Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality (Sim-II)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternal Mortality; Neonatal Mortality
• Intervention / Treatment: Other: Active peer learning

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 3456
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Data Santorino, MD; Phone Number: 0774500571; Email: sdata@must.ac.ug
• Study Contact Backup: Name: Francis Bajunirwe, MD, PhD; Phone Number: 0772 576 396; Email: fbaj@must.ac.ug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; HMS, HBS and peer learning in combination with AIR and PRISMS	Other: Active peer learning; HMS, HBS and peer learning in combination with AIR and PRISMS; Other Names: Enhanced HMS and HBS with PRISMS and AIR
Active Comparator: Comparison arm; HMS, HBS and peer learning in combination with PRISMS but no AIR	Other: Active peer learning; HMS, HBS and peer learning in combination with AIR and PRISMS; Other Names: Enhanced HMS and HBS with PRISMS and AIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal mortality	Neonatal mortality	Neonatal mortality at 6 months
Neonatal mortality	Neonatal mortality	Neonatal mortality at 18 months
Maternal mortality	Maternal mortality	Maternal mortality at 6 months
Maternal mortality	Maternal mortality	Maternal mortality at 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital	Number of days as length of stay	18 months
Completeness of newborn assessment	Completeness of newborn assessment checklist	At admission

Collaborators and Investigators

• Sponsor: Mbarara University of Science and Technology
• Collaborators: University of Calgary; Alberta Children's Hospital Research Institute; The ELMA Foundation; Laerdal Foundation; International Development Research Centre, Canada
• Investigators: Principal Investigator: Data Santorino, MD, Mbarara University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Parental Death; Maternal Death
• Other Study ID Numbers: 2020/MUST-5/SIM-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data includes sensitive material with video records

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No