RECRUITING

Partnering With Antenatal Navigators to Transform Health in Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Partnering With Antenatal Navigators to Transform Health in Pregnancy

Quick Facts

Study Start:2025-08
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06941974

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Singleton gestation \<20 weeks of gestation
  2. * Nulliparous: no prior pregnancies ≥20 weeks excluding terminations
  3. * Low income (public insurance or residence in a neighborhood in which \>10% of household incomes are \<125% of federal poverty line
  4. * Ability to speak and read English or Spanish
  5. * Established patient at one of practices associated with Northwestern Medical Group
  6. * Age 16 years or older
  7. * Intent to transfer care to an outside institution
  8. * Prior enrollment in PATH
  9. * Concurrent enrollment in a study with competing aims/intervention
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lynn M Yee, MD, MPH
CONTACT
312-472-0119
lynn.yee@northwestern.edu
Brittney R Williams, MPH
CONTACT
brittney.williams@northwestern.edu

Principal Investigator

Lynn M Yee, MD, MPH
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Lynn M Yee, MD, MPH, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2030-06

Study Record Updates

Study Start Date2025-08
Study Completion Date2030-06

Terms related to this study

Additional Relevant MeSH Terms

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