Simulation-based LearningSim-IINCT04872972
Scale-up the Introduction of Simulation Into Four New Health Professional Training Institutions in East and West Africa
A study testing Simulation based learning in people with Simulation-based Learning, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
Simulation based learning practice is limited in Sub-Saharan Africa. Experiences gained from our prior implementation in Phase I of this program show that simulation is feasible and significantly contributes to learning. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Learning
- What is being tested?
- Simulation based learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jun 2019to 30 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health professions Institutions in East and West Africa in the Sim for life program
- Institutional commitment to adopt simulation based learning Faculty at these health professions institutions
- Exclusion Criteria: Institutions outside East and West Africa Sim for life program
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara, 256
Data Santorino, MD, 0774500571, sdata@must.ac.ug
About this study
Official title: Scale-up and Introduction of Simulation Into Four New Health Professional Training Institutions in East and West Africa and the Factors That Influence Simulation Adoption at These Sites
Simulation based learning practice is limited in Sub-Saharan Africa. Experiences gained from our prior implementation in Phase I of this program show that simulation is feasible and significantly contributes to learning. However, the growth and sustainability of simulation methodologies in health training and service delivery institutions is subject to variability and institution specific factors. These factors may include but are not limited to ease of adoption of new technologies, human resources, space and institutional culture. These factors are likely to vary widely in Sub-Saharan Africa across countries and institutions.
It's not known how institutional factors will influence the introduction, adoption and sustainability of simulation methodologies in East and West African health training and service delivery institutions. We have partnered with four institutions in East and West Africa (in Uganda, Tanzania, and Nigeria) to learn about the process of introduction and scaling of simulation based learning in new frontiers.
Read the detailed description
The investigators in this proposal have partnered and propose to expand Simulation Based Learning to Lira University in northern Uganda, Busitema University in Eastern Uganda, the Catholic University of Health and Allied Sciences (CUHAS), Tanzania and University of Jos in Nigeria. All these health training and service institutions serve large rural and peri-urban populations with poor access to health care.
The investigators will engage the partners in the co-design of implementation plans to design solutions for the barriers to implementation that are anticipated, and ensure appropriate tailoring to the local context. The investigators will use a Train of trainers (ToT) Faculty development model and this will include web-based debrief mentorship using recorded debriefing sessions from real simulations at partner sites. These videos will be loaded onto a centralization server to facilitate peer-to-peer feedback using a quality of debriefing framework.
Based on the investigators' learning experience from Phase I of implementation, the team aims to develop two categories of simulation facilitators: 1) Simulation implementation faculty (SiF) and 2) Lead simulation faculty. Lead simulation faculty (LsF) will be trained at the Mbarara University of Science and Technology (MUST) simulation center of excellence and will receive support in assessing their sites' barriers and facilitators regarding the Sim intervention. The faculty trainees will undergo an intensive 1.5-day faculty development course followed by a 2-day placement at MUST sim center for mentored scenario execution practice.
- Conditions
- Simulation-based Learning
- Being tested
- Simulation based learning
- Keywords
- Simulation based learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based learningOther
Faculty development courses on simulation based learning
| Study group | Role | What they receive |
|---|---|---|
| Before/After | Other | Before and after simulation; Institutional faculty and facilities Receives: Other: Simulation based learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of simulation based learning
Adoption of simulation based learning
Measured: Change from baseline to 12 months after introduction of simulation based techniques
Barriers to simulation
Barriers to simulation based learning
Measured: Change from baseline to 12 months after introduction of simulation based techniques
Secondary outcomes (2)
Facilitators
Facilitators of simulation based learning
Measured: Change from baseline to 12 months after introduction of simulation based techniques
Institutional readiness
Institutional readiness to adopt simulation based learning
Measured: Change from baseline to 12 months after introduction of simulation based learning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jun 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based LearningStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Before and After approach
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872972
- Sponsor's protocol ID
- 2020/MUST-2/SIM-II
- Acronym
- Sim-II
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethics approval is required
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale-up and Introduction of Simulation Into Four New Health Professional Training Institutions in East and West Africa and the Factors That Influence Simulation Adoption at These Sites
- ClinicalTrials.gov ID
- NCT04872972
- Acronym / sponsor ID
- Sim-II / 2020/MUST-2/SIM-II
- Conditions
- Simulation-based Learning
- Keywords
- Simulation based learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 May 2021 (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.
Simulation based learning practice is limited in Sub-Saharan Africa. Experiences gained from our prior implementation in Phase I of this program show that simulation is feasible and significantly contributes to learning. However, the growth and sustainability of simulation methodologies in health training and service delivery institutions is subject to variability and institution specific factors. These factors may include but are not limited to ease of adoption of new technologies, human resources, space and institutional culture. These factors are likely to vary widely in Sub-Saharan Africa across countries and institutions.
It's not known how institutional factors will influence the introduction, adoption and sustainability of simulation methodologies in East and West African health training and service delivery institutions. We have partnered with four institutions in East and West Africa (in Uganda, Tanzania, and Nigeria) to learn about the process of introduction and scaling of simulation based learning in new frontiers.
Detailed description
The investigators in this proposal have partnered and propose to expand Simulation Based Learning to Lira University in northern Uganda, Busitema University in Eastern Uganda, the Catholic University of Health and Allied Sciences (CUHAS), Tanzania and University of Jos in Nigeria. All these health training and service institutions serve large rural and peri-urban populations with poor access to health care.
The investigators will engage the partners in the co-design of implementation plans to design solutions for the barriers to implementation that are anticipated, and ensure appropriate tailoring to the local context. The investigators will use a Train of trainers (ToT) Faculty development model and this will include web-based debrief mentorship using recorded debriefing sessions from real simulations at partner sites. These videos will be loaded onto a centralization server to facilitate peer-to-peer feedback using a quality of debriefing framework.
Based on the investigators' learning experience from Phase I of implementation, the team aims to develop two categories of simulation facilitators: 1) Simulation implementation faculty (SiF) and 2) Lead simulation faculty. Lead simulation faculty (LsF) will be trained at the Mbarara University of Science and Technology (MUST) simulation center of excellence and will receive support in assessing their sites' barriers and facilitators regarding the Sim intervention. The faculty trainees will undergo an intensive 1.5-day faculty development course followed by a 2-day placement at MUST sim center for mentored scenario execution practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and After approach
| Arm | Type | Receives |
|---|---|---|
| Before/After | Other | Other: Simulation based learningBefore and after simulation; Institutional faculty and facilities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Health professions Institutions in East and West Africa in the Sim for life program
- Institutional commitment to adopt simulation based learning Faculty at these health professions institutions
- Exclusion Criteria: Institutions outside East and West Africa Sim for life program
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Simulation based learningFaculty development courses on simulation based learning | Other | Before/After |
Primary outcome
Adoption of simulation based learning
Time frame: Change from baseline to 12 months after introduction of simulation based techniques
Adoption of simulation based learning
Barriers to simulation
Time frame: Change from baseline to 12 months after introduction of simulation based techniques
Barriers to simulation based learning
2 secondary outcomes
Facilitators
Time frame: Change from baseline to 12 months after introduction of simulation based techniques
Institutional readiness
Time frame: Change from baseline to 12 months after introduction of simulation based learning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No. Ethics approval is required
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation based learning in people with Simulation-based Learning, 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 0 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 5 May 2021. 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 Data Santorino, MD (0774500571, sdata@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of simulation based learning (time frame: Change from baseline to 12 months after introduction of simulation based techniques). The study lists 2 primary outcomes in all. 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 5 May 2021.