[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06941974":3,"trial-entities:NCT06941974":185,"trial-summary:NCT06941974":189},{"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":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":47,"sex":139,"minimum_age":140,"maximum_age":141,"healthy_volunteers":14,"eligibility_criteria":142,"std_ages":155,"locations":158,"central_contacts":174,"overall_officials":180,"references":183,"see_also_links":184},"NCT06941974","STU00218597","Partnering With Antenatal Navigators to Transform Health in Pregnancy","RECRUITING","2030-06-01","2026-04","2026-04-06","2025-10-06","Northwestern University","OTHER",false,"The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant women's experiences, and health care utilization outcomes among low-income pregnant women and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant women who are randomized to receive antenatal patient navigation will be compared to pregnant women who are randomized to receive usual care. Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing factors that influence health and access to care in order to promote self-efficacy, enhance access, and sustain long-term engagement.\n\nThe main objectives of the study are to:\n\n1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of antenatal patient navigation for low-income women will reduce the incidence of a composite of adverse maternal outcomes, all of which are known to be increased among women with barriers to care.\n2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal\u002Fpediatric health care utilization.\n3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.","In the US, high rates of maternal morbidity are urgent public health concerns. Limited access to health care combined with other non-medical challenges generate greater risk of adverse maternal and neonatal outcomes for women with low income. High-quality antenatal care supports optimal health, yet typically fails to meet the needs of some populations, including those with lower incomes. Improving the health of pregnant women in a patient-centered manner requires innovative models of care delivery across the spectrum of maternal care. One strategy is patient navigation, a longitudinal, barrier- focused, patient-centered intervention that offers support for health services. Our prior work has included the study of patient navigation for low-income postpartum women, finding that assignment to a navigator improves the receipt of postpartum care and the successful transition to primary care. Although antenatal care is an ideal setting for patient navigation, the benefits of antenatal patient navigation for overall maternal and perinatal health have not been rigorously evaluated in randomized trials. There has been no study of antenatal patient navigation as a comprehensive, wraparound service to improve a wide range of pregnancy outcomes.\n\nThis randomized controlled trial aims to test the efficacy of an innovative antenatal care patient navigation model that extends and expands care for low-income pregnant women via the Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) Trial. We will randomize nulliparous pregnant women with low income to receive antenatal patient navigation via the PATH program versus usual antenatal care. Participants randomized to receive PATH navigation will receive intensive, individualized patient navigation services throughout pregnancy. As a multilevel, multidomain, intervention, PATH navigation is grounded in understanding and addressing approaches to promote self-efficacy, enhance access, support communication, and sustain healthcare engagement. The PATH navigation program is a comprehensive antenatal patient navigator program which is guided by principles of barrier ascertainment and reduction, promotion of self-efficacy and health literacy skills, facilitation of communication, and enhancing antenatal care access. PATH navigators will incorporate best practices regarding non-medical needs assessment, motivational interviewing, health education, and capacity-building health behavior support.\n\nThe study will enroll and randomize 550 to 600 pregnant women, ages 16 and over, who have not had a previous live birth and who have publicly funded prenatal care or have low income. Participants assigned to navigation will be provided intensive, individualized, one-on-one navigation services from enrollment (at less than 20 weeks of gestation) through 2 weeks postpartum. All participants will undergo surveys, interviews, and medical record reviews at 5 study visits from enrollment (\\\u003C20 weeks of gestation) through 9 months postpartum. Visits will occur at the following intervals: before 20 weeks (V1), 28-32 weeks of gestation (V2), at the time of hospitalization for delivery (V3), 6-12 weeks postpartum (V4), and 9 months postpartum (V5).\n\nAim 1 will evaluate whether PATH, compared to usual care, improves a composite of maternal adverse outcomes (including hypertensive disorders, preterm birth, postpartum hemorrhage, severe maternal morbidity, maternal mortality). Sub-Aim 1 aims to evaluate whether PATH, compared to usual care, improves effective maternal healthcare utilization (antenatal hospital use, Adequacy of Prenatal Care Utilization index, postpartum care\u002Fadmission). Aim 2 will evaluate whether PATH, compared to usual care, improves a composite of perinatal adverse outcomes (including neonatal intensive care unit admission, low birthweight, small- and large-for-gestational age, perinatal death). Sub-Aim 2 aims to evaluate whether PATH, compared to usual care, improves effective neonatal\u002Fpediatric healthcare utilization (neonatal length-of-stay, neonatal hospital utilization, and pediatric care attendance). Exploratory Aims 1 and 2 will evaluate whether PATH's efficacy varies by different demographic factors (e.g. age), or chronic disease status.\n\nAim 3 will evaluate patient, clinician, navigator, and health system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim is guided by implementation science principles and will be accomplished via serial collection of patient-reported outcomes, individual interviews, and process mapping exercises. Specifically, Aim 3a will compare patient-reported outcomes, including perceived health status, quality of life, patient activation, stress level, and self-efficacy, for women who receive PATH navigation versus usual care. Aim 3b will use qualitative and process mapping methods among approximately 50 participants assigned to PATH to understand participants' engagement, feedback, pregnancy experience, antenatal care processes, and satisfaction with the level of social and medical care received with patient navigation. Aim 3c will similarly use qualitative and process mapping methods with approximately 20 clinicians, navigators, and health system administrators to understand the extent to which PATH facilitated clinical, administrative, and health system needs, as well as lessons for future program implementation, including the relative benefits of discrete elements of the PATH intervention.\n\nThe PATH Trial will fill a significant evidence gap by demonstrating whether antenatal patient navigation among low-income pregnant women, who are disproportionately at risk for adverse outcomes, is an effective strategy to improve perinatal health. The expected outcome of this project is to generate the empiric evidence needed to understand the effect of antenatal patient navigation and to plan for an optimized package of successful implementation strategies to prepare for broad dissemination.",[18,19,20,21,22],"Maternal Morbidity","Antenatal Health","Neonatal Morbidity","Retention in Care","Prenatal Care",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},600,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Patient Navigation Program","PATH navigation is an antenatal patient navigator program designed to reduce barriers to care, enhance access, improve self-efficacy and knowledge, and improve multiple perinatal health outcomes. PATH navigation is a flexible, multi-pronged, patient-centered program with the capacity to evolve with patient needs and preferences. Early in pregnancy, navigators will establish themselves as a non-medical resource and will introduce PATH as a program designed to help inform, support, and connect patients during pregnancy. Navigators will review screen and address supportive and adverse non-medical needs, facilitate communication, perform logistical support, provide advocacy and bridge communication with clinical teams, and perform health education. Navigation services will be tailored to individual medical, psychosocial, or logistical complexity.",[37],"Navigation Group",[39,43],{"measure":40,"description":41,"timeFrame":42},"Maternal adverse outcome composite (Aim 1 primary outcome)","Frequency of maternal composite, which includes hypertensive disorders of pregnancy, preterm birth, postpartum hemorrhage, severe maternal morbidity, or maternal mortality. Components of the primary outcome will also be examined as a score and individually as secondary outcomes (see below).","Enrollment through delivery hospitalization, an average of 28 weeks",{"measure":44,"description":45,"timeFrame":46},"Neonatal adverse outcome composite (Aim 2 primary outcome)","Frequency of the neonatal composite, which includes neonatal intensive care unit (NICU) admission, low birthweight, small-for-gestational-age (SGA), large-for-gestational-age (LGA) status, and\u002For perinatal death. Components of the composite outcome will also be examined as a score and individually as secondary outcomes (see below).","At birth\u002Fdelivery",[48,51,54,57,60,63,66,70,73,76,80,84,87,91,95,99,103,106,110,113,116,119,122,125,129,133,136],{"measure":49,"description":50,"timeFrame":42},"Hypertensive disorder of pregnancy (component of primary outcome)","Frequency of de novo hypertensive disorder of pregnancy, including gestational hypertension, preeclampsia with or without severe features, superimposed preeclampsia on chronic hypertension, eclampsia, or HELLP syndrome",{"measure":52,"description":53,"timeFrame":42},"Preterm birth (component of primary outcome)","Frequency of birth less than 37 weeks of gestation",{"measure":55,"description":56,"timeFrame":46},"Postpartum hemorrhage (component of primary outcome)","Frequency of estimated\u002Fquantitative blood loss \\>1000mL (during delivery hospitalization) or blood transfusion",{"measure":58,"description":59,"timeFrame":42},"Severe maternal morbidity (component of primary outcome)","Frequency of CDC-defined indicators for severe maternal",{"measure":61,"description":62,"timeFrame":42},"Maternal mortality (component of primary outcome)","Frequency of maternal death (any reason) during pregnancy or the delivery hospitalization",{"measure":64,"description":65,"timeFrame":46},"Neonatal intensive care unit admission (component of Aim 2 neonatal composite outcome)","Frequency of admission to the neonatal intensive care unit",{"measure":67,"description":68,"timeFrame":69},"Low birthweight (component of Aim 2 neonatal composite outcome)","Frequency of birth weight \\\u003C2500g","Immediately post-birth",{"measure":71,"description":72,"timeFrame":69},"Small-for-gestational-age (SGA) status (component of Aim 2 neonatal composite outcome)","Frequency of birth weight \\\u003C10%ile for gestational age and sex",{"measure":74,"description":75,"timeFrame":69},"Large-for-gestational-age (LGA) status (component of Aim 2 neonatal composite outcome)","Frequency of birth weight \\>90%ile for gestational age and sex",{"measure":77,"description":78,"timeFrame":79},"Perinatal death (component of Aim 2 neonatal composite outcome)","Frequency of intrauterine fetal demise (\\>20 weeks of gestation) or neonatal death (i.e., antenatal, intrapartum, or neonatal death)","20 weeks of gestational through birth hospitalization",{"measure":81,"description":82,"timeFrame":83},"Maternal health care utilization: Antenatal hospital utilization","Frequency of unanticipated obstetric triage or emergency department visit, or antepartum admission","Enrollment through delivery",{"measure":85,"description":86,"timeFrame":83},"Maternal health care utilization: Antenatal care adequacy","Adequacy of Prenatal Care Utilization Index score",{"measure":88,"description":89,"timeFrame":90},"Maternal health care utilization: Postpartum care","Frequency of attendance at a routine postpartum care visit within 12 weeks after delivery","Between delivery and 12 weeks after delivery",{"measure":92,"description":93,"timeFrame":94},"Maternal health care utilization: Postpartum admission or emergency department use","Frequency of hospital readmission or emergency department use within 9 months of delivery","Between delivery and 9 months postpartum",{"measure":96,"description":97,"timeFrame":98},"Neonatal health care utilization: Neonatal length of stay","Neonatal length of birth hospitalization (days)","During birth hospitalization",{"measure":100,"description":101,"timeFrame":102},"Neonatal health care utilization: Neonatal hospital utilization","Frequency of neonatal emergency department visit or hospital admission","From birth hospital discharge through 9 months",{"measure":104,"description":105,"timeFrame":102},"Neonatal health care utilization: Pediatric care attendance","Frequency of attendance at indicated neonatal\u002Fpediatric outpatient care in the recommended time frame in the first 9 months of life",{"measure":107,"description":108,"timeFrame":109},"Patient-reported outcome: Global health status","PROMIS Global Health score","During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum",{"measure":111,"description":112,"timeFrame":109},"Patient-reported outcome: Health-related quality of life","Short Form Health Survey score",{"measure":114,"description":115,"timeFrame":109},"Patient-reported outcome: Depressive symptoms","Patient Health Questionnaire-9 score",{"measure":117,"description":118,"timeFrame":109},"Patient-reported outcome: Anxiety symptoms","General Anxiety Disorder-7 score",{"measure":120,"description":121,"timeFrame":109},"Patient-reported outcome: Health-related self-efficacy","PROMIS Self-Efficacy-General score",{"measure":123,"description":124,"timeFrame":109},"Patient-reported outcome: Patient activation","Consumer Health Activation Index score",{"measure":126,"description":127,"timeFrame":128},"Patient-reported outcome: Difficulties in pregnancy","nuMoM2b Difficulties in Pregnancy Scale score","During pregnancy, delivery hospitalization, and 6-12 weeks postpartum",{"measure":130,"description":131,"timeFrame":132},"Patient-reported outcome: Pregnancy experiences","nuMoM2b Pregnancy Experience Scale-Brief score","3rd trimester, delivery hospitalization",{"measure":134,"description":135,"timeFrame":109},"Patient-reported outcome: Stress","Perceived Stress Scale score",{"measure":137,"description":138,"timeFrame":128},"Patient-reported outcome: Satisfaction with care (antenatal and postpartum)","Prenatal Care Satisfaction Scale score and modified scale for postpartum care satisfaction","FEMALE","16 Years","50 Years",{"inclusion":143,"exclusion":153,"raw_text":154},[144,145,146,147,148,149,150,151,152],"Singleton gestation \\\u003C20 weeks of gestation","Nulliparous: no prior pregnancies ≥20 weeks excluding terminations","Low income (public insurance or residence in a neighborhood in which \\>10% of household incomes are \\\u003C125% of federal poverty line","Ability to speak and read English or Spanish","Established patient at one of practices associated with Northwestern Medical Group","Age 16 years or older","Intent to transfer care to an outside institution","Prior enrollment in PATH","Concurrent enrollment in a study with competing aims\u002Fintervention",[],"Inclusion Criteria:\n\n* Singleton gestation \\\u003C20 weeks of gestation\n* Nulliparous: no prior pregnancies ≥20 weeks excluding terminations\n* Low income (public insurance or residence in a neighborhood in which \\>10% of household incomes are \\\u003C125% of federal poverty line\n* Ability to speak and read English or Spanish\n* Established patient at one of practices associated with Northwestern Medical Group\n* Age 16 years or older\n\nExclusion:\n\n* Intent to transfer care to an outside institution\n* Prior enrollment in PATH\n* Concurrent enrollment in a study with competing aims\u002Fintervention",[156,157],"CHILD","ADULT",[159],{"facility":160,"status":7,"city":161,"state":162,"zip":163,"country":164,"contacts":165,"geoPoint":171},"Northwestern Memorial Hospital","Chicago","Illinois","60611","United States",[166],{"name":167,"role":168,"phone":169,"email":170},"Brittney R Williams, MPH","CONTACT","312-503-3476","brittney.williams@northwestern.edu",{"lat":172,"lon":173},41.85003,-87.65005,[175,179],{"name":176,"role":168,"phone":177,"email":178},"Lynn M Yee, MD, MPH","312-472-0119","lynn.yee@northwestern.edu",{"name":167,"role":168,"email":170},[181],{"name":176,"affiliation":12,"role":182},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":186,"biomarkers":188},[187],"Pregnancy",[],{"nct_id":4,"found":190,"summary":191,"prompt_version":201},true,{"design":192,"status":193,"heading":194,"summary":195,"follow_up":196,"word_count":197,"commitments":198,"compensation":199,"drugs_mentioned":200},"This is an interventional study that plans to enroll 600 participants. It is a randomized controlled trial, meaning participants will be randomly assigned to either receive the patient navigation program or usual care.","completed","PATH Study: Patient Navigation for Pregnant Women","This study, called PATH (Partnering with Antenatal Navigators to Transform Health in Pregnancy), is testing a program where you would work with an antenatal patient navigator. This program aims to help reduce barriers to care, improve your access to healthcare, and enhance your knowledge about pregnancy. The study wants to see if this program can improve the health of both mothers and babies, as well as pregnant women's experiences with healthcare. You might be able to join if you are a woman between 16 and 50 years old, less than 20 weeks pregnant with one baby, have never had a pregnancy last 20 weeks or more (excluding terminations), have a low income, and can speak and read English or Spanish. The study will measure success by looking at maternal (mother's) and neonatal (newborn's) adverse outcomes. The current recruitment status is unclear.","Maternal adverse outcomes are measured through delivery hospitalization (an average of 28 weeks). Neonatal adverse outcomes are measured at birth\u002Fdelivery.",141,"Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The study will measure maternal outcomes from enrollment through delivery hospitalization (an average of 28 weeks) and neonatal outcomes at birth\u002Fdelivery.","Not stated in the trial record.",[],"v2"]