<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/NCT03258073</url>
  </required_header>
  <id_info>
    <org_study_id>MUST 21/06-16b</org_study_id>
    <nct_id>NCT03258073</nct_id>
  </id_info>
  <brief_title>Does Simulation Scenario Execution Improve Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies?</brief_title>
  <acronym>SimForLife</acronym>
  <official_title>Impact of Simulation Scenario Execution on Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies Among Pre-service Health Professional Trainees in Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mbarara University of Science and Technology</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>
      In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training&#xD;
      and intermittent opportunity to maintain skills in managing delivery complications and acute&#xD;
      newborn and pediatric conditions. Interventions like effective resuscitation assistance at&#xD;
      the time of birth are lifesaving. Every 30 second delay in establishing effective&#xD;
      resuscitation at birth increases the risk of death by 16%. The purpose of this study is to&#xD;
      test whether medical simulation can improve acute care skills and confidence related to&#xD;
      maternal and pediatric care emergencies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training&#xD;
      and intermittent opportunity to maintain skills in managing delivery complications and acute&#xD;
      newborn and pediatric conditions. Interventions like effective resuscitation assistance at&#xD;
      the time of birth are lifesaving. Every 30 second delay in establishing effective&#xD;
      resuscitation at birth increases the risk of death by 16%. The purpose of this study is to&#xD;
      test whether medical simulation can improve acute care skills and confidence related to&#xD;
      maternal and pediatric care emergencies.&#xD;
&#xD;
      A solid body of evidence now supports simulation-based learning as superior to didactic&#xD;
      teaching and problem-based learning for the acquisition of critical assessment and management&#xD;
      skills, particularly for clinical emergencies. Simulation-based training promotes skill&#xD;
      acquisition and retention, enhances teamwork, and increases knowledge and understanding of&#xD;
      key procedures. Simulation-based learning is now the norm in medical, nursing and paramedical&#xD;
      training in most high income settings. There remains a critical need to operationalize&#xD;
      simulation-based learning in resource-constrained settings&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Investigators will conduct a cohort study among medical and nursing students and follow groups of students according to their rotation in the four major clinical disciplines. A cohort will represent a group of students who start a clinical rotation and complete their clinical year together. A total of 4 rotations exist concurrently every academic year in a year of study (Pediatrics, Internal medicine, Surgery and Obstetrics). During each rotation, a cohort will be exposed to at least 1 simulation scenario relevant to the discipline of the rotation. Investigators hypothesize that repeated exposure to simulation scenario execution will improve CTS scores. Therefore in this cohort study, investigators will measure CTS scores before and after exposure to simulation scenario training.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking will be done</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Skills using the Scenario-execution-group test score</measure>
    <time_frame>Immediately Post scenario execution</time_frame>
    <description>This is a scenario specific score obtained from a multiple choice question (MCQ) test following execution of the scenario to measure. The MCQs are standard questions developed to accompany a given scenario. The maximum score is 100%. A scenario-execution-group test score of less than 60% will be a fail and a score of more than or equal to 60% will be a pass.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge</measure>
    <time_frame>Change in knowledge scores at 4 months from Baseline</time_frame>
    <description>Knowledge will be measured using multiple choice questions (MCQs) and Investigators will use the Retrospective pre-post survey (RPP survey) to assess performance confidence among participants. In the RPP, the participant is asked to compare their performance after the intervention with that before the intervention. This assessment removes the bias of over or underestimating how much the participant knew before the intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Maternal, Pediatric Care Emergencies</condition>
  <arm_group>
    <arm_group_label>Medical simulation using scenarion execution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will be exposed to medical simulation using scenario execution. In this exercise, participants will be exposed to a scenario that simulates a medical emergency. They will be required to respond. Following their response, the participants will have a chance to share with the investigators their experiences and what they have learnt from the exposure in a debriefing session. The investigator will then provide feedback on their performance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical simulation using scenario execution</intervention_name>
    <description>Each team of students will be exposed to simulation two times in a semester totaling to four times a year. In a scenario execution, participants are placed in a simulated experience of a medical emergency. Participants are required to respond and their reactions are observed by the investigators. After the experience, participants will have a debriefing session to learn from their experience of handling this emergency.</description>
    <arm_group_label>Medical simulation using scenarion execution</arm_group_label>
    <other_name>medical simulation methodology</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are medical and nursing students in active clinical rotation; third and&#xD;
             fifth year medical students and third and fourth year nursing students at Mbarara&#xD;
             University of Science and Technology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclude medical and nursing students in the pre-clinical years and those in&#xD;
             non-clinical rotations at the time of the intervention.&#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>Santorini Data, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mbarara University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mbarara University of Science and Technology</name>
      <address>
        <city>Mbarara</city>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>April 17, 2021</last_update_submitted>
  <last_update_submitted_qc>April 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>maternal</keyword>
  <keyword>newborn</keyword>
  <keyword>resuscitation</keyword>
  <keyword>emergencies</keyword>
  <keyword>medical simulation</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>Undecided</sharing_ipd>
    <ipd_description>Data to be shared when necessary permissions have been obtained</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03258073
org study id: MUST 21/06-16b
nct id: NCT03258073
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training
      and intermittent opportunity to maintain skills in managing delivery complications and acute
      newborn and pediatric conditions. Interventions like effective resuscitation assistance at
      the time of birth are lifesaving. Every 30 second delay in establishing effective
      resuscitation at birth increases the risk of death by 16%. The purpose of this study is to
      test whether medical simulation can improve acute care skills and confidence related to
      maternal and pediatric care emergencies.
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training
      and intermittent opportunity to maintain skills in managing delivery complications and acute
      newborn and pediatric conditions. Interventions like effective resuscitation assistance at
      the time of birth are lifesaving. Every 30 second delay in establishing effective
      resuscitation at birth increases the risk of death by 16%. The purpose of this study is to
      test whether medical simulation can improve acute care skills and confidence related to
      maternal and pediatric care emergencies.

      A solid body of evidence now supports simulation-based learning as superior to didactic
      teaching and problem-based learning for the acquisition of critical assessment and management
      skills, particularly for clinical emergencies. Simulation-based training promotes skill
      acquisition and retention, enhances teamwork, and increases knowledge and understanding of
      key procedures. Simulation-based learning is now the norm in medical, nursing and paramedical
      training in most high income settings. There remains a critical need to operationalize
      simulation-based learning in resource-constrained settings
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Investigators will conduct a cohort study among medical and nursing students and follow groups of students according to their rotation in the four major clinical disciplines. A cohort will represent a group of students who start a clinical rotation and complete their clinical year together. A total of 4 rotations exist concurrently every academic year in a year of study (Pediatrics, Internal medicine, Surgery and Obstetrics). During each rotation, a cohort will be exposed to at least 1 simulation scenario relevant to the discipline of the rotation. Investigators hypothesize that repeated exposure to simulation scenario execution will improve CTS scores. Therefore in this cohort study, investigators will measure CTS scores before and after exposure to simulation scenario training.
primary purpose: Other
masking: None (Open Label)
masking description: No masking will be done
measure: Skills using the Scenario-execution-group test score
time frame: Immediately Post scenario execution
description: This is a scenario specific score obtained from a multiple choice question (MCQ) test following execution of the scenario to measure. The MCQs are standard questions developed to accompany a given scenario. The maximum score is 100%. A scenario-execution-group test score of less than 60% will be a fail and a score of more than or equal to 60% will be a pass.
measure: Knowledge
time frame: Change in knowledge scores at 4 months from Baseline
description: Knowledge will be measured using multiple choice questions (MCQs) and Investigators will use the Retrospective pre-post survey (RPP survey) to assess performance confidence among participants. In the RPP, the participant is asked to compare their performance after the intervention with that before the intervention. This assessment removes the bias of over or underestimating how much the participant knew before the intervention.
arm group label: Medical simulation using scenarion execution
arm group type: Experimental
description: Study participants will be exposed to medical simulation using scenario execution. In this exercise, participants will be exposed to a scenario that simulates a medical emergency. They will be required to respond. Following their response, the participants will have a chance to share with the investigators their experiences and what they have learnt from the exposure in a debriefing session. The investigator will then provide feedback on their performance.
intervention type: Other
intervention name: Medical simulation using scenario execution
description: Each team of students will be exposed to simulation two times in a semester totaling to four times a year. In a scenario execution, participants are placed in a simulated experience of a medical emergency. Participants are required to respond and their reactions are observed by the investigators. After the experience, participants will have a debriefing session to learn from their experience of handling this emergency.
arm group label: Medical simulation using scenarion execution
other name: medical simulation methodology
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Santorini Data, MD
role: Principal Investigator
affiliation: Mbarara University of Science and Technology
facility: 
country: Uganda
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: Undecided
ipd description: Data to be shared when necessary permissions have been obtained