Ventilation Knowledge and Skills Retention Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool (Sim-II)

Ventilation Knowledge and Skills Retention Among Medical, Nursing and Midwifery Students Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool / "Electronic Coach".

Babies born not breathing at birth require effective gentle ventilation to survive and avert organ damage if initial resuscitation steps such as drying, and stimulation are unsuccessful at facilitating breathing. Training of health workers to impart skills on ventilation is a way to prevent these adverse outcomes. Effective ventilation skills are typically acquired through training programs such as Helping Babies Breath (HBB). However, these ventilation skills quickly decay following training and current skills retention methods such as refresher courses are costly and there is a paucity of skilled human resources to effectively facilitate frequent HBB training courses. This raises the need to explore approaches that are independent of retraining for skills maintenance.

The investigators hypothesize that simulation enhanced HBB training followed by self-administered ventilation practice (SAVP) sessions with the Augmented Infant Resuscitator (AIR) as an electronic coach will result into ventilation skills retention over 12 months. SAVP allows participants to maintain practice and training to enhance skills retention.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilation Skills Acquisition and Retention; Ventilation Knowledge Acquisition and Retention
• Intervention / Treatment: Other: Simulation enhanced HBB training

Detailed Description

The investigators will use a multi-methods approach. First, investigators will evaluate the effect of simulation enhanced HBB training and short self-administered practice with AIR device feedback on ventilation skills among undergraduate medical, nursing and midwifery students in Nigeria, Tanzania, and Uganda over a 12-month period. These short practice sessions will be conducted in skills labs. The investigators will equip each skills lab with at least 20 practice stations to enable increased number of students per unit time and reduce total required time in the skills labs for self-practice.

Second, the investigators will conduct focus group discussions with students before and after the intervention, to examine student experiences of simulation with SAVP vis-à-vis their expectations prior and post exposure.

Study design: This will be a 12-month cohort study among medical, nursing and midwifery students rotating in clinical disciplines. We will use a quasi-experimental design and measure ventilation skills before and after administration of a simulation enhanced HBB training plus SAVP with AIR as an intervention. The ventilation skills will also be measured prospectively every 4 months over a 12-month period in HBB scenario settings.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medicine students
• Nursing students
• Midwifery students
• Students at Mbarara University, Busitema University, Lira University, University of Jos

Exclusion Criteria:

• Students outside the participating institutions
• Students outside the Faculty of Medicine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Before/After; Before and after comparison- one arm study	Other: Simulation enhanced HBB training; Simulation enhanced HBB is a one-day course delivered using a format of Explain, Demonstrate and Facilitate practice. Compared to the standard HBB training, the simulation enhanced HBB course is designed with increased peer-to-peer feedback and scripted expert facilitator feedback at HBB practice exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation skills	Retention of ventilation skills measured using Helping babies breathe Objective Structured Clinical Examinations (OSCE)	12 months from baseline, after the training program
Time to effective ventilation	Time in seconds to effective ventilation	12 months from baseline, after the training program
Duration of effective ventilation	Time in seconds for the duration of effective ventilation	12 months from baseline, after the training program

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 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020/MUST-4/SIM-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data involves sensitive information such as video recordings and will therefore not be shared.

Drug and device information, study documents

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