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Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach

Primary Purpose

Stillbirth, Neonatal Death

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low dose high frequency health worker training approach
Active Comparison
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stillbirth focused on measuring institutional delivery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA - FACILITIES:

  • Public or faith based hospital
  • At least three skilled birth attendants on staff
  • At least 30 births per month

EXCLUSION CRITERIA - FACILITIES:

  • Private hospital
  • Public or faith based hospital with less than three skilled birth attendants on staff
  • Public or faith based hospital with less than 30 births per month

INCLUSION CRITERIA - SERVICE PROVIDERS:

* Health providers who attend births in participating health facilities and consent to be assessed at the time of enrollment and at several points in time over the study period

EXCLUSION CRITERIA - SERVICE PROVIDERS:

* Health providers who decline to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Comparison

    Arm Description

    Low-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices

    Training on data collection and reporting

    Outcomes

    Primary Outcome Measures

    institutional twenty-four hour newborn mortality rate
    death within 24 hours, or before discharge, of a newborn who breathed at birth
    institutional intrapartum stillbirth rate
    proportion of all facility births that resulted in intrapartum stillbirth

    Secondary Outcome Measures

    skilled birth attendant knowledge and skills
    score on written and practical examinations on routine and emergency obstetric and newborn care

    Full Information

    First Posted
    September 19, 2017
    Last Updated
    September 21, 2017
    Sponsor
    Jhpiego
    Collaborators
    Bill and Melinda Gates Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03290924
    Brief Title
    Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
    Official Title
    Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    February 28, 2017 (Actual)
    Study Completion Date
    February 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jhpiego
    Collaborators
    Bill and Melinda Gates Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stillbirth, Neonatal Death
    Keywords
    institutional delivery

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm 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 Title
    Comparison
    Arm Type
    Active Comparator
    Arm Description
    Training on data collection and reporting
    Intervention Type
    Behavioral
    Intervention Name(s)
    Low dose high frequency health worker training approach
    Intervention 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Comparison
    Intervention Description
    Training on data collection and reporting
    Primary Outcome Measure Information:
    Title
    institutional twenty-four hour newborn mortality rate
    Description
    death within 24 hours, or before discharge, of a newborn who breathed at birth
    Time Frame
    1 day
    Title
    institutional intrapartum stillbirth rate
    Description
    proportion of all facility births that resulted in intrapartum stillbirth
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    skilled birth attendant knowledge and skills
    Description
    score on written and practical examinations on routine and emergency obstetric and newborn care
    Time Frame
    Pre-test (before training) - post-test (immediately after training) - endline (12 months)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    INCLUSION CRITERIA - FACILITIES: Public or faith based hospital At least three skilled birth attendants on staff At least 30 births per month EXCLUSION CRITERIA - FACILITIES: Private hospital Public or faith based hospital with less than three skilled birth attendants on staff Public or faith based hospital with less than 30 births per month INCLUSION CRITERIA - SERVICE PROVIDERS: * Health providers who attend births in participating health facilities and consent to be assessed at the time of enrollment and at several points in time over the study period EXCLUSION CRITERIA - SERVICE PROVIDERS: * Health providers who decline to participate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia Gomez
    Organizational Affiliation
    Senior Technical Advisor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29566659
    Citation
    Gomez PP, Nelson AR, Asiedu A, Addo E, Agbodza D, Allen C, Appiagyei M, Bannerman C, Darko P, Duodu J, Effah F, Tappis H. Accelerating newborn survival in Ghana through a low-dose, high-frequency health worker training approach: a cluster randomized trial. BMC Pregnancy Childbirth. 2018 Mar 22;18(1):72. doi: 10.1186/s12884-018-1705-5.
    Results Reference
    derived

    Learn more about this trial

    Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach

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