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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard of Care
BehavioralParticipants 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
BehavioralUses 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).
Treatment groups
540 Participants
are divided into 2 treatment groupsGroup A: Comparison Group (Standard of Care)Active comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in number of SMM and maternal death events
This is a count measure that reflects the total number of SMM and/or death events during the delivery admission through 12-months of delivery according to the presence/absence of the 21 SMM indicator diagnosis codes (as published by the Centers for Disease Control and Prevention) and/or a death event documented in the EPIC electronic medical record.
Time frame
Baseline, 12 months postpartumSecondary outcomes
1
Change in number of post-delivery maternal morbidity (non-SMM) events
This is a count measure that reflects the total number of specific non-SMM maternal morbidities according to the presence/absence of ICD-10 diagnostic codes for postpartum hemorrhage without transfusion, hypertensive disorders, endometrial infection, venous thrombosis, depression or anxiety, substance use disorder for an emergency department visit or re-hospitalization event in the EPIC electronic medical record.
Time frame
Baseline, 12 months postpartumSponsors and contacts
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Emory University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov