Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality

Neonatal Mortality Clinical Trial

— Sim-II  

Official title:

Impact of Simulation-enhanced Peer Learning With Novel Tools on Maternal and Newborn Mortality Plus Knowledge, Skills Retention and Decision Making by Front-line Health Workers in Southwestern Uganda

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04904380
• Other study ID #: 2020/MUST-5/SIM-II
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2021
• Source: Mbarara University of Science and Technology
• Contact: Data Santorino, MD
• Phone: 0774500571
• Email: sdata[@]must.ac.ug
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the vast majority of developing nations, frontline birth attendants are often the only care providers responsible for newborn care including newborn resuscitation, thermal care, feeding and administration of medications. These midwives need knowledge and skills to provide all these newborn clinical care needs. However, frontline birth attendants in these circumstances are seldom exposed to the training and decision support tools that would empower them to holistically assess, decide and manage newborn babies in their care. Current training opportunities are fragmented and need to be administered as a comprehensive package.

A combination approach to training, skills retention, and the use of decision support tools such as Protecting Infants Remotely by SMS (PRISMS) and Augmented Infant Resuscitator (AIR) may provide a comprehensive package for the acquisition and retention of knowledge and skills on newborn care and empower birth attendants to provide effective, timely interventions.

Description:

The investigators will implement the Sim for Life Impart, Retain, Empower and Monitor (IREM) module at the University of Jos teaching Hospital and 4 high volume health facilities in Tanzania in addition to the Uganda sites. We propose to implement the program with all its components for each of the partner institutions.

The Sim for Life IREM module combines four strategies: Impart skills using Helping Babies Survive (HBS)/Helping Mothers Survive (HMS) courses, Retain skills (Simulation), Empower birth attendants (PRISMS and AIR) and Monitor progress objectively. The simulation sessions for health facilities will be conducted using the peer to peer learning methodology which equips participants with the skills to facilitate simulation scenarios in their health facilities. The scenarios will be provided by the Sim for life team. The topics for the scenarios will be based on common maternal and newborn illnesses like post-partum hemorrhage, pre-eclampsia, birth asphyxia, neonatal sepsis and prematurity.

All health facilities in this study will require smart phones for the PRISMS application, resuscitation practice tables, source of electricity to charge a phone, practice manikins / associated practice supplies and peer learning cards.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3456
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Newborns babies

• Mothers delivering at participating health facilities

• Health workers providing maternal and newborn care services at participating health facilities

Exclusion Criteria:

• Health care workers not providing maternal and newborn care services

• Male patients

• Non pregnant female patients seeking care at participating health facilities

Related Conditions & MeSH terms

• Maternal Death
• Maternal Mortality
• Neonatal Mortality

Intervention

Other:
• Active peer learning
HMS, HBS and peer learning in combination with AIR and PRISMS

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology	Alberta Children's Hospital Research Institute, International Development Research Centre, Canada, Laerdal Foundation, The ELMA Foundation, University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality	Neonatal mortality	Neonatal mortality at 6 months
Primary	Neonatal mortality	Neonatal mortality	Neonatal mortality at 18 months
Primary	Maternal mortality	Maternal mortality	Maternal mortality at 6 months
Primary	Maternal mortality	Maternal mortality	Maternal mortality at 18 months
Secondary	Length of stay in hospital	Number of days as length of stay	18 months
Secondary	Completeness of newborn assessment	Completeness of newborn assessment checklist	At admission