Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT07108335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Provider and Patient 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': 'ESTIMATED', 'count': 404}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of EHR (electronic health record) documented work-related counseling', 'timeFrame': 'From enrollment to 12 weeks after birth of child', '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': 'From enrollment to 12 weeks after birth of child', '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': 'From enrollment to 12 weeks after birth of baby', 'description': 'Determined by responses to surveys and qualitative interviews about work experiences.'}, {'measure': 'Number of participants with accommodation requests granted', 'timeFrame': 'From enrollment to 12 weeks after birth of baby', 'description': 'Determined by responses to surveys and qualitative interviews about work experiences.'}, {'measure': 'Number of participants with improved maternal-infant health in pregnancy', 'timeFrame': 'From enrollment to 12 weeks after birth of baby', '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. Investigators 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': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - Participants:\n\n* Pregnant patients who are 24 - 32 weeks gestation\n* Employed or unemployed and seeking paid employment\n\nInclusion Criteria - Providers:\n\n* Clinical team member (doctor, nurse, advanced practice provider, any medical assistant or administrative staff)\n\nExclusion Criteria - Participants:\n\n* Non- English language fluency\n* Unemployed with no desire to seek paid employment\n\nExclusion Criteria - Providers:\n\n* Not a clinical team member'}, 'identificationModule': {'nctId': 'NCT07108335', 'briefTitle': 'Provider and Patient RCT PROMOTE', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Provider Randomized Trial of the PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)', 'orgStudyIdInfo': {'id': 'Pro00116081'}, 'secondaryIdInfos': [{'id': '1R01HD115609-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD115609-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving Patient Education', 'description': 'This arm is provided with Patient Education from providers that have received training on PROMOTE.', 'interventionNames': ['Other: PROvider ReMote ObsTetric-Related Employment Education (PROMOTE)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'This arm has patients who receive care of a provider that was not trained on the PROMOTE curriculum.'}, {'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 of Provider', '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 Patient Education']}, {'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': {'centralContacts': [{'name': 'Sarahn Wheeler, MD', 'role': 'CONTACT', 'email': 'sarahn.wheeler@duke.edu', 'phone': '919-681-5220'}, {'name': 'Kristin Weaver', 'role': 'CONTACT', 'email': 'kristin.weaver@duke.edu'}], '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'}}}}