Partnering With Antenatal Navigators to Transform Health in Pregnancy

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.

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