What this study is
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.
What's being tested
- Patient Navigation Program
Intervention · 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
- Sponsor
- Northwestern University
- Conditions
- Maternal Morbidity · Antenatal Health · Neonatal Morbidity · Retention in Care · Prenatal Care
- Enrolling
- 600 people
- Starts
- 2025-10-06
- Est. completion
- 2030-06-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 16 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Intent to transfer care to an outside institution
- Prior enrollment in PATH
- Concurrent enrollment in a study with competing aims/intervention
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern Memorial Hospital
Chicago, Illinois, United States
- Brittney R Williams, MPH · Contact312-503-3476brittney.williams@northwestern.edu
Recruiting
Study team
Sponsor
Northwestern University
Study ID STU00218597
Principal investigator
Lynn M Yee, MD, MPH
Northwestern University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.