Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-29 @ 3:37 AM
Study NCT ID:
NCT05081635
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consenso2_F1 Delphi Consensus Study on Post-graduate Medical Education Success and Failure and Its Influencing Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consensus', 'timeFrame': '5 months', 'description': 'The level of agreement for all statements achieving consensus from the expert panel consensus is predefined as ≥ 75% of the panel rating a given statement 4 or 5 value according to a Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medical Education']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://epanf.pt/', 'label': 'Research project website'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to generate expert consensus statements on the definitions of success and failure and its influencing factors in Post-graduate medical education.', 'detailedDescription': 'A study will be performed using a e-Delphi process with Portuguese expert panel to generate recommendation statements related to the definitions of success and failure in Post-graduate medical education and its influencing factors and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:\n\n1. Success in Post-graduate medical education: definition, influencing factors\n2. Failure in Post-graduate medical education: definition, influencing factors\n3. Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (75% agreement).\n\nPart 1: planning and evidence review\n\n* Series of planning sessions with study investigators\n* Literature is reviewed/summarized\n* Initial statements will be developed based on Round 1 results. Round 1 will be composed of 4 open-ended questions\n\nPart 2: Survey to achieve consensus\n\n* Survey, based on the initial statements developed on Round 1 results\n* At least 2 additional rounds of review (remote rounds using an online platform) will be held to achieve consensus on each topic of interest and finalize consensus statements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Experts in Post-graduate medical education', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residency programs directors,\n* members of the medical residents representing committee,\n* members of patients representing associations,\n* members of health institutions management teams,\n* members of Portuguese Medical Association,\n* authors of relevant scientific articles on medical education\n\nExclusion Criteria:\n\n• Panelists who are not able to commit to all rounds of the modified Delphi process will be excluded.'}, 'identificationModule': {'nctId': 'NCT05081635', 'briefTitle': 'Consenso2_F1 Delphi Consensus Study on Post-graduate Medical Education Success and Failure and Its Influencing Factors', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar do Baixo Vouga'}, 'officialTitle': 'Definitions of Success and Failure in Post-graduate Medical Education and Its Influencing Factors: A Delphi Consensus Study', 'orgStudyIdInfo': {'id': 'Consenso2_Fase1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Delphi panel', 'description': "The Delphi panel will include 30 Portuguese experts in post-graduate medical education. The expert panel will include participants from the residency programs directors' coordination group, from the medical residents representing committee, from patients representing associations, from health institutions management teams, from the Portuguese Medical Association and also authors of relevant scientific articles on medical education. Study participants will be required to answer the questions of 3 questionnaires included in each of the 3 rounds of the study."}]}, 'contactsLocationsModule': {'locations': [{'zip': '1700-063', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Conselho Nacional do Internato Médico', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Nuno L Fernandes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar do Baixo Vouga'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar do Baixo Vouga', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional do Internato Médico', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nuno Filipe Maio Lopes Fernandes', 'investigatorAffiliation': 'Centro Hospitalar do Baixo Vouga'}}}}