<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/NCT02209038</url>
  </required_header>
  <id_info>
    <org_study_id>820002</org_study_id>
    <nct_id>NCT02209038</nct_id>
  </id_info>
  <brief_title>Choice Sets for Advance Directives</brief_title>
  <official_title>A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a large gap between the care seriously ill patients want and the care they receive.&#xD;
      Advance directives (ADs) offer an opportunity for patients to express specific end-of-life&#xD;
      preferences to avoid unwanted care. As promising as ADs may be for improving the quality of&#xD;
      care near the end of life, rates of AD completion remain low and previous efforts to&#xD;
      encourage their completion have had limited success. Principles of behavioral economics, such&#xD;
      as the effects of defaults and other framing effects, may offer a novel approach to bridge&#xD;
      the gap in end-of-life care. The goal of this study is to test whether the framing effect of&#xD;
      expanding choice sets can increase the completion of and specification of choices within&#xD;
      advance directives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been designed as two sequential randomized trials to test two separate&#xD;
      expanded choice set interventions, with the second randomization enrollment being contingent&#xD;
      on results from the first. All enrolled subjects will be asked if they would like to complete&#xD;
      an advance directive and will have been randomized to receive either an expanded answer&#xD;
      choice set or a standard answer choice, as described in detail elsewhere. Only those subjects&#xD;
      who express a desire to complete an advance directive from both arms will then be randomized&#xD;
      again in a stratified fashion to receive either a standard advance directive or one with an&#xD;
      expanded choice set for the decisions regarding life-sustaining therapy, as described in&#xD;
      detail elsewhere.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>advance directive</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>return of a completed and signed advance directive</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Short Form-12v2</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>change from baseline in Short Form-12v2 score at 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McGill Quality of Life Questionnaire</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>change from baseline in McGill Quality of Life Questionnaire at 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Decision Scale</measure>
    <time_frame>baseline</time_frame>
    <description>satisfaction with decision scale measured at baseline after decision to complete an advance directive is made</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Decisional Conflict Scale measured immediately after completion of an advance directive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>no life-sustaining therapy preference specified</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD</description>
  </secondary_outcome>
  <other_outcome>
    <measure>hospital admissions</measure>
    <time_frame>up to 4 years</time_frame>
    <description>number of hospital admissions from enrollment to study completion</description>
  </other_outcome>
  <other_outcome>
    <measure>ICU admissions</measure>
    <time_frame>up to 4 years</time_frame>
    <description>number of ICU admissions from enrollment to study completion</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospice admission</measure>
    <time_frame>up to 4 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>death</measure>
    <time_frame>up to 4 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>demographics of patients (ineligible) whom already completed a living will</measure>
    <time_frame>enrollment</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">321</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Expanded AD Choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Would you like to complete an advance directive with the assistance of any person(s) you choose?&quot;&#xD;
4 answer choices:&#xD;
Yes, I would like to complete a comprehensive version of an advance directive.&#xD;
Yes, I would like to complete an expanded version of an advance directive.&#xD;
Yes, I would like to complete a brief version of an advance directive.&#xD;
No, I do not wish to complete an advance directive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard AD Choice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>&quot;Would you like to complete an advance directive with the assistance of any person(s) you choose?&quot;&#xD;
2 answer choices:&#xD;
Yes, I would like to complete an AD.&#xD;
No, I do not wish to complete an advance directive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expanded Life-sustaining therapy Choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For each hypothetical illness state described in the living will:&#xD;
4 answer choices:&#xD;
No, I would not want life support.&#xD;
Yes, I would want life support.&#xD;
I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death.&#xD;
I do not wish to specify a preference at this time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Life-sustaining Therapy Choice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For each hypothetical illness state described in the living will:&#xD;
3 answer choices:&#xD;
No, I would not want life support.&#xD;
Yes, I would want life support.&#xD;
I do not wish to specify a preference at this time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expanded AD Choice</intervention_name>
    <arm_group_label>Expanded AD Choice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expanded Life-sustaining Therapy Choice</intervention_name>
    <arm_group_label>Expanded Life-sustaining therapy Choice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Proficient in English&#xD;
&#xD;
          -  Chronic hemodialysis for minimum 90 days&#xD;
&#xD;
          -  Does not currently have a living will&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blindness&#xD;
&#xD;
          -  Cognitive impairment that prohibits subject's provision of informed consent&#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>Scott D Halpern, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine R Courtright, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lourdes-Camden</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Market Street DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia 42nd Street DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia PMC-Lombard DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University City DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franklin DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PDI Walnut Tower DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Callowhill DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Line DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Broad Street</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cottman DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Philadelphia DaVita</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radnor DaVita</name>
      <address>
        <city>Radnor</city>
        <state>Pennsylvania</state>
        <zip>19087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington DaVita</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willow Grove DaVita</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>January 5, 2016</last_update_submitted>
  <last_update_submitted_qc>January 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>end stage renal disease</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>dialysis</keyword>
  <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>
  </condition_browse>
  <!-- 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/NCT02209038
org study id: 820002
nct id: NCT02209038
lead sponsor: 
has dmc: No
There is a large gap between the care seriously ill patients want and the care they receive.
      Advance directives (ADs) offer an opportunity for patients to express specific end-of-life
      preferences to avoid unwanted care. As promising as ADs may be for improving the quality of
      care near the end of life, rates of AD completion remain low and previous efforts to
      encourage their completion have had limited success. Principles of behavioral economics, such
      as the effects of defaults and other framing effects, may offer a novel approach to bridge
      the gap in end-of-life care. The goal of this study is to test whether the framing effect of
      expanding choice sets can increase the completion of and specification of choices within
      advance directives.
This study has been designed as two sequential randomized trials to test two separate
      expanded choice set interventions, with the second randomization enrollment being contingent
      on results from the first. All enrolled subjects will be asked if they would like to complete
      an advance directive and will have been randomized to receive either an expanded answer
      choice set or a standard answer choice, as described in detail elsewhere. Only those subjects
      who express a desire to complete an advance directive from both arms will then be randomized
      again in a stratified fashion to receive either a standard advance directive or one with an
      expanded choice set for the decisions regarding life-sustaining therapy, as described in
      detail elsewhere.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: advance directive
time frame: up to 4 weeks
description: return of a completed and signed advance directive
measure: Medical Outcomes Study Short Form-12v2
time frame: baseline and 3 months
description: change from baseline in Short Form-12v2 score at 3 months
measure: McGill Quality of Life Questionnaire
time frame: baseline and 3 months
description: change from baseline in McGill Quality of Life Questionnaire at 3 months
measure: Satisfaction with Decision Scale
time frame: baseline
description: satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
measure: Decisional Conflict Scale
time frame: up to 4 weeks
description: Decisional Conflict Scale measured immediately after completion of an advance directive
measure: no life-sustaining therapy preference specified
time frame: up to 4 weeks
description: among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD
measure: hospital admissions
time frame: up to 4 years
description: number of hospital admissions from enrollment to study completion
measure: ICU admissions
time frame: up to 4 years
description: number of ICU admissions from enrollment to study completion
measure: Hospice admission
time frame: up to 4 years
measure: death
time frame: up to 4 years
measure: demographics of patients (ineligible) whom already completed a living will
time frame: enrollment
arm group label: Expanded AD Choice
arm group type: Experimental
description: "Would you like to complete an advance directive with the assistance of any person(s) you choose?"
4 answer choices:
Yes, I would like to complete a comprehensive version of an advance directive.
Yes, I would like to complete an expanded version of an advance directive.
Yes, I would like to complete a brief version of an advance directive.
No, I do not wish to complete an advance directive.
arm group label: Standard AD Choice
arm group type: No Intervention
description: "Would you like to complete an advance directive with the assistance of any person(s) you choose?"
2 answer choices:
Yes, I would like to complete an AD.
No, I do not wish to complete an advance directive.
arm group label: Expanded Life-sustaining therapy Choice
arm group type: Experimental
description: For each hypothetical illness state described in the living will:
4 answer choices:
No, I would not want life support.
Yes, I would want life support.
I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death.
I do not wish to specify a preference at this time.
arm group label: Standard Life-sustaining Therapy Choice
arm group type: No Intervention
description: For each hypothetical illness state described in the living will:
3 answer choices:
No, I would not want life support.
Yes, I would want life support.
I do not wish to specify a preference at this time.
intervention type: Behavioral
intervention name: Expanded AD Choice
arm group label: Expanded AD Choice
intervention type: Behavioral
intervention name: Expanded Life-sustaining Therapy Choice
arm group label: Expanded Life-sustaining therapy Choice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott D Halpern, MD, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Katherine R Courtright, MD
role: Study Director
affiliation: University of Pennsylvania
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country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic