Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality (Sim-II)
Primary Purpose
Neonatal Mortality, Maternal Mortality
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active peer learning
Sponsored by
About this trial
This is an interventional health services research trial for Neonatal Mortality
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Comparison arm
Arm Description
HMS, HBS and peer learning in combination with AIR and PRISMS
HMS, HBS and peer learning in combination with PRISMS but no AIR
Outcomes
Primary Outcome Measures
Neonatal mortality
Neonatal mortality
Neonatal mortality
Neonatal mortality
Maternal mortality
Maternal mortality
Maternal mortality
Maternal mortality
Secondary Outcome Measures
Length of stay in hospital
Number of days as length of stay
Completeness of newborn assessment
Completeness of newborn assessment checklist
Full Information
NCT ID
NCT04904380
First Posted
April 30, 2021
Last Updated
May 26, 2021
Sponsor
Mbarara University of Science and Technology
Collaborators
University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04904380
Brief Title
Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology
Collaborators
University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Mortality, Maternal Mortality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized cluster trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3456 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
HMS, HBS and peer learning in combination with AIR and PRISMS
Arm Title
Comparison arm
Arm Type
Active Comparator
Arm Description
HMS, HBS and peer learning in combination with PRISMS but no AIR
Intervention Type
Other
Intervention Name(s)
Active peer learning
Other Intervention Name(s)
Enhanced HMS and HBS with PRISMS and AIR
Intervention Description
HMS, HBS and peer learning in combination with AIR and PRISMS
Primary Outcome Measure Information:
Title
Neonatal mortality
Description
Neonatal mortality
Time Frame
Neonatal mortality at 6 months
Title
Neonatal mortality
Description
Neonatal mortality
Time Frame
Neonatal mortality at 18 months
Title
Maternal mortality
Description
Maternal mortality
Time Frame
Maternal mortality at 6 months
Title
Maternal mortality
Description
Maternal mortality
Time Frame
Maternal mortality at 18 months
Secondary Outcome Measure Information:
Title
Length of stay in hospital
Description
Number of days as length of stay
Time Frame
18 months
Title
Completeness of newborn assessment
Description
Completeness of newborn assessment checklist
Time Frame
At admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Data Santorino, MD
Phone
0774500571
Email
sdata@must.ac.ug
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Bajunirwe, MD, PhD
Phone
0772 576 396
Email
fbaj@must.ac.ug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Data Santorino, MD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data includes sensitive material with video records
Learn more about this trial
Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality
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