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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03256591
Other study ID # MUST 21/06-16c
Secondary ID
Status Recruiting
Phase N/A
First received August 15, 2017
Last updated April 16, 2018
Start date October 30, 2017
Est. completion date December 30, 2020

Study information

Verified date March 2018
Source Mbarara University of Science and Technology
Contact Santorini Data, MD
Phone +256752214458
Email sdata@must.ac.ug
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.

Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.


Description:

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.

High levels of physical, emotional and conceptual realism are important features of simulation-based learning that impact learning outcomes. Formal debriefing is characterized as the most important element of simulation based education. Structured feedback in a safe learning environment provides the opportunity for learning of clinically relevant material. Guided reflection transfers the responsibility for learning to the participants and solidifies knowledge, skills and behaviors for transfer to clinical practice.

Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2020
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Only trained facilitators are eligible to participate

- Must hold a Faculty position or are a health care provider at KIU Teaching Hospital in western Uganda

- Are engaged in teaching health students.

- Participating medical students are those enrolled at KIU Teaching Hospital in western Uganda

Exclusion Criteria:

- Faculty and hospital workers who are not engaged in teaching health students.

- Medical students not enrolled at KIU Teaching Hospital, western Uganda

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HBB facilitators with simulation training
HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills

Locations

Country Name City State
Uganda Kampala International University Ishaka Bushenyi

Sponsors (2)

Lead Sponsor Collaborator
Mbarara University of Science and Technology University of Calgary

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge The primary outcome for this analysis is level of knowledge. For each course, learners will be assessed at baseline and at course-end to determine their knowledge via multiple choice test. Scores out of 100% will be computed Change in knowledge scores at 6 months from Baseline
Secondary Clinical skills The clinical skills outcome (via short neonatal resuscitation simulation scenario - HBB OSCE B). HBB OSCE B assessment will be conducted by the facilitator. Change in clinical skills at 6 months from baseline
Secondary Facilitator debriefing skills Facilitator debriefing skills will be assessed using the OSAD. OSAD assessments will be conducted by a pre-trained rater who will rate facilitator performance in real time. Change in facilitator skills at 6 months from baseline
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