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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03290924
Other study ID # OPP1087303
Secondary ID
Status Completed
Phase N/A
First received September 19, 2017
Last updated September 21, 2017
Start date September 1, 2014
Est. completion date February 28, 2017

Study information

Verified date September 2017
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 28, 2017
Est. primary completion date February 28, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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 NeoNatalieā„¢ 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 Comparison
Training on data collection and reporting

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Jhpiego Bill and Melinda Gates Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary institutional twenty-four hour newborn mortality rate death within 24 hours, or before discharge, of a newborn who breathed at birth 1 day
Primary institutional intrapartum stillbirth rate proportion of all facility births that resulted in intrapartum stillbirth 1 day
Secondary skilled birth attendant knowledge and skills score on written and practical examinations on routine and emergency obstetric and newborn care Pre-test (before training) - post-test (immediately after training) - endline (12 months)
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