Competency-Based EducationOPTIMISTNCT06753266
Optimizing OR Simulation in MEDI 045: Bias Reduction and Strategic Improvements (OPTIMIST)
An observational study of Competency-Based Education and Continuity of Patient Care, run by Walid Mohamed Ragab Mohamed Badwi at 4 sites in Saudi Arabia.
Trial summary
This study explores the evolving landscape of operating room (OR) simulation by identifying key trends, addressing potential biases, and providing actionable recommendations for improvement. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Competency-Based Education, Continuity of Patient Care, Medical Education
- How many people
- 1 participants
- Where
- 4 sitesSaudi Arabia
- Study dates
- 15 Nov 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of medical trainees enrolled in the MEDI 045 anesthesia program at King Saud Medical City. Participants will include individuals with varying levels of clinical experience who are eligible for simulation-based training. Participants will be randomly selected from a list of eligible trainees in the MEDI 045 program.
Who may be able to join
- Participants enrolled in the MEDI 045 anesthesia program at King Saud Medical City.
- Medical students or trainees with prior exposure to basic clinical simulation.
- Aged 18 years or older.
- Willingness to participate in simulation-based training sessions.
- Ability to provide informed consent.
Who cannot join
- Participants with prior advanced simulation training in anesthesia.
- Individuals with documented cognitive impairments or learning disabilities that may interfere with the study tasks.
- Refuse to participate in post-simulation assessments or follow-ups.
- Lack of fluency in the language of instruction used in the simulation.
Trial locations and contacts
4 sites in 1 country.
Saudi Arabia4 sites
King Saud University MedicalCity
Riyadh, Riydh, 11461-7805-41
King Saud University MedicalCity
Riyadh, 11461-7805-41
King Saud University , College of Medicine, Anesthesia Department
Riyadh, 11461
King Saud University Medical City (KSUMC), College of Medicine
Riyadh, 11461
About this study
Official title: OPTIMIST Optimizing OR Simulation in MEDI 045 Anesthesia Program: Trends, Bias Reduction, and Strategic Improvements and Shaping Future Practices OPTIMIST
This study explores the evolving landscape of operating room (OR) simulation by identifying key trends, addressing potential biases, and providing actionable recommendations for improvement. Using data-driven analysis, the research uncovers patterns in skill development and decision-making, offering insights into the effectiveness of current OR simulation programs. The study also tackles biases in data collection, including selection and response bias, ensuring the reliability of findings.
Read the detailed description
The effectiveness of simulation training is crucial in medical education, particularly for skills retention and perceived effectiveness. This section evaluates the overall effectiveness of SimMan3G sessions in enhancing clinical skills among participants.
Objectives
- To analyze the correlation between the number of SimMan3G sessions and skill retention.
- To assess the perceived effectiveness of simulation training.
- To provide actionable recommendations for improving simulation training effectiveness.
- Keywords
- Simulation-Based Training, Anesthesia Education, Patient Safety, Operating Room Simulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Bias in Clinical Decision-Making
Evaluate the change in cognitive bias during simulated clinical scenarios using the Cognitive Bias Assessment Tool (CBAT). This tool assesses the presence of cognitive biases (e.g., confirmation bias, anchoring bias) in decision-making.
The unit of measure will be the percentage of bias-free decisions or correct decisions made by participants, based on the CBAT scoring system.
The assessment will occur immediately after simulation training (within 1 day) and again 6 months post-training to measure both immediate and long-term changes in cognitive bias.
Measured: Immediately after simulation training (within 1 day) Over 6 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start15 Nov 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Competency-Based EducationStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid Mohamed Ragab Mohamed Badwi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Walid Mohamed Ragab Mohamed Badwi, King Saud Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753266
- Sponsor's protocol ID
- KSU-ORSim-2024
- Acronym
- OPTIMIST
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIST Optimizing OR Simulation in MEDI 045 Anesthesia Program: Trends, Bias Reduction, and Strategic Improvements and Shaping Future Practices OPTIMIST
- ClinicalTrials.gov ID
- NCT06753266
- Acronym / sponsor ID
- OPTIMIST / KSU-ORSim-2024
- Keywords
- Simulation-Based Training, Anesthesia Education, Patient Safety, Operating Room Simulation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Walid Mohamed Ragab Mohamed BadwiOther government
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
This study explores the evolving landscape of operating room (OR) simulation by identifying key trends, addressing potential biases, and providing actionable recommendations for improvement. Using data-driven analysis, the research uncovers patterns in skill development and decision-making, offering insights into the effectiveness of current OR simulation programs. The study also tackles biases in data collection, including selection and response bias, ensuring the reliability of findings.
Detailed description
The effectiveness of simulation training is crucial in medical education, particularly for skills retention and perceived effectiveness. This section evaluates the overall effectiveness of SimMan3G sessions in enhancing clinical skills among participants.
Objectives
- To analyze the correlation between the number of SimMan3G sessions and skill retention.
- To assess the perceived effectiveness of simulation training.
- To provide actionable recommendations for improving simulation training effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of medical trainees enrolled in the MEDI 045 anesthesia program at King Saud Medical City. Participants will include individuals with varying levels of clinical experience who are eligible for simulation-based training. Participants will be randomly selected from a list of eligible trainees in the MEDI 045 program.
Key inclusion criteria (5 listed)
- Participants enrolled in the MEDI 045 anesthesia program at King Saud Medical City.
- Medical students or trainees with prior exposure to basic clinical simulation.
- Aged 18 years or older.
- Willingness to participate in simulation-based training sessions.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- Participants with prior advanced simulation training in anesthesia.
- Individuals with documented cognitive impairments or learning disabilities that may interfere with the study tasks.
- Refuse to participate in post-simulation assessments or follow-ups.
- Lack of fluency in the language of instruction used in the simulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Cognitive Bias in Clinical Decision-Making
Time frame: Immediately after simulation training (within 1 day) Over 6 months post-training
Evaluate the change in cognitive bias during simulated clinical scenarios using the Cognitive Bias Assessment Tool (CBAT). This tool assesses the presence of cognitive biases (e.g., confirmation bias, anchoring bias) in decision-making. The unit of measure will be the percentage of bias-free decisions or correct decisions made by participants, based on the CBAT scoring system. The assessment will occur immediately after simulation training (within 1 day) and again 6 months post-training to measure both immediate and long-term changes in cognitive bias.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Competency-Based Education and Continuity of Patient Care, run by Walid Mohamed Ragab Mohamed Badwi at 4 sites in Saudi Arabia.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Cognitive Bias in Clinical Decision-Making (time frame: Immediately after simulation training (within 1 day) Over 6 months post-training). 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 31 Dec 2024.