xml: <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/NCT05997875</url>
    </required_header>
    <id_info>
      <org_study_id>853978</org_study_id>
      <nct_id>NCT05997875</nct_id>
    </id_info>
    <brief_title>Transforming Hemodialysis-Related Vascular Access Education</brief_title>
    <acronym>THRiVE</acronym>
    <official_title>Transforming Hemodialysis-Related Vascular Access Education (THRiVE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Pennsylvania</source>
    <oversight_info>
      <has_dmc>Yes</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 focus of this study is on vascular access for hemodialysis. This is a randomized clinical&#xD;
        trial testing 3 educational approaches to help patients with advanced chronic kidney disease&#xD;
        prepare for placement of hemodialysis vascular access. Study participants will each be&#xD;
        assigned to one of the 3 approaches: 1) &quot;Education&quot;, in which participants will be given a&#xD;
        video and brochure that provide information about the types of vascular access and what can&#xD;
        be expected before and after the vascular access is placed, 2) &quot;Education-Plus&quot;, in which&#xD;
        participants will be given the video and brochure and will also have sessions by telehealth&#xD;
        with a motivational interviewing coach to provide additional support around vascular access&#xD;
        placement, and 3) &quot;Usual Care&quot;, in which participants will have the usual education provided&#xD;
        by their kidney doctor and clinic staff just as if they were not in the study. Participants&#xD;
        in all 3 groups will be asked to complete questionnaires by telephone and may be invited to&#xD;
        be interviewed about their experience with the study intervention at the end of the study.&#xD;
        Study participation will last for about 12 months, with most of the study activities taking&#xD;
        place during the first 3 months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)</measure>
      <time_frame>Within 12 months after randomization or before hemodialysis initiation, whichever comes first</time_frame>
      <description>The proportion of participants who have arteriovenous access creation surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)</measure>
      <time_frame>Within 12 months after randomization or before hemodialysis initiation, whichever comes first</time_frame>
      <description>The proportion of participants with a scheduled appointment with a surgeon for evaluation for vascular access creation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)</measure>
      <time_frame>Within 12 months after randomization or before hemodialysis initiation, whichever comes first</time_frame>
      <description>The proportion of participants with a completed appointment with a surgeon for evaluation for vascular access creation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)</measure>
      <time_frame>Within 12 months after randomization or before hemodialysis initiation, whichever comes first</time_frame>
      <description>The proportion of participants with completed vascular imaging via ultrasound or angiography for planning arteriovenous vascular access creation surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usable Arteriovenous Vascular Access (Effectiveness outcome)</measure>
      <time_frame>Up to 4 years after randomization (full duration of the trial)</time_frame>
      <description>For participants who start hemodialysis, the proportion with a usable arteriovenous access at dialysis initiation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vascular Access Knowledge (Effectiveness outcome)</measure>
      <time_frame>12 weeks after randomization</time_frame>
      <description>The change from baseline in vascular access knowledge as measured by the Patient Perceived Vascular Access Knowledge scale. The total score ranges from 0 to 10, with higher scores indicating a higher level of vascular access knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decision Self-Efficacy (Effectiveness outcome)</measure>
      <time_frame>12 weeks after randomization</time_frame>
      <description>The change from baseline in decision self-efficacy as measured by the Decision Self-Efficacy Scale. The total score ranges from 0 to 11, with higher scores indicating a higher level of self-efficacy when making decisions about hemodialysis vascular access.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Activation Measure (Effectiveness outcome)</measure>
      <time_frame>12 weeks after randomization</time_frame>
      <description>The change from baseline in patient activation as measured by the Patient Activation Measure. The total score ranges from 0 to 100, with higher scores indicating a higher level of engagement in self-management tasks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preparedness for Decision-Making (Effectiveness outcome)</measure>
      <time_frame>12 weeks after randomization</time_frame>
      <description>A participant's level of preparedness for decision-making as measured by the Preparation for Decision-Making Scale. The total score ranges from 0-100, with higher scores indicating a higher perceived level of preparation for decision-making.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)</measure>
      <time_frame>Pre-Enrollment</time_frame>
      <description>An assessment of the demographic and socioeconomic characteristics of patients who are eligible for the trial.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)</measure>
      <time_frame>Baseline</time_frame>
      <description>An assessment of the demographic and socioeconomic characteristics of patients who enroll in the trial.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)</measure>
      <time_frame>12 months</time_frame>
      <description>An assessment of the demographic and socioeconomic characteristics of participants who complete the trial.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)</measure>
      <time_frame>From eligibility until 12 months</time_frame>
      <description>An assessment of the demographic and socioeconomic characteristics of participants who withdraw from the trial.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Declined Enrollment - quantitative reach assessment (Implementation outcome)</measure>
      <time_frame>Pre-enrollment</time_frame>
      <description>The reasons for declining enrollment as documented in screening logs and provided in aggregate for an enrolling center.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reasons for Participation - qualitative reach assessment (Implementation outcome)</measure>
      <time_frame>12-16 weeks after randomization</time_frame>
      <description>The reasons for participation and non-participation as identified through qualitative interviews</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)</measure>
      <time_frame>Up to 4 years after trial initiation (full duration of the trial)</time_frame>
      <description>The reasons that nephrologists opt out of having an eligible patient approached by the research team for possible enrollment as identified through qualitative interviews.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)</measure>
      <time_frame>12 -16 weeks after randomization</time_frame>
      <description>The acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM). The total score ranges from 1-5, with higher scores indicating a higher level of acceptability of the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)</measure>
      <time_frame>12 to 16 weeks after randomization</time_frame>
      <description>The acceptability of the content, delivery, and accessibility of educational materials and motivational interviewing coaching as identified through qualitative interviews.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)</measure>
      <time_frame>Within 12 months</time_frame>
      <description>The proportion of participants who attend a Chronic Kidney Disease education class provided by their nephrology clinic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)</measure>
      <time_frame>Within 12 weeks after randomization</time_frame>
      <description>The proportion of participants with confirmed receipt of the &quot;Getting Ready&quot; brochure (only be assessed for the Education and Education-Plus groups)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Viewing of Video - quantitative fidelity assessment (Implementation outcome)</measure>
      <time_frame>Within 12 weeks after randomization</time_frame>
      <description>The proportion of participants with confirmed viewing of the &quot;Getting Ready&quot; video, which will only be assessed for the Education and Education-Plus groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)</measure>
      <time_frame>Within 12 months after randomization</time_frame>
      <description>The proportion of participants who completed the scheduled motivational interviewing sessions (only be assessed for the Education-Plus group)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)</measure>
      <time_frame>Within 12 weeks after randomization</time_frame>
      <description>The selected mode for delivery of the &quot;Getting Ready&quot; brochure by center, clinic, and participant sociodemographic characteristics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)</measure>
      <time_frame>Within 12 weeks after randomization</time_frame>
      <description>The selected mode for viewing of the &quot;Getting Ready&quot; video by center, clinic, and participant sociodemographic characteristics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)</measure>
      <time_frame>12 month period after randomization</time_frame>
      <description>The number and type (email, phone, text messaging) of attempted and confirmed participant contacts by the motivational interviewing coach.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)</measure>
      <time_frame>12 month period after randomization</time_frame>
      <description>The number of missed motivational interviewing sessions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)</measure>
      <time_frame>Up to 4 years after trial initiation (full duration of the trial)</time_frame>
      <description>System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)</measure>
      <time_frame>Within 12 months</time_frame>
      <description>System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis</measure>
      <time_frame>Up to 4 years after randomization (full duration of the trial)</time_frame>
      <description>The creation of an arteriovenous vascular access without a subsequent need for hemodialysis is a potential unintended consequence of interventions.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Chronic Kidney Disease</condition>
    <condition>Hemodialysis Vascular Access</condition>
    <arm_group>
      <arm_group_label>Education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Education-Plus</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational Materials</intervention_name>
      <description>Participants are provided with the &quot;Getting Ready: Your Vascular Access Journey&quot; video and brochure about hemodialysis vascular access. The video is available for viewing via smartphone or computer. Both the brochure and video were created with input from patients with chronic kidney disease.</description>
      <arm_group_label>Education</arm_group_label>
      <arm_group_label>Education-Plus</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational Interviewing</intervention_name>
      <description>Participants receive coaching with telehealth-based motivational interviewing designed to prepare participants to move forward with vascular access creation. Motivational interviewing will consist of a minimum of 3 and maximum of 8 telehealth sessions with a coach. The coach will use patient-centered communication skills to work though the stages of pre-contemplative, contemplative, preparation, action, and maintenance of an arteriovenous vascular access.</description>
      <arm_group_label>Education-Plus</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Participants receive the non-standardized vascular access counseling and referral to the chronic kidney disease education class that comprises the standard care provided by their nephrology clinic.</description>
      <arm_group_label>Education</arm_group_label>
      <arm_group_label>Education-Plus</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient Lists for Clinicians: System-Level Intervention</intervention_name>
      <description>Nephrologists and clinic staff receive monthly, provider-specific, lists of patients potentially appropriate for AV access planning based on eGFR thresholds and kidney failure risk. These criteria identify patients at risk for progression to dialysis and are congruent with evidence-based guidelines for optimal timing of AV access evaluation referral.</description>
      <arm_group_label>Education</arm_group_label>
      <arm_group_label>Education-Plus</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 years or older&#xD;
  &#xD;
            2. Nephrology visit for chronic kidney disease during the last 18 months&#xD;
  &#xD;
            3. Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk&#xD;
               Equation score greater than 40%&#xD;
  &#xD;
            4. Documentation in the medical record or confirmation from the treating nephrologist of&#xD;
               a patient-nephrologist discussion about hemodialysis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Planning for peritoneal dialysis, preemptive transplant, or conservative management of&#xD;
               kidney failure&#xD;
  &#xD;
            2. Previous placement of an AV access&#xD;
  &#xD;
            3. Prior or scheduled appointment with surgeon for AV access evaluation or creation&#xD;
  &#xD;
            4. Cognitive dysfunction or severe visual impairment that prevents use of the education&#xD;
               materials&#xD;
  &#xD;
            5. Does not speak either English or Spanish&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laura M. Dember, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jennifer E. Flythe, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Deidra Crews, MD, ScM</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leah Bernardo</last_name>
      <phone>+1 215-746-4755</phone>
      <email>lleah@pennmedicine.upenn.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Clara Walling</last_name>
      <email>clara.walling@pennmedicine.upenn.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jennifer E. Flythe, MD, MPH</last_name>
      </contact>
      <investigator>
        <last_name>Jennifer E. Flythe, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Pennsylvania</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clara Walling, BA</last_name>
        <phone>215-746-4181</phone>
        <email>clara.walling@pennmedicine.upenn.edu</email>
      </contact>
      <investigator>
        <last_name>Laura M. Dember, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
      <investigator_full_name>Laura Dember, MD</investigator_full_name>
      <investigator_title>Professor of Medicine and Epidemiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997875
  org study id: 853978
  nct id: NCT05997875
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The focus of this study is on vascular access for hemodialysis. This is a randomized clinical
        trial testing 3 educational approaches to help patients with advanced chronic kidney disease
        prepare for placement of hemodialysis vascular access. Study participants will each be
        assigned to one of the 3 approaches: 1) "Education", in which participants will be given a
        video and brochure that provide information about the types of vascular access and what can
        be expected before and after the vascular access is placed, 2) "Education-Plus", in which
        participants will be given the video and brochure and will also have sessions by telehealth
        with a motivational interviewing coach to provide additional support around vascular access
        placement, and 3) "Usual Care", in which participants will have the usual education provided
        by their kidney doctor and clinic staff just as if they were not in the study. Participants
        in all 3 groups will be asked to complete questionnaires by telephone and may be invited to
        be interviewed about their experience with the study intervention at the end of the study.
        Study participation will last for about 12 months, with most of the study activities taking
        place during the first 3 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
  time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
  description: The proportion of participants who have arteriovenous access creation surgery.
  measure: Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
  time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
  description: The proportion of participants with a scheduled appointment with a surgeon for evaluation for vascular access creation.
  measure: Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
  time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
  description: The proportion of participants with a completed appointment with a surgeon for evaluation for vascular access creation.
  measure: Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)
  time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
  description: The proportion of participants with completed vascular imaging via ultrasound or angiography for planning arteriovenous vascular access creation surgery.
  measure: Usable Arteriovenous Vascular Access (Effectiveness outcome)
  time frame: Up to 4 years after randomization (full duration of the trial)
  description: For participants who start hemodialysis, the proportion with a usable arteriovenous access at dialysis initiation.
  measure: Vascular Access Knowledge (Effectiveness outcome)
  time frame: 12 weeks after randomization
  description: The change from baseline in vascular access knowledge as measured by the Patient Perceived Vascular Access Knowledge scale. The total score ranges from 0 to 10, with higher scores indicating a higher level of vascular access knowledge.
  measure: Decision Self-Efficacy (Effectiveness outcome)
  time frame: 12 weeks after randomization
  description: The change from baseline in decision self-efficacy as measured by the Decision Self-Efficacy Scale. The total score ranges from 0 to 11, with higher scores indicating a higher level of self-efficacy when making decisions about hemodialysis vascular access.
  measure: Patient Activation Measure (Effectiveness outcome)
  time frame: 12 weeks after randomization
  description: The change from baseline in patient activation as measured by the Patient Activation Measure. The total score ranges from 0 to 100, with higher scores indicating a higher level of engagement in self-management tasks.
  measure: Preparedness for Decision-Making (Effectiveness outcome)
  time frame: 12 weeks after randomization
  description: A participant's level of preparedness for decision-making as measured by the Preparation for Decision-Making Scale. The total score ranges from 0-100, with higher scores indicating a higher perceived level of preparation for decision-making.
  measure: Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)
  time frame: Pre-Enrollment
  description: An assessment of the demographic and socioeconomic characteristics of patients who are eligible for the trial.
  measure: Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)
  time frame: Baseline
  description: An assessment of the demographic and socioeconomic characteristics of patients who enroll in the trial.
  measure: Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)
  time frame: 12 months
  description: An assessment of the demographic and socioeconomic characteristics of participants who complete the trial.
  measure: Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)
  time frame: From eligibility until 12 months
  description: An assessment of the demographic and socioeconomic characteristics of participants who withdraw from the trial.
  measure: Declined Enrollment - quantitative reach assessment (Implementation outcome)
  time frame: Pre-enrollment
  description: The reasons for declining enrollment as documented in screening logs and provided in aggregate for an enrolling center.
  measure: Reasons for Participation - qualitative reach assessment (Implementation outcome)
  time frame: 12-16 weeks after randomization
  description: The reasons for participation and non-participation as identified through qualitative interviews
  measure: Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)
  time frame: Up to 4 years after trial initiation (full duration of the trial)
  description: The reasons that nephrologists opt out of having an eligible patient approached by the research team for possible enrollment as identified through qualitative interviews.
  measure: Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)
  time frame: 12 -16 weeks after randomization
  description: The acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM). The total score ranges from 1-5, with higher scores indicating a higher level of acceptability of the intervention.
  measure: Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)
  time frame: 12 to 16 weeks after randomization
  description: The acceptability of the content, delivery, and accessibility of educational materials and motivational interviewing coaching as identified through qualitative interviews.
  measure: Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)
  time frame: Within 12 months
  description: The proportion of participants who attend a Chronic Kidney Disease education class provided by their nephrology clinic
  measure: Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)
  time frame: Within 12 weeks after randomization
  description: The proportion of participants with confirmed receipt of the "Getting Ready" brochure (only be assessed for the Education and Education-Plus groups)
  measure: Viewing of Video - quantitative fidelity assessment (Implementation outcome)
  time frame: Within 12 weeks after randomization
  description: The proportion of participants with confirmed viewing of the "Getting Ready" video, which will only be assessed for the Education and Education-Plus groups.
  measure: Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)
  time frame: Within 12 months after randomization
  description: The proportion of participants who completed the scheduled motivational interviewing sessions (only be assessed for the Education-Plus group)
  measure: Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
  time frame: Within 12 weeks after randomization
  description: The selected mode for delivery of the "Getting Ready" brochure by center, clinic, and participant sociodemographic characteristics.
  measure: Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
  time frame: Within 12 weeks after randomization
  description: The selected mode for viewing of the "Getting Ready" video by center, clinic, and participant sociodemographic characteristics.
  measure: Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)
  time frame: 12 month period after randomization
  description: The number and type (email, phone, text messaging) of attempted and confirmed participant contacts by the motivational interviewing coach.
  measure: Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)
  time frame: 12 month period after randomization
  description: The number of missed motivational interviewing sessions.
  measure: System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)
  time frame: Up to 4 years after trial initiation (full duration of the trial)
  description: System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.
  measure: System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)
  time frame: Within 12 months
  description: System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.
  measure: Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis
  time frame: Up to 4 years after randomization (full duration of the trial)
  description: The creation of an arteriovenous vascular access without a subsequent need for hemodialysis is a potential unintended consequence of interventions.
  arm group label: Education
  arm group type: Experimental
  arm group label: Education-Plus
  arm group type: Experimental
  arm group label: Usual Care
  arm group type: Other
  intervention type: Behavioral
  intervention name: Educational Materials
  description: Participants are provided with the "Getting Ready: Your Vascular Access Journey" video and brochure about hemodialysis vascular access. The video is available for viewing via smartphone or computer. Both the brochure and video were created with input from patients with chronic kidney disease.
  arm group label: Education
  arm group label: Education-Plus
  intervention type: Behavioral
  intervention name: Motivational Interviewing
  description: Participants receive coaching with telehealth-based motivational interviewing designed to prepare participants to move forward with vascular access creation. Motivational interviewing will consist of a minimum of 3 and maximum of 8 telehealth sessions with a coach. The coach will use patient-centered communication skills to work though the stages of pre-contemplative, contemplative, preparation, action, and maintenance of an arteriovenous vascular access.
  arm group label: Education-Plus
  intervention type: Behavioral
  intervention name: Usual Care
  description: Participants receive the non-standardized vascular access counseling and referral to the chronic kidney disease education class that comprises the standard care provided by their nephrology clinic.
  arm group label: Education
  arm group label: Education-Plus
  arm group label: Usual Care
  intervention type: Other
  intervention name: Patient Lists for Clinicians: System-Level Intervention
  description: Nephrologists and clinic staff receive monthly, provider-specific, lists of patients potentially appropriate for AV access planning based on eGFR thresholds and kidney failure risk. These criteria identify patients at risk for progression to dialysis and are congruent with evidence-based guidelines for optimal timing of AV access evaluation referral.
  arm group label: Education
  arm group label: Education-Plus
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Laura M. Dember, MD
  role: Principal Investigator
  affiliation: University of Pennsylvania
  last name: Jennifer E. Flythe, MD, MPH
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Deidra Crews, MD, ScM
  role: Principal Investigator
  affiliation: Johns Hopkins University
  last name: Leah Bernardo
  phone: +1 215-746-4755
  email: lleah@pennmedicine.upenn.edu
  last name: Clara Walling
  email: clara.walling@pennmedicine.upenn.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pennsylvania
  investigator full name: Laura Dember, MD
  investigator title: Professor of Medicine and Epidemiology
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic