<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/NCT03290924</url>
  </required_header>
  <id_info>
    <org_study_id>OPP1087303</org_study_id>
    <nct_id>NCT03290924</nct_id>
  </id_info>
  <brief_title>Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach</brief_title>
  <official_title>Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jhpiego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jhpiego</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>
      This study assesses the effect of a low-dose, high-frequency training approach on long-term&#xD;
      evidence-based skill retention among skilled birth attendants and impact on adverse birth&#xD;
      outcomes at hospitals in Ghana.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In-service training for skilled birth attendants (SBAs) is one of the most common&#xD;
      interventions to address lack of knowledge and skills. However, these training interventions&#xD;
      are seldom evaluated for effectiveness in improving learning or performance.&#xD;
&#xD;
      This study study is a cluster-randomized waitlist trial implemented in 40 public and mission&#xD;
      hospitals in Ghana. It assesses the effect of a low-dose, high-frequency (LDHF) training&#xD;
      approach to update hospital-based SBAs in key evidence-based intrapartum and immediate&#xD;
      newborn care practices, using current global guidelines.The LDHF approach includes two 4-day&#xD;
      onsite sessions (low dose) with weekly practice sessions, SMS quizzes and reminders, and&#xD;
      mentoring via mobile phone and onsite visits between trainings (high frequency). The low-dose&#xD;
      sessions include competency acquisition through simulation, case-based learning, and small&#xD;
      content packages spread over short time intervals.&#xD;
&#xD;
      Eligible hospitals will be stratified by geographic region and caseload, and then randomly&#xD;
      assigned to one of four implementation waves. The pipeline randomization allows for rigorous&#xD;
      evaluation while the program is rolled out to all facilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>institutional twenty-four hour newborn mortality rate</measure>
    <time_frame>1 day</time_frame>
    <description>death within 24 hours, or before discharge, of a newborn who breathed at birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>institutional intrapartum stillbirth rate</measure>
    <time_frame>1 day</time_frame>
    <description>proportion of all facility births that resulted in intrapartum stillbirth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>skilled birth attendant knowledge and skills</measure>
    <time_frame>Pre-test (before training) - post-test (immediately after training) - endline (12 months)</time_frame>
    <description>score on written and practical examinations on routine and emergency obstetric and newborn care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Stillbirth</condition>
  <condition>Neonatal Death</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Training on data collection and reporting</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low dose high frequency health worker training approach</intervention_name>
    <description>Two 4-day training sessions for skilled birth attendants&#xD;
1-day peer practice coordinator training after first training session&#xD;
Weekly, peer-led practice sessions using MamaNatalie® and NeoNatalie™ anatomic models&#xD;
SMS reminder messages and quizzes&#xD;
Routine telephone calls between master mentors and peer practice coordinators, and between project staff and master mentors&#xD;
Health information officer training&#xD;
Data collection and use training&#xD;
Supply of simulators, newborn resuscitation equipment, and delivery sets</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Comparison</intervention_name>
    <description>Training on data collection and reporting</description>
    <arm_group_label>Comparison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA - FACILITIES:&#xD;
&#xD;
          -  Public or faith based hospital&#xD;
&#xD;
          -  At least three skilled birth attendants on staff&#xD;
&#xD;
          -  At least 30 births per month&#xD;
&#xD;
        EXCLUSION CRITERIA - FACILITIES:&#xD;
&#xD;
          -  Private hospital&#xD;
&#xD;
          -  Public or faith based hospital with less than three skilled birth attendants on staff&#xD;
&#xD;
          -  Public or faith based hospital with less than 30 births per month&#xD;
&#xD;
        INCLUSION CRITERIA - SERVICE PROVIDERS:&#xD;
&#xD;
        * Health providers who attend births in participating health facilities and consent to be&#xD;
        assessed at the time of enrollment and at several points in time over the study period&#xD;
&#xD;
        EXCLUSION CRITERIA - SERVICE PROVIDERS:&#xD;
&#xD;
        * Health providers who decline to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Gomez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Technical Advisor</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>institutional delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stillbirth</mesh_term>
    <mesh_term>Perinatal Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03290924
org study id: OPP1087303
nct id: NCT03290924
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study assesses the effect of a low-dose, high-frequency training approach on long-term
      evidence-based skill retention among skilled birth attendants and impact on adverse birth
      outcomes at hospitals in Ghana.
In-service training for skilled birth attendants (SBAs) is one of the most common
      interventions to address lack of knowledge and skills. However, these training interventions
      are seldom evaluated for effectiveness in improving learning or performance.

      This study study is a cluster-randomized waitlist trial implemented in 40 public and mission
      hospitals in Ghana. It assesses the effect of a low-dose, high-frequency (LDHF) training
      approach to update hospital-based SBAs in key evidence-based intrapartum and immediate
      newborn care practices, using current global guidelines.The LDHF approach includes two 4-day
      onsite sessions (low dose) with weekly practice sessions, SMS quizzes and reminders, and
      mentoring via mobile phone and onsite visits between trainings (high frequency). The low-dose
      sessions include competency acquisition through simulation, case-based learning, and small
      content packages spread over short time intervals.

      Eligible hospitals will be stratified by geographic region and caseload, and then randomly
      assigned to one of four implementation waves. The pipeline randomization allows for rigorous
      evaluation while the program is rolled out to all facilities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: institutional twenty-four hour newborn mortality rate
time frame: 1 day
description: death within 24 hours, or before discharge, of a newborn who breathed at birth
measure: institutional intrapartum stillbirth rate
time frame: 1 day
description: proportion of all facility births that resulted in intrapartum stillbirth
measure: skilled birth attendant knowledge and skills
time frame: Pre-test (before training) - post-test (immediately after training) - endline (12 months)
description: score on written and practical examinations on routine and emergency obstetric and newborn care
arm group label: Intervention
arm group type: Experimental
description: Low-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices
arm group label: Comparison
arm group type: Active Comparator
description: Training on data collection and reporting
intervention type: Behavioral
intervention name: Low dose high frequency health worker training approach
description: Two 4-day training sessions for skilled birth attendants
1-day peer practice coordinator training after first training session
Weekly, peer-led practice sessions using MamaNatalie® and NeoNatalie™ anatomic models
SMS reminder messages and quizzes
Routine telephone calls between master mentors and peer practice coordinators, and between project staff and master mentors
Health information officer training
Data collection and use training
Supply of simulators, newborn resuscitation equipment, and delivery sets
arm group label: Intervention
intervention type: Behavioral
intervention name: Active Comparison
description: Training on data collection and reporting
arm group label: Comparison
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Patricia Gomez
role: Principal Investigator
affiliation: Senior Technical Advisor
responsible party type: Sponsor
mesh term: Stillbirth
mesh term: Perinatal Death
sharing ipd: No