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/NCT06002542</url>
    </required_header>
    <id_info>
      <org_study_id>TMI</org_study_id>
      <nct_id>NCT06002542</nct_id>
    </id_info>
    <brief_title>Mobile Chat Service for Parents of Children in Pediatric Emergency Room</brief_title>
    <official_title>Mobile Chat Service for Parents of Children in Pediatric Emergency Room: A Randomized Control Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsung Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this clinical trial is to test giving all medical/non-medical information in the&#xD;
        pediatric emergency room(ER).&#xD;
  &#xD;
        Main questions it aims to answer are:&#xD;
  &#xD;
          -  Does providing medical/non-medical information to parents of patients visiting the&#xD;
             emergency room raise the satisfaction with the ER visit?&#xD;
  &#xD;
          -  Does providing medical/non-medical information to parents of patients visiting the&#xD;
             emergency room lower the workload of medical staff?&#xD;
  &#xD;
             60 participants will be randomly assigned to treatment group and control group. Both&#xD;
             groups will communicate freely with the researchers through mobile chat service.&#xD;
             Treatment group will get information of medical/non-medical information in emergency&#xD;
             room and control group will get information if they need. Before leaving the emergency&#xD;
             room, both group will fill out a questionnaire related to satisfaction with the&#xD;
             emergency room visits. 5 out of 30 participants of each group will be interviewed about&#xD;
             their satisfaction with service.&#xD;
  &#xD;
             10 nurses in charge of patients participating in the study record the number of&#xD;
             questions directly received and 5 out of 10 nurse will be interviewed about their&#xD;
             nursing experience for participants using mobile chatbot service.&#xD;
  &#xD;
        Researchers will compare treatment group and control group to see if providing&#xD;
        medical/non-medical information raise the satisfaction with emergency room visits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this clinical trial is to test giving all medical/non-medical information in the&#xD;
        pediatric emergency room.&#xD;
  &#xD;
        Main questions it aims to answer are:&#xD;
  &#xD;
          -  Does providing medical/non-medical information to parents of patients visiting the&#xD;
             emergency room raise the satisfaction with the ER visit?&#xD;
  &#xD;
          -  Does providing medical/non-medical information to parents of patients visiting the&#xD;
             emergency room lower the workload of medical staff?&#xD;
  &#xD;
        Design :&#xD;
  &#xD;
        60 participants will be randomly assigned to treatment group and control group. Both groups&#xD;
        will communicate freely with the researchers through mobile chat service. Treatment group&#xD;
        will get information of medical/non-medical information in emergency room and control group&#xD;
        will get information if they need. Before leaving the emergency room, both group will fill&#xD;
        out a questionnaire related to satisfaction with the emergency room visits.&#xD;
  &#xD;
        5 out of 30 participants of each group will be interviewed about their satisfaction with&#xD;
        service.&#xD;
  &#xD;
        10 nurses in charge of patients participating in the study record the number of questions&#xD;
        directly received and 5 out of 10 nurse will be interviewed about their nursing experience&#xD;
        for participants using mobile chatbot service.&#xD;
  &#xD;
        Researchers will compare treatment group and control group to see if providing&#xD;
        medical/non-medical information raise the satisfaction with emergency room visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>
      <intervention_model_description>open-label randomized control trial</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ED CAHPS(Emergency department Consumer Assessment of Healthcare Providers and System) Questionnaire score at discharge</measure>
      <time_frame>Discharge time, 6 hours on average from arriving emergency room.</time_frame>
      <description>ED CAHPS is a survey instrument for measuring patients' experience of care in emergency department.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Interview for participants</measure>
      <time_frame>After leaving the emergency room visit, within 48hours</time_frame>
      <description>Interview on the experience and satisfaction of using mobile chatbot services</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Questions to nurse</measure>
      <time_frame>average of 6 hours from the time participants arrived at the emergency room to discharge.</time_frame>
      <description>The nurse in charge counts the number of questions received from participants.</description>
    </other_outcome>
    <other_outcome>
      <measure>Interview for nurse</measure>
      <time_frame>After work, within 48hours after nursing participants.</time_frame>
      <description>Interviewing whether chatbot services lower their tasks</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Medical Informatics</condition>
    <condition>Pediatric Emergency Medicine</condition>
    <condition>Emergency Medicine</condition>
    <arm_group>
      <arm_group_label>Information provided</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are invited to the chat room and receive messages, which include the stages of their medical care, information about tests and medications, and non-medical information such as directions to pharmacy and parking information.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are invited to the chat room and they can get information when they request it.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Information provided</intervention_name>
      <description>get information at every stage of care in emergency room</description>
      <arm_group_label>Information provided</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>Information is only provided when participants request it.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Parents of patients whose KTAS(Korean Triage and Acuity Scale) is 2, 3, 4.&#xD;
  &#xD;
            -  Parents of patients whose chief complaints are fever, abdominal pain, dyspnea, nausea&#xD;
               and vomiting, and skin rash.&#xD;
  &#xD;
            -  Those who voluntarily agreed to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who didn't consent to participate in the study.&#xD;
  &#xD;
            -  Parents of patients whose KTAS(Korean Triage and Acuity Scale) is 1 or 5.&#xD;
  &#xD;
            -  Those who doesn't use mobile phone or those who don't have the appropriate level of&#xD;
               consciousness to send and receive messages.&#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>Wonchul Cha, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Samsung Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Minha Kim, MD</last_name>
      <phone>82-2-3410-2061</phone>
      <email>mhh.kim@samsung.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <state>Gangnam</state>
          <zip>06351</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Won Chul Cha, Dr</last_name>
        <phone>+82-2-6009-5614</phone>
        <email>wc.cha@samsung.com</email>
      </contact>
      <contact_backup>
        <last_name>Minha Kim, Master</last_name>
        <phone>+82-2-6009-5614</phone>
        <email>dokidoki9001@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <link>
      <url>https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/CAHPS/ED</url>
      <description>ED CAHPS survey and guideline</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Emergencies</mesh_term>
    </condition_browse>
    <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/NCT06002542
  org study id: TMI
  nct id: NCT06002542
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test giving all medical/non-medical information in the
        pediatric emergency room(ER).
  
        Main questions it aims to answer are:
  
          -  Does providing medical/non-medical information to parents of patients visiting the
             emergency room raise the satisfaction with the ER visit?
  
          -  Does providing medical/non-medical information to parents of patients visiting the
             emergency room lower the workload of medical staff?
  
             60 participants will be randomly assigned to treatment group and control group. Both
             groups will communicate freely with the researchers through mobile chat service.
             Treatment group will get information of medical/non-medical information in emergency
             room and control group will get information if they need. Before leaving the emergency
             room, both group will fill out a questionnaire related to satisfaction with the
             emergency room visits. 5 out of 30 participants of each group will be interviewed about
             their satisfaction with service.
  
             10 nurses in charge of patients participating in the study record the number of
             questions directly received and 5 out of 10 nurse will be interviewed about their
             nursing experience for participants using mobile chatbot service.
  
        Researchers will compare treatment group and control group to see if providing
        medical/non-medical information raise the satisfaction with emergency room visits.
  The goal of this clinical trial is to test giving all medical/non-medical information in the
        pediatric emergency room.
  
        Main questions it aims to answer are:
  
          -  Does providing medical/non-medical information to parents of patients visiting the
             emergency room raise the satisfaction with the ER visit?
  
          -  Does providing medical/non-medical information to parents of patients visiting the
             emergency room lower the workload of medical staff?
  
        Design :
  
        60 participants will be randomly assigned to treatment group and control group. Both groups
        will communicate freely with the researchers through mobile chat service. Treatment group
        will get information of medical/non-medical information in emergency room and control group
        will get information if they need. Before leaving the emergency room, both group will fill
        out a questionnaire related to satisfaction with the emergency room visits.
  
        5 out of 30 participants of each group will be interviewed about their satisfaction with
        service.
  
        10 nurses in charge of patients participating in the study record the number of questions
        directly received and 5 out of 10 nurse will be interviewed about their nursing experience
        for participants using mobile chatbot service.
  
        Researchers will compare treatment group and control group to see if providing
        medical/non-medical information raise the satisfaction with emergency room visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: open-label randomized control trial
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: ED CAHPS(Emergency department Consumer Assessment of Healthcare Providers and System) Questionnaire score at discharge
  time frame: Discharge time, 6 hours on average from arriving emergency room.
  description: ED CAHPS is a survey instrument for measuring patients' experience of care in emergency department.
  measure: Interview for participants
  time frame: After leaving the emergency room visit, within 48hours
  description: Interview on the experience and satisfaction of using mobile chatbot services
  measure: Questions to nurse
  time frame: average of 6 hours from the time participants arrived at the emergency room to discharge.
  description: The nurse in charge counts the number of questions received from participants.
  measure: Interview for nurse
  time frame: After work, within 48hours after nursing participants.
  description: Interviewing whether chatbot services lower their tasks
  arm group label: Information provided
  arm group type: Experimental
  description: Participants are invited to the chat room and receive messages, which include the stages of their medical care, information about tests and medications, and non-medical information such as directions to pharmacy and parking information.
  arm group label: Control
  arm group type: Experimental
  description: Participants are invited to the chat room and they can get information when they request it.
  intervention type: Behavioral
  intervention name: Information provided
  description: get information at every stage of care in emergency room
  arm group label: Information provided
  intervention type: Behavioral
  intervention name: Control
  description: Information is only provided when participants request it.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wonchul Cha, PhD
  role: Study Director
  affiliation: Samsung Medical Center
  last name: Minha Kim, MD
  phone: 82-2-3410-2061
  email: mhh.kim@samsung.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Korea, Republic of
  url: https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/CAHPS/ED
  description: ED CAHPS survey and guideline
  responsible party type: Sponsor
  mesh term: Emergencies
  sharing ipd: No