Simulation-based MethodologySim-GenderNCT04874987
Impact of Simulation Based Learning on Gender, and Equity Dynamics Among Inter-health Professional Teams
An observational study of Simulation-based Methodology, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
At Mbarara University of Science and Technology and partner sites, the investigators will explore the role of simulation in gender and equity. African societies are largely patriarchal, and this spills over into professional practice and medical education. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Methodology
- What is being tested?
- Simulation based learning with Advocacy inquiry and ladder of influence
- How many people
- 150 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jun 2019to 30 Dec 2022
- Phase
- Observational
- 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
Study population: Medical students, faculty members involved in delivery of scenario execution
Who may be able to join
- Medical students
- Faculty members in the Faculty of Medicine
- Based at Mbarara University, Lira University, Busitema University, or Muni University
Who cannot join
- Medical students and faculty outside the participating Universities
- Non-medical students
- Faculty not based in the Faculties of Medicine
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara
Santorino Data, MBChB, MMed, 256712214458, sdata@must.ac.ug
Santorino Data, MBChB, MMed
About this study
Official title: Impact of Simulation Based Learning on Gender, and Equity Dynamics Among Interhealth Professionals at Selected Institutions in Sub Saharan Africa
At Mbarara University of Science and Technology and partner sites, the investigators will explore the role of simulation in gender and equity. African societies are largely patriarchal, and this spills over into professional practice and medical education. Simulation methodology is at risk of suffering from a patriarchal dominance. The male dominance has potential to introduce power relationships between men and women learners in a scenario setting and between physicians and nurses. In the presence of such power differentials, the less dominant party could develop a "culture of silence," fail to take decisions on issues that affect them or their patients, fail to talk about these issues and take appropriate action.
Read the detailed description
To address the challenges of gender and equity: 1) the investigators will teach Advocacy Inquiry (AI) and the ladder of inference (LoI) as conversational strategies for all simulation faculty members to explore participant frames of action and thought processes, 2) the investigators will design and expose participants to simulated scenarios with embedded gender and or inter-professional power differentials, 3) study the effect of AI, the LoI and debriefed gender and equity scenarios on participant engagement strategies during gender and inter-professional conflict situations.
The Ladder of Influence allows facilitators select some data / observation, add interpretation, draw conclusions and take action. Though the Ladder of influence is a powerful approach to exploring situations, its prone to challenges if users jump to conclusions quickly without being curious about what alternative interpretations of the observed data / action could be. AI uses the "show", "think" and "wonder" as a strategy to slow facilitators from jumping up the LoI to draw conclusions before exploring learner perspectives. AI and the LoI in combination encourage self-reflection and good judgment. The investigators will deliberately encourage simulation teams to have both males and females and inter-professional with opportunities for team leaders to vary with both sex and profession.
- Conditions
- Simulation-based Methodology
- Being tested
- Simulation based learning with Advocacy inquiry and ladder of influence
- 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 learning with Advocacy inquiry and ladder of influenceOther
Also called Gender sensitive simulation based learning
Simulation scenarios based on identified gender and equity gaps. We will explore experiences of male and female participants, and inter-professional simulation participants (e.g nurses and doctors, medical and nursing students) post intervention exposure on their role and experiences in simulated sessions and clinical care experiences
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender and inter-professional conflicts in simulation
Frequency of gender and inter-professional conflicts reported in simulation session and or clinical care spaces during debriefing sessions
Measured: Change in conflicts 24 months after introduction of simulation based techniques
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 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 MethodologyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874987
- Sponsor's protocol ID
- 2020/MUST-3/SIM-II
- Acronym
- Sim-Gender
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared given the private nature (involves videos)
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Simulation Based Learning on Gender, and Equity Dynamics Among Interhealth Professionals at Selected Institutions in Sub Saharan Africa
- ClinicalTrials.gov ID
- NCT04874987
- Acronym / sponsor ID
- Sim-Gender / 2020/MUST-3/SIM-II
- Conditions
- Simulation-based Methodology
- Keywords
- Simulation based learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 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
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 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.
At Mbarara University of Science and Technology and partner sites, the investigators will explore the role of simulation in gender and equity. African societies are largely patriarchal, and this spills over into professional practice and medical education. Simulation methodology is at risk of suffering from a patriarchal dominance. The male dominance has potential to introduce power relationships between men and women learners in a scenario setting and between physicians and nurses. In the presence of such power differentials, the less dominant party could develop a "culture of silence," fail to take decisions on issues that affect them or their patients, fail to talk about these issues and take appropriate action.
Detailed description
To address the challenges of gender and equity: 1) the investigators will teach Advocacy Inquiry (AI) and the ladder of inference (LoI) as conversational strategies for all simulation faculty members to explore participant frames of action and thought processes, 2) the investigators will design and expose participants to simulated scenarios with embedded gender and or inter-professional power differentials, 3) study the effect of AI, the LoI and debriefed gender and equity scenarios on participant engagement strategies during gender and inter-professional conflict situations.
The Ladder of Influence allows facilitators select some data / observation, add interpretation, draw conclusions and take action. Though the Ladder of influence is a powerful approach to exploring situations, its prone to challenges if users jump to conclusions quickly without being curious about what alternative interpretations of the observed data / action could be. AI uses the "show", "think" and "wonder" as a strategy to slow facilitators from jumping up the LoI to draw conclusions before exploring learner perspectives. AI and the LoI in combination encourage self-reflection and good judgment. The investigators will deliberately encourage simulation teams to have both males and females and inter-professional with opportunities for team leaders to vary with both sex and profession.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical students, faculty members involved in delivery of scenario execution
Key inclusion criteria (3 listed)
- Medical students
- Faculty members in the Faculty of Medicine
- Based at Mbarara University, Lira University, Busitema University, or Muni University
Key exclusion criteria (3 listed)
- Medical students and faculty outside the participating Universities
- Non-medical students
- Faculty not based in the Faculties of Medicine
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 learning with Advocacy inquiry and ladder of influenceAlso: Gender sensitive simulation based learningSimulation scenarios based on identified gender and equity gaps. We will explore experiences of male and female participants, and inter-professional simulation participants (e.g nurses and doctors, medical and nursing students) post intervention exposure on their role and experiences in simulated sessions and clinical care experiences | Other | – |
Primary outcome
Gender and inter-professional conflicts in simulation
Time frame: Change in conflicts 24 months after introduction of simulation based techniques
Frequency of gender and inter-professional conflicts reported in simulation session and or clinical care spaces during debriefing sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No. Data will not be shared given the private nature (involves videos)
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?
An observational study of Simulation-based Methodology, 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 3 inclusion and 3 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 6 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?
Gender and inter-professional conflicts in simulation (time frame: Change in conflicts 24 months after introduction of simulation based techniques). 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 6 May 2021; AzTrials last refreshed its copy on 29 Oct 2026.