Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 4:34 AM
Study NCT ID:
NCT03510260
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2018-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Unblinded randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COMRADE Questionnaire', 'timeFrame': 'Up to 7 days after delivery', 'description': 'a survey assessing understanding of procedure and satisfaction,'}], 'secondaryOutcomes': [{'measure': 'Understanding Survey', 'timeFrame': 'Up to 7 days after delivery', 'description': "Survey or questionnaire to assess subject's understanding of the planned procedure"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean, Consent, Electronic, Satisfaction'], 'conditions': ['Satisfaction', 'Risk Reduction']}, 'descriptionModule': {'briefSummary': 'ยท The target population for our study is women who present in their last clinic visit before delivery and are scheduled for an elective cesarean section. In that visit, the provider will notify the research team in order for the subject to be screened for the study. If the subject consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent. After in-formed consent is obtained, the patient will be randomized to the following study groups:\n\nThe control group will undergo regular consenting only.\n\nStudy group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically and will proceed through the Confirmed Consent system prior to arrival to labor and delivery on day of surgery, which is the routine patient flow at this time. After completion of the survey, the subject will sign the regular paper consent for the procedure as standard in our institution.\n\nThe study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained by phone or in person after the completion of the paper consent form.', 'detailedDescription': "4.1 Screening, Recruitment, and Consenting:\n\n* Under the direction of the PI, trained research staff will be available 24/7 to screen and con-sent patients according to study protocol. Patients will be enrolled at the time a decision for planned repeat cesarean after VBAC counseling is made in clinic.\n* After informed consent is obtained, the patient will be randomized to the study group or the control group. A screening log will be used to track all patients approached for the study. Women will only be randomized in clinic.\n* Recruitment: We will recruit all pregnant patient's decision was made for scheduled cesarean after VBAC counseling made by their managing clinical team who do not meet any of the ex-clusion criteria listed below. Once the inclusion criteria for our study are met, the primary team will inform the patient about the study and ask her authorization to contact one of the study personnel.\n* Consenting process: Written consent will be obtained by direct person-to-person contact. The principal investigator, study coordinator, or a collaborator will be responsible for the informed consent. Non-English-speaking subjects are anticipated to be part of the study population and informed consent will be provided in their primary language.\n\nThe data collected will not be used for clinical diagnosis or treatment purposes.\n\nSubjects will be reassured that participation in the study is voluntary and will not interfere with diag-nose or treatment of her condition.\n\nThe subjects will receive the same care and expertise as any other patient treated in our institution.\n\n4.2. Randomization and Masking A confidential computer-generated simple randomization scheme (using STATA 14, Dallas, TX) will be prepared and provided on an ongoing basis to our study coordinator. A randomization log with group assignment, subject name, and medical record number will be used to track the randomization process.\n\nThe subject will be included in the analysis by intent-to-treat once the randomization assignment has been made.\n\n4.3. Interventions The control group will undergo regular consenting only. At our unit consent for an elective ce-sarean delivery occurs in the same day of surgery, few hours before the procedure in a private room in labor and delivery while awaiting surgery. The COMRADE questionnaire (our primary outcome) will be obtained after the completion of the paper consent form.\n\nStudy group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically and will proceed through the Confirmed Consent system prior to arrival to labor and delivery on day of surgery, which is the routine patient flow at this time. The COMRADE questionnaire (our primary outcome) will be obtained prior to the initiation of the traditional consent (as in control group) before the completion of the paper consent form, in order to assess satisfaction and understanding of the e-confirmed consenting process completed before the procedure. After completion of the survey, the subject will sign the regular paper consent for the procedure as standard in our institution.\n\nThe study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent is obtained in order to assess whether both methods combined together improve the subjects' satisfaction of the consenting methods and better understanding of the surgical procedure.\n\n4.4. Survey Collection This is our primary outcome. Before the subject has the procedure, our research staff will be collecting a survey assessing understanding of procedure and satisfaction, please see attached survey with appli-cation. This survey will be obtained according to the interventions detailed in sections 3 \\& 4.3"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Obstetrical population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women \\>18 and \\<50\n* Plan for scheduled elective Cesarean\n* English speaking\n\nExclusion Criteria:\n\n* Patient unwilling or unable to provide consent\n* Incarcerated patients\n* Unable to complete e-confirmed consent (not able to access the confirmed consent from home)'}, 'identificationModule': {'nctId': 'NCT03510260', 'acronym': 'ECCCO', 'briefTitle': 'Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Electronic Confirmed Versus Conventional Consenting Process (ECCCO)', 'orgStudyIdInfo': {'id': '18-0063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Subject will undergo regular consenting only. At our unit consent for an elective cesarean delivery occurs in the same day of surgery, few hours before the procedure in a private room in labor and delivery while awaiting surgery. The COMRADE questionnaire (our primary outcome) will be obtained after the completion of the paper consent form.', 'interventionNames': ['Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group I', 'description': 'Subject will receive an electronic invitation to complete the consent process electronically and will proceed through the Confirmed Consent system prior to arrival to labor and delivery on day of surgery, which is the routine patient flow at this time. The COMRADE questionnaire (our primary outcome) will be obtained prior to the initiation of the traditional consent (as in control group) before the completion of the paper consent form, in order to assess satisfaction and understanding of the e-confirmed consenting process completed before the procedure. After completion of the survey, the subject will sign the regular paper consent for the procedure as standard in our institution.', 'interventionNames': ['Other: Study Group I']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group II', 'description': "Subject will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent is obtained in order to assess whether both methods combined together improve the subjects' satisfaction of the consenting methods and better understanding of the surgical procedure.", 'interventionNames': ['Other: Study Group II']}], 'interventions': [{'name': 'Study Group I', 'type': 'OTHER', 'otherNames': ['e-confirmed consent'], 'description': 'Study group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically.The COMRADE questionnaire (our primary outcome) will be obtained prior to the initiation of the traditional consent (as in control group).', 'armGroupLabels': ['Study Group I']}, {'name': 'Study Group II', 'type': 'OTHER', 'otherNames': ['e-confirmed consent plus paper consent'], 'description': 'The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent', 'armGroupLabels': ['Study Group II']}, {'name': 'Control Group', 'type': 'OTHER', 'otherNames': ['Standard paper consent only'], 'description': 'Subject will go through the consenting process at the day of surgery at the preop visit as standard in our institution only.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}