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/NCT06018662</url>
    </required_header>
    <id_info>
      <org_study_id>A medication mobile app</org_study_id>
      <nct_id>NCT06018662</nct_id>
    </id_info>
    <brief_title>An Interventional Study to Establish a Medication Management Mobile Application for Pediatric Surgery Patients</brief_title>
    <official_title>Establishment of an Electronic Medication Management Application in a Pediatric Surgery Department</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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>
        An interventional study that aims to design, establish and implement an electronic&#xD;
        application for management of the usage of anesthetics, antimicrobials, and analgesics in a&#xD;
        pediatric surgery department, and assess the impact of the implementation of an electronic&#xD;
        medication management application on the appropriateness of medication use in a pediatric&#xD;
        surgery department&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mobile health (mHealth) refers to digital health technologies via mobile phones, tablets, and&#xD;
        other electronic devices to enhance health outcomes. mHealth has started to have an impact on&#xD;
        many health care and medical education aspects. With the increased number of smartphones and&#xD;
        increasing interest in using mobile applications (apps), healthcare related mobile apps offer&#xD;
        opportunities for advanced patient care allowing for better patient-provider communication.&#xD;
        Within anesthesia, mobile apps were developed to play an important role; pre, intra- and&#xD;
        postoperatively through providing patient-physician communication, reducing patient anxiety,&#xD;
        and offering on-the-go education.&#xD;
  &#xD;
        The development of medical mobile app is challenging. It incorporates producing an&#xD;
        easy-to-use display with appropriate clinical information. Although many medication errors&#xD;
        lead to little or no harm, some have overwhelming consequences for patients and, sometimes,&#xD;
        for practitioners.&#xD;
  &#xD;
        In pediatric patients, doses of anesthetics and other medications are calculated based on age&#xD;
        and/or weight. Also, preparations often require further dilutions, specifically for younger&#xD;
        patients like neonates and infants. These steps might increase risk for medication errors in&#xD;
        pediatric anesthesia. For pediatric patients, it is important to use appropriate weight-based&#xD;
        medication doses.&#xD;
  &#xD;
        Anesthetics, Antimicrobials and Analgesics are the three drug classes that have shown the&#xD;
        highest number of medication errors in the operating rooms of a pediatric surgery department.&#xD;
        To provide an appropriate age and/or weight-based drug information, we will develop an&#xD;
        electronic application to recommend the most appropriate drugs based on international&#xD;
        guidelines and calculate doses for Anesthetics, Antimicrobials and Analgesics for pediatric&#xD;
        patients in the operating rooms of a pediatric surgery department.&#xD;
  &#xD;
        Aim of the study:&#xD;
  &#xD;
        To design, establish and implement an electronic application for management of the usage of&#xD;
        anesthetics, antimicrobials, and analgesics in a pediatric surgery department. To assess the&#xD;
        impact of the implementation of an electronic medication management application on the&#xD;
        appropriateness of medication use in a pediatric surgery department&#xD;
  &#xD;
        Patients and methods:&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        Prospective, Interventional, Single-blinded, Randomized controlled study.&#xD;
  &#xD;
        Setting:&#xD;
  &#xD;
        The study will be conducted in the pediatric surgery department in the Children's hospital,&#xD;
        Ain Shams University, Cairo, Egypt.&#xD;
  &#xD;
        Patients:&#xD;
  &#xD;
        Pediatric patients undergoing surgical operations.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        The study will be performed according to the following phases;&#xD;
  &#xD;
        Phase 1: Application Design and Development&#xD;
  &#xD;
          -  The app will include all database required to provide appropriate medications and dosing&#xD;
             for pediatric patients intraoperatively, postoperatively and on discharge.&#xD;
  &#xD;
          -  The user will need to enter the patient's age and weight, choose the type of surgery and&#xD;
             the drug class and the app will show the appropriate medications and dosage.&#xD;
  &#xD;
          -  The app will present all the important information for drug administration by using; the&#xD;
             British National Formulary for children (BNF-C) and Lexicomp online database as the&#xD;
             dosage and administration references, and The American Health System Pharmacists (ASHP)&#xD;
             clinical practice guidelines and UpToDate evidence-based clinical decision support&#xD;
             resource will be used for to determine the appropriate anesthetics, antimicrobials, and&#xD;
             analgesics for the surgeries to be included in the study.&#xD;
  &#xD;
          -  The researcher will ensure that the application will be displayed properly on the iPhone&#xD;
             operating system (iOS) and Android mobile devices.&#xD;
  &#xD;
        Phase 2: Simulation and Validation&#xD;
  &#xD;
          -  To test app validation, a simulation study will be conducted, where, data of patient's&#xD;
             weight and age will be entered followed by selection of type of surgery and drug class.&#xD;
  &#xD;
          -  The app will provide the appropriate medications and dosage for each case scenario&#xD;
             according to international treatment protocols and guidelines.&#xD;
  &#xD;
          -  Medications doses in each drug class will be calculated twice using the app and twice&#xD;
             without the app, for each type of surgery.&#xD;
  &#xD;
        Phase 3: Physicians' training Physicians will be trained on how to use the application for&#xD;
        the selected types of surgeries. (List of surgeons will be accurately checked and randomly&#xD;
        50% of them will be allowed to enter training sessions for use of app in their practice&#xD;
        (interventional group), while the rest 50% will not be given the training sessions in order&#xD;
        to use the department policy (Control group).&#xD;
  &#xD;
        Phase 4: Patients' recruitment and Application use in pre-, intra-, and post-operative stage&#xD;
        Two hundred and seventy- six 276 patients will be randomly allocated to either control group&#xD;
        or intervention group via simple randomization technique.&#xD;
  &#xD;
        Control group (138 patients): The medications selection and dosage will be performed&#xD;
        according to the department policy without using the app.&#xD;
  &#xD;
        Intervention group (138 patients): The physicians use the app for appropriate medications&#xD;
        selection and dosage calculation.&#xD;
  &#xD;
        All patients will be followed up postoperatively during hospital stay. A follow-up form will&#xD;
        be used to record all required data during hospitalization.&#xD;
  &#xD;
        Cost estimation :&#xD;
  &#xD;
        Estimated cost savings will be calculated based on reduction in medication errors by using&#xD;
        the electronic app. This will include discontinuing unnecessary medications, modifications of&#xD;
        dose or duration, no medication indication, and inappropriate medication combination.&#xD;
  &#xD;
        Medication errors categories according to the National Coordinating Council for Medication&#xD;
        Error Reporting and Prevention (NCC MERP) will be included in the cost saving analysis.&#xD;
  &#xD;
        Phase 5: Usability testing An electronic form of the System Usability Scale (SUS), a widely&#xD;
        used and validated 10-questions Likert scale, for measuring the app usability will be used to&#xD;
        evaluate physicians' user experience of the app.&#xD;
  &#xD;
        Phase 6: Follow-up All patients will be followed up for two weeks after discharge for any&#xD;
        signs and symptoms of drug related problems or postoperative complications including pain,&#xD;
        nausea, vomiting and surgical site infection using an electronic form or phone calls. A&#xD;
        follow-up form will be used after discharge&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Control group (138 patients): The medications selection and dosage will be performed according to the department policy without using the application.&#xD;
  Intervention group (138 patients): The physicians use the application for appropriate medications selection and dosage calculation.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Appropriateness of medications (anesthetics, antimicrobials, and analgesics) used in different types of surgeries</measure>
      <time_frame>One year</time_frame>
      <description>Determined through measuring incidence of medication errors and drug related problems</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cost saving</measure>
      <time_frame>One year</time_frame>
      <description>Estimated cost savings will be calculated by calculating direct medical costs (including medication costs (multiplied by duration in days) of the intervened medications if the interventions belong to any of the mentioned types, laboratory tests, investigations and hospital care).&#xD;
  Estimated cost avoidance will be calculated based on the probability score (probability of an adverse drug event in the absence of the intervention).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost avoidance</measure>
      <time_frame>one year</time_frame>
      <description>Estimated cost avoidance will calculated based on the probability of an adverse drug event in the absence of the mobile application</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time saving</measure>
      <time_frame>one year</time_frame>
      <description>Time saving resulting from using the application will be calculated in seconds</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">276</enrollment>
    <condition>Medication Management</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine department therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interventional</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Anesthetics, antimicrobials and analgesics are selected and age/weight doses are calculated using the medication management mobile application</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>A medication management mobile application</intervention_name>
      <description>A mobile application to select the most appropriate drugs for anesthetics, antimicrobials and analgesics, in addition to dose calculations</description>
      <arm_group_label>Interventional</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pediatric patients undergoing any of the following surgeries: Circumcision, Inguinal&#xD;
               Hernia, Hypospadias, Esophageal dilatation, uncomplicated Appendectomy, and&#xD;
               complicated Appendectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiac patients&#xD;
  &#xD;
            -  Diabetic patients&#xD;
  &#xD;
            -  Hypertensive patients&#xD;
  &#xD;
            -  Immunocompromised patients&#xD;
  &#xD;
            -  Patients with renal and/or liver failure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Mai Fawaz</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Pediatric surgery</keyword>
    <keyword>Mobile application</keyword>
    <keyword>Medication errors</keyword>
    <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/NCT06018662
  org study id: A medication mobile app
  nct id: NCT06018662
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  An interventional study that aims to design, establish and implement an electronic
        application for management of the usage of anesthetics, antimicrobials, and analgesics in a
        pediatric surgery department, and assess the impact of the implementation of an electronic
        medication management application on the appropriateness of medication use in a pediatric
        surgery department
  Mobile health (mHealth) refers to digital health technologies via mobile phones, tablets, and
        other electronic devices to enhance health outcomes. mHealth has started to have an impact on
        many health care and medical education aspects. With the increased number of smartphones and
        increasing interest in using mobile applications (apps), healthcare related mobile apps offer
        opportunities for advanced patient care allowing for better patient-provider communication.
        Within anesthesia, mobile apps were developed to play an important role; pre, intra- and
        postoperatively through providing patient-physician communication, reducing patient anxiety,
        and offering on-the-go education.
  
        The development of medical mobile app is challenging. It incorporates producing an
        easy-to-use display with appropriate clinical information. Although many medication errors
        lead to little or no harm, some have overwhelming consequences for patients and, sometimes,
        for practitioners.
  
        In pediatric patients, doses of anesthetics and other medications are calculated based on age
        and/or weight. Also, preparations often require further dilutions, specifically for younger
        patients like neonates and infants. These steps might increase risk for medication errors in
        pediatric anesthesia. For pediatric patients, it is important to use appropriate weight-based
        medication doses.
  
        Anesthetics, Antimicrobials and Analgesics are the three drug classes that have shown the
        highest number of medication errors in the operating rooms of a pediatric surgery department.
        To provide an appropriate age and/or weight-based drug information, we will develop an
        electronic application to recommend the most appropriate drugs based on international
        guidelines and calculate doses for Anesthetics, Antimicrobials and Analgesics for pediatric
        patients in the operating rooms of a pediatric surgery department.
  
        Aim of the study:
  
        To design, establish and implement an electronic application for management of the usage of
        anesthetics, antimicrobials, and analgesics in a pediatric surgery department. To assess the
        impact of the implementation of an electronic medication management application on the
        appropriateness of medication use in a pediatric surgery department
  
        Patients and methods:
  
        Design:
  
        Prospective, Interventional, Single-blinded, Randomized controlled study.
  
        Setting:
  
        The study will be conducted in the pediatric surgery department in the Children's hospital,
        Ain Shams University, Cairo, Egypt.
  
        Patients:
  
        Pediatric patients undergoing surgical operations.
  
        Methods:
  
        The study will be performed according to the following phases;
  
        Phase 1: Application Design and Development
  
          -  The app will include all database required to provide appropriate medications and dosing
             for pediatric patients intraoperatively, postoperatively and on discharge.
  
          -  The user will need to enter the patient's age and weight, choose the type of surgery and
             the drug class and the app will show the appropriate medications and dosage.
  
          -  The app will present all the important information for drug administration by using; the
             British National Formulary for children (BNF-C) and Lexicomp online database as the
             dosage and administration references, and The American Health System Pharmacists (ASHP)
             clinical practice guidelines and UpToDate evidence-based clinical decision support
             resource will be used for to determine the appropriate anesthetics, antimicrobials, and
             analgesics for the surgeries to be included in the study.
  
          -  The researcher will ensure that the application will be displayed properly on the iPhone
             operating system (iOS) and Android mobile devices.
  
        Phase 2: Simulation and Validation
  
          -  To test app validation, a simulation study will be conducted, where, data of patient's
             weight and age will be entered followed by selection of type of surgery and drug class.
  
          -  The app will provide the appropriate medications and dosage for each case scenario
             according to international treatment protocols and guidelines.
  
          -  Medications doses in each drug class will be calculated twice using the app and twice
             without the app, for each type of surgery.
  
        Phase 3: Physicians' training Physicians will be trained on how to use the application for
        the selected types of surgeries. (List of surgeons will be accurately checked and randomly
        50% of them will be allowed to enter training sessions for use of app in their practice
        (interventional group), while the rest 50% will not be given the training sessions in order
        to use the department policy (Control group).
  
        Phase 4: Patients' recruitment and Application use in pre-, intra-, and post-operative stage
        Two hundred and seventy- six 276 patients will be randomly allocated to either control group
        or intervention group via simple randomization technique.
  
        Control group (138 patients): The medications selection and dosage will be performed
        according to the department policy without using the app.
  
        Intervention group (138 patients): The physicians use the app for appropriate medications
        selection and dosage calculation.
  
        All patients will be followed up postoperatively during hospital stay. A follow-up form will
        be used to record all required data during hospitalization.
  
        Cost estimation :
  
        Estimated cost savings will be calculated based on reduction in medication errors by using
        the electronic app. This will include discontinuing unnecessary medications, modifications of
        dose or duration, no medication indication, and inappropriate medication combination.
  
        Medication errors categories according to the National Coordinating Council for Medication
        Error Reporting and Prevention (NCC MERP) will be included in the cost saving analysis.
  
        Phase 5: Usability testing An electronic form of the System Usability Scale (SUS), a widely
        used and validated 10-questions Likert scale, for measuring the app usability will be used to
        evaluate physicians' user experience of the app.
  
        Phase 6: Follow-up All patients will be followed up for two weeks after discharge for any
        signs and symptoms of drug related problems or postoperative complications including pain,
        nausea, vomiting and surgical site infection using an electronic form or phone calls. A
        follow-up form will be used after discharge
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Control group (138 patients): The medications selection and dosage will be performed according to the department policy without using the application.
  Intervention group (138 patients): The physicians use the application for appropriate medications selection and dosage calculation.
  primary purpose: Other
  masking: Double (Participant, Care Provider)
  measure: Appropriateness of medications (anesthetics, antimicrobials, and analgesics) used in different types of surgeries
  time frame: One year
  description: Determined through measuring incidence of medication errors and drug related problems
  measure: Cost saving
  time frame: One year
  description: Estimated cost savings will be calculated by calculating direct medical costs (including medication costs (multiplied by duration in days) of the intervened medications if the interventions belong to any of the mentioned types, laboratory tests, investigations and hospital care).
  Estimated cost avoidance will be calculated based on the probability score (probability of an adverse drug event in the absence of the intervention).
  measure: Cost avoidance
  time frame: one year
  description: Estimated cost avoidance will calculated based on the probability of an adverse drug event in the absence of the mobile application
  measure: Time saving
  time frame: one year
  description: Time saving resulting from using the application will be calculated in seconds
  arm group label: Control
  arm group type: No Intervention
  description: Routine department therapy
  arm group label: Interventional
  arm group type: Experimental
  description: Anesthetics, antimicrobials and analgesics are selected and age/weight doses are calculated using the medication management mobile application
  intervention type: Other
  intervention name: A medication management mobile application
  description: A mobile application to select the most appropriate drugs for anesthetics, antimicrobials and analgesics, in addition to dose calculations
  arm group label: Interventional
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 12 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Mai Fawaz
  investigator title: Principal investigator
  sharing ipd: No