[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557733":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":57,"studyPopulation":47,"armGroups":58,"interventions":71,"overallOfficials":78,"centralContacts":87,"locations":93,"responsibleParty":116,"collaborators":119,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":47,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":47,"enrollmentInfo":133,"targetDuration":47,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":96,"whyStopped":47,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Michigan State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM)","A composite variable reflecting all pregnancy-related and associated morbidity and mortality conditions from pregnancy through 12 months postpartum, assessed using Medicaid claims data. The investigators will assess overall rates for African-American\u002FHispanic people and their rates relative to non-Hispanic white ones.","Continuous for 6 years",[14,18,21,24,27,31,34,37,41,44],{"measure":15,"description":16,"timeFrame":17},"Scale-up: Penetration","Penetration (% providers\u002Fstaff using recommended maternal health equity practices)","Assessed annually for 6 years",{"measure":19,"description":20,"timeFrame":17},"Scale-up: Reach","Number of perinatal people receiving recommended practices",{"measure":22,"description":23,"timeFrame":17},"Scale-up: Control for delivery","The degree to which control for delivery shifts to local actors and the practices are embedded in local delivery systems",{"measure":25,"description":26,"timeFrame":17},"Scale-up: Effectiveness","Effectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses.",{"measure":28,"description":29,"timeFrame":30},"Sustainment: Fidelity","Fidelity to core elements at each time point as assessed through provider behavior assessed using a self-reported y\u002Fn responses to a checklist of activities","Annually for 6 years",{"measure":32,"description":33,"timeFrame":30},"Sustainment: Health benefits","Health benefits continuing over time: Operationalized as the slope of PRAMM annually after the county moves into the \"intervention phase of the stepped wedge design",{"measure":35,"description":36,"timeFrame":30},"Sustainment: Capacity","Capacity continues over time. Operationalized as the slope of capacity annually after the county moves into the \"intervention\" phase of the stepped wedge design",{"measure":38,"description":39,"timeFrame":40},"Cost of implementation approaches","Cost via our grant accounting","Continuous over 6 years",{"measure":42,"description":43,"timeFrame":40},"Cost-effectiveness of implementation approaches","The primary cost-effectiveness measure will be non-severe maternal morbidity, calculating intervention costs per point of score reduction. Secondary cost-effectiveness measures will be severe maternal morbidity and maternal mortality. Prevented severe maternal morbidity (SMM) will be also monetized using Medicaid claims data by calculating the difference between Medicaid delivery expenditures between women\u002Fbirthing persons with SMM and without SMM using our own claims data and prior estimates. The value of a statistical life, currently around $10 million, will be used to monetize prevented maternal deaths.",{"measure":45,"description":46,"timeFrame":12},"Index (y\u002Fn) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality","These will be assessed during pregnancy and through one-year postpartum using state Medicaid claims records and death records. The investigators will assess overall rates and rates relative to non-Hispanic white people.",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":47,"timePerspective":47,"maskingInfo":53},"RANDOMIZED","SEQUENTIAL","Cluster-randomized stepped wedge design","PREVENTION",{"masking":54,"maskingDescription":47,"whoMasked":55},"SINGLE",[56],"CARE_PROVIDER","The project recruits prenatal and postnatal care providers in 12 Michigan counties. his project will develop and test a scale-up focused implementation approach for addressing pregnancy-related and -associated morbidity and mortality (PRAMM) disparities. Previous efforts have shown that use of hospital- focused maternal safety bundles are an important part of successful efforts to reduce PRAMM. However, overall quality of obstetric care improved in these efforts without any effect on disparities. Thus, unlike previous efforts, the proposed project will implement quality improvement bundles that: (1) focus on PRAMM disparities; and (2) focus on community care (i.e., care provided outside the hospital in outpatient and other community settings) and coordination among care settings. Given that 83% of U.S. pregnancy-related and pregnancy-associated deaths occur during pregnancy or postpartum (rather than around the time of delivery), outpatient and community efforts are vital. Bundles (the evidence-based practices to be implemented) are developed by the national Alliance for Innovation on Maternal Health Community Care Initiative (AIM-CCI), and include \"Community care for postpartum safety and wellness,\" and \"Community care for maternal mental health,\" \"Chronic conditions,\" and \"Intimate partner