Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 8:50 AM
Study NCT ID:
NCT06447233
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Perspectives Medicaid Title XIX Sterilization Consent Form
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient experience with the Medicaid Title XIX Sterilization consent form', 'timeFrame': 'Day 1, up to 1 hour', 'description': "Patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form. Patients' responses to interview questions will be translated into coded data using Dedoose, and grouped coded data will inform patterns of patient experience. Quantitative software will be used to analyze survey responses using descriptive statistics."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sterilization', 'Coercion', 'Understanding', 'Satisfaction'], 'conditions': ['Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'The goal of this survey and interview study is to learn about patient experience consenting for permanent contraception using the Medicaid Title XIX Sterilization Consent form. The main questions it aims to answer are:\n\n* To explore patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form.\n* To explore patient experience with the current consenting process, and thoughts regarding the ideal consenting process including how it would differ from the one currently in place, if at all.\n\nParticipants will complete a 10-15 minute survey and be offered participation in an in-depth one-on-one interview.', 'detailedDescription': 'The United States has a long history of coerced sterilization which was influenced by the eugenics and population control movements of the early and mid-20th century, respectively. The Medicaid Title XIX Sterilization Consent Form was created in response to these forced sterilizations to protect patients, but in recent years there have been questions regarding whether these forms are instead creating barriers to care for already marginalized populations. Prior studies demonstrated decreased rates of completion of postpartum permanent contraception requests secondary to invalid consent forms and negative attitudes among OBGYNs, including concerns regarding the ethics behind the forms. To date, there is very limited literature exploring patient perspectives. This will be a mixed methods study in which bilingual surveys will be distributed via REDCap to patients seeking permanent contraception at Columbia University affiliated OBGYN practices and complete in-depth interviews exploring patient experiences consenting for permanent contraception, and what an ideal consenting process might look like to them.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study participants will be patients seeking care at Columbia University affiliated OBGYN practices. The Columbia University affiliated OBGYN practices serve the Washington Heights and Inwood communities of New York City. The patient population is majority Hispanic and foreign-born. Approximately half of patients seeking permanent contraception are Spanish speaking.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seeking permanent contraception procedure through a Columbia University practice\n* English or Spanish speaking\n* Completed the Medicaid Title XIX Consent Form\n\nExclusion Criteria:\n\n-Currently pregnant and seeking immediate postpartum permanent contraception'}, 'identificationModule': {'nctId': 'NCT06447233', 'briefTitle': 'Patient Perspectives Medicaid Title XIX Sterilization Consent Form', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'An Exploratory Analysis of Patient Perspectives Regarding the Medicaid Title XIX Sterilization Consent Form', 'orgStudyIdInfo': {'id': 'AAAU9746'}}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tamara Kurek, MD', 'role': 'CONTACT', 'email': 'tk3018@cumc.columbia.edu', 'phone': '716-472-0180'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Tamara Kurek, MD', 'role': 'CONTACT', 'email': 'tk3018@cumc.columbia.edu', 'phone': '7164720180'}], 'overallOfficials': [{'name': 'Erika Levi, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}