Trial of Community-based Patient Navigation

Pregnancy Related Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pregnancy Related

• NCT number: NCT05588245
• Study type: Interventional
• Source: Emory University
• Contact: Anne L Dunlop, MD
• Phone: 678-480-5285
• Email: amlang@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Completion date: June 2027