[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627264":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":19,"locations":29,"responsibleParty":115,"collaborators":19,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":19,"maxAge":19,"enrollmentInfo":128,"targetDuration":19,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":140,"overallStatus":50,"whyStopped":19,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Women and Infants Hospital of Rhode Island","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Community-based Maternal Support Services (COMSS) model","EXPERIMENTAL","Patients will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and at 2-6 weeks postpartum for three sets of risk factors for adverse perinatal outcomes - high risk SDOH, substance use and mental health conditions, and high risk pregnancy factors. Patients who screen positive will be assigned to a care manager who will work with community health workers (CHW) to provide care navigation, care linkage, and connection with community-based partner services. Care managers and the CHWs will keep a secure registry of patients and will follow up with them on a weekly or biweekly basis, as appropriate, to ensure continuity of care",[13,14],"Other: Perinatal health screening","Other: Support services",{"label":16,"type":17,"description":18,"interventionNames":19},"Baseline","NO_INTERVENTION","No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention",null,[21,25],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":19},"Perinatal health screening","Patients will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and 2-6 weeks postpartum for three sets of risk factors for adverse perinatal outcomes - high risk SDOH, substance use and mental health conditions, and high risk pregnancy factors.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":19},"Support services","Patients who screen positive for known perinatal risk factors will be assigned to a care manager who will work with community health workers (CHW) to provide care navigation, care linkage, and connection with community-based partner services to address the need identified. Care managers and the CHWs will keep a secure registry of patients and will follow up with them on a weekly or biweekly basis, as appropriate, to ensure continuity of care",[9],[30,48,63,74,82,91,102],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Women's Care","NOT_YET_RECRUITING","Pawtucket","Rhode Island","02860","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-71.38256,41.87871,{"lat":42,"lon":41},[45],{"name":19,"role":46,"phone":47,"phoneExt":19,"email":19},"CONTACT","401-921-6924",{"facility":49,"status":50,"city":51,"state":34,"zip":52,"country":36,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Brown University OBGYN","RECRUITING","Providence","02904",{"type":39,"coordinates":54},[55,56],-71.41283,41.82399,{"lat":56,"lon":55},[59],{"name":60,"role":46,"phone":61,"phoneExt":19,"email":62},"LG Ward","401-606-3000","lgward@brown.edu",{"facility":64,"status":32,"city":51,"state":34,"zip":65,"country":36,"countryCode":37,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Obstetrics and Gynecology Care Center","02905",{"type":39,"coordinates":67},[55,56],{"lat":56,"lon":55},[70],{"name":71,"role":46,"phone":72,"phoneExt":73,"email":19},"Medical Director","(401) 274-1122","42735",{"facility":75,"status":32,"city":51,"state":34,"zip":65,"country":36,"countryCode":37,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Providence Community Health Center - Prairie",{"type":39,"coordinates":77},[55,56],{"lat":56,"lon":55},[80],{"name":19,"role":46,"phone":81,"phoneExt":19,"email":19},"401-444-0570",{"facility":5,"status":50,"city":51,"state":34,"zip":65,"country":36,"countryCode":37,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},{"type":39,"coordinates":84},[55,56],{"lat":56,"lon":55},[87],{"name":88,"role":46,"phone":89,"phoneExt":19,"email":90},"Methodius Tuuli, MD, MPH, MBA","401-274-1100","mtuuli@wihri.org",{"facility":92,"status":50,"city":51,"state":34,"zip":93,"country":36,"countryCode":37,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Providence Community Health Centers - Central","02907",{"type":39,"coordinates":95},[55,56],{"lat":56,"lon":55},[98],{"name":99,"role":46,"phone":100,"phoneExt":19,"email":101},"David Mills","401-444-0580","dmills@providencechc.org",{"facility":103,"status":32,"city":104,"state":34,"zip":105,"country":36,"countryCode":37,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Care New England Medical Group (CNEMG)","Warwick","02886",{"type":39,"coordinates":107},[108,109],-71.41617,41.7001,{"lat":109,"lon":108},[112],{"name":19,"role":46,"phone":113,"phoneExt":114,"email":19},"(401) 737-7000","48755",{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Methodius Tuuli","Professor and Chair of Obstetrics and Gynecology","100627264","rhode-island-community-based-maternal-support-services-100627264",false,"NCT07446374","Rhode Island Community-based Maternal Support Services","Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity","RICOMSS","Inclusion Criteria:\n\n* All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics\n\nExclusion Criteria:\n\n* Anyone not meeting the above criteria","FEMALE",{"count":129,"type":130},3000,"ESTIMATED","INTERVENTIONAL",[133],"NA","The purpose of this project is to improve perinatal health outcomes in Rhode Island by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations to build a service delivery model that addresses care coordination and social determinants of health (SDOH) as a part of a concerted effort towards achieving equitable perinatal health outcomes. Over 4 years, the hospital-led project team will implement the community-based maternal support services (COMSS) bundle in 6 affiliated clinics, including care coordination, doula care, and referrals and linkages to community-based organizations that address key SDOH (food, housing, transportation). Maternal and infant health outcomes will be compared pre and post program implementation.\n\nThe central hypothesis is that COMSS will reduce adverse maternal and infant outcomes and associated racial disparities.",[136,137,138,139],"Perinatal Outcomes","Social Determinants of Health (SDOH)","Health Disparity, Minority and Vulnerable Populations","Pregnancy",[141,142,143],"pregnancy","social determinants of health","perinatal outcomes","2026-03-02",{"date":146,"type":147},"2026-03-03","ACTUAL",{"date":149,"type":147},"2025-05-19",{"date":151,"type":130},"2028-12",{"name":5,"class":6},7]