<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/NCT01683097</url>
  </required_header>
  <id_info>
    <org_study_id>SVH 1195</org_study_id>
    <nct_id>NCT01683097</nct_id>
  </id_info>
  <brief_title>Patient Understanding of End of Life Care</brief_title>
  <official_title>Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Partners in Internal Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Partners in Internal Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at assessing factors that affect patient choices for end of life care. 300&#xD;
      patients would be assigned either to a control arm (questionnaire alone) or intervention arm&#xD;
      (standardized explanation+ questionnaire). Our intervention is a standardized explanation&#xD;
      which explains what code status, advance directive and end of life care mean. Based on&#xD;
      patient responses, factors that affect choices of code status would be analyzed. We will also&#xD;
      evaluate if a standardized explanation improves patient understanding of end of life issues.&#xD;
      This would be determined by generating a composite score of correct responses to a subset of&#xD;
      objective questions in the questionnaire&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">June 2010</completion_date>
  <primary_completion_date type="Actual">June 2010</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>Composite score of correct responses</measure>
    <time_frame>Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview</time_frame>
    <description>Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare differences in demographic, medical, social and associated factors on patient choice of code status</measure>
    <time_frame>Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Advance Directives</condition>
  <condition>Resuscitation Orders</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized explanation followed by questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized explanation</intervention_name>
    <description>Standardized explanation provided on code status, advance directives and end of life care</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Admitted to regular nursing floor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  altered mental status&#xD;
&#xD;
          -  admitted in ICU&#xD;
&#xD;
          -  positive screening for depression&#xD;
&#xD;
          -  terminal illness defined as life expectancy&lt; 100 days&#xD;
&#xD;
          -  inability to 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>George Abraham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Vincent Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kriti Mittal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Vincent Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Vincent Hospital</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</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>Death</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/NCT01683097
org study id: SVH 1195
nct id: NCT01683097
lead sponsor: 
has dmc: No
This study aims at assessing factors that affect patient choices for end of life care. 300
      patients would be assigned either to a control arm (questionnaire alone) or intervention arm
      (standardized explanation+ questionnaire). Our intervention is a standardized explanation
      which explains what code status, advance directive and end of life care mean. Based on
      patient responses, factors that affect choices of code status would be analyzed. We will also
      evaluate if a standardized explanation improves patient understanding of end of life issues.
      This would be determined by generating a composite score of correct responses to a subset of
      objective questions in the questionnaire
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Composite score of correct responses
time frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
description: Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire
measure: Compare differences in demographic, medical, social and associated factors on patient choice of code status
time frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
arm group label: Control
arm group type: No Intervention
description: Questionnaire
arm group label: Intervention
arm group type: Experimental
description: Standardized explanation followed by questionnaire
intervention type: Other
intervention name: Standardized explanation
description: Standardized explanation provided on code status, advance directives and end of life care
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Abraham, MD
role: Principal Investigator
affiliation: Saint Vincent Hospital
last name: Kriti Mittal, MD
role: Principal Investigator
affiliation: Saint Vincent Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Death