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Trial of Community-based Patient Navigation

RecruitingNAAges 18 Years - anyAllEmory University
NCT05588245 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment. Exclusion Criteria: * 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 * prisoners * cognitively impaired individuals with impaired decision-making capacity * individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)
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What it tests

  • Standard of Care
  • Community-based prenatal/perinatal/postpartum patient navigator
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Where

1 site
Grady Memorial Hospital
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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