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
About this trial
This is an interventional health services research trial for Stillbirth focused on measuring institutional delivery
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
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
NCT ID
NCT03290924
First Posted
September 19, 2017
Last Updated
September 21, 2017
Sponsor
Jhpiego
Collaborators
Bill and Melinda Gates Foundation
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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