search
Back to results

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

Primary Purpose

Maternal, Pediatric Care Emergencies

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Medical simulation using scenario execution
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Maternal, Pediatric Care Emergencies focused on measuring maternal, newborn, resuscitation, emergencies, medical simulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medical simulation using scenarion execution

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 14, 2017
Last Updated
April 17, 2021
Sponsor
Mbarara University of Science and Technology
Collaborators
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT03258073
Brief Title
Does Simulation Scenario Execution Improve Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies?
Acronym
SimForLife
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology
Collaborators
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal, Pediatric Care Emergencies
Keywords
maternal, newborn, resuscitation, emergencies, medical simulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical simulation using scenarion execution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medical simulation using scenario execution
Other Intervention Name(s)
medical simulation methodology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skills using the Scenario-execution-group test score
Description
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.
Time Frame
Immediately Post scenario execution
Secondary Outcome Measure Information:
Title
Knowledge
Description
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.
Time Frame
Change in knowledge scores at 4 months from Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santorini Data, MD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
ZIP/Postal Code
256
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data to be shared when necessary permissions have been obtained

Learn more about this trial

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

We'll reach out to this number within 24 hrs