Trial of Community-based Patient Navigation

NCT ID: NCT05588245

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2027-06-30

Brief Summary

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.

Detailed Description

Severe maternal morbidities (SMM) are outcomes of labor and delivery that result in serious effects on short- or long-term health. Many SMM represent "near miss" events for maternal deaths. In Georgia, Black women experience SMM at a rate far higher than women of other races and ethnicities. Equity-centered models of care - such as embedding patient navigators into the maternity care continuum - offer promise for improving maternal health through meeting the social needs, lowering stress, and promoting access to and utilization of care for those giving birth. To date, however, research about maternity care navigation's effectiveness and needed inputs for its adoption into clinical care are lacking. To fill this research gap, the investigators propose to complete a pragmatic randomized controlled trial (RCT) of integrating community-based patient navigators into maternal care of Black women being cared for through Grady Health System (a safety net health system in Atlanta). 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. The first arm (the comparison group) will receive the standard of care. The second arm (the intervention group) 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. For participants in both arms, the researchers will collect data on patient-level measures upon enrollment (<20 weeks' of pregnancy), at 6-8 weeks postpartum, and at 12 months postpartum; data collection will involve questionnaires, review of case logs and review of medical records. Measures of effectiveness will include the number of SMM and maternal death events per woman (primary outcome). To evaluate how the intervention might reduce primary outcomes, questionnaires will also assess measures of unmet need, stress and depressive symptoms, attendance of prenatal and postpartum care. Embedded process evaluation will assess the number and content of navigation encounters in which the woman participates and the acceptability of the intervention from patient and provider perspectives.

Written informed consent will be obtained as a criterion for participation. All participants will be compensated for their time. Confidentiality will be maintained on several levels including training of investigators and staff, restrictions on data access, and use of HIPPA-compliant data storage procedures. Data will be stripped of identifiers before analysis and destroyed when no longer needed.

This study will be among the first to 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Comparison Group (Standard of Care)

Participants will receive the standard of care.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Community-based prenatal/perinatal/postpartum patient navigator

Intervention Type: 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).

Interventions

Standard of Care

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).

Intervention Type: BEHAVIORAL

Community-based prenatal/perinatal/postpartum patient navigator

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

PPP-PN

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Anne Lang Dunlop

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne L Dunlop, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne L Dunlop, MD

Role: CONTACT

amlang@emory.edu

678-480-5285

Facility Contacts

Anne L Dunlop, MD

Role: primary

Other Identifiers

R01NR020756-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004987

Identifier Type: -

Identifier Source: org_study_id