violence\" bundles. All bundles target PRAMM disparities. • Aim 1 of the proposed project will analyze bundle implementation experiences in 2 counties to develop a county-wide scale-up focused implementation approach for the bundles in partnership with stakeholders date to create and manualize a scale-up implementation intervention. • Aim 2 will evaluate the effectiveness and cost-effectiveness of the scale-up implementation intervention using a stepped wedge design in 12 Michigan counties with a total population of nearly 6 million people. PRAMM outcomes (individual level) will be extracted from a pre-existing statewide linked dataset. The sample for these analyses will include all Medicaid insured individuals in the 12 counties observed during pregnancy, at birth, and up to 1 year postpartum during the project period (\\~151,920 births, including \\~49,110 births to African American and\u002For Hispanic mothers). Implementation outcomes (provider-level) include scale-up (penetration, reach, control for delivery, and intervention effectiveness at scale) and sustainment (maintenance of fidelity to core elements, health benefits, and capacity to deliver core elements over time). This project is innovative because it: (1) is the first controlled implementation trial to test approaches to implementing quality improvement bundles that: (a) specifically target PRAMM disparities; and (b) focus on community care; (2) advances the science of scale-up (it is the first study to test scale- up or sustainment implementation approaches to addressing maternal morbidity\u002Fmortality disparities); and (3) works to improve services across many (vs. a single) health systems. The project is significant because the field needs to reach pregnant people at scale, and scale-up is an understudied aspect of implementation science.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Services as usual","ACTIVE_COMPARATOR","Services as usual before maternal health equity implementation efforts",[64],"Other: Services as usual",{"label":66,"type":67,"description":68,"interventionNames":69},"Scale-up implementation approach","EXPERIMENTAL","An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners.",[70],"Other: Scale-up implementation approach",[72,75],{"type":6,"name":60,"description":73,"armGroupLabels":74,"otherNames":47},"During this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures",[60],{"type":6,"name":66,"description":76,"armGroupLabels":77,"otherNames":47},"An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners. It may involve implementation approaches such as training, facilitation, learning collaboratives, coalitions, and other activities.",[66],[79,82,85],{"name":80,"affiliation":5,"role":81},"Jennifer E. Johnson, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":83,"affiliation":84,"role":81},"Jaye Clement, MPH, MPP","Henry Ford Health",{"name":86,"affiliation":84,"role":81},"Amy Loree, PhD",[88],{"name":89,"role":90,"phone":91,"phoneExt":47,"email":92},"Simran Dhaliwal Project Coordinator","CONTACT","810-600-5630","MHMiracle@Msu.edu",[94],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Michigan State University on behalf on 12 Michigan counties","RECRUITING","Flint","Michigan","48503-4684","United States","US",{"type":103,"coordinates":104},"Point",[105,106],-83.68746,43.01253,{"lat":106,"lon":105},[109,113],{"name":110,"role":90,"phone":111,"phoneExt":47,"email":112},"Jennifer Johnson, PhD","810-600-5669","jjohns@msu.edu",{"name":86,"role":90,"phone":114,"phoneExt":47,"email":115},"313-874-5452","aloree1@hfhs.org",{"type":81,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Jennifer E. Johnson","Chair, Charles Stewart Mott Department of Public Health",[120],{"name":121,"class":122},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100557733","scaling-up-maternal-health-equity-best-practices-100557733",false,"NCT06541951","Scaling up Maternal Health Equity Best Practices","Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality (MIRACLE Center Project 3)","Provider Inclusion Criteria:\n\n-Be a provider or staff person at agencies offering prenatal and\u002For postnatal services in Wayne, Oakland, Ingham, Isabella, Macomb, Muskegon, Calhoun, Jackson, Saginaw, Kalamazoo, Barrien, or Washtenaw counties in Michigan.\n\nProvider Exclusion Criteria:\n\n* None\n\nPatient outcomes are assessed through population-level Medicaid data, without direct recruitment.\n\nPatient Inclusion criteria:\n\n-All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan\n\nPatient Exclusion criteria:\n\n-None",true,"ALL","18 Years",{"count":134,"type":135},600,"ESTIMATED","INTERVENTIONAL",[138],"NA","This study works with prenatal and postnatal care providers in 12 Michigan counties to scale up best practices for maternal health equity.",[141,142],"Maternal Mortality Disparities","Maternal Morbidity Disparities",[144,145,146,147,148,149,150],"health inequities","maternal health","maternal mortality","implementation science","healthcare disparities","African Americans","Hispanic","2025-03-18",{"date":153,"type":154},"2025-03-21","ACTUAL",{"date":156,"type":154},"2024-11-01",{"date":158,"type":135},"2030-11",{"name":5,"class":6},1]