Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Stillbirth Neonatal Death Behavioral: Low dose high frequency health worker training approach Behavioral: Active Comparison Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Arm Intervention/treatment
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
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

Active Comparator: Comparison
Training on data collection and reporting
Behavioral: Active Comparison
Training on data collection and reporting




Primary Outcome Measures :
  1. 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

  2. institutional intrapartum stillbirth rate [ Time Frame: 1 day ]
    proportion of all facility births that resulted in intrapartum stillbirth


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290924


Sponsors and Collaborators
Jhpiego
Bill and Melinda Gates Foundation
Investigators
Layout table for investigator information
Principal Investigator: Patricia Gomez Senior Technical Advisor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03290924     History of Changes
Other Study ID Numbers: OPP1087303
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jhpiego:
institutional delivery

Additional relevant MeSH terms:
Layout table for MeSH terms
Stillbirth
Perinatal Death
Fetal Death
Pregnancy Complications
Death
Pathologic Processes