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/NCT05974800</url>
    </required_header>
    <id_info>
      <org_study_id>10842</org_study_id>
      <nct_id>NCT05974800</nct_id>
    </id_info>
    <brief_title>Potential Improvements in Acute Cancer Care According to Clinical Staff in the Emergency Department Care</brief_title>
    <acronym>OVERSEE-II</acronym>
    <official_title>Identification of Potential Improvements Among Cancer Patients and Clinical Staff in the Emergency Department Care Pathway: a Semi-qualitative Study (OVERSEE-II Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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 goal of this Single center prospective cross-sectional study is to identify the&#xD;
        facilitators and barriers among caregivers in the emergency department that influence&#xD;
        disposition of patients with solid and hematology malignancies. The main question it aims to&#xD;
        answer is what the agreement between the emergency department (ED) caregivers predicted&#xD;
        outcome and the actual outcome is. Participants will be asked for permission, afterwards a&#xD;
        short interview will be held with the different ED caregivers (ED nurse, attending physician&#xD;
        and supervising physician).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this to identify the facilitators and barriers among caregivers in the emergency&#xD;
        department (ED) that influence disposition of patients with solid and hematology&#xD;
        malignancies. The main question it aims to answer is: what is the agreement between the ED&#xD;
        caregivers predicted outcome and the actual outcome. Participants will be asked for&#xD;
        permission, afterwards a short interview will be held with the different caregivers (ED&#xD;
        nurse, attending physician and supervising physician) in the ED. The interviews will be held&#xD;
        in the order of the ED care pathway, meaning ED nurse first, treating physician second and&#xD;
        supervising physician at last. The interviews will be conducted for every patient with each&#xD;
        of the caregivers. Each interview will be conducted after the caregiver has made the first&#xD;
        examination of the patient. The interview focuses on several parts of the emergency care&#xD;
        process: The first part is regarding the actions that are executed during an ED visit. It&#xD;
        will be established, which actions are executed and why. The second part are regarding the&#xD;
        suspected outcome for the patient. The third part will be about any potential improvements on&#xD;
        de emergency care process for the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Emergency department (ED) length of stay (LOS)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Emergency department length of stay</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Outcome after ED admission, being home or admission</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between ED-LOS and disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between ED-LOS and disposition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ED nurse agreement of disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Agreement between ED nurse expected disposition and the actual disposition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attending physician agreement of disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Agreement between treating physician expected disposition and the actual disposition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Supervising physician agreement of disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Agreement between supervising physician expected disposition and the actual disposition</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time-to-disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time between patient's arrival at the ED and the decision to disposition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time-to-ward</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time between the decision to hospitalize and the arrival at the ward</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between time-to-disposition and the ED-LOS</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between time-to-disposition and the ED-LOS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between time-to-ward and the ED-LOS</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between time-to-ward and the ED-LOS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ED nurse identified categories of facilitator and barriers</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Categories of facilitator and barriers identified by the ED nurse for the ED care of patients with cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attending physician identified categories of facilitator and barriers</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Categories of facilitator and barriers identified by the attending physician for the ED care of patients with cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Supervising physician identified categories of facilitator and barriers</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Categories of facilitator and barriers identified by the supervising physician for the ED care of patients with cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in categories</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The difference in the percentages in categories between the different caregivers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ED nurse summary of actions</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Summary of actions taken by ED nurse in the ED care for patients with cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attending physician summary of actions</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Summary of actions taken by attending physician in the ED care for patients with cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Supervising physician summary of actions</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Summary of actions taken by supervising physician in the ED care for patients with cancer</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient characteristics</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>age, sex, type of cancer, type of treatment, main complaint, triage category, number of prior ED visits.</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">175</enrollment>
    <condition>Cancer</condition>
    <condition>Emergencies</condition>
    <arm_group>
      <arm_group_label>Cancer patients</arm_group_label>
      <description>All adult patients with solid and hematologic malignancies and receiving systemic therapy admitted to the emergency department of the Erasmus Medical Center (MC) for the oncology, hematology, lung- and neuro-oncology medical unit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Emergency department caregivers interview</intervention_name>
      <description>The interview focuses on several parts of the emergency care process: The first part is regarding the actions that are executed during an emergency department visit. The investigators will establish, which actions are executed and why. The second part are regarding the suspected outcome for the patient. The third part will be about any potential improvements on de emergency care process for the patient.</description>
      <arm_group_label>Cancer patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          In the emergency department (ED) of Erasmus MC yearly around 1600 patients with cancer are&#xD;
          presented to the ED. To conduct this prospective semi-qualitative trail the principles of&#xD;
          qualitative research and the one in ten rule of statistics were followed. Therefore, the&#xD;
          investigators will conduct interviews with the ED nurse, treating physician and supervising&#xD;
          physician for 75 to 175 patient cases with solid and hematologic malignancies and receiving&#xD;
          systemic therapy admitted to the ED department of the Erasmus MC for the oncology,&#xD;
          hematology, lung- and neuro-oncology medical unit.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  - Patients with solid and/or hematology malignancies and receiving system therapy&#xD;
  &#xD;
            -  Presented at the emergency department or admitted from the emergency department (ED)&#xD;
               to the oncology, hematology or lung-oncology clinical unit&#xD;
  &#xD;
            -  Awake and conscious&#xD;
  &#xD;
            -  Possible to answer questions within 48 hours after presentation in the ED&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years old&#xD;
  &#xD;
            -  Primarily received a surgical intervention as treatment&#xD;
  &#xD;
            -  Admitted to the ED for the surgical department&#xD;
  &#xD;
            -  Not willing or able to give written informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jason den Duijn</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jason den Duijn</last_name>
      <phone>+31107040704</phone>
      <email>j.denduijn@erasmusmc.nl</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Jason den Duijn</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </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/NCT05974800
  org study id: 10842
  nct id: NCT05974800
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this Single center prospective cross-sectional study is to identify the
        facilitators and barriers among caregivers in the emergency department that influence
        disposition of patients with solid and hematology malignancies. The main question it aims to
        answer is what the agreement between the emergency department (ED) caregivers predicted
        outcome and the actual outcome is. Participants will be asked for permission, afterwards a
        short interview will be held with the different ED caregivers (ED nurse, attending physician
        and supervising physician).
  The goal of this to identify the facilitators and barriers among caregivers in the emergency
        department (ED) that influence disposition of patients with solid and hematology
        malignancies. The main question it aims to answer is: what is the agreement between the ED
        caregivers predicted outcome and the actual outcome. Participants will be asked for
        permission, afterwards a short interview will be held with the different caregivers (ED
        nurse, attending physician and supervising physician) in the ED. The interviews will be held
        in the order of the ED care pathway, meaning ED nurse first, treating physician second and
        supervising physician at last. The interviews will be conducted for every patient with each
        of the caregivers. Each interview will be conducted after the caregiver has made the first
        examination of the patient. The interview focuses on several parts of the emergency care
        process: The first part is regarding the actions that are executed during an ED visit. It
        will be established, which actions are executed and why. The second part are regarding the
        suspected outcome for the patient. The third part will be about any potential improvements on
        de emergency care process for the patient.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Emergency department (ED) length of stay (LOS)
  time frame: Through study completion, an average of 6 months
  description: Emergency department length of stay
  measure: Disposition
  time frame: Through study completion, an average of 6 months
  description: Outcome after ED admission, being home or admission
  measure: Correlation between ED-LOS and disposition
  time frame: Through study completion, an average of 6 months
  description: Correlation between ED-LOS and disposition
  measure: ED nurse agreement of disposition
  time frame: Through study completion, an average of 6 months
  description: Agreement between ED nurse expected disposition and the actual disposition
  measure: Attending physician agreement of disposition
  time frame: Through study completion, an average of 6 months
  description: Agreement between treating physician expected disposition and the actual disposition
  measure: Supervising physician agreement of disposition
  time frame: Through study completion, an average of 6 months
  description: Agreement between supervising physician expected disposition and the actual disposition
  measure: Time-to-disposition
  time frame: Through study completion, an average of 6 months
  description: The time between patient's arrival at the ED and the decision to disposition
  measure: Time-to-ward
  time frame: Through study completion, an average of 6 months
  description: The time between the decision to hospitalize and the arrival at the ward
  measure: Correlation between time-to-disposition and the ED-LOS
  time frame: Through study completion, an average of 6 months
  description: Correlation between time-to-disposition and the ED-LOS
  measure: Correlation between time-to-ward and the ED-LOS
  time frame: Through study completion, an average of 6 months
  description: Correlation between time-to-ward and the ED-LOS
  measure: ED nurse identified categories of facilitator and barriers
  time frame: Through study completion, an average of 6 months
  description: Categories of facilitator and barriers identified by the ED nurse for the ED care of patients with cancer
  measure: Attending physician identified categories of facilitator and barriers
  time frame: Through study completion, an average of 6 months
  description: Categories of facilitator and barriers identified by the attending physician for the ED care of patients with cancer.
  measure: Supervising physician identified categories of facilitator and barriers
  time frame: Through study completion, an average of 6 months
  description: Categories of facilitator and barriers identified by the supervising physician for the ED care of patients with cancer.
  measure: Difference in categories
  time frame: Through study completion, an average of 6 months
  description: The difference in the percentages in categories between the different caregivers
  measure: ED nurse summary of actions
  time frame: Through study completion, an average of 6 months
  description: Summary of actions taken by ED nurse in the ED care for patients with cancer
  measure: Attending physician summary of actions
  time frame: Through study completion, an average of 6 months
  description: Summary of actions taken by attending physician in the ED care for patients with cancer
  measure: Supervising physician summary of actions
  time frame: Through study completion, an average of 6 months
  description: Summary of actions taken by supervising physician in the ED care for patients with cancer
  measure: Patient characteristics
  time frame: Through study completion, an average of 6 months
  description: age, sex, type of cancer, type of treatment, main complaint, triage category, number of prior ED visits.
  arm group label: Cancer patients
  description: All adult patients with solid and hematologic malignancies and receiving systemic therapy admitted to the emergency department of the Erasmus Medical Center (MC) for the oncology, hematology, lung- and neuro-oncology medical unit.
  intervention type: Behavioral
  intervention name: Emergency department caregivers interview
  description: The interview focuses on several parts of the emergency care process: The first part is regarding the actions that are executed during an emergency department visit. The investigators will establish, which actions are executed and why. The second part are regarding the suspected outcome for the patient. The third part will be about any potential improvements on de emergency care process for the patient.
  arm group label: Cancer patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Jason den Duijn
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  last name: Jason den Duijn
  phone: +31107040704
  email: j.denduijn@erasmusmc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Jason den Duijn
  investigator title: Principal Investigator
  mesh term: Emergencies
  sharing ipd: No