<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/NCT01713894</url>
  </required_header>
  <id_info>
    <org_study_id>Decision Aid - Prematurity</org_study_id>
    <nct_id>NCT01713894</nct_id>
  </id_info>
  <brief_title>Decision Aid - Extreme Prematurity</brief_title>
  <official_title>Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christiana Care Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Virtua Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NorthShore University HealthSystem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Christiana Care Health Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess in a pilot randomized controlled trial the following&#xD;
      PICOT question: In parents facing extreme premature delivery, does the use of an existing&#xD;
      validated visual decision aid as compared to standard counseling, reduce the primary outcome&#xD;
      of parental decisional conflict? Furthermore, is such a decision aid understood and&#xD;
      applicable across differing populations of different ethnic backgrounds and social classes?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">October 15, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decisional conflict</measure>
    <time_frame>within 1 week after consult</time_frame>
    <description>Decisional conflict is the state of uncertainty about the course of action to take when making choices involving risk or uncertainty of outcomes. Decisional conflict is assessed using the Decisional Conflict Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge</measure>
    <time_frame>within 1 week after consult</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Prematurity; Decision Support</condition>
  <arm_group>
    <arm_group_label>Decision Aid</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this arm of the study, parents will be counseled using a decision aid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this arm of the study, parents will be counseled using current standard methods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <arm_group_label>Decision Aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard</intervention_name>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physicians who counsel women at the limits of viability&#xD;
&#xD;
          -  women who are receiving counseling at the limits of viability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known congenital malformations or lethal anomalies, still birth in which the fetuses'&#xD;
             death was known before labor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ursula Guillen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christiana Care Health Systems</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christiana Care Health System</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Christiana Care Health Services</investigator_affiliation>
    <investigator_full_name>Ursula Guillen</investigator_full_name>
    <investigator_title>Principal Investigator; Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Counseling</keyword>
  <keyword>Limits of viability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT01713894
org study id: Decision Aid - Prematurity
nct id: NCT01713894
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess in a pilot randomized controlled trial the following
      PICOT question: In parents facing extreme premature delivery, does the use of an existing
      validated visual decision aid as compared to standard counseling, reduce the primary outcome
      of parental decisional conflict? Furthermore, is such a decision aid understood and
      applicable across differing populations of different ethnic backgrounds and social classes?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Decisional conflict
time frame: within 1 week after consult
description: Decisional conflict is the state of uncertainty about the course of action to take when making choices involving risk or uncertainty of outcomes. Decisional conflict is assessed using the Decisional Conflict Scale
measure: Knowledge
time frame: within 1 week after consult
arm group label: Decision Aid
arm group type: Other
description: In this arm of the study, parents will be counseled using a decision aid.
arm group label: Standard
arm group type: Other
description: In this arm of the study, parents will be counseled using current standard methods.
intervention type: Other
intervention name: Decision Aid
arm group label: Decision Aid
intervention type: Other
intervention name: Standard
arm group label: Standard
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ursula Guillen, MD
role: Principal Investigator
affiliation: Christiana Care Health Systems
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Christiana Care Health Services
investigator full name: Ursula Guillen
investigator title: Principal Investigator; Assistant Professor
mesh term: Premature Birth