Partnering With Antenatal Navigators to Transform Health in Pregnancy

NCT ID: NCT06941974

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2029-05-31

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 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.

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 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.

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 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.

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 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.

The 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 (<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 different demographic factors (e.g. age), 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 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.

The 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.

Conditions

Maternal Morbidity; Antenatal Health; Neonatal Morbidity; Retention in Care; Prenatal Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Navigation Group

Pregnant participants who are randomized to receive PATH patient navigation will be assigned to a patient navigator. The patient navigator will meet with the patient in early pregnancy for introductions, education, and assessing factors that influence health and access to care. The patient navigator will offer support and resources (e.g., appointment coordination and scheduling, communication with clinical team, transportation, community referrals, support for mental health, support for other non-medical needs, etc.). The navigator will provide support and continue linkage to resources through 2 weeks postpartum.

Group Type: EXPERIMENTAL

Patient Navigation Program

Intervention Type: BEHAVIORAL

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.

Non-navigation Group

No navigation will be provided; pregnant participants will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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 <125% 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Lynn M Yee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynn M Yee, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lynn M Yee, MD, MPH

Role: CONTACT

lynn.yee@northwestern.edu

312-472-0119

Brittney R Williams, MPH

Role: CONTACT

brittney.williams@northwestern.edu

Facility Contacts

Brittney R Williams, MPH

Role: primary

brittney.williams@northwestern.edu

312-503-3476

Other Identifiers

R01MD020130

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00218597

Identifier Type: -

Identifier Source: org_study_id