<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/NCT03256591</url>
  </required_header>
  <id_info>
    <org_study_id>MUST 21/06-16c</org_study_id>
    <nct_id>NCT03256591</nct_id>
  </id_info>
  <brief_title>Implementation of HBB Training With Facilitators That Have Undergone Simulation Methodology Training</brief_title>
  <acronym>SimHBB</acronym>
  <official_title>A Comparison of the Implementation of HBB Training Using Facilitators With and Without Simulation Methodology Training</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>
      Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths&#xD;
      and reduction in fresh stillbirths. HBB has successfully integrated some aspects of&#xD;
      simulation into an educational curriculum that teach the management of neonatal emergencies&#xD;
      in resource-constrained countries.&#xD;
&#xD;
      Simulation based training brings special advantages and may enhance HBB training. Critical&#xD;
      elements of simulation such as enhanced realism and post-event debriefing may carry potential&#xD;
      to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness&#xD;
      of this combined approach is limited.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths&#xD;
      and reduction in fresh stillbirths. HBB has successfully integrated some aspects of&#xD;
      simulation into an educational curriculum that teach the management of neonatal emergencies&#xD;
      in resource-constrained countries.&#xD;
&#xD;
      High levels of physical, emotional and conceptual realism are important features of&#xD;
      simulation-based learning that impact learning outcomes. Formal debriefing is characterized&#xD;
      as the most important element of simulation based education. Structured feedback in a safe&#xD;
      learning environment provides the opportunity for learning of clinically relevant material.&#xD;
      Guided reflection transfers the responsibility for learning to the participants and&#xD;
      solidifies knowledge, skills and behaviors for transfer to clinical practice.&#xD;
&#xD;
      Simulation based training brings special advantages and may enhance HBB training. Critical&#xD;
      elements of simulation such as enhanced realism and post-event debriefing may carry potential&#xD;
      to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness&#xD;
      of this combined approach is limited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</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>Investigators will conduct a prospective, randomized controlled trial to determine if the implementation of a simulation facilitator training program for HBB compared with no facilitator training in simulation is superior in terms of the acquisition of knowledge, acute care skills, and teamwork skills of pre-service medical students. Investigators will randomly randomly assign study participants to either intervention or control arm in a 1:1 ratio.</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>Knowledge</measure>
    <time_frame>Change in knowledge scores at 6 months from Baseline</time_frame>
    <description>The primary outcome for this analysis is level of knowledge. For each course, learners will be assessed at baseline and at course-end to determine their knowledge via multiple choice test. Scores out of 100% will be computed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical skills</measure>
    <time_frame>Change in clinical skills at 6 months from baseline</time_frame>
    <description>The clinical skills outcome (via short neonatal resuscitation simulation scenario - HBB OSCE B). HBB OSCE B assessment will be conducted by the facilitator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facilitator debriefing skills</measure>
    <time_frame>Change in facilitator skills at 6 months from baseline</time_frame>
    <description>Facilitator debriefing skills will be assessed using the OSAD. OSAD assessments will be conducted by a pre-trained rater who will rate facilitator performance in real time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Maternal Health</condition>
  <condition>Newborn; Vitality</condition>
  <arm_group>
    <arm_group_label>HBB plus simulation training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive training from facilitators for HBB training with simulation skills</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive training from facilitators for HBB training without simulation skills</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HBB facilitators with simulation training</intervention_name>
    <description>HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills</description>
    <arm_group_label>HBB plus simulation training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only trained facilitators are eligible to participate&#xD;
&#xD;
          -  Must hold a Faculty position or are a health care provider at KIU Teaching Hospital in&#xD;
             western Uganda&#xD;
&#xD;
          -  Are engaged in teaching health students.&#xD;
&#xD;
          -  Participating medical students are those enrolled at KIU Teaching Hospital in western&#xD;
             Uganda&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Faculty and hospital workers who are not engaged in teaching health students.&#xD;
&#xD;
          -  Medical students not enrolled at KIU Teaching Hospital, western Uganda&#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>
  <overall_contact>
    <last_name>Santorini Data, MD</last_name>
    <phone>+256752214458</phone>
    <email>sdata@must.ac.ug</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francis Bajunirwe, PhD</last_name>
    <phone>+256772576396</phone>
    <email>fbaj@must.ac.ug</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kampala International University</name>
      <address>
        <city>Ishaka</city>
        <state>Bushenyi</state>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cathy Kyakwera, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be shared after appropriate 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/NCT03256591
org study id: MUST 21/06-16c
nct id: NCT03256591
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths
      and reduction in fresh stillbirths. HBB has successfully integrated some aspects of
      simulation into an educational curriculum that teach the management of neonatal emergencies
      in resource-constrained countries.

      Simulation based training brings special advantages and may enhance HBB training. Critical
      elements of simulation such as enhanced realism and post-event debriefing may carry potential
      to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness
      of this combined approach is limited.
Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths
      and reduction in fresh stillbirths. HBB has successfully integrated some aspects of
      simulation into an educational curriculum that teach the management of neonatal emergencies
      in resource-constrained countries.

      High levels of physical, emotional and conceptual realism are important features of
      simulation-based learning that impact learning outcomes. Formal debriefing is characterized
      as the most important element of simulation based education. Structured feedback in a safe
      learning environment provides the opportunity for learning of clinically relevant material.
      Guided reflection transfers the responsibility for learning to the participants and
      solidifies knowledge, skills and behaviors for transfer to clinical practice.

      Simulation based training brings special advantages and may enhance HBB training. Critical
      elements of simulation such as enhanced realism and post-event debriefing may carry potential
      to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness
      of this combined approach is limited.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Investigators will conduct a prospective, randomized controlled trial to determine if the implementation of a simulation facilitator training program for HBB compared with no facilitator training in simulation is superior in terms of the acquisition of knowledge, acute care skills, and teamwork skills of pre-service medical students. Investigators will randomly randomly assign study participants to either intervention or control arm in a 1:1 ratio.
primary purpose: Other
masking: None (Open Label)
masking description: No masking will be done
measure: Knowledge
time frame: Change in knowledge scores at 6 months from Baseline
description: The primary outcome for this analysis is level of knowledge. For each course, learners will be assessed at baseline and at course-end to determine their knowledge via multiple choice test. Scores out of 100% will be computed
measure: Clinical skills
time frame: Change in clinical skills at 6 months from baseline
description: The clinical skills outcome (via short neonatal resuscitation simulation scenario - HBB OSCE B). HBB OSCE B assessment will be conducted by the facilitator.
measure: Facilitator debriefing skills
time frame: Change in facilitator skills at 6 months from baseline
description: Facilitator debriefing skills will be assessed using the OSAD. OSAD assessments will be conducted by a pre-trained rater who will rate facilitator performance in real time.
arm group label: HBB plus simulation training
arm group type: Experimental
description: Participants receive training from facilitators for HBB training with simulation skills
arm group label: Control
arm group type: No Intervention
description: Participants receive training from facilitators for HBB training without simulation skills
intervention type: Other
intervention name: HBB facilitators with simulation training
description: HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills
arm group label: HBB plus simulation training
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
last name: Santorini Data, MD
phone: +256752214458
email: sdata@must.ac.ug
last name: Francis Bajunirwe, PhD
phone: +256772576396
email: fbaj@must.ac.ug
facility: 
status: Recruiting
contact: 
country: Uganda
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Data will be shared after appropriate permissions have been obtained.