Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-02 @ 11:55 AM
Study NCT ID:
NCT07126405
Status:
WITHDRAWN
Last Update Posted:
2025-10-27
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Provider RCT PROMOTE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study has been combined with the patient portion of this study under Pro00116081', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of EHR (electronic health record) documented work-related counseling', 'timeFrame': 'Up to 1 year', 'description': "Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy."}, {'measure': 'Number of participants who adhere to employer documentation recommendations', 'timeFrame': 'Up to 1 year', 'description': "Used to determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy."}, {'measure': 'Number of participants with undesired wage or advancement reduction', 'timeFrame': 'Up to 1 year', 'description': 'Determined by responses to surveys and qualitative interviews about work experiences.'}, {'measure': 'Number of participants with accommodation requests granted', 'timeFrame': 'Up to 1 year', 'description': 'Determined by responses to surveys and qualitative interviews about work experiences.'}, {'measure': 'Number of participants with improved maternal-infant health in pregnancy', 'timeFrame': 'Up to 1 year', 'description': 'Determined by EHR-documented maternal infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal Health', 'Pregnancy', 'Employment']}, 'descriptionModule': {'briefSummary': "Research Aim 1: Determine the effectiveness of PROMOTE vs. usual care to increase patients' receipt of counseling about workplace accommodations and pregnancy. We will recruit and randomize Obstetric providers to the PROMOTE intervention or usual care. The investigators will compare the frequency of EHR documented work- related counseling and adherence to employer documentation recommendations between the two study arms.\n\nHypothesis: Patients receiving care by a provider randomized to PROMOTE will have higher rates of documented counseling about work and pregnancy.\n\nResearch Aim 2: Determine the effectiveness of PROMOTE vs. usual care to reduce undesired wage or advancement reduction, increase accommodation requests granted, and improve maternal-infant health. The investigators will recruit a racially and socioeconomically diverse cohort of 304 pregnant patients and compare responses to surveys and qualitative interviews about work experiences and EHR-documented maternal-infant health outcomes among patients receiving care by providers randomized to PROMOTE vs. usual care.\n\nHypothesis: Compared to patients receiving care by providers randomized to usual care, participants receiving care by providers randomized to PROMOTE will have less undesired loss of wages and advancement, increased accommodation request granted, and improved maternal-infant health during pregnancy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)\n\nExclusion Criteria:\n\n* Not a clinical team member'}, 'identificationModule': {'nctId': 'NCT07126405', 'briefTitle': 'Provider RCT PROMOTE', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)', 'orgStudyIdInfo': {'id': 'Pro00118409'}, 'secondaryIdInfos': [{'id': '1R01HD115609-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD115609-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving Provider PROMOTE Training', 'description': 'Providers in this arm will receive training on PROMOTE', 'interventionNames': ['Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Providers in this arm will continue usual care.'}], 'interventions': [{'name': 'PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)', 'type': 'OTHER', 'description': 'An on-demand 30-minute web-based training for clinical team members that provides a high-level summary of federal employment laws, work note templates embedded into the electronic health record (EHR) that prompt the clinician team member to include relevant information, and a patient-facing infographic designed to facilitate clinician counseling.', 'armGroupLabels': ['Receiving Provider PROMOTE Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27565', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sarahn Wheeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}