Partnering With Antenatal Navigators to Transform Health in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-50
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Patient Navigation Program
BehavioralPATH 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Navigation GroupExperimental treatment 1 intervention
Group B: Non-navigation GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Maternal adverse outcome composite (Aim 1 primary outcome)
Frequency of maternal composite, which includes hypertensive disorders of pregnancy, preterm birth, postpartum hemorrhage, severe maternal morbidity, or maternal mortality. Components of the primary outcome will also be examined as a score and individually as secondary outcomes (see below).
Time frame
Enrollment through delivery hospitalization, an average of 28 weeks2
Neonatal adverse outcome composite (Aim 2 primary outcome)
Frequency of the neonatal composite, which includes neonatal intensive care unit (NICU) admission, low birthweight, small-for-gestational-age (SGA), large-for-gestational-age (LGA) status, and/or perinatal death. Components of the composite outcome will also be examined as a score and individually as secondary outcomes (see below).
Time frame
At birth/deliverySecondary outcomes
1
Hypertensive disorder of pregnancy (component of primary outcome)
Frequency of de novo hypertensive disorder of pregnancy, including gestational hypertension, preeclampsia with or without severe features, superimposed preeclampsia on chronic hypertension, eclampsia, or HELLP syndrome
Time frame
Enrollment through delivery hospitalization, an average of 28 weeks2
Preterm birth (component of primary outcome)
Frequency of birth less than 37 weeks of gestation
Time frame
Enrollment through delivery hospitalization, an average of 28 weeks3
Postpartum hemorrhage (component of primary outcome)
Frequency of estimated/quantitative blood loss \>1000mL (during delivery hospitalization) or blood transfusion
Time frame
At birth/delivery4
Severe maternal morbidity (component of primary outcome)
Frequency of CDC-defined indicators for severe maternal
Time frame
Enrollment through delivery hospitalization, an average of 28 weeksOther outcomes
1
Participant experiences with patient navigation and antenatal care process mapping
Participants randomized to receive navigation will complete in-depth qualitative interviews on their experiences with the navigation program. Interviews will address satisfaction with social and medical care received, engagement with the program, antenatal care experience, relationship with the navigator, experience with PATH navigation, and areas for improvement. Interviews will also include process mapping to understand antenatal care processes and PATH's contributions to their optimization
Time frame
Enrollment through delivery hospitalization, an average of 28 weeks2
Satisfaction with navigation (interpersonal aspects)
Survey - Patient Satisfaction with Interpersonal Relationship with Navigator Scale (among participants receiving navigation)
Time frame
During pregnancy and through 9 months postpartum3
Satisfaction with navigation (logistical aspects)
Survey - Patient Satisfaction with Logistical Aspects with Navigator Scale (among participants receiving navigation)
Time frame
During pregnancy and through 9 months postpartum4
Clinician, navigator, and administrator interviews and process mapping
Clinicians, navigators, and administrators will complete in-depth interviews and process mapping exercises. Interviews will solicit their input whether PATH is successful, preferred patient navigation elements, and how they perceive PATH to affect patient care. Interviews will also include implementation science-guided process mapping exercises to understand how PATH navigation intersects with system-level healthcare, patient-level needs, and organizational processes.
Time frame
Through completion of study, an average of 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov