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/NCT05994196</url>
    </required_header>
    <id_info>
      <org_study_id>NI2021_01</org_study_id>
      <nct_id>NCT05994196</nct_id>
    </id_info>
    <brief_title>Evaluation of a Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department</brief_title>
    <acronym>OPTIMUM</acronym>
    <official_title>Evaluation of a Patient Prioritization Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Lille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Lille</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 randomized, controlled, open-label trial is to test the use of secondary&#xD;
        prioritization software (Optimum®) in the pediatric emergency department (PED).&#xD;
  &#xD;
        The aim of this study is to determine:&#xD;
  &#xD;
          1. whether the use of this secondary prioritization software (Optimum®) reduces the&#xD;
             patients' median length of stay (LOS) in the PED&#xD;
  &#xD;
          2. how this software is accepted by the staff. The PED staff will be asked to manage the&#xD;
             patients according to the Optimum® software indications (intervention) or according to&#xD;
             the standard dashboard (control).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design: randomized, controlled open-label trial in the PED at Lille University Medical&#xD;
        Center, Lille, France.&#xD;
  &#xD;
        Period: between March 15th and April 23rd, 2021.&#xD;
  &#xD;
        Randomization: each day was randomized for the use of Optimum® software (intervention group)&#xD;
        or the PED's standard patient management dashboard (control group).&#xD;
  &#xD;
        Inclusion criteria:&#xD;
  &#xD;
        - All children admitted between 10:00 am and 0:00 am at the PED.&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          -  Patients who left without being seen&#xD;
  &#xD;
          -  Patients admitted to a short-stay unit at the PED.&#xD;
  &#xD;
        Authorizations: the study protocol was registered with the French National Data Protection&#xD;
        Commission (Commission Nationale de l'Informatique et des Libertés, Paris, France;&#xD;
        registration number: DEC21-056). This research was submitted to the institutional review&#xD;
        board, which replied that this type of study, without patient intervention, did not require&#xD;
        validation by the ethics committee. The patients and their parents were shown a study&#xD;
        information sheet at the PED reception desk and were free to object to their child's&#xD;
        participation.&#xD;
  &#xD;
        The prioritization software: Optimum® was developed in 2015. Five variables with a&#xD;
        statistically significant influence on the LOS were identified; the reason for admission, the&#xD;
        number of patients present in the PED simultaneously, the prescription of imaging, the&#xD;
        prescription of blood tests, and the prescription of treatment. Optimum®'s purpose is to&#xD;
        remove the mental load of prioritization from the PED staff. The software first prioritizes&#xD;
        the triage of new patients by the PED staff and the first evaluation of a new patient by the&#xD;
        medical team. Optimum® then prioritizes blood sample collections and care (for nurses) and&#xD;
        checks on imaging results, blood test results or an evaluation by a specialist (for&#xD;
        physicians). Lastly, Optimum® prioritizes the final step in patient management by a senior&#xD;
        physician, when appropriate.&#xD;
  &#xD;
        Primary endpoint: the LOS for each patient. Number of patients needed: with a hypothesis of a&#xD;
        15-minute difference in the LOS between the Optimum® and control groups, when considering a&#xD;
        mean of 78 patients/day and a median LOS of 190 minutes, with an α-risk of 0.05 and a power&#xD;
        (1-ß risk) of 0.8, a total of 1542 patients had to be included (i.e., 771 per group).&#xD;
  &#xD;
        Secondary endpoints:&#xD;
  &#xD;
          -  number of patients present at the same time in the PED,&#xD;
  &#xD;
          -  time intervals between each stage in patient management from nurse triage to discharge,&#xD;
  &#xD;
          -  PED staff's level of satisfaction using the standardized System Usability Scale (SUS).&#xD;
  &#xD;
        Study procedures :&#xD;
  &#xD;
          1. training of all the PED staff members in use of Optimum® 2 weeks prior to the study.&#xD;
  &#xD;
          2. study setting up: with days randomized to Optimum® vs. the standard dashboard using the&#xD;
             &quot;random&quot; formula in Excel® (Microsoft Corporation, Redmond, WA, USA). Weekdays and&#xD;
             weekend/public holiday days were randomized separately. An investigator not involved in&#xD;
             the management of the patients during the study period was present throughout the&#xD;
             inclusion period and prospectively recorded the time intervals for each patient's stay&#xD;
             in the PED: time of arrival at the PED, evaluation by the triage nurse, the first&#xD;
             medical evaluation (by a medical student or a junior physician), the first evaluation by&#xD;
             a senior physician, the evaluation by a specialist physician (if applicable), the&#xD;
             results of imaging and lab tests (if prescribed), the final medical decision, and&#xD;
             discharge.&#xD;
  &#xD;
        Data collected: in addition to the LOS and to the time intervals of the different phases of&#xD;
        management, the other variables recorded were age, gender, reason for admission, triage&#xD;
        level, and mode of discharge. There were five categories of reasons for admission: fever, a&#xD;
        respiratory disorder, a digestive tract disorder, trauma, and other reasons.&#xD;
  &#xD;
        3) the PED staff involved in the study will fill out the standardized SUS questionnaire as a&#xD;
        guide to the perceived utility of the Optimum® software and the level of user satisfaction.&#xD;
        According to the literature, the SUS score is considered to be very poor if it is less than&#xD;
        51, poor if between 51 and 68, average if 68, good if between 68 and 80.3, and excellent if&#xD;
        greater than 80.3.&#xD;
  &#xD;
        Statistical analysis:&#xD;
  &#xD;
          1. description of patients' characteristics&#xD;
  &#xD;
          2. the normality of the data distributions was checked graphically and using the&#xD;
             Shapiro-Wilk test.&#xD;
  &#xD;
          3. Intergroup comparisons of the total LOS and the various time intervals during patient&#xD;
             management times were performed by covariance analysis.&#xD;
  &#xD;
          4. Analysis of the standardized System Usability Scale (SUS) questionnaire filled out by&#xD;
             the PED staff at th end of the study to perceive the utility of the Optimum® software&#xD;
             and the level of user satisfaction. A Spearman's test was used to analyze the&#xD;
             correlation between the age of the PED staff and the SUS score.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 15, 2021</start_date>
    <completion_date type="Actual">April 23, 2021</completion_date>
    <primary_completion_date type="Actual">April 23, 2021</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Length of stay</measure>
      <time_frame>from admission to discharge, assessed up to 1 day.</time_frame>
      <description>the length of stay for each patient</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients present</measure>
      <time_frame>1 day</time_frame>
      <description>Number of patients present at the same time in the pediatric emergency department during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time intervals between each stage</measure>
      <time_frame>1 day</time_frame>
      <description>The time intervals between each stage in patient management from nurse triage to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric emergency department staff satisfaction</measure>
      <time_frame>through study completion, an average of 3 months</time_frame>
      <description>To measure the pediatric emergency department staff's level of satisfaction with the System Usability Scale. Values range from 0 to 100 points. Higher scores mean a better satisfaction.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">1599</enrollment>
    <condition>Length of Stay</condition>
    <arm_group>
      <arm_group_label>Optimum</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the secondary prioritization software of patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>the standard dashboard of patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)</intervention_name>
      <description>Optimum®'s purpose is to remove the mental load of prioritization from the Pediatric ED staff. The software first prioritizes the triage of new patients by the ED staff and the first evaluation of a new patient by the medical team. Optimum® then prioritizes blood sample collections and care (for nurses) and checks on imaging results, blood test results or an evaluation by a specialist (for physicians). Lastly, Optimum® prioritizes the final step in patient management by a senior physician, when appropriate.</description>
      <arm_group_label>Optimum</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All children admitted between 10:00 am and 0:00 am&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who left without being seen&#xD;
  &#xD;
            -  Patients subsequently admitted to the short-stay unit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Days</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>François Dubos, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lille University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hôpital Roger Salengro, CHU</name>
        <address>
          <city>Lille</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <link>
      <url>https://digital.ahrq.gov/sites/default/files/docs/survey/systemusabilityscale%2528sus%2529_comp%255B1%255D.pdf</url>
      <description>Description of the standardized System Usability Scale (SUS)</description>
    </link>
    <reference>
      <citation>Schiro J, Marcilly R, Leroy N, Wawrzyniak C, Martinot A, Pelayo S. Design and evaluation of a patient website to reduce crowding in emergency departments: a preliminary study. Stud Health Technol Inform. 2015;210:663-5.</citation>
      <PMID>25991232</PMID>
    </reference>
    <reference>
      <citation>Windal F, Jeribi K, Ficheur G, Degoul S, Martinot A, Beuscart R, Renard JM. Pediatric emergency department crowding: survival tree clustering for length of patient stay. Stud Health Technol Inform. 2014;205:1095-9.</citation>
      <PMID>25160358</PMID>
    </reference>
    <reference>
      <citation>Gravel J, Fitzpatrick E, Gouin S, Millar K, Curtis S, Joubert G, Boutis K, Guimont C, Goldman RD, Dubrovsky AS, Porter R, Beer D, Doan Q, Osmond MH. Performance of the Canadian Triage and Acuity Scale for children: a multicenter database study. Ann Emerg Med. 2013 Jan;61(1):27-32.e3. doi: 10.1016/j.annemergmed.2012.05.024. Epub 2012 Jul 27.</citation>
      <PMID>22841173</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Patient flow</keyword>
    <keyword>Patient prioritization</keyword>
    <keyword>Pediatric Emergency Department</keyword>
    <keyword>Usage assessment</keyword>
    <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/NCT05994196
  org study id: NI2021_01
  nct id: NCT05994196
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized, controlled, open-label trial is to test the use of secondary
        prioritization software (Optimum®) in the pediatric emergency department (PED).
  
        The aim of this study is to determine:
  
          1. whether the use of this secondary prioritization software (Optimum®) reduces the
             patients' median length of stay (LOS) in the PED
  
          2. how this software is accepted by the staff. The PED staff will be asked to manage the
             patients according to the Optimum® software indications (intervention) or according to
             the standard dashboard (control).
  Design: randomized, controlled open-label trial in the PED at Lille University Medical
        Center, Lille, France.
  
        Period: between March 15th and April 23rd, 2021.
  
        Randomization: each day was randomized for the use of Optimum® software (intervention group)
        or the PED's standard patient management dashboard (control group).
  
        Inclusion criteria:
  
        - All children admitted between 10:00 am and 0:00 am at the PED.
  
        Exclusion criteria:
  
          -  Patients who left without being seen
  
          -  Patients admitted to a short-stay unit at the PED.
  
        Authorizations: the study protocol was registered with the French National Data Protection
        Commission (Commission Nationale de l'Informatique et des Libertés, Paris, France;
        registration number: DEC21-056). This research was submitted to the institutional review
        board, which replied that this type of study, without patient intervention, did not require
        validation by the ethics committee. The patients and their parents were shown a study
        information sheet at the PED reception desk and were free to object to their child's
        participation.
  
        The prioritization software: Optimum® was developed in 2015. Five variables with a
        statistically significant influence on the LOS were identified; the reason for admission, the
        number of patients present in the PED simultaneously, the prescription of imaging, the
        prescription of blood tests, and the prescription of treatment. Optimum®'s purpose is to
        remove the mental load of prioritization from the PED staff. The software first prioritizes
        the triage of new patients by the PED staff and the first evaluation of a new patient by the
        medical team. Optimum® then prioritizes blood sample collections and care (for nurses) and
        checks on imaging results, blood test results or an evaluation by a specialist (for
        physicians). Lastly, Optimum® prioritizes the final step in patient management by a senior
        physician, when appropriate.
  
        Primary endpoint: the LOS for each patient. Number of patients needed: with a hypothesis of a
        15-minute difference in the LOS between the Optimum® and control groups, when considering a
        mean of 78 patients/day and a median LOS of 190 minutes, with an α-risk of 0.05 and a power
        (1-ß risk) of 0.8, a total of 1542 patients had to be included (i.e., 771 per group).
  
        Secondary endpoints:
  
          -  number of patients present at the same time in the PED,
  
          -  time intervals between each stage in patient management from nurse triage to discharge,
  
          -  PED staff's level of satisfaction using the standardized System Usability Scale (SUS).
  
        Study procedures :
  
          1. training of all the PED staff members in use of Optimum® 2 weeks prior to the study.
  
          2. study setting up: with days randomized to Optimum® vs. the standard dashboard using the
             "random" formula in Excel® (Microsoft Corporation, Redmond, WA, USA). Weekdays and
             weekend/public holiday days were randomized separately. An investigator not involved in
             the management of the patients during the study period was present throughout the
             inclusion period and prospectively recorded the time intervals for each patient's stay
             in the PED: time of arrival at the PED, evaluation by the triage nurse, the first
             medical evaluation (by a medical student or a junior physician), the first evaluation by
             a senior physician, the evaluation by a specialist physician (if applicable), the
             results of imaging and lab tests (if prescribed), the final medical decision, and
             discharge.
  
        Data collected: in addition to the LOS and to the time intervals of the different phases of
        management, the other variables recorded were age, gender, reason for admission, triage
        level, and mode of discharge. There were five categories of reasons for admission: fever, a
        respiratory disorder, a digestive tract disorder, trauma, and other reasons.
  
        3) the PED staff involved in the study will fill out the standardized SUS questionnaire as a
        guide to the perceived utility of the Optimum® software and the level of user satisfaction.
        According to the literature, the SUS score is considered to be very poor if it is less than
        51, poor if between 51 and 68, average if 68, good if between 68 and 80.3, and excellent if
        greater than 80.3.
  
        Statistical analysis:
  
          1. description of patients' characteristics
  
          2. the normality of the data distributions was checked graphically and using the
             Shapiro-Wilk test.
  
          3. Intergroup comparisons of the total LOS and the various time intervals during patient
             management times were performed by covariance analysis.
  
          4. Analysis of the standardized System Usability Scale (SUS) questionnaire filled out by
             the PED staff at th end of the study to perceive the utility of the Optimum® software
             and the level of user satisfaction. A Spearman's test was used to analyze the
             correlation between the age of the PED staff and the SUS score.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Length of stay
  time frame: from admission to discharge, assessed up to 1 day.
  description: the length of stay for each patient
  measure: Number of patients present
  time frame: 1 day
  description: Number of patients present at the same time in the pediatric emergency department during the study period
  measure: Time intervals between each stage
  time frame: 1 day
  description: The time intervals between each stage in patient management from nurse triage to discharge
  measure: Pediatric emergency department staff satisfaction
  time frame: through study completion, an average of 3 months
  description: To measure the pediatric emergency department staff's level of satisfaction with the System Usability Scale. Values range from 0 to 100 points. Higher scores mean a better satisfaction.
  arm group label: Optimum
  arm group type: Experimental
  description: the secondary prioritization software of patients
  arm group label: Control
  arm group type: No Intervention
  description: the standard dashboard of patients
  intervention type: Behavioral
  intervention name: Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)
  description: Optimum®'s purpose is to remove the mental load of prioritization from the Pediatric ED staff. The software first prioritizes the triage of new patients by the ED staff and the first evaluation of a new patient by the medical team. Optimum® then prioritizes blood sample collections and care (for nurses) and checks on imaging results, blood test results or an evaluation by a specialist (for physicians). Lastly, Optimum® prioritizes the final step in patient management by a senior physician, when appropriate.
  arm group label: Optimum
  criteria: 
  gender: All
  minimum age: 3 Days
  maximum age: 16 Years
  healthy volunteers: No
  last name: François Dubos, MD, PhD
  role: Principal Investigator
  affiliation: Lille University Hospital
  facility: 
  country: France
  url: https://digital.ahrq.gov/sites/default/files/docs/survey/systemusabilityscale%2528sus%2529_comp%255B1%255D.pdf
  description: Description of the standardized System Usability Scale (SUS)
  citation: Schiro J, Marcilly R, Leroy N, Wawrzyniak C, Martinot A, Pelayo S. Design and evaluation of a patient website to reduce crowding in emergency departments: a preliminary study. Stud Health Technol Inform. 2015;210:663-5.
  PMID: 25991232
  citation: Windal F, Jeribi K, Ficheur G, Degoul S, Martinot A, Beuscart R, Renard JM. Pediatric emergency department crowding: survival tree clustering for length of patient stay. Stud Health Technol Inform. 2014;205:1095-9.
  PMID: 25160358
  citation: Gravel J, Fitzpatrick E, Gouin S, Millar K, Curtis S, Joubert G, Boutis K, Guimont C, Goldman RD, Dubrovsky AS, Porter R, Beer D, Doan Q, Osmond MH. Performance of the Canadian Triage and Acuity Scale for children: a multicenter database study. Ann Emerg Med. 2013 Jan;61(1):27-32.e3. doi: 10.1016/j.annemergmed.2012.05.024. Epub 2012 Jul 27.
  PMID: 22841173
  responsible party type: Sponsor
  mesh term: Emergencies
  sharing ipd: No