<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/NCT04466865</url>
  </required_header>
  <id_info>
    <org_study_id>2022-0193</org_study_id>
    <secondary_id>1R01AG065365-01</secondary_id>
    <secondary_id>A539750</secondary_id>
    <secondary_id>SMPH/SURGERY</secondary_id>
    <secondary_id>Protocol Version 5/31/2022</secondary_id>
    <secondary_id>2019-1074</secondary_id>
    <nct_id>NCT04466865</nct_id>
  </id_info>
  <brief_title>A Communication Tool to Assist Older Adults Facing Dialysis Choices</brief_title>
  <official_title>Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients With End-Stage Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Palliative Care Research Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</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 purpose of this study is to test the effect of the &quot;Best Case/Worse Case&quot; (BC/WC)&#xD;
      communication tool on receipt of palliative care and intensity of treatment at the end of&#xD;
      life, quality of life, and quality of communication for older patients with end-stage renal&#xD;
      disease (ESRD) receiving outpatient care at ten nephrology clinics. The intervention was&#xD;
      developed and tested with acute care surgical patients at the University of Wisconsin (UW)&#xD;
      and is now being testing to see if the intervention will work in a different setting.&#xD;
&#xD;
      The intervention will be tested with 320 older adults who have end-stage renal disease (ESRD)&#xD;
      and are receiving care from a nephrologist enrolled in the study. Randomly assigned&#xD;
      nephrologists within each site will receive the intervention (training to use the BC/WC tool)&#xD;
      or to be in the waitlist control, meaning that they will not be offered BC/WC training until&#xD;
      the end of the study, when all participants have been enrolled. Participants will be on&#xD;
      follow up with surveys and chart review for up to two years after study enrollment.&#xD;
      Caregivers will also be invited to participate and complete surveys.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will test the effect of the Best Case/Worst Case intervention on receipt of&#xD;
      palliative care and intensity of treatment at the end of life, quality of life, and quality&#xD;
      of communication for older patients with end-stage renal disease (ESRD). This multi-site&#xD;
      cluster randomized trial will enroll 320 participants who are making a dialysis initiation&#xD;
      decision and receive care from a nephrologist trained to use the Best Case/Worst Case tool,&#xD;
      or care from a nephrologist who has not been trained to use this tool (usual care). Randomly&#xD;
      assigned nephrologists within each site will receive the intervention or waitlist control&#xD;
      (upon study completion). Participants will be on follow up for up to two years after study&#xD;
      enrollment via regular surveys and chart review. This study has three aims:&#xD;
&#xD;
      Aim 1: To test the effect of the Best Case/Worst Case intervention on (1) receipt of&#xD;
      palliative care and (2) intensity of treatment at the end of life for older patients with&#xD;
      ESRD. Chart reviews will be used to determine whether participants have received at least one&#xD;
      outpatient or inpatient palliative care consultation within 12 months of enrollment in the&#xD;
      study. These consultations must be clearly marked as palliative care, provided by a clinician&#xD;
      with palliative care training and have documented discussion of goals clarification, advance&#xD;
      care planning, symptom management, coping, spiritual needs, or end-of-life care. To measure&#xD;
      intensity of treatment received at the end of life, it will be determined whether&#xD;
      participants have had an ICU admission within 30 days of death as a primary outcome and ICU&#xD;
      admission, emergency room (ER) visit, or hospital admission within 30 days of death as a&#xD;
      composite secondary outcome.&#xD;
&#xD;
      Aim 2: To test the effect of the Best Case/Worst Case intervention on quality of life. The&#xD;
      primary outcome for Aim 2 is quality of life as measured by the Functional Assessment of&#xD;
      Chronic Illness Therapy -Palliative Care (FACIT-Pal Version 4) at baseline, and every three&#xD;
      months for up to 2 years after study enrollment. The hypothesis is that the overall quality&#xD;
      of life will decline over time as participants become more infirm. The average change in&#xD;
      health-related quality of life over time which has been shown to decline less with the&#xD;
      receipt of concurrent palliative care will be compared.&#xD;
&#xD;
      Aim 3: To test the effect of the Best Case/Worst Case intervention on the quality of&#xD;
      communication. To evaluate participant's assessment of nephrologist communication, the&#xD;
      Quality of Communication (QOC) scale developed by Randy Curtis will be used. Unlike other&#xD;
      measurements of physician communication that have high ceiling effects and limited ability to&#xD;
      measure change, the QOC includes 7 items specific to end-of-life communication, which, if not&#xD;
      performed by the clinician, are scored as zero. This will allow us to discriminate between&#xD;
      quality of communication attributable to participant satisfaction (with high ceiling effects)&#xD;
      versus content.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of palliative care consult within 12 months of study enrollment, as determined by chart review or report by patient or caregiver</measure>
    <time_frame>From enrollment up to 12 months</time_frame>
