Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS)

NCT06755203 | Recruiting DMC

• 2 other identifiers: King Saud Medical CityIRB Ref. No. 24/1145/IRB
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Simulation-based training has emerged as a valuable tool for enhancing communication skills among healthcare professionals. This study aimed to evaluate the impact of operating room (OR) simulations on the development of communication skills for patient safety. The study focused on two key areas: the development of communication skills for patient-centered care and the role of the WHO Surgical Safety Checklist in enhancing communication and patient safety during simulations.

Conditions

Patient-Centered Care; Competency-Based Education

Keywords

Patient safety; WHO Surgical Safety Checklist; Team communication; Stress management; Protocol adherence; Risk assessment; Operating room simulations

Outcome Measures

Primary Outcomes (1)

• Improving Patient Safety Training through Simulation

  Evaluate the effectiveness of simulation-based training in promoting patient safety with a focus on: Authenticity: Scenarios mirroring real operating room environments. Stress Management \& Communication: Improving interpersonal dynamics, team synergy, and decision-making under pressure. Protocol Compliance \& Risk Evaluation: Ensuring adherence to patient safety best practices. WHO Surgical Safety Checklist: Enhancing communication and protocol adherence. Evaluation Tool: Patient Safety Simulation Assessment Scale (PSSAS). Scale Range: 0-10 Criteria: 0-3: Minimal improvement. 4-6: Moderate improvement. 7-8: Significant improvement. 9-10: Excellent improvement. Higher scores indicate better outcomes.

  7-8 months

Secondary Outcomes (1)

• Improvement in Communication Skills during Simulations

  7-8 months

Study Arms (1)

Simulation Training Group

Participants will engage in operating room simulations designed to improve communication skills, stress management, and adherence to the WHO Surgical Safety Checklist.

Other: Operating Room Simulation Training

Interventions

Operating Room Simulation Training OTHER

The intervention involves high-fidelity OR simulations focusing on critical areas of patient safety, including: Communication Skills: Emphasizing clear communication during surgical procedures. Stress Management: Training participants to manage stress effectively in high-pressure situations. Protocol Adherence: Practicing adherence to the WHO Surgical Safety Checklist. Risk Assessment: Identifying and mitigating potential safety risks in simulated scenarios

Also known as: Patient Safety Simulation

Simulation Training Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes medical students enrolled in the MEDI 045 course at King Saud University. These students are actively engaged in clinical education and exposed to scenarios requiring the development of communication skills and adherence to the WHO Surgical Safety Checklist. Key Characteristics: Academic Level: Medical students introduced to clinical practices in anesthesia. Training Context: Students participating in structured educational activities, such as logbook maintenance and simulation-based learning. Sample Size: Approximately 109 students to ensure robust analysis of communication skills and logbook preferences.

You may qualify if:

• Participants must be medical students enrolled in the MEDI 045 course at King Saud University.
• Must have prior exposure to basic patient safety and communication skills training.
• Age: 18-25 years. Students must voluntarily consent to participate in the study and complete the required simulations and assessments.

You may not qualify if:

• Students who have already completed formal simulation-based training on communication or patient safety outside the MEDI 045 curriculum.
• Students are unable to participate in simulation sessions due to scheduling conflicts or medical reasons.
• Participants were unwilling to provide informed consent.

Sponsors & Collaborators

• King Saud Medical City: lead

Study Sites (1)

King Saud University , College of Medicine, Anesthesia Department

Riyadh, 11461, Saudi Arabia

RECRUITING

Central Study Contacts

Walid M Badwi, MD

CONTACT

00966547874681; waledbadawy@yahoo.com

jumana B BAAJ, consultant

CONTACT

009664670011; bjumana@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A resident in anesthesia department, king Saud Medical City Teacher and Instructor in (Basic Anesthesia and Resuscitation-MEDI 045) King Saud University College of Medicine / anesthesia department Undergraduate Education Organizer

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 1, 2025
• Study Start: March 3, 2024
• Primary Completion: January 25, 2025
• Study Completion: February 25, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)