Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

Study Overview
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Brief Summary
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Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person. During the COVID-19 pandemic, many subject matter experts were unable to travel to conduct HBB courses. Innovative methods for teaching HBB are needed to promote the acquisition and retention of resuscitation skills and knowledge.

Detailed Description
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In this non-inferiority randomized controlled trial, medical students, nursing students, and midwifery students will be randomized to receive either standard in-person HBB training (control) or virtual telesimulation training (intervention). The hypothesis is that virtual delivery is as effective as in-person training of HBB content when teaching neonatal resuscitation skills and knowledge to medical, nursing, and midwifery students.

Official Title
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Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

Conditions
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Neonatal Death, Birth Asphyxia

Intervention / Treatment
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* Behavioral: HBB Virtual Training
* Behavioral: HBB In-person Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Year IV through year VI medical students; year II through year IV nursing students; year II through year III midwifery students at Jimma University in Jimma, Ethiopia. Exclusion Criteria: Minors Individuals who are not medical, nursing, or midwifery students at Jimma University. Individuals who attended a neonatal resuscitation training course in the preceding year. Individuals who would be unavailable or unwilling to participate in follow-up study activities throughout the 2-month post-initial training period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The content of each arm of the study is the same and will be taught live by the same HBB instructors; the only difference is the teaching method.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual HBB Teaching<br>HBB Virtual Training (Intervention): Participants will receive a blend of virtual training and telesimulation delivered by pediatricians from Ethiopia. The intervention consists of one day of virtual lectures and didactics from the HBB curriculum and skill assessments using neonatal mannequins. | Behavioral: HBB Virtual Training<br>* HBB Virtual Training (Intervention): The 2nd edition HBB training course focuses on preparation for birth, routine care for all babies, the Golden Minute, and continued ventilation with normal or slow heart rate. The one-day virtual training will be delivered remotely to participants via Zoom. Facilitators and training materials will be the same in both the control and intervention arms.<br>|
| Active Comparator: In-person HBB Teaching<br>Participants will receive in-person HBB instruction by pediatricians from Ethiopia. The control consists of one day of HBB lectures and didactics and skill assessments using neonatal mannequins. | Behavioral: HBB In-person Training<br>* HBB In-Person Training (Control): The 2nd edition HBB training course focuses on preparation for birth, routine care for all babies, the Golden Minute, and continued ventilation with normal or slow heart rate. The one-day in-person training will be delivered in person. Facilitators and training materials will be the same in both the control and intervention arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B | Compare skill retention between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 17 out of 23 is required to pass. Score range: 0 to 23, higher scores indicate better HBB skills, and a score of 17 or higher is required to pass. | Two months after HBB training (approximately 15 minutes to assess) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A | Compare skill acquisition between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 9 out of 12 is required to pass. Score range: 0 to 12, higher scores indicate better HBB skills, and a score of 9 or higher is required to pass. | Immediately after HBB training (approximately 10 minutes to assess) | 
| Helping Babies Breathe Bag and Mask Ventilation score | Compare skill acquisition between virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of bag and mask ventilation, a score out of 14. Score range: 0 to 14, higher scores indicate better HBB skills, and a score of 14 is required to pass. | Immediately after HBB training (approximately 10 minutes to assess) | 
| Helping Babies Breathe Bag and Mask Ventilation score | Compare skill retention between virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of bag and mask ventilation, a score out of 14. Score range: 0 to 14, higher scores indicate better HBB skills, and a score of 14 is required to pass. | Two months after HBB training (approximately 10 minutes to assess) | 
| Helping Babies Breathe Multiple Choice Questionnaire score | Determine baseline understanding of HBB material for each participant. This exam contains 18 questions pertaining to HBB curriculum. Score range: 0 to 18, higher scores indicate better HBB knowledge, and a score of 15 or higher is required to pass. | Immediately before HBB training (approximately 20 minutes to assess) | 
| Helping Babies Breathe Multiple Choice Questionnaire score | Determine knowledge acquisition of HBB material for each participant. This exam contains 18 questions pertaining to HBB curriculum. Score range: 0 to 18, higher scores indicate better HBB knowledge, and a score of 15 or higher is required to pass. | Immediately after HBB training (approximately 20 minutes to assess) | 
| Helping Babies Breathe Multiple Choice Questionnaire score | Determine knowledge retention of HBB material for each participant. This exam contains 18 questions pertaining to HBB curriculum. Score range: 0 to 18, higher scores indicate better HBB knowledge, and a score of 15 or higher is required to pass. | Two months after HBB training (approximately 20 minutes to assess) | 
| NeoNatalie Live Data: Heart rate | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. During each simulation, the heart rate of the mannequin will be collected per participant. | Immediately after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Ventilation pressure | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. During each simulation, the ventilation pressure of the mannequin will be collected per participant. | Immediately after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Time to spontaneous breathing | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. Data about the amount of time it takes to reach a ventilation rate of 40-60 breaths per minute will be collected per participant. | Immediately after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Ventilation attempts | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. Data about the number of ventilation attempts will be collected per participant. | Immediately after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Heart rate | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. During each simulation, the heart rate of the mannequin will be collected per participant. | Two months after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Ventilation pressure | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. During each simulation, the ventilation pressure of the mannequin will be collected per participant. | Two months after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Time to spontaneous breathing | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. Data about the amount of time it takes to reach a ventilation rate of 40-60 breaths per minute will be collected per participant. | Two months after HBB training (approximately 10 minutes to assess) | 
| NeoNatalie Live Data: Ventilation attempts | NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. Data about the number of ventilation attempts will be collected per participant. | Two months after HBB training (approximately 10 minutes to assess) | 
| Attitude Questionnaire | 5-point Likert scale designed to assess perceived confidence in performing HBB skills. | Immediately before HBB training (approximately 5 minutes to assess) | 
| Attitude Questionnaire | 5-point Likert scale designed to assess perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors. | Immediately after HBB training (approximately 5 minutes to assess) | 
| Attitude Questionnaire | 5-point Likert scale designed to assess sustained perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors. | Two months after HBB training (approximately 5 minutes to assess) | 
| Profile of perceived barriers and facilitators | Focus group discussions will be intended to understand differences in perceived barriers/facilitators of training. This will explore confidence in performing HBB techniques and attitudes toward virtual and in-person delivery of content. The objective of the focus groups will be to identify key themes around participants' perspectives of the HBB training to provide context around the outcomes listed above. | Two months after HBB training (approximately 60 minutes to assess) | 
| Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B | Compare skill acquisition between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 17 out of 23 is required to pass. Score range: 0 to 23, higher scores indicate better HBB skills, and a score of 17 or higher is required to pass. | Immediately after HBB training (approximately 15 minutes to assess) | 
| Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A | Compare skill retention between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 9 out of 12 is required to pass. Score range: 0 to 12, higher scores indicate better HBB skills, and a score of 9 or higher is required to pass. | Two months after HBB training (approximately 10 minutes to assess) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helping Babies Breathe (HBB) training