Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 9:02 PM
Study NCT ID:
NCT04701450
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2021-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2021-01-01', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction after informed consent', 'timeFrame': 'Immediately after obtaining informed consent', 'description': 'Assessment of subjectively experienced satisfaction with the process of obtaining informed consent for anesthesia'}], 'secondaryOutcomes': [{'measure': 'Overall waiting time of patients', 'timeFrame': 'Up to three hours; from administration for informed consent until completion of informed consent', 'description': "Patient's overall waiting time in the process of obtaining consent"}, {'measure': 'Time expense of informed consent', 'timeFrame': 'Up to 60 minutes; from start until end of informed consent', 'description': 'Overall time expense for the anaesthesiologist who is connsenting the patient'}, {'measure': 'Intraoperative complications', 'timeFrame': 'Up to 12 hours; From start until end of the planned surgical procedure', 'description': 'Incidence of unexpected medical complications during the surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aim to evaluate patient satisfaction between three methods of obtaining informed consent for anaesthesia. Patients are asked to partake in a short survey after being informed about the anaesthetic procedure either conventionally in the anesthesia department, telephonically or digitally.', 'detailedDescription': 'Patient satisfaction plays an important role to improve the process of medical procedures as well as patient outcome. Evaluating the subjectively experienced satisfaction is challenging. The investigators will use a questionnaire and assess waiting times in the process to determine patient satisfaction between digital, telephonic and conventional obtaining of informed consent for anaesthesia.\n\nIn this questionnaire study, patients are asked to partake in a survey after the process of obtaining consent for anaesthesia is completed. The questionnaire covers aspects of patient satisfaction with the process, such as subjective assessment of comprehensibility, waiting time and privacy.\n\nPatients are divided into three groups. In one group, consent is obtained conventionally, in form of a visit to our anaesthesia department. In the other two groups, consent is obtained telephonically and digitally, respectively. Patients are not randomised into these groups, but included into the study after the process of obtaining consent by one of the three methods mentioned above is completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients for whom consent for anaesthesia is obtained for an elective procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for whom consent for anaesthesia is obtained\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Language barrier\n* Patients with appointed legal guardians\n* Patients unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04701450', 'briefTitle': 'Evaluation of Digital, Telephonic and Conventional Consent for Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Questionnaire Study to Evaluate Patient Satisfaction Between Digital, Telephonic and Conventional Obtaining of Consent for Anaesthesia', 'orgStudyIdInfo': {'id': '1688/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'conventional', 'description': 'consent for anaesthesia is obtained as part of a conversation with physical attendance'}, {'label': 'telephonic', 'description': 'consent for anaesthesia is obtained telephonically'}, {'label': 'digital', 'description': 'a digital survey and video information is used to inform the patient about the anaesthetic procedure', 'interventionNames': ['Other: digital consent']}], 'interventions': [{'name': 'digital consent', 'type': 'OTHER', 'description': "the patient's medical history is taken in a digital survey, information about the anaesthetic procedure is aided by video material", 'armGroupLabels': ['digital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna General Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'David M. Baron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. PD Dr. David Baron, EDIC', 'investigatorFullName': 'David M Baron, MD, PhD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}