Trial of Community-based Patient Navigation
ConditionPregnancy Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.
Eligibility criteria
Qualifiers
A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),
≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record),
covered by Medicaid
for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs
Disqualifiers
The intent to transfer care to a health system outside of metro Atlanta
incarceration, which would interfere with intervention provision and outcome ascertainment
adults unable to give consent
individuals who are not yet adults
Trial design
Treatments tested in this trial
- Standard of Care
- Community-based prenatal/perinatal/postpartum patient navigator
Treatment groups
540 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov