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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290924
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Jhpiego

Tracking Information
First Submitted Date  ICMJE September 19, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date September 25, 2017
Actual Study Start Date  ICMJE September 1, 2014
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
  • institutional twenty-four hour newborn mortality rate [ Time Frame: 1 day ]
    death within 24 hours, or before discharge, of a newborn who breathed at birth
  • institutional intrapartum stillbirth rate [ Time Frame: 1 day ]
    proportion of all facility births that resulted in intrapartum stillbirth
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
skilled birth attendant knowledge and skills [ Time Frame: Pre-test (before training) - post-test (immediately after training) - endline (12 months) ]
score on written and practical examinations on routine and emergency obstetric and newborn care
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
Official Title  ICMJE Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Stillbirth
  • Neonatal Death
Intervention  ICMJE
  • Behavioral: Low dose high frequency health worker training approach
    • 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
  • Behavioral: Active Comparison
    Training on data collection and reporting
Study Arms  ICMJE
  • Experimental: Intervention
    Low-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices
    Intervention: Behavioral: Low dose high frequency health worker training approach
  • Active Comparator: Comparison
    Training on data collection and reporting
    Intervention: Behavioral: Active Comparison
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03290924
Other Study ID Numbers  ICMJE OPP1087303
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jhpiego
Study Sponsor  ICMJE Jhpiego
Collaborators  ICMJE Bill and Melinda Gates Foundation
Investigators  ICMJE
Principal Investigator: Patricia Gomez Senior Technical Advisor
PRS Account Jhpiego
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP