SimHBB: Implementation of HBB Training With Facilitators That Have Undergone Simulation Methodology Training

Sponsor

Mbarara University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT03256591

Collaborator

University of Calgary (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Health Newborn; Vitality	Other: HBB facilitators with simulation training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Investigators will conduct a prospective, randomized controlled trial to determine if the implementation of a simulation facilitator training program for HBB compared with no facilitator training in simulation is superior in terms of the acquisition of knowledge, acute care skills, and teamwork skills of pre-service medical students. Investigators will randomly randomly assign study participants to either intervention or control arm in a 1:1 ratio.Investigators will conduct a prospective, randomized controlled trial to determine if the implementation of a simulation facilitator training program for HBB compared with no facilitator training in simulation is superior in terms of the acquisition of knowledge, acute care skills, and teamwork skills of pre-service medical students. Investigators will randomly randomly assign study participants to either intervention or control arm in a 1:1 ratio.

Masking:

None (Open Label)

Masking Description:

No masking will be done

Primary Purpose:

Other

Official Title:

A Comparison of the Implementation of HBB Training Using Facilitators With and Without Simulation Methodology Training

Actual Study Start Date :

Oct 30, 2017

Anticipated Primary Completion Date :

Dec 30, 2018

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HBB plus simulation training Participants receive training from facilitators for HBB training with simulation skills	Other: HBB facilitators with simulation training HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills
No Intervention: Control Participants receive training from facilitators for HBB training without simulation skills

Arm

Intervention/Treatment

Experimental: HBB plus simulation training

Participants receive training from facilitators for HBB training with simulation skills

Other: HBB facilitators with simulation training

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

No Intervention: Control

Participants receive training from facilitators for HBB training without simulation skills

Outcome Measures

Primary Outcome Measures

Knowledge [Change in knowledge scores at 6 months from Baseline]
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

Secondary Outcome Measures

Clinical skills [Change in clinical skills at 6 months from baseline]
The clinical skills outcome (via short neonatal resuscitation simulation scenario - HBB OSCE B). HBB OSCE B assessment will be conducted by the facilitator.
Facilitator debriefing skills [Change in facilitator skills at 6 months from baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kampala International University	Ishaka	Bushenyi	Uganda	256

Sponsors and Collaborators

Mbarara University of Science and Technology
University of Calgary

Investigators

Principal Investigator: Santorini Data, MD, Mbarara University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mbarara University of Science and Technology

ClinicalTrials.gov Identifier:

NCT03256591

Other Study ID Numbers:

MUST 21/06-16c

First Posted:

Aug 22, 2017

Last Update Posted:

Apr 17, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 17, 2018