Maternal, Pediatric Care EmergenciesSimForLifeNCT03258073
Does Simulation Scenario Execution Improve Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies?
A study testing Medical simulation using scenario execution in people with Maternal, Pediatric Care Emergencies, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal, Pediatric Care Emergencies
- What is being tested?
- Medical simulation using scenario execution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUganda
- Study dates
- 30 Aug 2017to 31 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
- Participants are medical and nursing students in active clinical rotation; third and fifth year medical students and third and fourth year nursing students at Mbarara University of Science and Technology.
Who cannot join
- Exclude medical and nursing students in the pre-clinical years and those in non-clinical rotations at the time of the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Simulation Scenario Execution on Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies Among Pre-service Health Professional Trainees in Uganda
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.
Read the detailed description
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.
A solid body of evidence now supports simulation-based learning as superior to didactic teaching and problem-based learning for the acquisition of critical assessment and management skills, particularly for clinical emergencies. Simulation-based training promotes skill acquisition and retention, enhances teamwork, and increases knowledge and understanding of key procedures. Simulation-based learning is now the norm in medical, nursing and paramedical training in most high income settings. There remains a critical need to operationalize simulation-based learning in resource-constrained settings
- Conditions
- Maternal, Pediatric Care Emergencies
- Being tested
- Medical simulation using scenario execution
- Keywords
- maternal, newborn, resuscitation, emergencies, medical simulation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical simulation using scenario executionOther
Also called medical simulation methodology
Each team of students will be exposed to simulation two times in a semester totaling to four times a year. In a scenario execution, participants are placed in a simulated experience of a medical emergency. Participants are required to respond and their reactions are observed by the investigators. After the experience, participants will have a debriefing session to learn from their experience of handling this emergency.
| Study group | Role | What they receive |
|---|---|---|
| Medical simulation using scenarion execution | Experimental | Study participants will be exposed to medical simulation using scenario execution. In this exercise, participants will be exposed to a scenario that simulates a medical emergency. They will be required to respond. Following their response, the participants will have a chance to share with the investigators their experiences and what they have learnt from the exposure in a debriefing session. The investigator will then provide feedback on their performance. Receives: Other: Medical simulation using scenario execution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skills using the Scenario-execution-group test score
This is a scenario specific score obtained from a multiple choice question (MCQ) test following execution of the scenario to measure. The MCQs are standard questions developed to accompany a given scenario. The maximum score is 100%. A scenario-execution-group test score of less than 60% will be a fail and a score of more than or equal to 60% will be a pass.
Measured: Immediately Post scenario execution
Secondary outcomes (1)
Knowledge
Knowledge will be measured using multiple choice questions (MCQs) and Investigators will use the Retrospective pre-post survey (RPP survey) to assess performance confidence among participants. In the RPP, the participant is asked to compare their performance after the intervention with that before the intervention. This assessment removes the bias of over or underestimating how much the participant knew before the intervention.
Measured: Change in knowledge scores at 4 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 posted23 Aug 2017
- Study start30 Aug 2017
- Primary completion30 Aug 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal, Pediatric Care EmergenciesStudies 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
- Investigators will conduct a cohort study among medical and nursing students and follow groups of students according to their rotation in the four major clinical disciplines. A cohort will represent a group of students who start a clinical rotation and complete their clinical year together. A total of 4 rotations exist concurrently every academic year in a year of study (Pediatrics, Internal medicine, Surgery and Obstetrics). During each rotation, a cohort will be exposed to at least 1 simulation scenario relevant to the discipline of the rotation. Investigators hypothesize that repeated exposure to simulation scenario execution will improve CTS scores. Therefore in this cohort study, investigators will measure CTS scores before and after exposure to simulation scenario training.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
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
- NCT03258073
- Sponsor's protocol ID
- MUST 21/06-16b
- Acronym
- SimForLife
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2017
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data to be shared when necessary permissions have been obtained
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Simulation Scenario Execution on Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies Among Pre-service Health Professional Trainees in Uganda
- ClinicalTrials.gov ID
- NCT03258073
- Acronym / sponsor ID
- SimForLife / MUST 21/06-16b
- Conditions
- Maternal, Pediatric Care Emergencies
- Keywords
- maternal, newborn, resuscitation, emergencies, medical simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 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.
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.
Detailed description
In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.
A solid body of evidence now supports simulation-based learning as superior to didactic teaching and problem-based learning for the acquisition of critical assessment and management skills, particularly for clinical emergencies. Simulation-based training promotes skill acquisition and retention, enhances teamwork, and increases knowledge and understanding of key procedures. Simulation-based learning is now the norm in medical, nursing and paramedical training in most high income settings. There remains a critical need to operationalize simulation-based learning in resource-constrained settings
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigators will conduct a cohort study among medical and nursing students and follow groups of students according to their rotation in the four major clinical disciplines. A cohort will represent a group of students who start a clinical rotation and complete their clinical year together. A total of 4 rotations exist concurrently every academic year in a year of study (Pediatrics, Internal medicine, Surgery and Obstetrics). During each rotation, a cohort will be exposed to at least 1 simulation scenario relevant to the discipline of the rotation. Investigators hypothesize that repeated exposure to simulation scenario execution will improve CTS scores. Therefore in this cohort study, investigators will measure CTS scores before and after exposure to simulation scenario training.
| Arm | Type | Receives |
|---|---|---|
| Medical simulation using scenarion execution | Experimental | Other: Medical simulation using scenario executionStudy participants will be exposed to medical simulation using scenario execution. In this exercise, participants will be exposed to a scenario that simulates a medical emergency. They will be required to respond. Following their response, the participants will have a chance to share with the investigators their experiences and what they have learnt from the exposure in a debriefing session. The investigator will then provide feedback on their performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants are medical and nursing students in active clinical rotation; third and fifth year medical students and third and fourth year nursing students at Mbarara University of Science and Technology.
Key exclusion criteria (1 listed)
- Exclude medical and nursing students in the pre-clinical years and those in non-clinical rotations at the time of the intervention.
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 |
|---|---|---|
| Medical simulation using scenario executionAlso: medical simulation methodologyEach team of students will be exposed to simulation two times in a semester totaling to four times a year. In a scenario execution, participants are placed in a simulated experience of a medical emergency. Participants are required to respond and their reactions are observed by the investigators. After the experience, participants will have a debriefing session to learn from their experience of handling this emergency. | Other | Medical simulation using scenarion execution |
Primary outcome
Skills using the Scenario-execution-group test score
Time frame: Immediately Post scenario execution
This is a scenario specific score obtained from a multiple choice question (MCQ) test following execution of the scenario to measure. The MCQs are standard questions developed to accompany a given scenario. The maximum score is 100%. A scenario-execution-group test score of less than 60% will be a fail and a score of more than or equal to 60% will be a pass.
1 secondary outcome
Knowledge
Time frame: Change in knowledge scores at 4 months from Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: Undecided. Data to be shared when necessary permissions have been obtained
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 Medical simulation using scenario execution in people with Maternal, Pediatric Care Emergencies, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skills using the Scenario-execution-group test score (time frame: Immediately Post scenario execution). 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 20 Apr 2021.