    <description>Number of patients with 1 or more palliative care consults within 12 months of study enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receipt of palliative care during 2-year follow up as determined by chart review or report by patient or caregiver</measure>
    <time_frame>From enrollment for up to 2 years</time_frame>
    <description>Number of patients with receipt of any palliative care as determined by chart review or patient or caregiver report during 2-year follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported health-related quality of life</measure>
    <time_frame>Every 3 months for up to 2 years after enrollment</time_frame>
    <description>Patient-reported health related quality of life will be measured using the 46-item Functional Assessment of Chronic Illness Therapy-Palliative Care Version 4 (FACIT-Pal); the investigators will compare the average score and average change (slope) in health-related quality of life over time, using the total score at last follow up. Possible scores for the FACIT-Pal total score range from 0-184. Higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported health-related quality of life</measure>
    <time_frame>Every 3 months for up to 2 years after enrollment</time_frame>
    <description>Patient-reported health related quality of life will be measured using the 27-item Functional Assessment of Cancer Therapy - General (FACT-G) scale (used here in non-cancer patients as part of the FACIT-Pal instrument). Possible scores for the FACT-G total score range from 0-108. Higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported health-related quality of life</measure>
    <time_frame>Every 3 months for up to 2 years after enrollment</time_frame>
    <description>Patient-reported health related quality of life will be measured using the 19-item FACIT-Pal palliative care subscale (PalS). Possible scores for the PalS range from 0-76. Higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported quality of communication (QOC) received from study nephrologist</measure>
    <time_frame>48 hours after enrollment</time_frame>
    <description>Patient-reported general quality of communication will be measured using the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average composite score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported general quality of communication (QOC) received from study nephrologist</measure>
    <time_frame>48 hours after enrollment</time_frame>
    <description>Patient-reported general quality of communication will be measured using the 6-item general communication subscale of the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported quality of end-of-life communication (QOC) received from study nephrologist</measure>
    <time_frame>48 hours after enrollment</time_frame>
    <description>Patient-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 19-item Quality of Communication scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospice enrollment during 2-year follow up as determined by chart review or report by patient or caregiver</measure>
    <time_frame>From enrollment for up to 2 years</time_frame>
    <description>Number of patients with documentation of hospice enrollment as determined by chart review and patient or caregiver report during 2-year follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Documentation of new advance care planning during 2-year follow up as determined by chart review or report by patient or caregiver</measure>
    <time_frame>From enrollment for up to 2 years</time_frame>
    <description>Number of patients with new documentation of advance care planning as determined by chart review or patient or caregiver report during 2-year follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment intensity at the end of life review as determined by chart review or report by patient or caregiver</measure>
    <time_frame>Within 30 days of death</time_frame>
    <description>Number of patients with one or more of the following within 30 days of death: ER visit, ICU stay or hospitalization as determined by chart review or patient or caregiver report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical treatment intensity at the end of life as determined by chart review or report by patient or caregiver</measure>
    <time_frame>Within 30 days of death</time_frame>
    <description>Number of patients who had one or more surgical procedure within 30 day as determined by chart review or patient or caregiver report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initiation of dialysis as determined by chart review or report by patient or caregiver</measure>
    <time_frame>From enrollment for up to 2 years</time_frame>
    <description>Number of patients initiating dialysis as determined by chart review or patient or caregiver report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to on-study death</measure>
    <time_frame>From enrollment for up to 2 years</time_frame>
    <description>Time, in six month intervals, from baseline to 2 years. The Kaplan-Meier estimate reports the percentage of participants who experience death within 2 years from randomization. Participant death will be ascertained through medical record review and caregiver report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver-reported quality of dying and death</measure>
    <time_frame>3 months after death</time_frame>
    <description>Quality of dying and death as perceived by the patient's caregiver will be measured using the Quality of Death and Dying (QODD) survey that asks about the patient's final 30 days of life. Possible scores on this measure range from 0 to 100 and higher scores indicate higher quality of dying and death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver-reported health related quality of life</measure>
    <time_frame>Every 3 months for up to 2 years after enrollment</time_frame>
    <description>Caregiver-reported health related quality of life will be measured using the Cambridge Palliative Audit Schedule (CAMPAS-R). Possible scores on this survey range from 0-100 and higher scores indicate greater symptomology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver-reported general quality of communication (QOC) received from study nephrologist</measure>
    <time_frame>Within 48 hours after enrollment</time_frame>
    <description>Caregiver-reported general quality of communication will be measured using the 6-item general communication subscale of the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. Possible scores on this subscale range from 0-60. Higher scores indicate higher perceived quality of communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist</measure>
    <time_frame>Within 48 hours after enrollment</time_frame>
    <description>Caregiver-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 19-item Quality of Communication scale. The QOC is a validated self-report instrument. Possible scores on this subscale range from 0-70. Higher scores indicate higher perceived quality of communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment intensity at the end of life as determined by chart review or report by patient or caregiver</measure>
    <time_frame>Within 30 days before death</time_frame>
    <description>Number of patients with 1 or more ICU admission within 30 days of death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">680</enrollment>
  <condition>Palliative Care</condition>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Decision Making</condition>
  <condition>Decision Support Techniques</condition>
  <condition>Renal Dialysis</condition>
  <condition>Dialysis</condition>
  <condition>Kidney Diseases</condition>
  <condition>Nephrologists</condition>
  <condition>Decision Aid</condition>
  <condition>End of Life</condition>
  <condition>End-Stage Renal Disease</condition>
  <condition>Late-Stage Renal Disease</condition>
  <condition>Communication</condition>
  <condition>Life-Supporting Treatments</condition>
  <arm_group>
    <arm_group_label>Best Case/Worst Case communication tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant's enrolled nephrologist will have completed training on the Best Case/Worst Case communication tool and will be encouraged to use it with the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care conversations are typically focused on mode and timing of dialysis, management of electrolytes and scheduling of laboratory testing. Conservative management or a treatment option of &quot;no dialysis&quot; is rarely mentioned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Case/Worst Case communication tool training</intervention_name>
    <description>The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of kidney disease. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning the intervention is designed to lead to a discussion of participants preferences and consideration of outcomes.&#xD;
The nephrologist verbally describes the &quot;best case,&quot; &quot;worst case,&quot; and &quot;most likely&quot; outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The nephrologist also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences.</description>
    <arm_group_label>Best Case/Worst Case communication tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) of less than or equal to 24&#xD;
&#xD;
          -  Not currently on dialysis (participants are eligible if they have had intermittent&#xD;
             dialysis in the past or have dialysis access in place but are not currently on&#xD;
             dialysis)&#xD;
&#xD;
          -  Participants must meet one or more of the following criteria: age greater than 80,&#xD;
             evidence from the medical record that the patient has comorbid illness such that the&#xD;
             modified Charlson score is 4 or greater, or a negative response to the standard&#xD;
             &quot;Surprise Question&quot; (&quot;Would you be surprised if this patient died in the next year?&quot;)&#xD;
             from the participant's nephrologist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently on dialysis&#xD;
&#xD;
          -  Lack decision-making capacity&#xD;
&#xD;
          -  Do not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret L Schwarze, MD, MPP, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amar Bansal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katharine Cheung, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Deidra Crews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katie Colborn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Holly Koncicki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean Kutner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Lam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alvin Moss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maya Rao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dawn Wolfgram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeniann Yi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tamara Isakova, MD, MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado, Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>173364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medicine, University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Schell JO, Patel UD, Steinhauser KE, Ammarell N, Tulsky JA. Discussions of the kidney disease trajectory by elderly patients and nephrologists: a qualitative study. Am J Kidney Dis. 2012 Apr;59(4):495-503. doi: 10.1053/j.ajkd.2011.11.023. Epub 2012 Jan 4.</citation>
    <PMID>22221483</PMID>
  </reference>
  <reference>
    <citation>Ladin K, Lin N, Hahn E, Zhang G, Koch-Weser S, Weiner DE. Engagement in decision-making and patient satisfaction: a qualitative study of older patients' perceptions of dialysis initiation and modality decisions. Nephrol Dial Transplant. 2017 Aug 1;32(8):1394-1401. doi: 10.1093/ndt/gfw307.</citation>
    <PMID>27576590</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A de-identified data set from this project will be stored in the Palliative Care Research Cooperative Group (PCRC) De-identified Data Repository (DiDR).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>One year after study completion or two months after initial manuscript has been accepted for publication (whichever comes first), UW will securely transfer a de-identified dataset to the PCRC Data Repository.</ipd_time_frame>
    <ipd_access_criteria>Investigators may request access to de-identified study data for secondary analyses using the PCRC Data Repository webform. Requests must include a summary of the following: research questions, objectives, hypotheses, statistical analysis plan, and project timeline. Requestors must provide a list of specific variables they would like included in the secondary data set. Each request must also include a data security plan and explanation of how the data will be stored and who will have access to it. The PCRC staff and UW PI will review all requests assessing the scientific integrity, feasibility and analytic rigor.</ipd_access_criteria>
    <ipd_url>https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 28, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04466865/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04466865
org study id: 2022-0193
secondary id: 1R01AG065365-01
secondary id: A539750
secondary id: SMPH/SURGERY
secondary id: Protocol Version 5/31/2022
secondary id: 2019-1074
nct id: NCT04466865
lead sponsor: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC)
      communication tool on receipt of palliative care and intensity of treatment at the end of
      life, quality of life, and quality of communication for older patients with end-stage renal
      disease (ESRD) receiving outpatient care at ten nephrology clinics. The intervention was
      developed and tested with acute care surgical patients at the University of Wisconsin (UW)
      and is now being testing to see if the intervention will work in a different setting.

      The intervention will be tested with 320 older adults who have end-stage renal disease (ESRD)
      and are receiving care from a nephrologist enrolled in the study. Randomly assigned
      nephrologists within each site will receive the intervention (training to use the BC/WC tool)
      or to be in the waitlist control, meaning that they will not be offered BC/WC training until
      the end of the study, when all participants have been enrolled. Participants will be on
      follow up with surveys and chart review for up to two years after study enrollment.
      Caregivers will also be invited to participate and complete surveys.
This study will test the effect of the Best Case/Worst Case intervention on receipt of
      palliative care and intensity of treatment at the end of life, quality of life, and quality
      of communication for older patients with end-stage renal disease (ESRD). This multi-site
      cluster randomized trial will enroll 320 participants who are making a dialysis initiation
      decision and receive care from a nephrologist trained to use the Best Case/Worst Case tool,
      or care from a nephrologist who has not been trained to use this tool (usual care). Randomly
      assigned nephrologists within each site will receive the intervention or waitlist control
      (upon study completion). Participants will be on follow up for up to two years after study
      enrollment via regular surveys and chart review. This study has three aims:

      Aim 1: To test the effect of the Best Case/Worst Case intervention on (1) receipt of
      palliative care and (2) intensity of treatment at the end of life for older patients with
      ESRD. Chart reviews will be used to determine whether participants have received at least one
      outpatient or inpatient palliative care consultation within 12 months of enrollment in the
      study. These consultations must be clearly marked as palliative care, provided by a clinician
      with palliative care training and have documented discussion of goals clarification, advance
      care planning, symptom management, coping, spiritual needs, or end-of-life care. To measure
      intensity of treatment received at the end of life, it will be determined whether
      participants have had an ICU admission within 30 days of death as a primary outcome and ICU
      admission, emergency room (ER) visit, or hospital admission within 30 days of death as a
      composite secondary outcome.

      Aim 2: To test the effect of the Best Case/Worst Case intervention on quality of life. The
      primary outcome for Aim 2 is quality of life as measured by the Functional Assessment of
      Chronic Illness Therapy -Palliative Care (FACIT-Pal Version 4) at baseline, and every three
      months for up to 2 years after study enrollment. The hypothesis is that the overall quality
      of life will decline over time as participants become more infirm. The average change in
      health-related quality of life over time which has been shown to decline less with the
      receipt of concurrent palliative care will be compared.

      Aim 3: To test the effect of the Best Case/Worst Case intervention on the quality of
      communication. To evaluate participant's assessment of nephrologist communication, the
      Quality of Communication (QOC) scale developed by Randy Curtis will be used. Unlike other
      measurements of physician communication that have high ceiling effects and limited ability to
      measure change, the QOC includes 7 items specific to end-of-life communication, which, if not
      performed by the clinician, are scored as zero. This will allow us to discriminate between
      quality of communication attributable to participant satisfaction (with high ceiling effects)
      versus content.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Receipt of palliative care consult within 12 months of study enrollment, as determined by chart review or report by patient or caregiver
time frame: From enrollment up to 12 months
description: Number of patients with 1 or more palliative care consults within 12 months of study enrollment.
measure: Receipt of palliative care during 2-year follow up as determined by chart review or report by patient or caregiver
time frame: From enrollment for up to 2 years
description: Number of patients with receipt of any palliative care as determined by chart review or patient or caregiver report during 2-year follow up.
measure: Patient-reported health-related quality of life
time frame: Every 3 months for up to 2 years after enrollment
description: Patient-reported health related quality of life will be measured using the 46-item Functional Assessment of Chronic Illness Therapy-Palliative Care Version 4 (FACIT-Pal); the investigators will compare the average score and average change (slope) in health-related quality of life over time, using the total score at last follow up. Possible scores for the FACIT-Pal total score range from 0-184. Higher scores indicate better quality of life.
measure: Patient-reported health-related quality of life
time frame: Every 3 months for up to 2 years after enrollment
description: Patient-reported health related quality of life will be measured using the 27-item Functional Assessment of Cancer Therapy - General (FACT-G) scale (used here in non-cancer patients as part of the FACIT-Pal instrument). Possible scores for the FACT-G total score range from 0-108. Higher scores indicate better quality of life.
measure: Patient-reported health-related quality of life
time frame: Every 3 months for up to 2 years after enrollment
description: Patient-reported health related quality of life will be measured using the 19-item FACIT-Pal palliative care subscale (PalS). Possible scores for the PalS range from 0-76. Higher scores indicate better quality of life.
measure: Patient-reported quality of communication (QOC) received from study nephrologist
time frame: 48 hours after enrollment
description: Patient-reported general quality of communication will be measured using the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average composite score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.
measure: Patient-reported general quality of communication (QOC) received from study nephrologist
time frame: 48 hours after enrollment
description: Patient-reported general quality of communication will be measured using the 6-item general communication subscale of the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.
measure: Patient-reported quality of end-of-life communication (QOC) received from study nephrologist
time frame: 48 hours after enrollment
description: Patient-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 19-item Quality of Communication scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.
measure: Hospice enrollment during 2-year follow up as determined by chart review or report by patient or caregiver
time frame: From enrollment for up to 2 years
description: Number of patients with documentation of hospice enrollment as determined by chart review and patient or caregiver report during 2-year follow up.
measure: Documentation of new advance care planning during 2-year follow up as determined by chart review or report by patient or caregiver
time frame: From enrollment for up to 2 years
description: Number of patients with new documentation of advance care planning as determined by chart review or patient or caregiver report during 2-year follow up.
measure: Treatment intensity at the end of life review as determined by chart review or report by patient or caregiver
time frame: Within 30 days of death
description: Number of patients with one or more of the following within 30 days of death: ER visit, ICU stay or hospitalization as determined by chart review or patient or caregiver report.
measure: Surgical treatment intensity at the end of life as determined by chart review or report by patient or caregiver
time frame: Within 30 days of death
description: Number of patients who had one or more surgical procedure within 30 day as determined by chart review or patient or caregiver report.
measure: Initiation of dialysis as determined by chart review or report by patient or caregiver
time frame: From enrollment for up to 2 years
description: Number of patients initiating dialysis as determined by chart review or patient or caregiver report.
measure: Time to on-study death
time frame: From enrollment for up to 2 years
description: Time, in six month intervals, from baseline to 2 years. The Kaplan-Meier estimate reports the percentage of participants who experience death within 2 years from randomization. Participant death will be ascertained through medical record review and caregiver report.
measure: Caregiver-reported quality of dying and death
time frame: 3 months after death
description: Quality of dying and death as perceived by the patient's caregiver will be measured using the Quality of Death and Dying (QODD) survey that asks about the patient's final 30 days of life. Possible scores on this measure range from 0 to 100 and higher scores indicate higher quality of dying and death.
measure: Caregiver-reported health related quality of life
time frame: Every 3 months for up to 2 years after enrollment
description: Caregiver-reported health related quality of life will be measured using the Cambridge Palliative Audit Schedule (CAMPAS-R). Possible scores on this survey range from 0-100 and higher scores indicate greater symptomology.
measure: Caregiver-reported general quality of communication (QOC) received from study nephrologist
time frame: Within 48 hours after enrollment
description: Caregiver-reported general quality of communication will be measured using the 6-item general communication subscale of the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. Possible scores on this subscale range from 0-60. Higher scores indicate higher perceived quality of communication.
measure: Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist
time frame: Within 48 hours after enrollment
description: Caregiver-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 19-item Quality of Communication scale. The QOC is a validated self-report instrument. Possible scores on this subscale range from 0-70. Higher scores indicate higher perceived quality of communication.
measure: Treatment intensity at the end of life as determined by chart review or report by patient or caregiver
time frame: Within 30 days before death
description: Number of patients with 1 or more ICU admission within 30 days of death.
arm group label: Best Case/Worst Case communication tool
arm group type: Experimental
description: The participant's enrolled nephrologist will have completed training on the Best Case/Worst Case communication tool and will be encouraged to use it with the participant.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care conversations are typically focused on mode and timing of dialysis, management of electrolytes and scheduling of laboratory testing. Conservative management or a treatment option of "no dialysis" is rarely mentioned.
intervention type: Other
intervention name: Best Case/Worst Case communication tool training
description: The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of kidney disease. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning the intervention is designed to lead to a discussion of participants preferences and consideration of outcomes.
The nephrologist verbally describes the "best case," "worst case," and "most likely" outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The nephrologist also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences.
arm group label: Best Case/Worst Case communication tool
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Margaret L Schwarze, MD, MPP, FACS
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Amar Bansal, MD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Katharine Cheung, MD, PhD
role: Principal Investigator
affiliation: University of Vermont
last name: Deidra Crews, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Katie Colborn, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Holly Koncicki, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Jean Kutner, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Daniel Lam, MD
role: Principal Investigator
affiliation: University of Washington
last name: Alvin Moss, MD
role: Principal Investigator
affiliation: West Virginia University
last name: Maya Rao, MD
role: Principal Investigator
affiliation: Columbia University
last name: Dawn Wolfgram, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Jeniann Yi, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Tamara Isakova, MD, MMSc
role: Principal Investigator
affiliation: Northwestern University
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country: United States
citation: Schell JO, Patel UD, Steinhauser KE, Ammarell N, Tulsky JA. Discussions of the kidney disease trajectory by elderly patients and nephrologists: a qualitative study. Am J Kidney Dis. 2012 Apr;59(4):495-503. doi: 10.1053/j.ajkd.2011.11.023. Epub 2012 Jan 4.
PMID: 22221483
citation: Ladin K, Lin N, Hahn E, Zhang G, Koch-Weser S, Weiner DE. Engagement in decision-making and patient satisfaction: a qualitative study of older patients' perceptions of dialysis initiation and modality decisions. Nephrol Dial Transplant. 2017 Aug 1;32(8):1394-1401. doi: 10.1093/ndt/gfw307.
PMID: 27576590
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency
mesh term: Death
sharing ipd: Yes
ipd description: A de-identified data set from this project will be stored in the Palliative Care Research Cooperative Group (PCRC) De-identified Data Repository (DiDR).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: One year after study completion or two months after initial manuscript has been accepted for publication (whichever comes first), UW will securely transfer a de-identified dataset to the PCRC Data Repository.
ipd access criteria: Investigators may request access to de-identified study data for secondary analyses using the PCRC Data Repository webform. Requests must include a summary of the following: research questions, objectives, hypotheses, statistical analysis plan, and project timeline. Requestors must provide a list of specific variables they would like included in the secondary data set. Each request must also include a data security plan and explanation of how the data will be stored and who will have access to it. The PCRC staff and UW PI will review all requests assessing the scientific integrity, feasibility and analytic rigor.
ipd url: https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr
provided document: 