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

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05854745
Collaborator
Jimma University (Other), Laerdal Foundation (Other)
320
1
2
2
159.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HBB Virtual Training
  • Behavioral: HBB In-person Training
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Health Services Research
Official Title:
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual HBB Teaching

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
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.

Active Comparator: In-person HBB Teaching

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
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.

Outcome Measures

Primary Outcome Measures

  1. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B [Two months after HBB training (approximately 15 minutes to assess)]

    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.

Secondary Outcome Measures

  1. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B [Immediately after HBB training (approximately 15 minutes to assess)]

    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.

  2. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A [Two months after HBB training (approximately 10 minutes to assess)]

    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.

  3. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A [Immediately after HBB training (approximately 10 minutes to assess)]

    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.

  4. Helping Babies Breathe Bag and Mask Ventilation score [Immediately after HBB training (approximately 10 minutes to assess)]

    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.

  5. Helping Babies Breathe Bag and Mask Ventilation score [Two months after HBB training (approximately 10 minutes to assess)]

    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.

  6. Helping Babies Breathe Multiple Choice Questionnaire score [Immediately before HBB training (approximately 20 minutes to assess)]

    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.

  7. Helping Babies Breathe Multiple Choice Questionnaire score [Immediately after HBB training (approximately 20 minutes to assess)]

    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.

  8. Helping Babies Breathe Multiple Choice Questionnaire score [Two months after HBB training (approximately 20 minutes to assess)]

    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.

  9. NeoNatalie Live Data: Heart rate [Immediately after HBB training (approximately 10 minutes to assess)]

    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.

  10. NeoNatalie Live Data: Ventilation pressure [Immediately after HBB training (approximately 10 minutes to assess)]

    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.

  11. NeoNatalie Live Data: Time to spontaneous breathing [Immediately after HBB training (approximately 10 minutes to assess)]

    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.

  12. NeoNatalie Live Data: Ventilation attempts [Immediately after HBB training (approximately 10 minutes to assess)]

    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.

  13. NeoNatalie Live Data: Heart rate [Two months after HBB training (approximately 10 minutes to assess)]

    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.

  14. NeoNatalie Live Data: Ventilation pressure [Two months after HBB training (approximately 10 minutes to assess)]

    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.

  15. NeoNatalie Live Data: Time to spontaneous breathing [Two months after HBB training (approximately 10 minutes to assess)]

    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.

  16. NeoNatalie Live Data: Ventilation attempts [Two months after HBB training (approximately 10 minutes to assess)]

    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.

  17. Attitude Questionnaire [Immediately before HBB training (approximately 5 minutes to assess)]

    5-point Likert scale designed to assess perceived confidence in performing HBB skills.

  18. Attitude Questionnaire [Immediately after HBB training (approximately 5 minutes to assess)]

    5-point Likert scale designed to assess perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors.

  19. Attitude Questionnaire [Two months after HBB training (approximately 5 minutes to assess)]

    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.

  20. Profile of perceived barriers and facilitators [Two months after HBB training (approximately 60 minutes to assess)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jimma University Jimma Ethiopia

Sponsors and Collaborators

  • Stanford University
  • Jimma University
  • Laerdal Foundation

Investigators

  • Study Chair: Rishi Mediratta, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rishi Mediratta, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05854745
Other Study ID Numbers:
  • 62973
First Posted:
May 11, 2023
Last Update Posted:
May 11, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rishi Mediratta, Clinical Assistant Professor, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2023