Partnering With Antenatal Navigators to Transform Health in Pregnancy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06941974
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Patient Navigation Program — 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.

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Apr 2026
Primary completion
Dec 1, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • No Intervention: Non-navigation Group
    No navigation will be provided; pregnant participants will receive usual care.

Primary Outcome Measure

Maternal adverse outcome composite (Aim 1 primary outcome) [ Time Frame: Enrollment through delivery hospitalization, an average of 28 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Brittney R Williams, MPH
[email protected]
312-503-3476

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By research site
Northwestern Memorial Hospital· Chicago, IL

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