Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-11 @ 12:51 PM
Study NCT ID:
NCT01994356
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physician Self Disclosure of IUC Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction with contraceptive method', 'timeFrame': 'immediately following clinical enocunter and at 2 months', 'description': 'All subjects were surveyed to determine satisfaction with their contraceptive method of choice immediately following their clinical encounter and at 2 months. Satisfaction was measured using a 5 point scale.'}, {'measure': 'Satisfaction with provider', 'timeFrame': 'immediately following clinical encounter and at 2 months', 'description': 'All subjects were surveyed to determine satisfaction with their provider immediately following their clinical encounter and at 2 months. Satisfaction was measured using a 5 point scale.'}], 'primaryOutcomes': [{'measure': 'Intrauterine contraceptive use', 'timeFrame': 'immediately following clinical encounter and at 2 months', 'description': 'All subjects were surveyed to determine use of intrauterine contraceptive immediately after their clinical visit where contraceptive counseling was received and at 2 months after their clinical encounter to assess intrauterine contraceptive use.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with clinical encounter', 'timeFrame': 'immediately following clinical encounter and at 2 months', 'description': 'All subjects were surveyed to determine their with satisfaction with their overall clinical encounter immediately following their clinical encounter at at 2 months. Satisfaction was measured using a 5 point scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraceptive counseling', 'Physician self disclosure', 'Satisfaction', 'Intrauterine contraceptive use'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': "As many as one-third of female healthcare providers use intrauterine contraception (IUC), but only about 8 percent of US women overall do. This begs the question: Might physician self-disclosure of personal IUC use increase IUC use among patients? However, the positive or negative impact of physician self disclosure on IUC uptake or patient satisfaction is generally unknown. The purpose of this study was to evaluate if physician self-disclosure of personal IUC use increases patient use of IUC or impacts patients' satisfaction with their clinical encounter.", 'detailedDescription': 'We performed a prospective randomized block design pilot trail of usual contraceptive counseling versus usual counseling plus physician self-disclosure of personal intrauterine contraceptive use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reproductive age\n* currently sexually active\n* scheduled for benign gynecology visit, annual exam, or family planning visit\n\nExclusion Criteria:\n\n* seeking pregnancy within 1 year\n* currently using IUC\n* prior sterilization procedure\n* currently pregnant'}, 'identificationModule': {'nctId': 'NCT01994356', 'briefTitle': 'Physician Self Disclosure of IUC Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Pilot Study of Physician Self-disclosure of Personal Intrauterine Contraceptive Use Versus Usual Counseling', 'orgStudyIdInfo': {'id': 'IUC Disclosure'}, 'secondaryIdInfos': [{'id': 'N014264', 'type': 'OTHER_GRANT', 'domain': 'Sociey of Family Planning'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual contraceptive counseling', 'description': 'subjects received usual contraceptive counseling', 'interventionNames': ['Behavioral: Usual contraceptive counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Physician self-disclosure of IUC use', 'description': 'subjects received usual contraceptive counseling plus intervention which was Physician self-disclosure of personal IUC use during the counseling', 'interventionNames': ['Behavioral: Physician self-disclosure of personal IUC use']}], 'interventions': [{'name': 'Physician self-disclosure of personal IUC use', 'type': 'BEHAVIORAL', 'description': 'Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling', 'armGroupLabels': ['Physician self-disclosure of IUC use']}, {'name': 'Usual contraceptive counseling', 'type': 'BEHAVIORAL', 'otherNames': ['contraceptive counseling'], 'description': 'all subjects recieved usual contraceptive counseling', 'armGroupLabels': ['Usual contraceptive counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer', 'investigatorFullName': 'Mya Zapata', 'investigatorAffiliation': 'University of Michigan'}}}}