Clinical trial NCT04904380: Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Mortality
Maternal Mortality
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: The ELMA Foundation
name: Alberta Children's Hospital Research Institute
name: Laerdal Foundation
name: International Development Research Centre, Canada
First posted: 2021-05-27
Enrollment: 3456
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized cluster trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal mortality
timeFrame: Neonatal mortality at 6 months
measure: Neonatal mortality
timeFrame: Neonatal mortality at 18 months
measure: Maternal mortality
timeFrame: Maternal mortality at 6 months
measure: Maternal mortality
timeFrame: Maternal mortality at 18 months
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: 18 months
measure: Completeness of newborn assessment
timeFrame: At admission
Other outcomes:
Locations:
Study officials:
affiliation: Mbarara University of Science and Technology
name: Data Santorino, MD
role: PRINCIPAL_INVESTIGATOR
References: