Maternal HealthSimHBBNCT03256591
Implementation of HBB Training With Facilitators That Have Undergone Simulation Methodology Training
A study testing HBB facilitators with simulation training in people with Maternal Health and Newborn; Vitality, run by Mbarara University of Science and Technology at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Newborn; Vitality
- What is being tested?
- HBB facilitators with simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUganda
- Study dates
- 30 Oct 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Faculty and hospital workers who are not engaged in teaching health students.
- Medical students not enrolled at KIU Teaching Hospital, western Uganda
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Kampala International University
Ishaka, Bushenyi, 256
Cathy Kyakwera, MD
About this study
Official title: A Comparison of the Implementation of HBB Training Using Facilitators With and Without Simulation Methodology Training
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.
Read the detailed 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.
- Conditions
- Maternal Health, Newborn; Vitality
- Being tested
- HBB facilitators with simulation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBB facilitators with simulation trainingOther
HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills
| Study group | Role | What they receive |
|---|---|---|
| HBB plus simulation training | Experimental | Participants receive training from facilitators for HBB training with simulation skills Receives: Other: HBB facilitators with simulation training |
| Control | No intervention | Participants receive training from facilitators for HBB training without simulation skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in knowledge scores at 6 months from Baseline
Secondary outcomes (2)
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.
Measured: Change in clinical skills at 6 months from baseline
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.
Measured: Change in facilitator skills at 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start30 Oct 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Santorini Data, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256591
- Sponsor's protocol ID
- MUST 21/06-16c
- Acronym
- SimHBB
- Status last verified
- Mar 2018
- First submitted
- 15 Aug 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared after appropriate permissions have been obtained.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Implementation of HBB Training Using Facilitators With and Without Simulation Methodology Training
- ClinicalTrials.gov ID
- NCT03256591
- Acronym / sponsor ID
- SimHBB / MUST 21/06-16c
- Conditions
- Maternal Health, Newborn; Vitality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HBB plus simulation training | Experimental | Other: HBB facilitators with simulation trainingParticipants receive training from facilitators for HBB training with simulation skills |
| Control | No intervention | –Participants receive training from facilitators for HBB training without simulation skills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Faculty and hospital workers who are not engaged in teaching health students.
- Medical students not enrolled at KIU Teaching Hospital, western Uganda
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBB facilitators with simulation trainingHBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills | Other | HBB plus simulation training |
Primary outcome
Knowledge
Time frame: 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
2 secondary outcomes
Clinical skills
Time frame: Change in clinical skills at 6 months from baseline
Facilitator debriefing skills
Time frame: Change in facilitator skills at 6 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided. Data will be shared after appropriate permissions have been obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santorini Data, MD principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBB facilitators with simulation training in people with Maternal Health and Newborn; Vitality, run by Mbarara University of Science and Technology at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Santorini Data, MD (+256752214458, sdata@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: Change in knowledge scores at 6 months from Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.