Clinical trial NCT06941974: Partnering With Antenatal Navigators to Transform Health in Pregnancy
Official title: Partnering With Antenatal Navigators to Transform Health in Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Morbidity
Antenatal Health
Neonatal Morbidity
Retention in Care
Prenatal Care
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-04-24
Enrollment: 600
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two cohorts: One cohort will be provided intensive, individualized, one-on-one navigation services from early pregnancy (before 20 weeks of gestation) through 2 weeks postpartum. The second cohort will receive usual care. Both cohorts will be followed through 9 months postpartum.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 persons' experiences, and health care utilization outcomes among low-income pregnant individuals 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 individuals who are randomized to receive antenatal patient navigation will be compared to pregnant individuals who are randomized to receive usual care. Navigators will support birthing people from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement.

The main objectives of the study are to:

1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of bundled social- and health systems-focused antenatal patient navigation for racially and ethnically diverse low-income individuals will reduce the incidence of a composite of adverse maternal outcomes all known to be associated with socioeconomic disadvantage and SDoH. We will also investigate maternal health care utilization.
2. 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/pediatric health care utilization.
3. 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.

Detailed description: In the United States, pervasive and insidious disparities in maternal health are urgent public health concerns. Social determinants of health, such as poverty, exposure to racism, and limited access to care, critically shape perinatal outcomes, resulting in greater risk of adverse maternal and neonatal health outcomes for low-income and minority individuals. High-quality, comprehensive antenatal care supports optimal health, yet typically fails to meet the needs of marginalized populations. Improving the health of pregnant people in a patient-centered, equity-focused 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 individuals, 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.

This 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 individuals via the Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) Trial. We will randomize nulliparous pregnant individuals 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, health equity-focused intervention, PATH navigation is grounded in understanding and addressing social determinants of health 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 social determinants of health assessment, motivational interviewing, health education, and capacity-building health behavior support.

The study will enroll and randomize 550 to 600 racially and ethnically diverse pregnant individuals, ages 16 and over, who have not had a previous live birth and who have publicly funded prenatal care or reside in a low-income neighborhood. 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 (\<20 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).

Aim 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/admission). 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/pediatric 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 age, self-reported race/ethnicity, or chronic disease status.

Aim 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 individuals 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.

The PATH Trial will fill a significant evidence gap by demonstrating whether antenatal patient navigation among low-income pregnant individuals, who are disproportionately at risk for adverse outcomes, is an effective strategy to improve perinatal health and reduce disparities. 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. PATH represents a critical step in understanding how to improve maternal health for disadvantaged individuals.

Eligibility criteria: Inclusion Criteria:

* Singleton gestation \<20 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 \<200% 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

Exclusion:

* Intent to transfer care to an outside institution
* Prior enrollment in PATH
* Concurrent enrollment in a study with competing aims/intervention

Primary outcomes:
measure: Maternal adverse outcome composite (Aim 1 primary outcome)
timeFrame: Enrollment through delivery hospitalization, an average of 28 weeks
measure: Neonatal adverse outcome composite (Aim 2 primary outcome)
timeFrame: At birth/delivery
Secondary outcomes:
measure: Hypertensive disorder of pregnancy (component of primary outcome)
timeFrame: Enrollment through delivery hospitalization, an average of 28 weeks
measure: Preterm birth (component of primary outcome)
timeFrame: Enrollment through delivery hospitalization, an average of 28 weeks
measure: Postpartum hemorrhage (component of primary outcome)
timeFrame: At birth/delivery
measure: Severe maternal morbidity (component of primary outcome)
timeFrame: Enrollment through delivery hospitalization, an average of 28 weeks
measure: Maternal mortality (component of primary outcome)
timeFrame: Enrollment through delivery hospitalization, an average of 28 weeks
measure: Neonatal intensive care unit admission (component of Aim 2 neonatal composite outcome)
timeFrame: At birth/delivery
measure: Low birthweight (component of Aim 2 neonatal composite outcome)
timeFrame: Immediately post-birth
measure: Small-for-gestational-age (SGA) status (component of Aim 2 neonatal composite outcome)
timeFrame: Immediately post-birth
measure: Large-for-gestational-age (LGA) status (component of Aim 2 neonatal composite outcome)
timeFrame: Immediately post-birth
measure: Perinatal death (component of Aim 2 neonatal composite outcome)
timeFrame: 20 weeks of gestational through birth hospitalization
measure: Maternal health care utilization: Antenatal hospital utilization
timeFrame: Enrollment through delivery
measure: Maternal health care utilization: Antenatal care adequacy
timeFrame: Enrollment through delivery
measure: Maternal health care utilization: Postpartum care
timeFrame: Between delivery and 12 weeks after delivery
measure: Maternal health care utilization: Postpartum admission or emergency department use
timeFrame: Between delivery and 9 months postpartum
measure: Neonatal health care utilization: Neonatal length of stay
timeFrame: During birth hospitalization
measure: Neonatal health care utilization: Neonatal hospital utilization
timeFrame: From birth hospital discharge through 9 months
measure: Neonatal health care utilization: Pediatric care attendance
timeFrame: From birth hospital discharge through 9 months
measure: Patient-reported outcome: Global health status
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Health-related quality of life
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Depressive symptoms
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Anxiety symptoms
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Health-related self-efficacy
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Patient activation
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Difficulties in pregnancy
timeFrame: During pregnancy, delivery hospitalization, and 6-12 weeks postpartum
measure: Patient-reported outcome: Stress
timeFrame: During pregnancy, delivery hospitalization, 6-12 weeks postpartum, and 9 months postpartum
measure: Patient-reported outcome: Satisfaction with antenatal care
timeFrame: During pregnancy, delivery hospitalization, and 6-12 weeks postpartum
Other outcomes:
measure: Participant experiences with patient navigation and antenatal care process mapping
timeFrame: Enrollment through delivery hospitalization, an average of 28 weeks
measure: Satisfaction with navigation (interpersonal aspects)
timeFrame: During pregnancy and through 9 months postpartum
measure: Satisfaction with navigation (logistical aspects)
timeFrame: During pregnancy and through 9 months postpartum
measure: Clinician, navigator, and administrator interviews and process mapping
timeFrame: Through completion of study, an average of 5 years
measure: Navigation intensity and activities
timeFrame: Through completion of study, an average of 5 years
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lynn M Yee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: