Optimizing OR Simulation in MEDI 045: Bias Reduction and... | NCT06753266

Studies
Optimizing OR Simulation in MEDI 045: Bias Reduction and Strategic Improvements (OPTIMIST)

NCT06753266

Sponsor

Walid Mohamed Ragab Mohamed Badwi

Status

Active, not recruiting

Last Update Posted

Dec 31, 2024Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Competency-Based Education
Continuity of Patient Care
Medical Education

Interventions

Not provided

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2024Actual

Primary Completion Date

Jan 15, 2025Estimated

Completion Date

Mar 15, 2025Estimated

First Submitted Date

Dec 16, 2024

First Submission Date that Met QC Criteria

Dec 20, 2024

First Posted Date

Dec 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2024

Last Update Posted Date

Dec 31, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walid Mohamed Ragab Mohamed Badwi, Resident in Anesthesia, Instructor in MEDI 045, King Saud University College of Medicine., King Saud Medical CitySponsor-Investigator

Lead Sponsor

Walid Mohamed Ragab Mohamed BadwiOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Immediately after simulation training (within 1 day) Over 6 months post-training

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Saud University MedicalCity		Riyadh	Riydh	11461-7805-41	Saudi Arabia
King Saud University MedicalCity