Trial of Community-based Patient Navigation

Description

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.

Conditions

Pregnancy Related

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Study Overview

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Study Details

Study overview

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.

A Pragmatic Trial of Integrating Community-based Patient Navigation Into the Continuum of Maternal Care for Black Women in a Safety-Net Health System: Effects on Maternal Health, Health Care, Morbidity, and Mortality

Trial of Community-based Patient Navigation

Condition
Pregnancy Related
Intervention / Treatment

-

Contacts and Locations

Atlanta

Grady Memorial Hospital, Atlanta, Georgia, United States, 30303

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Emory University,

Anne L Dunlop, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2027-06