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Does Simulation Scenario Execution Improve Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies? (SimForLife)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258073
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Mbarara University of Science and Technology

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Maternal, Pediatric Care Emergencies Other: Medical simulation using scenario execution Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: No masking will be done
Primary Purpose: Other
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
Estimated Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medical simulation using scenarion execution
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.
Other: Medical simulation using scenario execution
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.
Other Name: medical simulation methodology




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Knowledge [ Time Frame: Change in knowledge scores at 4 months from Baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclude medical and nursing students in the pre-clinical years and those in non-clinical rotations at the time of the intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258073


Contacts
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Contact: Santorini Data, MD +256752214458 sdata@must.ac.ug
Contact: Francis Bajunirwe, PhD +256772576396 fbaj@must.ac.ug

Sponsors and Collaborators
Mbarara University of Science and Technology
University of Calgary
Investigators
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Principal Investigator: Santorini Data, MD Mbarara University of Science and Technology
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Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT03258073    
Other Study ID Numbers: MUST 21/06-16b
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data to be shared when necessary permissions have been obtained

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mbarara University of Science and Technology:
maternal
newborn
resuscitation
emergencies
medical simulation
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes