKT&#xD;
&#xD;
          -  Listed for a liver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erie County Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>James Rodrigue</investigator_full_name>
    <investigator_title>Vice Chair of Clinical Research</investigator_title>
  </responsible_party>
  <keyword>Kidney Paired Donation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013829
org study id: 2016P000409
nct id: NCT03013829
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
The investigators will conduct a randomized controlled trial (RCT) to examine the
      effectiveness of a video-based KPD education intervention to improve knowledge,
      self-efficacy, concerns, and informed decision-making about KPD among potential live kidney
      donor and kidney transplant patients.

      There will be equal allocation of LKDs and intended recipients to both KPD education
      conditions: (1) Usual Care (UC) group and (2) UC plus video-based KPD education group. All
      enrolled LKDs and intended recipients will complete a baseline survey and another survey 2
      weeks post-intervention. Additionally, follow-up data will be gathered on KPD
      decision-making, participation, and reasons for non-participation at 3 months
      post-intervention.

      Settings and target population:

      The study will be conducted at three kidney transplant programs in the United States: Beth
      Israel Deaconess Medical Center (BIDMC; Boston, MA), the Medical University of South Carolina
      (MUSC; Charleston, SC), and Erie County Medical Center (ECMC; Buffalo, NY). BIDMC will act as
      the coordinating center for this study and will be responsible for study design, oversite,
      reporting, updates, and final data analysis. MUSC and ECMC will rely on the CCI at BIDMC for
      review. This study will target potential LKDs and their intended recipients.

      Randomization:

      Random assignment to the usual education or usual education plus video intervention group
      will occur within the 48 hours following completion of the baseline survey. The BIDMC study
      coordinator will oversee randomization after receiving an automated notification of baseline
      completion by participants from all study sites. Randomization will be done with the LKD,
      with the randomized group matched to the intended recipient. We have decided to ensure that
      the randomized group is the same for any LKD-recipient pairs to reduce the risk of
      contamination, which is a critical threat to internal validity in this type of study. For
      instance, if a LKD was assigned to the KPD video-based education group and their intended
      recipient was assigned to the UC group, there is the real possibility that there would be
      some diffusion of treatments in which the LKD discusses some elements of the intervention
      with the recipient and this, in turn, may influence the recipient's living donation and KPD
      knowledge, concerns, and decision-making processes. A simple unrestricted random allocation
      sequence will be used. We will use REDCap to generate the randomization sequence, which will
      be accessible to the site coordinators and transplant educators. The PI and Co-Investigators
      will be blinded to the subjects' allocation assignment.

      Interventions:

      Usual Care (UC) Living Donation and KPD Education:

      Potential LKDs and recipients will receive living donation and KPD-specific education as they
      usually do at their respective kidney transplant programs.

      Typically, potential LKDs are informed of their incompatibility during a phone call with the
      donor nurse coordinator. At this time, the KPD option is described and the potential LKD is
      provided with kidney paired donation information. 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. An identical KPD educational
      process occurs for the intended recipient, although this is done with their own transplant
      nurse coordinator and only if their potential donor decides to initiate the full donation
      evaluation.

      For study purposes, we will approach waitlisted recipients and any potential donors who
      complete an online health screening. LKDs and recipients assigned to the UC group will be
      sent an email after randomization, which will include a reminder to visit the usual
      educational websites and link to the usual care brochures. Participants will only be shown
      the materials provided as standard of care at their respective institutions.

      Video-Based KPD Education:

      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.

      Assessment Time-points:

      Study data will be collected from participants at three different time points.

      Baseline. Participants will complete a 30-minute online assessment via REDCap following email
      consent but prior to randomization. The questionnaire assessment will gather sociodemographic
      information, assess primary and secondary outcomes, and measure important covariates.

      Post-Intervention. Two weeks after randomization, participants will complete a 20-minute
      REDCap assessment of the primary and secondary outcomes, uptake of the written and video
      educational elements, any discussions they have had with others about living donation or KPD,
      educational intervention process and evaluation, and any steps they have taken to pursue
      further donation evaluation. The rationale for the timing of this assessment is to re-assess
      the primary and secondary outcomes in close proximity to the delivery of living donation and
      KPD-specific education yet that provides sufficient time for the participant to assimilate
      and consider the information acquired.

      Follow-up. Three months following the living donation and KPD-specific education,
      participants will complete a final REDCap assessment on living donation and KPD knowledge, as
      well as a brief assessment to learn of their final decision regarding living donation and the
      factors that contributed to it. The rationale for the timing of this follow-up assessment is
      that the vast majority of incompatible potential LKDs and recipients who have been offered
      KPD have achieved a final disposition within this time period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Living Donation and KPD Knowledge
time frame: at baseline
description: A questionnaire will be used to assess living donation and KPD knowledge.
measure: Living Donation and KPD Knowledge
time frame: 2 weeks post-intervention
description: A questionnaire will be used to assess living donation and KPD knowledge.
measure: Living Donation and KPD Knowledge
time frame: three months post-intervention
description: A questionnaire will be used to assess living donation and KPD knowledge.
measure: Living Donation and KPD Concerns
time frame: at baseline
description: Living donation and KPD concerns will be assessed using a Concerns about Living Donation scale and the Kidney Exchange Concerns (KEC) questionnaire.Questionnaire results will be aggregated to evaluate concerns about living donation and KPD.
measure: Living Donation and KPD Concerns
time frame: 2 weeks post-intervention
description: Living donation and KPD concerns will be assessed using a Concerns about Living Donation scale and the Kidney Exchange Concerns (KEC) questionnaire. Questionnaire results will be aggregated to evaluate concerns about living donation and KPD.
measure: Informed Decision-Making
time frame: at baseline
description: The investigators will measure living donation and KPD informed decision-making using five true-false items.
measure: Informed Decision-Making
time frame: 2 weeks post-intervention
description: The investigators will measure living donation and KPD informed decision-making using five true-false items.
measure: Living Donation and KPD Self-Efficacy
time frame: at baseline
description: The investigators will assess self-efficacy using a measure developed for the current NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)-funded House Calls RCT. This measure includes a list of actions or behaviors that are related to KPD, to which participants will indicate their level of confidence in carrying them out.
measure: Living Donation and KPD Self-Efficacy
time frame: 2 weeks post-intervention
description: The investigators will assess self-efficacy using a measure developed for the current NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)-funded House Calls RCT. This measure includes a list of actions or behaviors that are related to KPD, to which participants will indicate their level of confidence in carrying them out.
measure: Living Donation and KPD Discussions
time frame: at baseline
description: For the House Calls RCT, the investigators developed and validated a measure designed to assess the amount of time individuals spend talking to others about living donation. This measure asks whether the LKD or intended recipient talked to the donor/recipient, family members, friends, or healthcare providers about living donation and KPD, and if so, approximately how much time was spent discussing donation (TALKeD).
measure: Living Donation and KPD Discussions
time frame: 2 weeks post-intervention
description: For the House Calls RCT, the investigators developed and validated a measure designed to assess the amount of time individuals spend talking to others about living donation. This measure asks whether the LKD or intended recipient talked to the donor/recipient, family members, friends, or healthcare providers about living donation and KPD, and if so, approximately how much time was spent discussing donation (TALKeD).
measure: Living donation and KPD Activation- Evaluation of Actions Taken
time frame: three months post-intervention
description: As part of the final follow-up assessment, the investigators will assess living donation and KPD activation, which asks participants to indicate whether they spoke to the donor/recipient about living donation and KPD, pursued further evaluation for living donation and KPD, entered the KPD registry, and/or donated or received a transplant. Participants will also be asked about reasons for not pursuing further evaluation or not registering for KPD. This outcome will measure action steps taken with regards to living donation and KPD.
arm group label: Usual Care
arm group type: No Intervention
description: 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.
arm group label: Video-Based KPD education
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: KPD Educational Video
description: 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.
arm group label: Video-Based KPD education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: James Rodrigue
investigator title: Vice Chair of Clinical Research
sharing ipd: No