Trial of Community-based Patient Navigation

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 groups

Locations

1
Grady Memorial Hospital30303, AtlantaGeorgia, United States

Sponsors and collaborators

Emory University

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator