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/NCT05980078</url>
    </required_header>
    <id_info>
      <org_study_id>2017-05-0033</org_study_id>
      <nct_id>NCT05980078</nct_id>
    </id_info>
    <brief_title>Interactive Informed Consent and Decision Conflict</brief_title>
    <official_title>A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas at Austin</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Informed consent for surgery can address the legal aspects while also being simple,&#xD;
        informative, and empathic. It can help people confirm that the potential harms are acceptable&#xD;
        in light of the potential benefits. Standard consent forms just document this process, while&#xD;
        a computer-based, interactive consent process can also standardize and potentially enhance&#xD;
        it.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It's not clear that the current informed consent process adequately addresses common&#xD;
        misconceptions and adequately confirms patient understanding of potential harms and potential&#xD;
        benefits. Thoughtful patient consideration of potential benefits and potential harms of&#xD;
        surgery might be facilitated by a step-by-step, iterative, interactive electronic consent&#xD;
        process designed to help patients: 1) become aware of their values, 2) understand the actual&#xD;
        and potential harms of surgery, 3) understand the potential benefits of surgery, and 4) guide&#xD;
        people away from common misconceptions and towards decisions based on their values.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2017</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2020</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>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Decision Conflict Scale</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>The Decision Conflict Scale consists of sixteen 4- point items regarding comfort with decision-making.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Jefferson Scale of Patient's Perceptions of Physician Empathy</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">94</enrollment>
    <condition>Upper Extremity Problem</condition>
    <arm_group>
      <arm_group_label>Interactive consent</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They were randomized to complete an interactive consent</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard written consent</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>They were randomized to complete a standard written consent</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interactive consent</intervention_name>
      <description>They were randomized to complete an interactive consent.</description>
      <arm_group_label>Interactive consent</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard consent</intervention_name>
      <description>They were randomized to complete a standard written consent.</description>
      <arm_group_label>Standard written consent</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. English and Spanish-speaking adults&#xD;
  &#xD;
            2. Older than 18 years of age&#xD;
  &#xD;
            3. One of six common upper extremity conditions including carpal tunnel release, cubital&#xD;
               tunnel release, trigger finger release, plate and screw fixation of a distal radius&#xD;
               fracture, removal of a benign lump including a ganglion cyst, and Dupuytren&#xD;
               contracture release.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          People with cognitive deficits were excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Ring, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Professor of orthopedic surgery at The university of Texas at Austin</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Texas Health Austin (UTHA)</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78701</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
      <investigator_full_name>David Ring</investigator_full_name>
      <investigator_title>Professor of Surgery and Perioperative Care Department</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05980078
  org study id: 2017-05-0033
  nct id: NCT05980078
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Informed consent for surgery can address the legal aspects while also being simple,
        informative, and empathic. It can help people confirm that the potential harms are acceptable
        in light of the potential benefits. Standard consent forms just document this process, while
        a computer-based, interactive consent process can also standardize and potentially enhance
        it.
  It's not clear that the current informed consent process adequately addresses common
        misconceptions and adequately confirms patient understanding of potential harms and potential
        benefits. Thoughtful patient consideration of potential benefits and potential harms of
        surgery might be facilitated by a step-by-step, iterative, interactive electronic consent
        process designed to help patients: 1) become aware of their values, 2) understand the actual
        and potential harms of surgery, 3) understand the potential benefits of surgery, and 4) guide
        people away from common misconceptions and towards decisions based on their values.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Decision Conflict Scale
  time frame: through study completion, an average of 6 months
  description: The Decision Conflict Scale consists of sixteen 4- point items regarding comfort with decision-making.
  measure: Jefferson Scale of Patient's Perceptions of Physician Empathy
  time frame: through study completion, an average of 6 months
  description: The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.
  arm group label: Interactive consent
  arm group type: Experimental
  description: They were randomized to complete an interactive consent
  arm group label: Standard written consent
  arm group type: Active Comparator
  description: They were randomized to complete a standard written consent
  intervention type: Other
  intervention name: Interactive consent
  description: They were randomized to complete an interactive consent.
  arm group label: Interactive consent
  intervention type: Other
  intervention name: Standard consent
  description: They were randomized to complete a standard written consent.
  arm group label: Standard written consent
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: David Ring, MD
  role: Principal Investigator
  affiliation: Professor of orthopedic surgery at The university of Texas at Austin
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas at Austin
  investigator full name: David Ring
  investigator title: Professor of Surgery and Perioperative Care Department
  sharing ipd: No