Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 11:12 AM
Study NCT ID:
NCT07025057
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multilevel Community-Centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063130', 'term': 'Maternal Death'}], 'ancestors': [{'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provider confidence. Assessed through questionnaire.', 'timeFrame': 'Assessment immediately after the provider training intervention', 'description': 'Pre-post intervention change in provider confidence regarding provider-patient interactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maternal mortality', 'Maternal morbidity'], 'conditions': ['Provider Confidence', 'Provider Behavior']}, 'descriptionModule': {'briefSummary': 'The goal of the study involving human subjects is to train providers to address patient-provider interactions. The study will survey providers to assess pre-post knowledge, understanding, and behavior changes.', 'detailedDescription': 'Provider/practice level intervention. The study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including CHWs and HV, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal NHB/H women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Providing care to pregnant and postpartum women in Wayne, Kent, and Genesee Counties in MI\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07025057', 'briefTitle': 'Multilevel Community-Centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Multilevel Community-centered Intervention to Reduce Pregnancy Related and Associated Morbidity and Mortality (PRAMM) Disparities in Non-Hispanic Black and Hispanic Medicaid-insured Individuals', 'orgStudyIdInfo': {'id': 'STUDY00009358'}, 'secondaryIdInfos': [{'id': 'U54HD113291', 'link': 'https://reporter.nih.gov/quickSearch/U54HD113291', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Provider training', 'description': 'The providers in this arm will receive training', 'interventionNames': ['Behavioral: Provider training']}], 'interventions': [{'name': 'Provider training', 'type': 'BEHAVIORAL', 'description': 'The study will address patient-provider interactions through actionable, experiential provider trainings focused on communication provider, cultural relevance, and awareness of and referrals to community care services including Community Health Workers (CHW) and home visiting, for both clinical and community settings. Trainings are rooted in both history and in current research about how to address maternal mortality disparities, and will include self-learning, didactics, reflection, discussion, and identifying ways to tailor trainees settings to better hear, respect, and meet the needs of perinatal Black and Hispanic women.', 'armGroupLabels': ['Provider training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurie Fitzpatrik', 'role': 'CONTACT', 'email': 'fitz125@msu.edu', 'phone': '2487161043'}], 'facility': 'Strong Beginings', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'centralContacts': [{'name': 'Jennifer Raffo, MA', 'role': 'CONTACT', 'email': 'overfiel@msu.edu', 'phone': '12487161043'}], 'overallOfficials': [{'name': 'Cristian Meghea, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "The study is collecting data and later will be sharing project-generated data according to NIH's requirements for depositing relevant de-identified data into appropriate NIH data archives."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cristian Meghea', 'investigatorAffiliation': 'Michigan State University'}}}}