Trial of Community-based Patient Navigation

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05588245
Status
Recruiting
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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Standard of Care — BEHAVIORAL
    Participants will undergo the same SDoH screener (AHC-Health Related Social Needs Tool) as full intervention participants, which will serve as the basis for a one-time brief session with the clinical research coordinator that will involve review of a 'Resource Guide' that provides a listing of available community resources to meet common social needs. Participants in this arm will also complete other prenatal and postpartum data collection items over the course of the study (with the exception of qualitative interviews).
  • Community-based prenatal/perinatal/postpartum patient navigator — BEHAVIORAL
    Uses Freeman's principles of navigation to enhance patient access to care (e.g., help patients manage appointments), promote patient self-efficacy (e.g., connect patients to community housing, food, transportation resources), and sustain engagement with the healthcare system (e.g., bridge perinatal and primary care).

Study Details

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.

Key Dates

Start date
Jan 25, 2024
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Comparison Group (Standard of Care)
    Participants will receive the standard of care.
  • Experimental: Intervention Group
    Participants will receive a community-based patient navigator with 3 prenatal contacts and 5 postpartum contacts; during each contact, the community-based patient navigator will offer health assessment and education, along with group education and social support.

Primary Outcome Measure

Change in number of SMM and maternal death events [ Time Frame: Baseline, 12 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Memorial HospitalAtlantaGeorgia30303
Anne L Dunlop, MD

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By research site
Grady Memorial Hospital· Atlanta, GA

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