Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-28 @ 5:50 AM
Study NCT ID:
NCT06755203
Status:
RECRUITING
Last Update Posted:
2025-01-01
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving Patient Safety Training through Simulation', 'timeFrame': '7-8 months', 'description': 'Evaluate the effectiveness of simulation-based training in promoting patient safety with a focus on:\n\nAuthenticity: Scenarios mirroring real operating room environments. Stress Management \\& Communication: Improving interpersonal dynamics, team synergy, and decision-making under pressure.\n\nProtocol Compliance \\& Risk Evaluation: Ensuring adherence to patient safety best practices.\n\nWHO Surgical Safety Checklist: Enhancing communication and protocol adherence. Evaluation Tool: Patient Safety Simulation Assessment Scale (PSSAS).\n\nScale Range: 0-10\n\nCriteria:\n\n0-3: Minimal improvement. 4-6: Moderate improvement. 7-8: Significant improvement. 9-10: Excellent improvement. Higher scores indicate better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Communication Skills during Simulations', 'timeFrame': '7-8 months', 'description': 'Evaluate the enhancement of communicative competencies, placing particular emphasis on:\n\nClarity of Communication: The proficiency in transmitting information with efficacy. Teamwork: The synergy and coordination exhibited within the group. Adherence to Structured Communication Protocols: The implementation of standardized tools such as SBAR (Situation-Background-Assessment-Recommendation). Measurement Tool: A bespoke Structured Communication Skills Evaluation Checklist (SCSEC) will be employed. Scale Range: 0-10 Scoring Criteria: 0-3: Insignificant clarity and teamwork, accompanied by inadequate adherence to protocols. 4-6: Moderate clarity and teamwork, coupled with partial compliance to protocols. 7-8: Robust clarity and teamwork, characterized by commendable adherence to protocols. 9-10: Exemplary clarity and teamwork, demonstrating complete adherence to protocols. Elevated scores signify superior outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient safety', 'WHO Surgical Safety Checklist', 'Team communication', 'Stress management', 'Protocol adherence', 'Risk assessment', 'Operating room simulations'], 'conditions': ['Patient-Centered Care', 'Competency-Based Education']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This study will provide valuable insights into student preferences for logbook formats in anesthesiology education, specifically within the MEDI 045 course. By comparing Excel sheet logbooks with traditional paper logbooks, it aims to elucidate how different documentation methods impact student engagement, satisfaction, and learning outcomes.\n\nUnderstanding these preferences is crucial, as logbooks are not merely administrative tools but integral components of the educational experience that promote reflection, accountability, and skill development in clinical practice.\n\nThe findings will contribute to existing knowledge by identifying specific advantages and disadvantages of each format, highlighting the aspects that enhance or hinder student learning. Moreover, the research will inform curriculum designers and educators about effective strategies for logbook implementation, ultimately leading to improved educational tools that better align with students' needs"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nKey Characteristics:\n\nAcademic Level: Medical students introduced to clinical practices in anesthesia.\n\nTraining Context: Students participating in structured educational activities, such as logbook maintenance and simulation-based learning.\n\nSample Size: Approximately 109 students to ensure robust analysis of communication skills and logbook preferences.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must be medical students enrolled in the MEDI 045 course at King Saud University.\n\nMust have prior exposure to basic patient safety and communication skills training.\n\nAge: 18-25 years. Students must voluntarily consent to participate in the study and complete the required simulations and assessments.\n\nExclusion Criteria:\n\nStudents who have already completed formal simulation-based training on communication or patient safety outside the MEDI 045 curriculum.\n\nStudents are unable to participate in simulation sessions due to scheduling conflicts or medical reasons.\n\nParticipants were unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06755203', 'acronym': 'EIORS-CPS', 'briefTitle': 'Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Saud Medical City'}, 'officialTitle': 'Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety', 'orgStudyIdInfo': {'id': 'King Saud Medical City'}, 'secondaryIdInfos': [{'id': 'IRB Ref. No. 24/1145/IRB', 'type': 'OTHER', 'domain': 'College of Medicine, KSU, Riyadh, Saudi Arabia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Simulation Training Group', 'description': 'Participants will engage in operating room simulations designed to improve communication skills, stress management, and adherence to the WHO Surgical Safety Checklist.', 'interventionNames': ['Other: Operating Room Simulation Training']}], 'interventions': [{'name': 'Operating Room Simulation Training', 'type': 'OTHER', 'otherNames': ['Patient Safety Simulation'], 'description': 'The intervention involves high-fidelity OR simulations focusing on critical areas of patient safety, including:\n\nCommunication Skills: Emphasizing clear communication during surgical procedures.\n\nStress Management: Training participants to manage stress effectively in high-pressure situations.\n\nProtocol Adherence: Practicing adherence to the WHO Surgical Safety Checklist. Risk Assessment: Identifying and mitigating potential safety risks in simulated scenarios', 'armGroupLabels': ['Simulation Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11461', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Dr. Walid M Badwi, MD', 'role': 'CONTACT', 'email': 'Wbadawi@ksu.edu.sa', 'phone': '+966 547 874 681'}], 'facility': 'King Saud University , College of Medicine, Anesthesia Department', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Walid M Badwi, MD', 'role': 'CONTACT', 'email': 'waledbadawy@yahoo.com', 'phone': '00966547874681'}, {'name': 'jumana B BAAJ, consultant', 'role': 'CONTACT', 'email': 'bjumana@gmail.com', 'phone': '009664670011'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At this time, there are no plans to share individual participant data (IPD) publicly. The study will retain data within the institution for research purposes only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud Medical City', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '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', 'investigatorFullName': 'Walid Mohamed Ragab Mohamed Badwi', 'investigatorAffiliation': 'King Saud Medical City'}}}}