[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06956352":3,"trial-entities:NCT06956352":92,"trial-summary:NCT06956352":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":63,"sex":64,"minimum_age":65,"maximum_age":29,"healthy_volunteers":14,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":83,"overall_officials":84,"references":90,"see_also_links":91},"NCT06956352","STUDY24030140","Impact of Collaborative Care for Pregnant Women With Opioid Use Disorder in Low-Resource Obstetric Settings","ENROLLING_BY_INVITATION","2031-08","2025-10","2025-10-14","2025-06-24","University of Pittsburgh","OTHER",false,"The investigators seek to adapt a collaborative care model (CCM) for community-based, low-resource obstetric settings and to test the effects of this adapted CCM on health outcomes among Pregnant, postpartum, and parenting person (PPPP) with Opioid use disorder (OUD) and their families. To achieve this goal, investigators will conduct a nonrandomized, Type 1 hybrid implementation-effectiveness study across 3 community-based, low-resource obstetric sites in Northwest PA, a region with rates of maternal opioid-related diagnoses 4 times higher than national averages.","Our central hypothesis is that person-centered, recovery supports, provided in the CCM will increase medication for OUD (MOUD) initiation and continuation, decrease overdose and reduce child removal rates among PPPP with OUD.\n\nSpecifically, investigators will:\n\n1. Conduct an intervention adaptation project to adapt the Pregnancy and Women's Recovery Center (PWRC) CCM for rural and low-resource obstetric settings; and\n2. Create a common data model to harmonize variables across data sources and data collection processes across study sites.\n\nInvestigators will also:\n\n1. Evaluate the effects of the adapted PWRC CCM on outcomes among PPPP with OUD;\n2. Determine if improvements in person-centered, recovery supports mediate the relationship between PWRC Community and outcomes using causal mediation methods; and\n3. Identify PWRC Community adaptations that are associated with increased MOUD access, improved outcomes and that facilitate sustainability and scalability.\n\nResearch findings will:\n\n1. provide high-quality evidence on how CCMs affect service delivery and health outcomes for PPPP with OUD,\n2. inform stakeholders about ways to adapt CCMs for low-resource and rural healthcare settings, and\n3. inform policymakers about the adaptations necessary to replicate these models widely.",[18,19,20],"Pregnancy","Postpartum Period","Opioid Use Disorder",[22,23,24,25,18,26,27],"HEAL Inititative","HEAL","MOUD","OUD","Postpartum","Substance","OBSERVATIONAL",null,[],{"count":32,"type":33},1350,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Usual Care","Usual, referral-based, care.",[40],"Usual care",{"type":36,"name":42,"description":43,"armGroupLabels":44},"Adapted Collaborative Care Model (CCM)","Person-centered, recovery supports.",[42],[46,50,53,56,60],{"measure":47,"description":48,"timeFrame":49},"Patient Initiation of Medication for Opioid Use Disorder (MOUD)","Patient Initiation of Medication for Opioid Use Disorder (MOUD) as measured by total buprenorphine or methadone initiation in Electronic Health Record (EHR) and Medicaid claims data","During pregnancy (up to 40 weeks), up to 1 year post delivery",{"measure":51,"description":52,"timeFrame":49},"Patient Duration of MOUD","Patient Duration of MOUD as measured by proportion of days' covered incorporating buprenorphine or methadone treatment in EHR and claims data",{"measure":54,"description":55,"timeFrame":49},"Patient Overdose","Patient Overdose as measured by total count of nonfatal or fatal overdose events in EHR and claims data",{"measure":57,"description":58,"timeFrame":59},"Patient child foster care placement","Patient child foster care placement as measured by total child placements in foster care system according to child protective service data linked with Medicaid data","Delivery through 1 year postpartum",{"measure":61,"description":62,"timeFrame":59},"Patient utilization of well-child services","Patient utilization of well-child services as measured by total well-child visits in EHR and claims data",[],"ALL","18 Years",{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n(Stakeholder Participant)\n\n1. 18 years or older\n2. Providing care at participating obstetric site\n3. English speaking\n\n(Patient Participant)\n\n1. 18 years or older\n2. Receiving care at participating obstetric site\n3. English speaking\n\nExclusion Criteria:\n\n1\\. Unwillingness to have participation audio recorded.",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Magee Womens Hospital of UPMC","Pittsburgh","Pennsylvania","15213","United States",{"lat":81,"lon":82},40.44062,-79.99589,[],[85,88],{"name":86,"affiliation":12,"role":87},"Elizabeth Krans, MD","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":12,"role":87},"Marian Jarlenski, PhD",[],[],{"nct_id":4,"conditions":93,"biomarkers":94},[20,19,18],[],{"nct_id":4,"found":14,"summary":29,"prompt_version":29}]