Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-06 @ 9:20 AM
Study NCT ID:
NCT04261894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 548}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Receipt of Perinatal Care Components', 'timeFrame': 'Baseline through 6 months postpartum', 'description': 'The primary outcome will be a composite proportion of perinatal care components across three domains, including prenatal care, postpartum care, and social determinants of health content compared between the intervention and control arms.'}], 'secondaryOutcomes': [{'measure': 'Rate of breastfeeding', 'timeFrame': '6 weeks, 3 months, and 6 months postpartum', 'description': 'Measured by patient report of feedings per day and week'}, {'measure': 'Rate of depressive symptoms', 'timeFrame': 'Baseline through 6 months postpartum', 'description': 'Proportion of women with postpartum depression as measured by Patient Health Questionnaire-9'}, {'measure': 'Rate of postpartum contraception uptake and adherence', 'timeFrame': 'Up to 6 months postpartum', 'description': 'Proportion of women receiving and maintaining contraception'}, {'measure': 'Rate of influenza vaccine uptake', 'timeFrame': 'Up to 6 months postpartum', 'description': 'Proportion of women receiving influenza vaccine'}, {'measure': 'Rate of Tetanus, Diphtheria, Pertussis vaccine uptake', 'timeFrame': 'Up to 6 months postpartum', 'description': 'Proportion of women receiving Tetanus, Diphtheria, Pertussis vaccine'}, {'measure': 'Rate of human papillomavirus vaccine', 'timeFrame': 'Up to 6 months postpartum', 'description': 'Proportion of women receiving human papillomavirus vaccine'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care.', 'detailedDescription': 'African American women and their infants experience profound perinatal health disparities. The purpose of this study is to develop and evaluate the OPTIMIZE intervention, which is an integrated and comprehensive perinatal care checklist with patient navigation support, using a Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial among 600 African American women (15-45 years of age and 1st-2nd trimester of pregnancy) recruited from approximately 20 clinics affiliated with two Chicago area community health center networks that are the largest providers of perinatal care for low-income African American women in Chicago. Clinic sites will be randomized 1:1 to standard perinatal care (control arm) or standard perinatal care plus the OPTIMIZE checklist with Patient Navigation support starting from the initial prenatal visit and up through 12-weeks postpartum (intervention arm).\n\nThe study will test the central hypothesis that African American women in the OPTIMIZE intervention group will have received a greater proportion of recommended perinatal care components (prenatal care content, postpartum care content, and social determinants of health content) consistent with American College of Obstetricians and Gynecologists guidelines than African American women in the standard care group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 15 to 45 years\n* Self-identified as Black/African American\n* Pregnant or recently gave birth (less than 6 months post-delivery)\n* English speaking\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Incarceration\n* Adults unable to consent'}, 'identificationModule': {'nctId': 'NCT04261894', 'briefTitle': 'The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care', 'orgStudyIdInfo': {'id': 'SP0052930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPTIMIZE', 'description': 'This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support.', 'interventionNames': ['Behavioral: OPTIMIZE']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'This arm includes provision of standard perinatal care.'}], 'interventions': [{'name': 'OPTIMIZE', 'type': 'BEHAVIORAL', 'description': "The study intervention is implementation of the OPTIMIZE perinatal care checklist with patient navigation support. The checklist will contain perinatal care components to be assessed for each participant. Specifically, the checklist will be built into the electronic health record as a secure digital record of: (1) the participant's adherence to the recommended prenatal and postpartum visit schedule, (2) the completion of procedures and processes in a participant's prenatal and postpartum standard care plan, and (3) the completion of processes to address social determinants of health, along with completion of referrals to appropriate support resources. The OPTIMIZE checklist will also include records of patient navigation review, engagement, and tracking of barrier status and resolution", 'armGroupLabels': ['OPTIMIZE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60609', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'ACCESS Community Health Network', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Melissa A Simon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair of Clinical Research', 'investigatorFullName': 'Melissa Simon', 'investigatorAffiliation': 'Northwestern University'}}}}