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/NCT06010836</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00268333</org_study_id>
      <nct_id>NCT06010836</nct_id>
    </id_info>
    <brief_title>Anesthesia Counseling, Consent, &amp; Professionalism</brief_title>
    <acronym>ACCP</acronym>
    <official_title>Anesthesiology Counseling, Consent, &amp; Professionalism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johns Hopkins University</source>
    <oversight_info>
      <has_dmc>No</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 anesthesia consent form has become a standard before surgery. However, verbal aspects of&#xD;
        anesthesia consent and of the value of the preoperative anesthesia discussion has not been&#xD;
        addressed. This study will use preoperative discussions and postoperative patient&#xD;
        questionnaires to examine the degree of awareness that the patients and the patients families&#xD;
        have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and&#xD;
        the specifics of what the participants are agreeing to by signing the consent form.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is a substantial body of work regarding the written anesthesia consent form. As a&#xD;
        result, the written anesthesia consent form has become a standard requirement throughout the&#xD;
        United States of America. However, there has been little examination of verbal aspects of&#xD;
        anesthesia consent and of the value of the preoperative anesthesia discussion that should&#xD;
        take place prior to surgery. Non-anesthesia medical studies have indicated that inadequate&#xD;
        patient-physician communication and an inadequate patient-physician relationship will result&#xD;
        in misunderstanding and an increased malpractice risk. Lack of understanding of the duties&#xD;
        and responsibilities of anesthesiologists is also damaging to the professional status of the&#xD;
        field of anesthesiology. This study will utilize patient interviews and questionnaires to&#xD;
        examine the degree of awareness that the patients and the patients families possess regarding&#xD;
        what general anesthesia is, the duties and responsibilities of the anesthesiologist, the role&#xD;
        of the anesthesiologist within the operating room and the specifics of what the participants&#xD;
        are agreeing to by signing the consent form. If it is determined that a more structured and&#xD;
        thorough pre-anesthesia discussion will help patients and the patients families understand&#xD;
        what general anesthesia is, understand the specific responsibilities of anesthesiology&#xD;
        providers, understand the professional status of anesthesiologists, give the participants a&#xD;
        better feeling of autonomy and better understand what the participants are agreeing to by&#xD;
        signing the consent form, then there will be substantial ramifications to the priority and&#xD;
        importance given to pre-anesthesia discussions nationwide. Secondary benefits include&#xD;
        influences on anesthesia residency training and improved patient satisfaction with the&#xD;
        anesthesia experience.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 1, 2021</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Actual">November 17, 2022</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative recall of conversation about the anesthesia as assessed by questionnaire by developed by study team</measure>
      <time_frame>up to 3 days after surgery</time_frame>
      <description>Recall of team members score 0-100 with higher score indicating better recall of anesthesia team members</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative recall of anesthesia risks as assessed by questionnaire by developed by study team</measure>
      <time_frame>up to 3 days after surgery</time_frame>
      <description>anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative recall of anesthetic plan as assessed by questionnaire by developed by study team</measure>
      <time_frame>up to 3 days after surgery</time_frame>
      <description>Recall of anesthetic plan; one question correct signifies recall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative understanding of anesthetic plan as assessed by the questionnaire developed by the study team</measure>
      <time_frame>up to 3 days after surgery</time_frame>
      <description>Demonstrate understanding of anesthetic plan; score total 0-100 with a higher score more understanding.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction with anesthesia conversation as assessed by questionnaire developed by the study team</measure>
      <time_frame>up to three days after surgery</time_frame>
      <description>Rating of satisfaction with anesthetic conversation using likert scale rating; extremely satisfied (5) to extremely dissatisfied (1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of explanation of anesthesia plan as assessed by questionnaire developed by study team</measure>
      <time_frame>up to three days after surgery</time_frame>
      <description>Patients rate quality of anesthesia plan using likert scale very detailed (5) to very poor (1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preoperative anxiety as assessed by questionnaire developed by study team</measure>
      <time_frame>up to 3 days after surgery</time_frame>
      <description>Patients are asked about any change in anxiety after the preoperative conversation using likert scale extremely reduced (5) to extremely more anxious (1)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">240</enrollment>
    <condition>Communication</condition>
    <condition>Preoperative</condition>
    <condition>Ethics</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Group getting standard treatment without script guided intervention in the preoperative period</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Script guided intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group getting script guided intervention during the preoperative conversation</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Script guided conversation</intervention_name>
      <description>Patients getting script guided intervention of 3 domains in the preoperative period</description>
      <arm_group_label>Script guided intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 and up&#xD;
  &#xD;
            -  Elective Procedures&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Consenting for general anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Obstetric patients&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Emergency cases&#xD;
  &#xD;
            -  Patients under age 18&#xD;
  &#xD;
            -  Patients don't speak English&#xD;
  &#xD;
            -  Not consented for general anesthesia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John Sampson, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Johns Hopkins Hospital</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21287</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>May 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Communication</keyword>
    <keyword>Medical ethics</keyword>
    <keyword>Professionalism</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>None to be shared</ipd_description>
    </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/NCT06010836
  org study id: IRB00268333
  nct id: NCT06010836
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The anesthesia consent form has become a standard before surgery. However, verbal aspects of
        anesthesia consent and of the value of the preoperative anesthesia discussion has not been
        addressed. This study will use preoperative discussions and postoperative patient
        questionnaires to examine the degree of awareness that the patients and the patients families
        have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and
        the specifics of what the participants are agreeing to by signing the consent form.
  There is a substantial body of work regarding the written anesthesia consent form. As a
        result, the written anesthesia consent form has become a standard requirement throughout the
        United States of America. However, there has been little examination of verbal aspects of
        anesthesia consent and of the value of the preoperative anesthesia discussion that should
        take place prior to surgery. Non-anesthesia medical studies have indicated that inadequate
        patient-physician communication and an inadequate patient-physician relationship will result
        in misunderstanding and an increased malpractice risk. Lack of understanding of the duties
        and responsibilities of anesthesiologists is also damaging to the professional status of the
        field of anesthesiology. This study will utilize patient interviews and questionnaires to
        examine the degree of awareness that the patients and the patients families possess regarding
        what general anesthesia is, the duties and responsibilities of the anesthesiologist, the role
        of the anesthesiologist within the operating room and the specifics of what the participants
        are agreeing to by signing the consent form. If it is determined that a more structured and
        thorough pre-anesthesia discussion will help patients and the patients families understand
        what general anesthesia is, understand the specific responsibilities of anesthesiology
        providers, understand the professional status of anesthesiologists, give the participants a
        better feeling of autonomy and better understand what the participants are agreeing to by
        signing the consent form, then there will be substantial ramifications to the priority and
        importance given to pre-anesthesia discussions nationwide. Secondary benefits include
        influences on anesthesia residency training and improved patient satisfaction with the
        anesthesia experience.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: Postoperative recall of conversation about the anesthesia as assessed by questionnaire by developed by study team
  time frame: up to 3 days after surgery
  description: Recall of team members score 0-100 with higher score indicating better recall of anesthesia team members
  measure: Postoperative recall of anesthesia risks as assessed by questionnaire by developed by study team
  time frame: up to 3 days after surgery
  description: anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly
  measure: Postoperative recall of anesthetic plan as assessed by questionnaire by developed by study team
  time frame: up to 3 days after surgery
  description: Recall of anesthetic plan; one question correct signifies recall
  measure: Postoperative understanding of anesthetic plan as assessed by the questionnaire developed by the study team
  time frame: up to 3 days after surgery
  description: Demonstrate understanding of anesthetic plan; score total 0-100 with a higher score more understanding.
  measure: Patient Satisfaction with anesthesia conversation as assessed by questionnaire developed by the study team
  time frame: up to three days after surgery
  description: Rating of satisfaction with anesthetic conversation using likert scale rating; extremely satisfied (5) to extremely dissatisfied (1)
  measure: Quality of explanation of anesthesia plan as assessed by questionnaire developed by study team
  time frame: up to three days after surgery
  description: Patients rate quality of anesthesia plan using likert scale very detailed (5) to very poor (1)
  measure: Preoperative anxiety as assessed by questionnaire developed by study team
  time frame: up to 3 days after surgery
  description: Patients are asked about any change in anxiety after the preoperative conversation using likert scale extremely reduced (5) to extremely more anxious (1)
  arm group label: Control
  arm group type: No Intervention
  description: Group getting standard treatment without script guided intervention in the preoperative period
  arm group label: Script guided intervention
  arm group type: Experimental
  description: Group getting script guided intervention during the preoperative conversation
  intervention type: Behavioral
  intervention name: Script guided conversation
  description: Patients getting script guided intervention of 3 domains in the preoperative period
  arm group label: Script guided intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: John Sampson, MD
  role: Principal Investigator
  affiliation: Johns Hopkins University
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: None to be shared